On December 11th, the Education Committee of the Health Law Section organized a fabulous session on MassHealth payment and care delivery innovation featuring Robin Callahan, Deputy Medicaid Director in the Executive Office of Health & Human Services. Attendees learned about the new health plan options for MassHealth managed care (MCOs) members available beginning March 1, 2018 including the introduction of Accountable Care Organizations (ACOs) and Community Partners (CPs). With the launch of these initiatives, MassHealth seeks to (i) improve population health and care coordination through payment reform and value-based payment models; (ii) improve integration of physical and behavioral health care; (iii) scale innovative approaches for populations receiving long-term services and supports; and (iv) ensure the financial stability of the MassHealth program. If you were unable to attend, more detailed information on the ACO and CP initiatives may be found in the program presentation materials available here:
Posts Categorized: Uncategorized
by Lynn M. Squillace, Esq., MPH
In the Matter of GP (“GP”) called on the Supreme Judicial Court to consider the limits of GL c. 123 §35 (“§35”), which authorizes involuntary civil commitment in cases of a “likelihood of serious harm as a result of [a] person’s alcoholism or substance abuse, or both.” Involuntary civil commitment involves a serious suspension of liberty; accordingly, a respondent is afforded several legal rights. In this case the SJC considered issues of evidence and procedure, concluding, inter alia, that there is a temporal element to be applied when weighing evidence at a §35 hearing and that clear and convincing evidence is acceptable to demonstrate the statutorily required likelihood of serious harm.
The petitioner, GP, had been involuntarily committed by the District Court pursuant to §35, but was no longer committed at the time the matter was reserved and reported by a single justice, ostensibly rendering her challenge to the commitment order moot. Nonetheless, the Court (noting that issues concerning §35 commitment are likely to evade review given the duration of the commitment) decided the case, as it presented issues concerning §35 as well as the Uniform Trial Court Rules for Civil Commitment Proceedings for Alcohol and Substance Abuse (“uniform rules”) scheduled to go into effect on February 1, 2016.
GP’s mother petitioned the New Bedford District Court to have GP committed pursuant to §35 in May 2015. The petition was heard the following day. The allegations in the petition and in the designated forensic psychologist’s testimony concerned GP’s heroin use, GP’s having pushed her mother, GP’s two failed detox attempts and suicidality, and GP’s minor child having found a needle. The psychologist’s testimony was based on an examination of GP and a conversation with GP’s sister. GP denied being homicidal or suicidal, but did disclose unmedicated depression and anxiety, and hepatitis C.
The psychologist’s testimony concluded with the opinion that GP met the requirements for a §35 commitment because GP was unable to stop using heroin on her own, that GP was “a danger to herself by use of her heroin,” and that if GP’s child was indeed finding syringes those syringes could be contaminated with hepatitis C, thereby putting the child at risk. The District Court judge ordered GP committed after crediting the psychologist’s testimony as fact, noting that GP pushed her mother and concluding that the evidence mitigated in favor of commitment as GP tried but was not able to “dry herself out.” This appeal followed.
The court addressed five reported questions, the first two were evidentiary. First, §35 does not state a standard of proof to be applied at the hearing; the uniform rules require that the judge find by clear and convincing evidence: a) that the respondent is an alcoholic and/or substance abuser; and b) clear and convincing evidence that there is a likelihood of serious harm resulting from the respondent’s alcoholism or substance abuse. GP pointed to the beyond a reasonable doubt standard applied in other types of civil commitment (see e.g. commitment of dangerous persons pursuant to G.L. c. 123 §§7, 8) arguing that the same high standard of proof should apply to §35 proceedings. In concluding that the clear and convincing evidence standard is appropriate for §35 commitments, the court found that a beyond a reasonable doubt standard of proof is not constitutionally required for all civil commitment proceedings, drawing a distinction between §35 commitments that are statutorily limited to ninety days, and commitments for mental illness pursuant to G.L. c. 123 §§7 and 8 that may continue indefinitely.  Second, the Court found that the “flexible nature” of a §35 hearing, where the respondent is entitled to counsel and the petitioner may be a close family member of the respondent without an attorney, does not require strict adherence to the rules of evidence and that hearsay may be permitted if the judge finds such evidence to be substantially reliable.
Turning to the three remaining questions, GP first challenged as illusory the method of appeal delineated by the applicable statute and uniform rules (an initial appeal to the Appellate Division of the court having heard the petition, then, if aggrieved, a right of appeal to the Appeals Court) because the Appeals Court lacks the statutory authority to vacate a commitment order. GP argued that her only avenue of appeal was a petition for extraordinary relief pursuant to G.L. c. 211 §3. The court disagreed finding that the Appeals Court does in fact have the appropriate power and noting that the Appellate Division and Appeals Court appeals of a §35 order may be expedited upon request.
Second, the Court provided important guidance to judges as to how evidence of the respondent’s past behavior should be considered when making a determination (the second statutory definition of “likelihood of serious harm”). In considering the evidence of the respondent’s past conduct, the Court declined to define a specific timeframe required for such evidence, but concluded that evidence of more recent behaviors should be accorded more weight in determining the likelihood that the respondent will inflict serious harm on herself or others in the future. Likewise, the more serious or frequent previous attempts of suicide or self-harm are demonstrated, the more significant such evidence. Here the Court noted that evidence must be carefully reviewed, as although the suspension of liberty caused by a §35 order is time limited, it is substantial and “hardly momentary.” The definition references homicidally and violent behavior, signaling the legislature’s intent that a substantial level of force be presented prior to a §35 commitment on the basis of likelihood of serious harm to another. The Court further noted that the assessment of a substantial risk of him become less reliable as events are forecasted further out into the future. Consequently, the Court clarified that the petitioner must prove a “substantial and imminent risk of serious injury” to the respondent or others in order for the respondent to be committed due to alcohol or substance use. 
Finally, the Court examined the third statutory definition of “likelihood of serious harm,” specifically, what constitutes a “very substantial” risk of harm. It is insufficient to simply demonstrate that the respondent is a chronic substance abuser or alcoholic, but GP argued that the third definition requires a higher level of proof of likelihood of serious harm than do the first two, that the respondent must be proved unable to sustain himself (even marginally). The Court agreed that the third definition (a very substantial risk of harm) requires a higher level of proof than the first two (substantial risk of harm) but declined to adopt GP’s interpretation of the statute. The Court instead found that the evidence under the third definition must address the temporal concerns (discussed above), in addition to the degree of the respondent’s impaired judgement due to alcohol or drug abuse, the likelihood that the respondent will sustain or inflict an injury do to said impairment, and the inability of the respondent’s community to prevent such injury.
Though GP was no longer committed at the time of the Court’s decision the Court did apply its holding to her case, with the intention of providing guidance for future cases and indicated that there was an insufficient basis for the §35 order in GP’s case. The Court recognized GP’s as an unfortunate situation, but not one allowing for the deprivation of liberty associated with a §35 commitment. Practitioners should note the Court’s affirmation of the uniform rules’ clear and convincing evidence standard as well as the preference for more recent evidence of past behavior when applying the second statutory definition of likelihood of serious harm.
 In the Matter of G.P., 473 Mass. 112, 113 (2015). A police officer, physician, spouse, blood relative, guardian or District or Juvenile Court officer may file a petition for an order of commitment of a person believed to be an alcoholic or substance abuser pursuant to §35. Id. at 116 citing GL c. 123 §35, third par. Upon filing of a petition the court must immediately schedule a hearing.
 Id. at 113. Following a public comment period, the Trial Court published a set of uniform rules to govern §35 proceedings. The uniform rules referenced the instant case and noted that the court’s decision may necessitate a revision to the rules. Id. at Note 9.
 Id. at 114.
 Id. at 114-115.
 Id. at 115.
 When GP’s appeal of the commitment order was denied by the Appellate Division of the District Court she filed a petition for relief pursuant to GL c. 211 §3. A single justice reported the case to the full court. Id.
 Id. at 118-120.
 Id. at 121-122.
 Id. at 123-124.
 Id. at 124-125. G.L. c. 123 §1 defines likelihood of serious harm as, 1) “a substantial risk of physical harm to the person himself as manifested by evidence of, threats of, or attempts at, suicide or serious bodily harm; 2) a substantial risk of physical harm to other persons as manifested by evidence of homicidal or other violent behavior or evidence that others are placed in reasonable fear of violent behavior and serious physical harm to them; or 3) a very substantial risk of physical impairment or injury to the person himself as manifested by evidence that such person’s judgment is so affected that he is unable to protect himself in the community and that reasonable provision for his protection is not available in the community.”
 In the Matter of G.P., 473 Mass. at 126.
 Id. at 127.
 Id. at 128.
 Id. at 129.
 Id. at 129-130.
By: Elizabeth McEvoy and Colin Zick
In January 2015, Governor Baker appointed Marylou Sudders as the Commonwealth’s Secretary of the Executive Office of Health & Human Services. As the leader of the largest executive agency in Massachusetts, Secretary Sudders manages 22,000 employees and oversees critical health services affecting almost one in four Massachusetts residents. Prior to her appointment, Secretary Sudders, who is professionally trained as a social worker, has been a public official, provider executive, advocate and college professor and served on the state’s Health Policy Commission. Despite her very busy schedule, Secretary Sudders took the time to discuss her long career advocating for underprivileged individuals in Massachusetts, as well as her career-long efforts to increase access to mental health services.
Over the past fifteen months, Secretary Sudders has joined Governor Baker in leading a bipartisan working group to address the growing opioid epidemic in the Commonwealth. Most recently, those efforts culminated in the passing of landmark legislation to address the opioid and heroin epidemic. That bill was signed into law by Governor Baker on March 14, 2016. Among other things, it establishes a seven-day limit on first-time opioid prescriptions and implements early evaluation and addiction screening for patients.
Secretary Sudders, you’ve had a distinguished career in public service. Can you explain how you first became involved in public service?
I began my career in public service as an intern in the Governor’s Office of Constituent Services during the Dukakis administration. Prior to entering the master’s program for social work at Boston University, I was lucky enough to obtain a work study position in the Office of Constituent Services. This was my introduction to state government. That three-month internship then became the lens through which I would view public service throughout my career.
That was in the 1970s, and it was a different era of politics. Constituents would walk directly into the State House and sit on the sofas outside the Governor’s Office, waiting to voice their concerns. My role in the Office of Constituent Services was to meet our constituents and help work through their concerns. I became completely fascinated by the way individual citizens interacted with the government. I saw first-hand how the government could be both an effective problem-solver, but also the unintended, negative consequences that some government policies caused. But I also observed the countless smart and talented people working in the various branches of the government. Knowing such individuals were involved in these government processes was reassuring to me.
While studying social work, I completed two field placements with the Massachusetts Department of Mental Health, including one at the state’s Metropolitan State Hospital. Before receiving my masters, I spearheaded the creation of the Hospital’s first on-campus residential program designed to help adult patients transition from the hospital setting back into the community. However, I immediately ran into major regulatory challenges and difficulty securing funding in the state budget; these two challenges have been present throughout my career as a public servant.
My interest in social work stemmed from my own experiences dealing with mental illness in my family. I wanted to study social work to better understand the causes and effects of mental illness, and also how to break down the many barriers that make treatment so difficult. I always thought I would work in the clinical setting. At the start of my career, I never envisioned I would be where I am today or that I would be able to have such an effect on public policy.
Throughout your career, you’ve constantly returned to public service from the private sector. What has drawn you back to the world of public service?
In my career, I’ve had four different positions in the private sector. Yet, I always find myself returning to public service. Even while serving as a faculty member at Boston College, I accepted positions serving on government task forces, such as the Speaker’s Task Force for Gun Safety and the Health Policy Commission, to which I was appointed by former Attorney General Martha Coakley. I have always defined myself as a public servant—even while working in the private sector. And I’ve always used my position in the public sector to address behavioral health issues.
You mentioned your experience as a faculty member at Boston College. What challenges did you face in transitioning from direct service positions to academia?
Even though I left my position as a full-time member of the Boston College faculty to serve as Secretary of Health and Human Services, I have continued as a visiting professor at the school. Teaching young people is very rewarding. I have had the extraordinary opportunity to reach students and impress upon them the many benefits of pursuing a career in public service.
Tell us about your tenure with the Health Policy Commission and how the HPC has impacted health care costs in the Commonwealth?
Chapter 224 [of the Acts of 2012] created the HPC. Chapter 224 is a voluminous and complex law, and it will take time to fully implement it. Similarly, the HPC is still in its infancy and remains a work in progress.
The HPC, however, has already had an incredibly important role in shaping health policy in the Commonwealth. In the past few years, it has claimed an identity as a true bully pulpit to raise concerns about health care spending issues in the Commonwealth. Hopefully, the HPC’s attention to spending and other issues will prompt other agencies to take the necessary steps to address these critical issues.
An example of this is HPC’s review of the Partners-South Shore Hospital merger. That is just one illustration of how the HPC can have a direct impact on shaping the cost and quality of health care in the Commonwealth. But I think it would be a good idea to revisit Chapter 224 in a few years and evaluate which aspects have proven successful and which aspects may require revisions. In the meantime, I view the HPC as a good laboratory to identify and examine issues relating to health care as the industry continues to evolve and change. Massachusetts is truly an example to the rest of the country in addressing the dual issues of coverage and costs.
Based on your experience advocating for children and adults with mental illness and serving as the Commissioner of Mental Health, why do you think gaining access to mental health services remains so difficult for so many in the Commonwealth?
Stigma remains a powerful barrier to treatment.
Part of the reason that access to mental health services remains so difficult for so many is that historically, mental health treatment was segregated from the rest of health care. Unlike physical illnesses, there is a lack of consensus among health care professionals as to where individuals with mental illness should be treated. The integration of treatment for individuals with mental health issues is far behind the level of integration that exists for purely physical health-related conditions.
In developing an integrated care model, we should incorporate social work into primary care practices. While the Massachusetts health care model provides a greater number of social work resources for children, it does not provide the same level of support for adults.
You’ve worked closely with Governor Baker to address the opioid crisis in Massachusetts. Why do you think Governor Baker has made alleviating opioid abuse such a priority?
The opioid crisis was a topic near and dear to Massachusetts residents during Governor Baker’s campaign. In each city and town he visited, he heard numerous stories from constituents about the devastating effects that opioids have had on their lives. One of the reasons it has caught the public’s attention is because it has hit all segments of the population very hard.
What barriers that have made treatment of opioid addiction so difficult in the past?
Past efforts to address opioid addiction have been unsuccessful because Massachusetts has historically used jails and the court system to treat these clinical conditions. We cannot use the criminal justice system as a way out of the opioid crisis. The Governor has always viewed opioid addiction as a public health problem, rather than a criminal justice one. Opioids truly are an “epidemic.” We, therefore, need to approach addiction as a disease, and as with any disease, be conscious that relapses can and will happen. Our end goal should be to design a health care system that addresses that reality.
The numbers behind the opioid crisis are staggering. In 2014, Massachusetts prescribers issued 4.6 million opioid prescriptions. That is approximately 240 million opioid pills in circulation. This number becomes all the more troubling when you consider the well-recognized progression from opioid addiction to heroin use.
Can you describe some of the efforts you and the Governor are currently taking to halt the growing crisis?
I am proud to have worked with Governor Baker to shine a spotlight on these important issues by chairing the Governor’s bipartisan Opioid Addiction Working Group, which made 65 tangible recommendations to address the crisis head on.
Implementation of these action items requires fiscal support. This past year’s budget allocated $114 million for substance abuse treatments. The legislature passed a supplemental budget to dedicate another $27 million toward these efforts. We can expect the new fiscal budget to dedicate even more funds to tackling the opioid and heroin crises. There are also ongoing efforts by Boston area medical schools to increase the education concerning the prescribing or use of opioids, making opioid competency a part of the core curriculum medical students must pass.
What do you view as the largest barriers to treating opioid addiction in a way to effect long-term change?
The largest barrier to addressing and moving past opioid addiction is the stigma that society has traditionally attached to this illness, known for chronic relapses. This phenomenon is similar to the stigma associated with mental illness over the years. And the two are not dissimilar. As a trained social worker, I have first-hand experience with addiction and understand how addiction can completely transform the way addicts’ process information and think about the world around them. Many times, all an addict is able to comprehend is where she or he will get the next fix. This kind of preoccupation changes the brain’s function and impacts an addict’s entire life.
There is a need for a long-term strategy, prevention, and most importantly, education. Despite recent efforts to reduce opioid use in the future, the statistics for this past year will show that opioid-related fatalities continue to increase. This is something deeply troubling to me. Transparency is critical to addressing this issue. Massachusetts should continue to collect and circulate data to make the public aware of how severe the crisis has become.
Do you have any advice for young lawyers who are interested in pursuing a path in public service, and in particular, health care policy?
Well, I am surrounded by lawyers who are not practicing in the traditional sense, but who nevertheless bring excellent legal skills to bear. There are several attorneys working in public health-related service positions in the Commonwealth, including the Undersecretary of Health, Alice Moore; my chief of staff, Leslie Darcy; my Director of Legislative Affairs, Rebecca Brink; and the Child Advocate, Maria Z. Mossaides.
It is easy to be critical of the government or public service, but I have encountered smart and dedicated people working in government. Having spent time working both in and out of government has allowed me to better understand the unique challenges, and opportunities, that face government policy makers. A legal education provides lawyers with a structure for approaching these complex problems and is invaluable.
By David Chorney and Maggie Schmid
The Balanced Budget Act of 1997 (the “BBA”) represented the first comprehensive revision to federal status governing Medicaid managed care since the 1980s, and in 2002, regulations were promulgated to implement the standards set forth in the BBA. Since 2002, the Medicaid health care delivery landscape has changed dramatically, but the Centers for Medicare and Medicaid Services (“CMS”) guidance has been minimal.
Recognizing the need for updated guidance, especially after the passage of the Affordable Care Act (“ACA”), CMS released a proposed rule (the “Proposed Rule” or the “Rule”) on May 26, 2015 that aims to modernize the Medicaid program, with a particular focus on revamping the regulatory framework governing Managed Care Organizations (“MCOs”) contracted to provide services to Medicaid beneficiaries. The Rule has multiple aims: to clarify the concept of actuarial soundness by refining the methodology underlying rate setting; to modernize the Medicaid managed care regulatory structure to facilitate and support delivery system reform initiatives to improve health outcomes and the beneficiary experience while managing costs; and to align Medicaid managed care with other sources of coverage (specifically, Medicare Advantage and Exchange plans). The foregoing initiatives support the Proposed Rule’s ultimate goal to bring Medicaid MCO regulations in line with industry standards while at the same time balancing states’ flexibility with increased regulatory oversight and accountability.
This article summarizes certain key MCO-related provisions set forth in the Proposed Rule and points out areas of specific change for Massachusetts. Given the Rule’s expansive scope and preliminary form, however, this summary should not be relied upon as a comprehensive source of information. Additionally, while this article focuses on reforms to Medicaid MCOs, the proposed regulations also incorporate changes to the Children’s Health Insurance Program (“CHIP”) that are not addressed herein.
ALIGNMENT WITH OTHER HEALTH COVERAGE PROGRAMS
The Proposed Rule seeks to align Medicaid MCOs with Qualified Health Plans (“QHPs”) by changing the rules governing MCO marketing, appeals and grievances processes, and Medical Loss Ratios (“MLRs”). A QHP is a private health plan that meets ACA requirements to be sold on a state or federal health insurance exchange. CMS recognizes that with expanded Medicaid coverage, many beneficiaries will swing between qualifying for full Medicaid coverage to being eligible for QHP and/or private coverage. The purpose of this market alignment is to increase Medicaid beneficiaries’ awareness of MCOs and to create a smooth transition for beneficiaries who move from Medicaid insurance products to non-Medicaid health insurance products (and vice versa).
The Proposed Rule provides that CMS will conduct a comprehensive review of Medicaid managed care capitation rates. Shifting away from the old, process-based framework, the new Rule amplifies the old rule’s definition of “actuarially sound” by emphasizing substantive review and assessment of the actuarial assumptions and methodologies underlying the development of the MCO rates. CMS proposes to define actuarially sound capitation rates as rates that are projected to provide for “all reasonable, appropriate, and attainable costs that are required under the terms of the contract” in the context of both the time period and the covered population(s).
In developing the Rule’s formula for actuarial soundness, CMS relied on the following principles: (1) capitation rates should be sufficient and appropriate for the anticipated service utilization of the populations and services covered under the contract and provide appropriate compensation to the health plans for reasonable non-benefit costs; (2) capitation rates should promote program goals, such as quality of care, improved population health, community integration of enrollees, and cost containment; (3) the actuarial rate certification underlying the capitation rates should provide sufficient detail, documentation, and transparency of the rate-setting components; and (4) a transparent and uniformly applied rate review and approval process based on actuarial practices should ensure that both the state and CMS act effectively as fiscal stewards and in the interests of beneficiary access to care.
To help with rate setting, MCOs must submit audited financial statements on an annual basis, conducted in accordance with generally accepted accounting principles. CMS proposes that a minimum MLR for MCOs be calculated, reported, and used in the development of actuarially sound capitation rates. Currently, MassHealth (Massachusetts’s Medicaid program) does not require contracted MCOs to meet any MLR standard, and thus, the Proposed Rule will impact the way Massachusetts develops actuarially sound capitation rates for MCOs.
MEDICAL LOSS RATIOS
As noted above, CMS intends to utilize MLR – the ratio of how much of an individual’s premium is spent on medical expenses versus how much is spent on administrative expenses – to improve the actuarial soundness of MCO contracts. Currently, Medicaid and CHIP are the only two public health benefit coverage programs that do not utilize a MLR; the ACA sets forth a MLR for private health insurance plans and for Medicare Advantage. While Massachusetts has strict MLR requirements for private health plans operating within its borders, the Commonwealth does not presently impose a MLR requirement upon Medicaid MCOs.
The Proposed Rule requires MCOs to use projected revenue and costs for a given Rate Year to achieve a minimum MLR of 85%. States that currently have higher minimum MLR standards will be able to keep their MLR requirements, states with minimum MLRs below 85% will need to increase their requirements. Federally, commercial Medicare Advantage plans must meet an MLR of 85%. Given this, it is likely that Massachusetts will set its MLR at 85% or 90%. As of 2013, all Massachusetts MCOs would be able to meet an MLR of 85%.
By requiring the MLR to be included in a MCO’s rate setting process, CMS aims to ensure that Medicaid program dollars spent by MCOs are spent on health care services, covered benefits, and quality improvement efforts rather than administrative expenses. In addition to factoring projected MLR into current rates, CMS is requiring states to take into account real MLR from previous years when determining future rates. Meaning, if a MCO has not met the MLR standard of 85% in previous years, the state would take that into account in determining future capitation rates.
MLR is calculated by taking the sum of a MCO’s incurred claims, expenditures on activities that improve health care quality, and required compliance activities divided by the adjusted premium revenue collected. In the most basic sense, the MLR may be thought of as a simple fraction, with the numerator being incurred claims plus regulatory qualified expenditures over, divided by, the denominator, adjusted premium revenue collected. As noted below, premium revenues (the denominator), can only be adjusted when specifically authorized through regulation. The goal of MLRs is to incentivize the MCO to use premium revenue for the payment of health care services received by its members instead of using such revenue for administrative or other less member-centric initiatives. As such, to meet the MLR threshold, a MCO will pay as many claims as possible to increase the numerator and, in addition, take advantage of any express regulatory rules that allow the MCO to decrease its denominator (i.e., premium revenue). The proposed rules on calculating MLR are generally the same as the rules for calculating Medicare Advantage plans.
Under the Proposed Rule, states are not required, but are urged, to require rebates from an MCO if the MCO falls below the MLR standard for any reporting period. If a state chooses not to require rebates, the MCO will still need to rebate the federal government their share. Massachusetts currently requires health plans that do not meet applicable MLR standards to submit rebates. As such, it is highly likely this requirement will be extended to Massachusetts MCOs.
Under the Proposed Rule, MLR reporting is to start with state MCO contracts beginning on or after January 1, 2017. States have the discretion to align MLR reporting deadlines with either the calendar year or the MCO contracting year. No matter which reporting year a state chooses, it must be for a period of no more than 12 months. CMS realizes there are a lot of unknowns for new plans and as such, there is no reporting requirement for the first year in which the MCO contracts with the state. All MLRs will need to be recalculated and reported in any state that makes a retroactive change to capitation rates that changes the MLR calculation for a given reporting year.
STANDARD CONTRACT TERMS/NEW CONTRACT TERMS
MassHealth MCOs enter into robust contracts with Massachusetts’s Executive Office of Health and Human Services to provide services to the Commonwealth’s Medicaid beneficiaries. The Proposed Rule attempts to standardize certain MCO contract provisions by organizing the contract structure into five subsections: (1) standard contract terms, (2) actuarial soundness, (3) rate development standards, (4) special contract provisions related to payment, and (5) rate certification submission.
CMS hopes that these strengthened terms will increase access and quality of health services and better delineate the administrative duties to be carried out by carriers on behalf of the state. For example, the standard contract terms set forth specific performance standards that states must include in their managed care contracts. In addition, sexual orientation is added as a protected class for the purposes of MCO enrollment (i.e., a MCO cannot discriminate enrollment based on an enrollee’s sexual orientation). While Massachusetts already includes sexual orientation as a protected class, MCO contracts with the Commonwealth may need to be updated to incorporate these new standards once the final rules are published and effective.
A. Contract standards for prescription drugs
The Proposed Rule requires all state contracts with MCOs to include coverage of those covered outpatient drugs required under federal Medicaid requirements. This includes the amount, duration and scope of coverage, coverage limits, utilization management, and prior authorization. The Proposed Rule also requires MCOs to report utilization data, so states can apply for rebates from drug manufacturers. To report utilization data, a MCO must conduct a drug utilization review to ensure prescriptions (1) are appropriate, (2) medically necessary, and (3) not likely to result in adverse medical results. CMS recommends states’ drug utilization review boards (in the Commonwealth, the MassHealth Drug Utilization Review Board) coordinate with MCOs to conduct review activities on an annual basis. Finally, the Proposed Rule requires that MCOs respond to a dispensation request for a covered outpatient drug within 24 hours and provide a 72 hour supply of a covered outpatient drug in an emergency situation.
B. Increased access for dually eligible populations
For MCOs covering a dually eligible population, the Proposed Rule requires MCOs to sign a “Coordination of Benefits Agreement” and to participate in Medicare’s automated crossover process. Given the complex reimbursement and regulatory scheme surrounding dually eligible beneficiaries, the new standard terms aim to encourage MCOs to serve dually eligible beneficiaries. At this time, the Commonwealth does not allow Medicare beneficiaries to be eligible to participate in MassHealth’s MCO program. Rather, dual eligible beneficiaries residing in Massachusetts participate in the Commonwealth’s OneCare program (a managed care program structured specifically for dual eligible beneficiaries).
C. Substance abuse and mental health payments – An exception to CMS’ IMD Exclusion
Currently, Federal Medicaid rules do not allow for Federal Financial Participation (“FFP”) for services provided to adult (21 to 64 years of age) residents of institutions for mental diseases (“IMDs”). An IMD is an inpatient facility with 16 or more beds where more than 51% of its current patients are individuals with severe mental illness or substance abuse issues. CMS’s outdated policy related to payment for IMD stays has exacerbated access and coverage issues for Medicaid beneficiaries seeking short-stay inpatient mental health or substance abuse services. Under the Proposed Rule, states are authorized to include short-term IMD stays in capitation payments. Short-term stays must be limited to 15 days in a given month; however, a stay can be extended by combining two short-term stays over two consecutive months, resulting in a 30 day stay. To qualify for this exception, “the facility [must be] a hospital providing psychiatric or substance use disorder (“SUD”) inpatient care or subacute facility providing psychiatric or SUD crisis residential services and the stay in the IMD is less than 15 days in that month.”
The Proposed Rule also provides updated guidance on the use of substitute providers, or CMS’s “in lieu of” policy. This change in policy recognizes MCO’s history of having the flexibility to provide care in alternative settings. Under the “in lieu of” policy, a MCO could consider a short-term inpatient stay at an IMD as “in lieu of services” covered under a state plan. However, a MCO cannot require an enrollee to use such “in lieu of” services. CMS describes the “in lieu of” policy as limited, in that “the use of IMD settings in lieu of covered settings for this care is sufficiently limited so as to not contravene the Medicaid coverage exclusion … Our proposal recognizes that managed care plans have flexibility in ensuring access and availability of covered services while ensuring that use of an appropriate alternate setting does not endanger beneficiaries’ overall access to Medicaid benefits for the entire month during which a brief stay occurs.” While the Proposed Rule provides an option for MCOs and states to work around traditional coverage limitations, many states have not taken advantage of similar opportunities under the ACA.
Currently, MassHealth members enrolled in the Primary Care Clinician plan receive behavioral health services through a behavioral health contractor, and MassHealth-contracted MCOs coordinate for the provision of covered behavioral health services to their enrollees. By relaxing it’s policy related to IMD stays, CMS is giving MassHealth another tool to use to ensure that MassHealth members’ behavioral health needs are met.
While the Proposed Rule still bars certain marketing practices like pressured sales or misrepresentations, the Rule now allows carriers to advertise their full range of products to consumers. Meaning, a carrier can advertise its QHP to Medicaid beneficiaries even where the carrier is the entity providing those beneficiaries with a Medicaid managed care plan. So long as the QHP is not sold “in conjunction with” or as a “tie-in” to the Medicaid managed care plan, direct advertising to a beneficiary regarding a QHP offered by their MCO carrier is not prohibited. This Proposed Rule by CMS clarifies previous rules and aims to make the transition between Medicaid and QHPs that many Americans may experience easier. As noted by CMS, “consumers may experience periodic transition between Medicaid and QHP eligibility, and families may have members who are divided between Medicaid and QHP coverage, selecting a carrier that offers both types of products may be the most effective way for some consumers to manage their health care.”
PROTECTIONS FOR BENEFICIARIES
CMS proposes several new requirements related to Medicaid beneficiary enrollment in Medicaid managed care plans. Under the Proposed Rule states still have flexibility to enroll Medicaid beneficiaries through either mandatory or voluntary processes; however, CMS states that “[i]n both voluntary and mandatory managed care programs, we believe that beneficiaries are best served when they affirmatively exercise their right to make a choice of delivery system or plan enrollment.” Regardless of the enrollment mode, the Proposed Rule requires states to provide beneficiaries with informational notices, followed by a 14 day choice period accompanied by interim fee-for-service coverage, if necessary. Massachusetts currently provides a 14 day window in which eligible MassHealth beneficiaries may select their MCO of choice, so this particular provision of the Rule will not impact Medicaid participants in the Commonwealth.
The Proposed Rule also clarifies CMS’s position on its 90 day “without cause” enrollee requested disenrollment period. Formerly, the Agency’s regulations were interpreted to allow enrollees to disenroll from a MCO during the first 90 days of the beneficiary’s enrollment in the plan and reenroll in another MCO until the beneficiary had exhausted all contracted MCO options for which he or she was eligible. Having concluded that such an approach is disruptive to the goals of establishing enrollee-provider relationships that support a coordinated delivery system and dissatisfied with an inconsistent application of this rule, CMS now proposes to limit the 90 day disenrollment period to the first 90 days of an enrollee’s initial enrollment into any MCO. Thus, under the new Rule, an enrollee is only permitted one 90 day “without cause” disenrollment per enrollment period. In terms of notice required for disenrollment, the Proposed Rule clarifies that states have the flexibility to accept disenrollment requests either orally, in written form, or both if the state so desires.
Massachusetts MassHealth MCO beneficiaries have heretofore enjoyed the flexibility of being able to transfer to or from an available managed care provider at any time without cause, so MassHealth MCO beneficiaries will certainly feel the impact of this change. However, for a MassHealth MCO to disenroll a beneficiary from a MCO, the MCO must demonstrate to MassHealth that the MCO has made reasonable efforts to provide medically necessary services to the member and, “despite such efforts, the continued enrollment of the member with the MCO seriously impairs the MCO’s ability to furnish services to either this particular member or other members.”
Grievances & Appeals
The Proposed Rule aligns MCO grievance and appeals procedures to make them more compatible across markets. These changes include providing any reasonable assistance, upon request of a beneficiary, in completing forms and other procedural steps required by a MCO’s grievance process. In addition, individuals reviewing appeals and grievances are required to take into account all comments, documents, records, and other information submitted, even if such information was not considered in the initial review. Under the Proposed Rule, beneficiaries would also have a right to the case file including the medical record.
However, the most significant changes regarding grievances and appeals are contained in provisions regarding time frames, notice standards, and the process for receiving a State Fair Hearing (“SFH”). The Proposed Rule shortens the timeframe for which a MCO can take to make a decision on an internal grievance or appeal from 45 to 30 days. This change will impact Massachusetts MCOs directly as such entities are currently given 45 days to resolve standard internal appeals. In addition, the Proposed Rule requires that expedited appeals be determined within 72 hours of receipt. MCOs are required to allow an external review request within 60 days, while some states require far shorter times. Of note, and depending on the circumstances, Massachusetts allows either 120 days or 30 days from receiving a final adverse determination.
Before a beneficiary can request a SFH, they must exhaust the MCO’s internal appeals process. However, throughout the appeals process and any SFH, the beneficiary will continue to be covered. This portion of the Proposed Rule tracks with Massachusetts requirements as Medicaid beneficiaries in Massachusetts are covered throughout the appeals process.
B. Coverage & Authorization of Services & Continuation of Benefits While Appeal is Pending
Under the Proposed Rule, Medicaid managed care plans are estopped from denying coverage for services pending determination of beneficiary appeals. CMS acknowledged that the current standards reflect an “acute care model of health care delivery and do not speak to the appropriate medical management of individuals with ongoing or chronic conditions, or the authorization of non-clinical services that maximize opportunities for individuals to have access to the benefits of community living and the opportunity to receive services in the most integrated setting.” The Proposed Rule emphasizes continuity of care and seeks to put those beneficiaries that have ongoing chronic conditions on equal footing with other beneficiaries who might utilize services on a discrete basis. Subsequent to an adverse benefit determination, states may decide to allow recoupment from an enrollee so long as the same standard is applied between Medicaid FFS and managed Medicaid. Currently, Massachusetts requires the continuation of coverage when an appealable action involves the reduction, suspension, termination, or restriction of assistance.
C. Continued Services to Beneficiaries
In 2002, when the current regulations were finalized, the use of managed care to provide medical services to complex populations was not as prevalent and, thus, not substantially reflected in the regulations. The Proposed Rule requires states to have a transition of care policy for individuals switching from one delivery system to another within Medicaid. Such transition of care policies must include, among other things, receipt of services for a period of time and assurance that medical records are transitioned. As of the effective date of Medicaid expansion in Massachusetts, MCOs have been required to provide care transition plans for their MassHealth enrollees.
D. Beneficiary Support System
CMS proposes to require states to develop and implement a beneficiary support system to provide support before and after beneficiary enrollment. The system must include: (1) choice counseling for all beneficiaries; (2) training for MCOs and provider networks on community-based resources and supports that can be linked with covered benefits; (3) assistance for enrollees in understanding managed care; and (4) assistance for enrollees who utilize long-term services and supports. The foregoing beneficiary supports must be available through multiple mediums, including telephone, internet, in-person, and via auxiliary aides.
E. Managed Long-Term Services & Supports
Managed long-term services and supports (“MLTSS”) refers to an arrangement between state Medicaid programs and MCOs through which the MCO receives a capitated payment for providing long-term services and supports (“LTSS”). The Proposed Rule codifies CMS’s previous guidance governing managed LTSS waivers and demonstration programs (including program planning, stakeholder engagement, enhanced home and community-based services, payment alignment, beneficiary support and protections, qualified providers, and quality) and applies them across all MLTSS programs. As part of these new requirements, states will be required to establish network adequacy standards for MLTSS programs, including time and distance standards and network provider accommodations for disabled beneficiaries, and must submit documentation demonstrating compliance with the rule.
MODERNIZATION OF REGULATORY STANDARDS
A. Availability of Services
Availability of services and network adequacy are given much consideration in the Proposed Rule and the Agency sets forth an extensive regulatory framework designed to align with other insurance markets (e.g., the market for health plans sold on state Exchanges). CMS proposes that time and distance standards be required for the following network provider types: primary care (adult and pediatric), OB/GYN, behavior health, specialist (adult and pediatric), hospital, pharmacy, pediatric dental, and additional provider types when it promotes the objectives of the Medicaid program. Massachusetts assigns members to MCOs based on the provider’s service type, member’s geographic service area, the physical accessibility of the provider’s building to the member, provider’s suitability to member based on member’s age and sex, availability of necessary interpretation services, and availability of any necessary transportation services.
In addition to the foregoing, the Proposed Rule outlines factors that states must consider in setting their standards, including anticipated enrollment, expected service utilization, population health needs, the number and types of providers needed to deliver contractual services, the number of network providers not accepting new patients, and geographic accessibility of providers to enrollees.
B. State Monitoring Standards
The Proposed Rule mandates that a state’s monitoring system address, at a minimum, specific aspects of a managed care program such as administration and management, appeal and grievance systems, claims management, enrollee materials and customer services, finance, information systems, marketing, medical management, program integrity, provider network management, quality improvement, and the delivery of LTSS. Contracted MCOs will also be subject to states’ readiness reviews at various program points, including prior to the start of a new managed care program, when a new contractor enters an existing program, or when the state adds new benefits, populations, or geographic areas to the scope of its contracted managed care plans.
C. Quality of Care
Approaches to assessing quality, access, and timeliness of care have evolved significantly since 2002, and the Proposed Rule reflects this evolution by expanding quality improvement efforts, aligning with Medicare and State Exchange standards, and increasing consumer and stakeholder engagement. The proposed changes focus on standards for performance measures and topics for performance improvement projects, performance review and approval process, the development of a quality rating system, the expansion of a comprehensive quality strategy, and revisions to the external quality review system.
CMS proposes the development of an expanded quality rating system for all states contracting with MCOs. States would be required to set minimum standards to be used in developing and implementing a Medicaid managed care quality rating system. The components of the rating system will be based on the same summary indicators that are currently used for QHPs: clinical quality management, member experience, plan efficiency, affordability, and management. For states that have an existing quality rating system, the Proposed Rule offers the option to retain or modify the existing system with CMS approval.
The Agency’s Proposed Rule also contemplates a comprehensive quality improvement strategy extending to all state Medicaid programs. The strategy would apply as a general state plan administration requirement, separate and apart from states’ managed care programs. According to health policy expert Sara Rosenbaum, “[t]his requirement represents an outgrowth of earlier guidance on Quality Considerations in Medicaid and CHIP, which ‘explains how to incorporate a state’s managed care quality strategy into a larger, statewide comprehensive Medicaid quality strategy.” To ensure that states’ quality improvement strategies are up-to-date and relevant to the Medicaid population, the Proposed Rule sets forth a detailed outline for the development, evaluation, and revision of such quality improvement strategies.
In addition to updating and clarifying the Agency’s pre-existing external quality review regulations, CMS makes clear that states are expected to have a monitoring system for its MCOs to address a broad range of issues including, but not limited to, administration and management, appeal and grievance systems, claims management, enrollee materials and customer services, finance and medical loss ratios, information systems and encounter reporting, marketing, medical management and utilization management, program integrity and provider network management, quality improvement, and LTSS delivery. States will also be required to submit an annual program assessment to the Agency to help improve the Agency’s oversight efforts.
THIRD PARTY LIABILITY
Finally, the Proposed Rule updates the Agency’s requirements related to third-party liability. State Medicaid programs are required to identify and seek payment from liable third parties before billing Medicaid. CMS proposes to eliminate all references to a specific coding system (e.g., ICD-9, ICD-10) and replace such references with a general description of the types of trauma-related diagnoses that states are expected to review with the objective of ascertaining third-party liability. The Agency’s revisions to this portion of the regulation will not require Massachusetts to change its process for identifying third party liability. Rather, the alterations set forth in the Proposed Rule will provide MassHealth with greater discretionary authority in developing trauma code edits to best identify liable third parties and achieve the highest third party liability return.
Margaret Schmid is an Assistant General Counsel with the Massachusetts Executive Office of Health and Human Services (EOHHS). Before joining EOHHS, Ms. Schmid was an associate at Donoghue Barrett & Singal (DBS) in the firm’s health care practice group. In that role, Ms. Schmid advised both institutional and individual providers on corporate and regulatory matters. Prior to working for DBS, Ms. Schmid was a legal intern at EOHHS. She also worked for the U.S. Department of Health and Human Services, Office of the General Counsel, Public Health Division during her third year of law school. Ms. Schmid received her law degree from The Catholic University, Columbus School of Law (‘11), where she was a Note and Comment Editor on the Journal of Contemporary Health Law and Policy. She received her undergraduate degree from Kenyon College (‘06). This article was prepared Ms. Schmid in her personal capacity. The opinions expressed herein are the author’s own and do not reflect the view of EOHHS.
David Chorney, Esq. (email@example.com) is an associate with Donoghue, Barrett & Singal and a member of the firm’s corporate health care practice where he advises a variety of providers and health care entities, including hospitals, physicians groups, MCOs, clinics, and non-profits, on insurance laws and regulations, fraud and abuse, transaction matters, and other health care related issues. A graduate of Suffolk University Law School (’15), his practice can be found at http://dbslawfirm.com/people/david-chorney
|Proposed Law||Possible Effect|
|Third party liability||No substantive changes to Massachusetts’ process of identifying third party liability. However the proposed rules will allow MassHealth to have greater discretionary authority in developing trauma code edits to better identify third parties to achieve a better third party liability return.|
|Availability of services||Currently MassHealth uses the following criteria to assign members to a MCO provider only where the provider, (1) is available for the member’s coverage type; (2) in the member’s service area; (3) physically accessible to the member, if member is disabled; (4) suitable for the member’s age and sex; (5) able to communicate with the member directly or through an interpreter, unless there is no other medical care available; and (6) located in an area to which the member has available transportation.
The proposed rules would require MassHealth to also consider the following: (1) anticipated enrollment; (2) expected service utilization; (3) population health needs; (4) the number and types of providers needed to deliver contractual services; (5) the number of network providers not accepting new patients; (6) and geographic accessibility of providers to enrollees.
|Medical Loss Ratios||Massachusetts does not currently require Medicaid MCOs to have a MLR. However, as of 2013 data, 100% of MCOs would be able to meet a MLR of 85%.
It is likely that Massachusetts will require MCOs to provide MassHealth and the federal government with rebates if the MCO does not meet the established MLR standard. Massachusetts currently requires commercial insurance plans to provide rebates to consumers.
|Contract standards for prescription drugs||This proposed standard is unlikely to substantively change MCO contracts in Massachusetts. Currently, the MassHealth Drug Utilization Review Board and Program requires that prescriptions be appropriate, medically necessary, and unlikely to result in adverse medication-related problems.
Like the Proposed Rules, Massachusetts requires a MCO to respond to a dispensation request within 24 hours for covered outpatient drugs and to provide a 72 hour supply for covered outpatient drugs in emergency situations.
|Dual Eligible||The Proposed Rules are likely to create substantial changes in Massachusetts because, currently, Medicare beneficiaries are not eligible to participate in MassHealth’s MCO program.|
|IMD Exception||This Proposed Rule should increase the availability of mental health and substance abuse services for those MassHealth MCO members. The proposed IMD exception would allow MassHealth MCOs to cover up to 15 days, per month, as an inpatient at an IMD.|
|Enrollment and Disenrollment Protections||CMS proposes to limit the time period in which an enrollee can request disenrollment to the first 90 days of an enrollee’s initial enrollment into any MCO. Therefore under the Proposed Rule, an enrollee is only permitted one 90 day “without cause” disenrollment per enrollment period. In terms of notice required for disenrollment, the Proposed Rule clarifies that states have the flexibility to accept disenrollment requests either orally, in written form, or both if the state so desires.
Massachusetts MassHealth MCO beneficiaries have enjoyed the flexibility of being able to transfer to or from an available managed care provider at any time without cause, so MassHealth MCO beneficiaries will certainly feel the impact of this change.
|Grievances and Appeals||While appeal rights of MCO members will not undergo significant changes, the timing of filing and hearing such appeals will. The Proposed Rules shorten the amount of time a MCO has to make a decision on an internal appeal from 45 days to 30 days. Additionally, in certain circumstances, MassHealth MCO members will have more time to request an external review of a grievance. Depending on the circumstances of the determination, MassHealth currently allows an external review request to be made within 30 to 120 days of a final adverse determination.|
|Continuation of coverage during appeals and care transitions||The Proposed Rules will mean few changes for Massachusetts. Currently Massachusetts allows for the continuation of coverage for beneficiaries when an appealable action involves the reduction, suspension, termination, or restriction of assistance. MassHealth also, as required by the Proposed Rules, has a care transition plan which allows beneficiaries, depending on the acuteness of their condition, to switch from one delivery system to another within the Commonwealth’s Medicaid program.|
 In 1992, 2.4 million Medicaid beneficiaries (or 8% of all Medicaid beneficiaries) accessed part or all of their Medicaid benefits through capitated health plans; by 1998, that number had increased fivefold to 12.6 million (or 41% of all Medicaid beneficiaries). In fiscal year 2011, at least 39 million people (or 58% of all Medicaid beneficiaries) in 39 states and the District of Columbia accessed part or all of their Medicaid benefits through such capitated health plans. Medicaid and CHIP Payment and Access Commission, Report to Congress on Medicaid and CHIP (June 2014), tables 11 and 14 at pgs. 106 and 120. In addition, since 2002, Congress has passed the Medicare Improvement for Patients and Providers Act (“MIPPA”)(Pub. L. 110-275); the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)(sections 511 and 512 of the Tax Extenders and Alternative Minimum Tax Relief Act of 2008); the Children’s Health Insurance Program Reauthorization Act (“CHIPRA”)(Pub. L. 111-3); and the Affordable Care Act (“ACA”)(Pub. L. 111-148).
 At the time of publication, the comment period for the Proposed Rule has closed but the final rule has not been published.
 80 Fed. Reg. 31102
 80 Fed. Reg. 31107
 80 Fed. Reg. 31119
 80 Fed. Reg. 31257.
 80 Fed. Reg. 31119.
 80 Fed. Reg. 31256
 80 Fed. Reg. 31107
 For non-Medicaid plans, Massachusetts requires an MLR of either 85% or 90% depending on the market in which the health plan is offered.
 Center for Health Information and Analysis, Annual Report Series 2015: Performance of Massachusetts health Care System, Massachusetts Medical Loss Ratios, Publication No.: 15-316-CHIA-01 available at http://www.chiamass.gov/assets/docs/r/pubs/15/MLR-Brief-2015.pdf
 80 Fed. Reg. 31107
 For instance, most MCO programs, including Massachusetts, require MCOs that have taken on less risk (i.e., have healthier enrollees), to make risk payments to the state. These payments are in turn distributed to those MCOs that have taken on more risk. Amounts paid by a state to a MCO with a riskier (i.e., sicker) member population must be subtracted from incurred claims. Additionally, if the state operates a Medicaid specific solvency or trust fund and requires the MCO to pay into those funds, such payments will be added to incurred claims. Payments made to conduct anti-fraud activities can be added to the numerator of the MLR calculation; however this amount is capped at .5% of the MCO’s total premium revenues. If a MCO intends to add the salary paid to an employee conducting anti-fraud activities, such employee must be essential to and directly carry out the anti-fraud activity. Similar to private plan rules, taxes, licensing and regulatory fees are subtracted from premium revenues, the denominator. However, fines and penalties are not deducted from premium revenues and must be considered non-claims costs.
 80 Fed. Reg. 31111
 80 Fed. Reg. 31112-13
 80 Fed. Reg. 31113
 80 Fed. Reg. 31257
 80 Fed. Reg. 31116; Massachusetts already complies with this requirement. See 130 CMR 410.466.
 80 Fed. Reg. 31157
 130 CMR 508.004.
 80 Fed. Reg. 31116
 80 FR 31116.
 See Alexandra Gates, el al., Coverage of Preventative Services for Adults in Medicaid, Kaiser Family Foundation, (Nov. 13, 2014)(noting that only 8 states have taken advantage of the ACAs 1% Medicaid match rate increase for preventive services provided with no cost sharing).
 80 Fed. Reg. 31107
 80 FR 31102
 80 Fed. Reg. 31133
 80 Fed. Reg. 31135
 80 Fed. Reg. 31133
 130 C.M.R. 508.002(E).
 130 C.M.R. 508.002(G)
 80 Fed. Reg. 31102
 130 C.M.R. 508.009
 130 CMR 610.015 Which allows 30 days to appeal after an applicant or member receives written notice from MassHealth. The regulation also allows 120 days where MassHealth fails to act on the application, request for appeal, to send timely notice, and in instances where the member failed to file for appeal because they reasonably believed the problem was being resolved and the appeal was made in good faith.
 80 Fed. Reg. 31137
 80 Fed. Reg. 31138
 130 CMR 610.036.
 80 Fed. Reg. 31139
 80 Fed. Reg. 31139 “[r]equire that states have a transition of care policy in place for individuals moving to managed care from FFS, or from one MCO, PIHP, PAHP, PCCM …” Id.
 Executive Office of Health and Human Services, Important Information about MassHealth Coverage Changes Effective January 1, (Jan. 2014) available at http://www.mass.gov/eohhs/docs/masshealth/aca/provider-update-on-aca-coverage-changes.pdf
 80 Fed. Reg. 31142
 80 Fed. Reg. 31141
 80 Fed. Reg. 31144
 80 Fed. Reg. 31147
 130 CMR 508.002
 80 Fed. Reg. 31159
 80 Fed. Reg. 31148
 S. Rosenbaum (citing 80 Fed. Reg. 31153)
By Elta Mariani
In Amarin Pharma, Inc. v. FDA (“Amarin”), the United States District Court for the Southern District of New York (the “Court”) ruled that truthful, non-misleading promotion of a drug approved by the U.S. Food and Drug Administration (“FDA”) for non-FDA approved (“off-label”) use is protected under the First Amendment of the Constitution. As long as this speech remains truthful and non-misleading, it cannot be “chilled” with threats including that of a misbranding action under the Federal Food, Drug and Cosmetic Act (“FDCA”). The Court reached this decision by interpreting predecessor case United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) broadly and engaged in re-writing of Amarin Pharma, Inc. (“Amarin”) proposed statements to ensure they were truthful and non-misleading. While Amarin’s request for preliminary relief from criminal action under the FDCA was granted, its claim for preliminary relief from civil action under the False Claims Act was deemed not yet ripe.
This case was brought by biopharmaceutical company Amarin Pharma, Inc. (“Amarin”) and multiple physicians for preliminary relief on First Amendment, and alternatively due process, grounds. Amarin’s drug Vascepa is FDA-approved for the treatment of patients with very high blood triglyceride levels (“severe hypertriglyceridemia”). Comprised of the omega-3 fatty acid “pure eicosapentaenoic acid,” Vasepa is considered safe for use by such patients. The issue in this case arose when Amarin sought to make truthful statements to doctors regarding an off-label use of Vascepa, but feared FDA prosecution on FDCA misbranding charges.
FDA regulation of pharmaceuticals dates back to 1938, when Congress first enacted the FDCA. In 1962, Congress amended the FDCA to required manufacturers to demonstrate that their products are safe and effective for their intended use prior to distribution, and gave approval power to the FDA (which established pre-clinical and clinical trial requirements towards this end). On its face, the FDCA prohibits misbranding (punishable by fines and imprisonment), not off-label promotion of drugs, but the FDA has interpreted the FDCA prohibition on misbranding to include off-label promotion. Recent FDA actions show an increased interest in bringing mislabeling charges under this interpretation of the FDCA, and the result has been large settlements (e.g., the 2012 GlaxoSmithKline guilty plea in the District of Massachusetts involving a $1 billion fine).
Amarin was the culmination of Amarin’s efforts to approve and market Vascepa for an additional, off-label use for patients on statin therapy with high (as opposed to very high) triglyceride blood levels. On July 6, 2009, it entered into a written, special protocol assessment (“SPA”) agreement with the FDA. Such an agreement guarantees FDA approval if certain size and design parameters are met. In this study, Vascepa also had to sufficiently reduce triglyceride levels for patients with high triglyceride blood levels on statin therapy. The resulting ANCHOR study met these parameters and benchmarks for effectiveness.
SPA guidance indicates that the FDA will only break an SPA agreement if “a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after testing has begun.” The FDA claimed this condition was met and rescinded the SPA agreement for this secondary use of Vascepa, pointing to various other studies with different drugs that indicated an unclear link between lowering triglyceride levels and reduced cardiovascular risk.
After appealing the decision through three FDA review levels and receiving guidance from the FDA indicating that it would pursue mislabeling charges if Amarin tried to promote the off-label use tested in the ANCHOR study, Amarin filed an action for relief on May 7, 2015. The two main ways Amarin desired to promote the off-label use were 1) distribution of ANCHOR results, and 2) additional reports supporting the correlation between lowering triglyceride levels and reduced cardiovascular risk. After much back-and-forth, the two sides were unable agree on language satisfactory to both.
The Court analyzed the communications between the parties and determined that Amarin met the requirements for preliminary relief because 1) it is likely to succeed on the merits, 2) it is likely to suffer irreparable harm absent preliminary relief, 3) the balance of equities tips in its favor, and 4) preliminary relief is in the public interest. First, reading predecessor case Caronia broadly and beyond its specific facts, the Court deemed Amarin likely to succeed on the merits because its statements are truthful and non-misleading promotion of off-label use. Any language the Court believed not truthful or misleading, it redrafted. The Court next determined that the FDA’s misbranding action threat was enough of a specific present objective harm or threat to establish a claim for irreparable harm. The Court addressed the last two elements together, and determined that the public interest favored granting Amarin relief because of the importance of preserving First Amendment rights. The FDA’s concerns that relief would undermine the drug approval process and endanger the public health were dismissed as having no basis.
In Amarin, the FDA offered three counterarguments that were all rejected by the Court in turn. The first FDA argument, that protecting truthful speech to promote off-label drug use was an attack on Congress’s new drug approval framework, was dismissed as contrary to contemporary First Amendment interpretation. The second FDA contention, that only certain types of truthful and non-misleading manufacturer statements about off-label use deserved protection, was met with the observation that Caronia did not limit its holding to certain types of speech. Finally, the third FDA argument, that Caronia did not preclude it from using statements as evidence to prove intent or motive in a criminal misbranding action, was deemed irrelevant in this situation, where the act itself is legal and the speech is true.
In response to the FDA’s concerns, the Court noted three limitations on commercial speech promoting off-label drug use. False or misleading speech is not protected, false or misleading conduct is not protected, and finally, the subjective nature of “false or misleading” plus the developing nature of science and medicine will likely guarantee pharmaceutical consultation with the FDA regarding statements promoting off-label use. The Court also determined that going forward, Amarin carries the burden of ensuring that new studies and data do not change the (as now modified) truthful and non-misleading nature of its statements.
Amarin is noteworthy because its ruling, consistent with Caronia, provides momentum to the Caronia court’s pro-pharmaceutical company ruling involving the First Amendment. As both rulings come from district courts, they do not have tremendous precedential weight, but they could represent a new court trend nationwide in such cases. The arguments used by both parties, the tests and standards used in the Court’s analysis, and the Court’s comfort with stepping in and literally rewriting statements intended to be shared with physicians are in some ways unprecedented, and potentially prophetic.
Additionally, Amarin’s claim for preliminary relief from civil action under the False Claims Act was deemed not yet ripe. This leaves open another avenue for FDA action that has yet to be addressed and is worth watching. If Amarin could face civil penalties, its “win” in Amarin (protection from criminal action for misbranding) would be bittersweet.
Finally, this case like any other must be read in the greater national regulatory and political context. As drug prices have increased, pushing pharmaceutical companies into the spotlight for seemingly opportunist behavior in their acquisitions and other business practices, government scrutiny, from not only the FDA but also Congress, has increased. Rulings like Amarin and Caronia do not seem to support recent government attempts to reign in pharmaceuticals, and the Amarin court’s dicta about extant limitations on pharmaceutical company statements may not be sufficient. Demands of non-price sensitive consumers for the latest and best medicine could encourage profit-focused pharmaceutical company behavior despite these limitations. Thus, court rulings protecting pharmaceutical company speech and relying on such limitations may actually undermine government regulatory efforts. With the unsure fate of the Affordable Care Act and the delay of its special taxes on pharmaceutical companies, this in-flux area of law continues to be prescient and watch-worthy.
Elta Mariani is a 3L student at Boston College Law. During law school, she has served as a president of the student-run Health Law Society, and worked at athenahealth, Tufts Medical Center, and the law firm of Donoghue, Barrett & Singal. She received her undergraduate degree from Cornell University.
 The Court did not address this alternative ground for relief.
 U.S. Food and Drug Admin., Guidance for Industry: Special Protocol Assessment (2002), at 10, http://www.fda.gov/
 In Caronia, the Court of Appeals for the Second Circuit reversed a pharmaceutical salesman’s conviction for making truthful statements about off-label use of a drug to physicians. Determining that FDA had prosecuted the salesman for his speech alone, and applying the principle of constitutional avoidance, the court narrowly construed the FDCA provisions regarding illegal misbranding. Pharmaceutical marketing speech was determined protected expression under the First Amendment in the context of promoting off-label use when it passes the Central Hudson four-prong test for constitutionally protected commercial speech and promotes a lawful, off-label use of an FDA-approved drug.
David Sontag, Jerry Tichner, Meg Cosgrove, Colin Zick
Co-editors, Health Law Reporter
Happy Summer! Jerry, David and I are excited to present the Summer edition of the Boston Bar Association’s Health Law Reporter. In this issue, Andrew Levine, Robert Blaisdell and Kate Harrell have authored the first in a two-part series on the medical use of marijuana and the legal issues associated with the registered marijuana dispensaries in Massachusetts. As a follow up, our fall edition will focus on the physician-related issues including patient eligibility, the certification requirements, and patient rights and responsibilities following certification. In her thought-provoking article on the rights of parents with disabilities, Robyn Powell explores the significant legal, medical and familial resistance that certain disabled individuals continue to encounter when trying to become parents. To round out our lead articles, Samantha Morton, Kirsten Meisinger, M.D., and Deborah Durant explore the implications of patient-centered, accountable healthcare for the legal profession including the need for the legal community to expand the depth of our “lawyer’s toolbox” in order to remain effective advocates for our clients.
We are also very appreciative that Sarah Iselin, Senior Vice President of Strategy, Policy and Community Partnerships and Chief Strategy Officer at Blue Cross Blue Shield of Massachusetts, took the time to sit down with Margaret Schmid to discuss her role as a policymaker in Massachusetts including her recent position as a Special Assistant to Governor Deval Patrick tasked with overseeing the fixes to the Massachusetts Health Connector. Sarah offers some interesting insights into the current state of the Health Connector as well as future challenges in healthcare in Massachusetts.
This edition also includes a summary of several recent health law cases in Massachusetts: Walden Behavioral v. K.I., which is currently pending on appeal, held that the patient-psychotherapist privilege does not apply to civil commitment hearings; two cases that limit the kinds of decisions that a health care proxy is authorized to make on behalf of a principal, Johnson v. Kindred Healthcare, Inc. and Licata v. GGNSC Malden Dexter LLC; and Bryant v. Jackson, a case that addresses the intentional release of a patient’s HIV status by a hospital employee.
On a separate note, we also wanted to warmly welcome our new co-editor, Colin Zick, and our new peer review coordinator, Tad Heuer, both of Foley Hoag LLP. Colin and Tad bring years of experience and expertise to the Reporter and we are incredibly happy and lucky to have them join the team.
The Medical Use of Marijuana and Legal Issues Associated with MA Registered Marijuana Dispensaries
By Andrew S. Levine, Robert K. Blaisdell, and Kathleen A. Harrell
Lawyering as Problem-Solving: Implications of Patient-Centered, Accountable Healthcare for the Legal Profession
By Samantha J. Morton, Kirsten Meisinger, Deborah Durant
Policymaker Profile: Sarah Iselin
By Margaret Schmid
Health Law Case Briefs:
Walden Behavioral Care v. K.I.
By Stephanie Regan
Bryant v. Jackson
By Andrew Egan
By: Robyn M. Powell, Esq.
The right to raise a family is undoubtedly one of the rights most cherished by Americans. The United States Supreme Court has avowed continuously and with conviction that parents’ rights to the care and custody of their children are protected under the Due Process Clause of the 14th Amendment. Parental rights have long been held as fundamental, beginning with the seminal 1923 decision in Meyer v. Nebraska, in which the Supreme Court held that parents have the due process right to see to the education of their children together with the duty to give children a suitable education. Two years after Meyer, the Supreme Court, in Pierce v. Society of Sisters, ruled that parents have the liberty “to direct the upbringing and education of children under their control.” In this landmark case, the Supreme Court found, “The child is not the mere creature of the State; those who nurture him and direct his destiny have the right, coupled with the high duty, to recognize and prepare him for additional obligations.” Subsequent decisions have further defined the contours of the law’s protections of parental rights.
Despite recognition of the fundamental right to raise a family, people with disabilities continue to encounter pervasive and systemic discrimination when seeking to create and maintain families. In 2012, the National Council on Disability (“NCD”), an independent federal agency, released its groundbreaking report, Rocking the Cradle: Ensuring the Rights of Parents with Disabilities and Their Children (hereinafter “Rocking the Cradle”). Rocking the Cradle is a comprehensive policy study that explores the pervasive prejudices faced by parents with disabilities. The report exposes the disparate treatment often encountered by parents with disabilities and their children within the legal and social services systems and offers draft model state and federal statutory language to correct the discrimination faced by parents with disabilities throughout the United States.
This article, an adaption of the Rocking the Cradle report, provides readers with an understanding of this largely overlooked civil rights issue inherent in the discrimination faced by parents with disabilities, focusing on the legal and policy considerations. The first section provides a historical context on the parenting rights of people with disabilities. The following sections examine the four key areas wherein parents and prospective parents with disabilities face discrimination: child welfare, family law, adoption, and assisted reproductive technologies. Finally, the article concludes with a discussion on what Massachusetts is doing to remedy this unjust phenomenon and provides a call to action to Massachusetts advocates and policymakers.
History of Parenting Rights in the Disability Community
The desire to raise a family crosses all cultural, physical, and political boundaries. However, for people with disabilities, this inherent desire has long been forestalled by societal bias. This opposition has deep and disturbing roots.
To begin with, the eugenics movement, during which more than 30 states legalized involuntary sterilization, characterized the first half of the 20th century. This legislative trend was premised on the notion that people with disabilities were “socially inadequate” and burdensome to society. Because of these state statutes, more than 65,000 Americans had been involuntarily sterilized by 1970. Many of these individuals were sterilized because of an intellectual or psychiatric disability or belonged to socially disadvantaged groups.
In 1927, the United States Supreme Court sanctioned this practice. In his notorious decision upholding the constitutionality of Virginia’s law requiring the involuntary sterilization of people with disabilities, Justice Oliver Wendell Holmes, Jr. declared,
It is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind…Three generations of imbeciles are enough.
Disgracefully, this Supreme Court decision has yet to be overruled. In fact, in 1995, the Supreme Court denied the petition for certiorari of a woman with an intellectual disability challenging Pennsylvania’s involuntary sterilization statute. Bell was cited by a federal appeals court as recently as 2001, in Vaughn v. Ruoff. In this case, the plaintiff had a “mild” intellectual disability and both of her children were removed by the state. Immediately following the birth of her second child, the social worker told the mother that if she agreed to be sterilized, her chances of regaining custody of her children would improve. The mother agreed to sterilization, but approximately three months later, the state informed her that it would recommend termination of parental rights. The district court found that the plaintiff had a protected liberty interest in the 14th Amendment and that the social worker’s conduct violated her due process rights. The U.S. Court of Appeals affirmed the judgment for the Eighth Circuit. However, the appeals court, citing Bell, acknowledged, “involuntary sterilization is not always unconstitutional if it is a narrowly tailored means to achieve a compelling government interest.”
Even today, as we near the 25th anniversary of the Americans with Disabilities Act (“ADA”), several states retain a form of involuntary sterilization law on their books. A few even retain the original statutory language, which labels the targets of these procedures as possessing hereditary forms of “idiocy” and “imbecility,” and state that the best interests of society would be served by preventing them from procreating.
In fact, there appears to be a growing trend toward sterilizing people with intellectual or psychiatric disabilities. Locally, in the fall of 2011, the Massachusetts Department of Mental Health filed a petition to have the parents of a woman with a psychiatric disability appointed as temporary guardians in order to consent to an abortion, despite the fact that the woman had refused such a procedure, citing her religious beliefs. The court ordered that the woman’s parents be appointed as co-guardians and said she could be “coaxed, bribed, or even enticed … by ruse” into a hospital where she would be sedated and an abortion would be performed. The judge also ordered the facility that performed the abortion to sterilize the woman “to avoid this painful situation from recurring in the future.” The decision was reversed on appeal. With regard to the sterilization order, the appeals court ruled, “No party requested this measure, none of the attendant procedural requirements has been met, and the judge appears to have simply produced the requirement out of thin air.” In overturning the order to terminate the pregnancy, the court stated, “The personal decision whether to bear or beget a child is a right so fundamental that it must be extended to all persons, including those who are incompetent.” The appropriate result of the proceedings does not erase its troubling origin – a state agency that intervened to terminate a pregnancy based on the disability of the pregnant woman, despite her objection to having an abortion.
Shamefully, the power of the eugenics ideology persists. Today, as NCD’s Rocking the Cradle reveals, people with disabilities continue to encounter significant legal, medical, and familial resistance to their decision to become parents.
Discrimination in the Child Welfare System
Parents with disabilities face multiple layers of discrimination from the moment they enter the child welfare system. For example, in 2010, a Missouri couple had their two-day-old daughter taken into custody by the state because both parents were blind. This removal was not based on allegations of abuse, just a fear that the parents would be unable to care for their daughter. Because the couple was presumed unfit, for nearly two months they were permitted to visit their daughter only two to three times a week, for just an hour at a time, with a foster parent monitoring. Questions arose within hours of their daughter’s birth, after awkward first attempts at breast-feeding – something many new mothers experience. Following this incident, a nurse wrote on a chart, “The child is without proper custody, support or care due to both of parents being blind and they do not have specialized training to assist them.” “Her words set into motion the state mechanisms intended to protect children from physical or sexual abuse, unsanitary conditions, neglect, or absence of basic needs being met.” A social worker from the state came by the mother’s hospital room and asked her a variety of questions about how they would care for their daughter. The social worker then told the parents they would need 24-hour care for their daughter, which the parents replied they could not afford and did not need. Nonetheless, their daughter was taken into foster care, and a 57-day battle ensued before they were finally reunited with her.
Unfortunately, the experience of the above mentioned parents is not unique for parents with disabilities. Parents with disabilities and their children are overly, and often inappropriately, referred to child welfare services and, once child welfare services become involved, are separated at disproportionately high rates. Indeed, research reveals removal rates as high as 70 percent to 80 percent where parents have a psychiatric disability, and from 40 percent to 80 percent when the parent has an intellectual disability. Likewise, parents with physical disabilities as well as the deaf and blind communities also report extremely high rates of child removal and loss of parental rights. 
The reasons for this pervasive discrimination are myriad. First, as recently as 2010, a study found that 37 states, including Massachusetts, still contain disability as grounds for terminating parental rights. These laws often rely upon antiquated and offensive terminology, vague definitions of disability, and place emphasis on a parent’s diagnosis or condition rather than on their actions and behaviors as parents. As researchers Elizabeth Lightfoot and Traci LaLiberte of the University of Minnesota note, “When a parent’s disability is explicitly included in legislation outlining the grounds for termination of parental rights, the disability can easily become the focus of a child protection case, even though the statutes do not say it can be the sole grounds for termination.”
Moreover, parents with disabilities contend with the disparate impact of certain provisions of the federal Adoption and Safe Families Act of 1997 (“ASFA”); perceived limits on the application of the ADA, especially at the termination of parental rights phase; bias, speculation, and the “unfit parent” standard; and a lack of training in relevant systems regarding parents with disabilities.
Bias in the Family Law System
Similarly, parents with disabilities who are seeking or defending custody or visitation rights often encounter a family law system that is riddled with practices that discriminate against them and lacks familiarity regarding parents with disabilities and their children. For instance, in 2009, Kaney O’Neill, a veteran and quadriplegic mother, faced an unexpected battle when her former boyfriend filed for custody of their 10-week-old son, alleging that Kaney was “not a fit and proper person” to care for their son and that her disability “greatly limits her ability to care for the minor, or even wake up if the minor is distressed.” Refuting this allegation, Kaney demonstrated her ability to care for their son. Indeed, she had prepared for motherhood by working with an occupational therapy program for expectant mothers and parents, adapting her house for parenting, securing adapted baby care equipment, and using personal assistants to help her as needed. Illustrating the bias that pervades the family law system, an attorney who was not affiliated with the case remarked, “Certainly, I sympathize with the mom, but assuming both parties are equal (in other respects), isn’t the child obviously better off with the father?” This attorney, who has specialized in divorce and custody cases for more than 40 years, said that Kaney “would likely not be able to teach her son to write, paint or play ball.” The attorney went on to comment, “What’s the effect on the child—feeling sorry for the mother and becoming the parent?” Kaney’s battle endured for a year-and-a-half before both parties came to an agreement that gives the father visitation rights. Although she was elated with the outcome, Kaney told reporters that she was “…disappointed that the courts allow for someone to question your ability to have custody based on your disability.”
Across the country, parents with disabilities encounter a patchwork quilt of state domestic relations laws. Some state laws overtly discriminate against parents with disabilities, and many fail to protect parents from unsupported allegations that they are unfit or create a detrimental impact on their children solely based on their disability.
Family courts apply the “best interest of the child” standard to determine custody and visitation matters. Most states have developed their own list of factors to determine this standard, but the best interest analysis always allows the consideration of a parent’s “health.” All too often, a parent’s disability is classified as a “health concern” and a discredit to the parent’s ability to provide for the best interests of a child. Because of considerable attitudinal prejudice regarding disability, the mere presence of disability is often used against the parent. The prevalence of this type of bias and lack of cultural competence is seen throughout unpublished court documents and evaluations, which use of offensive phrases such as “afflicted,” “wheelchair bound,” “suffering” from a particular disability, and the like. Such cases frequently reflect underlying biased presumptions that it is not in a child’s best interest to live with – or in some cases even visit – a parent with a disability.
Custody and visitation decisions should be based on the best interest of the child; a parent’s status as having a disability should be irrelevant to the analysis without an evidentiary showing of a nexus between the parent’s disability and a detrimental impact on the child.
Inequity in the Adoption System
Despite a growing need for foster and adoptive parents, the foster care and adoption systems are replete with discriminatory practices that forestall prospective parents with disabilities from opening their hearts and homes to children in need. Illustrating the discrimination often encountered by prospective parents with disabilities, NCD’s Rocking the Cradle recounts Rachel and her partner’s heartbreaking story:
In 1995, when Rachel and her partner (both wheelchair users) decided to adopt, they had no idea they were embarking on a 15-year journey to become parents. They contacted the local child welfare agency to express interest in becoming foster or adoptive parents. They were immediately told that because of their disabilities they were not qualified. After they worked their way “up the chain” and threatened a lawsuit, the agency finally allowed them to apply. The couple met all the requirements and completed the necessary training. Soon after that, a brother and sister were placed with them. After only three months, the agency removed the foster children because their birth mother did not want them placed with a disabled couple. The agency offered another child, who proved to be an inappropriate match. Nearly five years later, with no communication from the agency, Rachel and her partner went through the training process again. Despite successful completion of training a second time, they never heard from the agency.
In 2004, after Rachel’s partner started a new job that paid well, the couple decided to apply for private adoption, hoping a private agency would better engage and assist prospective parents with disabilities. But the private adoption process was also riddled with discrimination. In 2006, the couple applied to adopt a young girl. After a home study and nearly two years of silence, they inquired again. Finally, in early 2009, Rachel and her partner were allowed to meet a child. In March 2009, the agency contacted the couple and told them that the girl’s foster parents were relinquishing her (which Rachel and her partner assumed was owing to her significant intellectual and psychiatric disabilities) and asked if they would like to become her foster parents. They agreed and she moved into their home in April 2009. In June 2010, 15 years after beginning their journey to become parents, Rachel and her partner adopted their daughter. Tragically, Rachel’s partner passed away five months later.
Many people with disabilities seek to form families through domestic adoption. For some, the type of disability may make adoption the sole means by which parenting becomes possible. Unfortunately, discriminatory practices often impede access to domestic adoption. Many prospective parents with disabilities are categorically denied the opportunity to adopt because of their disability, while others encounter bias and speculation concerning their parenting abilities. Owing to the unspoken ranking system used among domestic adoption agencies, prospective adoptive parents with disabilities are often completely precluded from adopting or forced to wait for indefinite periods before a match is found. As stated by attorney Brenda K. DeVries, “[i]n order to place as many children as possible, no one group of prospective parents should ever be categorically excluded.”
Prospective parents with disabilities encounter varied results with international adoption. Some nations have less stringent requirements, and international home studies tend to be less rigorous. On the other hand, some countries categorically deny prospective parents with disabilities. For instance, of the top five sending countries in 2011, three had eligibility criteria that completely or nearly precluded prospective parents with disabilities from adopting children from their countries. Moreover, prospective adoptive parents with disabilities often face barriers to accessibility and travel. For example, some prospective parents with disabilities may need specialized equipment, personal assistance services, accessible hotels, and transportation. This can be cost-prohibitive for some, thus precluding them from international adoption.
Barriers to Accessing Assisted Reproductive Technologies
Assisted reproductive technologies (“ART”) can allow many people to procreate who would otherwise be unable to do so. However, many people with disabilities face significant, and sometimes insurmountable, barriers to receiving ART. ART providers regularly engage in discriminatory practices against people with disabilities. Moreover, the growing costs of ART, combined with the limited insurance coverage for these treatments, leave many people with disabilities, who have lower incomes and greater expenses, unable to afford the treatment.
Discriminatory practices by ART providers are not surprising in light of the significant and pervasive obstacles people with disabilities encounter when accessing reproductive health care. As discussed in the NCD report The Current State of Health Care for People with Disabilities, women with disabilities require health services related to sexuality, reproductive care, and childbearing, just as women without disabilities do. However, social misperceptions and stereotypes about disability can make it difficult for women with disabilities to obtain information, medical care, and services to ensure that their reproductive needs are met. Other barriers to reproductive health care faced by people with disabilities include inaccessible facilities; limited professional training and competency of primary care and reproductive care specialists; inadequate or no health insurance coverage for visits to specialists; poor physical access to usable and adapted or specialized examination and diagnostic equipment; and negative or discriminatory provider attitudes.
Regrettably, people with disabilities often contend with stereotypes and ignorance by ART providers, as well as health care providers generally. Likening this to the eugenics philosophy, law professor Carl H. Coleman says,
Our society has a long history of efforts to prevent people with disabilities from having children, a history in which the medical profession played an especially prominent role. While we no longer embrace the coercive eugenics policies of the early twentieth century, the perception that some individuals with disabilities are inherently incapable of being parents remains common in our society. Hence, there is a real danger that disability-related denials of ART will be based on ignorance or bias against people with disabilities, even more so than when physicians deny individuals with disabilities other types of medical care.
What is Massachusetts Doing?
This legislative session, the Massachusetts Joint Committee on the Judiciary considered a comprehensive bill that would prohibit discrimination against parents with disabilities in family law and child welfare proceedings. House Bill 1379, An Act Prohibiting Discrimination Against Adults with Disabilities in Family and Juvenile Court Proceedings (hereinafter “HB 1379”), was introduced by Representative Paul Heroux and co-sponsored by 15 additional legislators. Despite significant support by the disability community, in late June, HB 1379 was sent to study, effectively killing it for the remainder of the session.
HB 1379 requires that, when a court uses a parent’s disability as a factor in a custody or visitation determination, the court must have written findings to determine whether a parent’s disability causes harm to his or her child. This law would also require courts to determine whether the harm to the child can be alleviated by “adaptive parenting equipment” or “supportive parenting services,” which are both defined in the bill. Moreover, HB 1379 raises the burden of proof to preponderance of the evidence for most domestic relations matters concerning parents with disabilities and to a clear and convincing standard for child welfare proceedings where a parent has a disability.
HB 1379 is consistent with current Massachusetts case law, federal and state anti-discrimination law, and a trend in state family law. Notably, HB 1379 will not cost the state money to implement and may even save the state money by preventing unnecessary foster care placements.
HB1379 was an important step forward in ensuring the rights of parents with disabilities in Massachusetts, and the disability community urges the Commonwealth to swiftly pass it in the next legislative session. If passed, Massachusetts will join the ranks of other states that have enacted similar laws – Idaho, Missouri, Kansas, Tennessee, Oregon, and Washington.
Conclusion: A Call to Action to Advocates and Policymakers
As this article demonstrates, parents and prospective parents with disabilities face systemic and pervasive discrimination when exercising their fundamental right to raise families. The legal system is not sufficiently protecting the rights of parents with disabilities and their children. Leadership is needed within the legal community as well as by policymakers and state advocacy groups in Massachusetts. Whether action is taken as an amendment, a regulatory change, or a new law, the need for action is timely and clear.
In Massachusetts, the Executive Office of Health and Human Services, Department of Children and Families, Department of Public Health, and Massachusetts Judicial Branch must take immediate action to eradicate discriminatory practices within child welfare, family law, adoption, and assisted reproductive technologies. These agencies must swiftly revise policies and procedures that are discriminatory and amend regulations to ensure the rights of these families. In addition, state agencies must provide training on parents with disabilities to all relevant personnel.
Action by litigators and research by legal scholars must also be undertaken to determine ADA violations that may exist in the above mentioned areas. Unquestionably, the legal community plays an integral, and difficult, role in ensuring that these families are afforded the rights they deserve.
Although parents with disabilities are especially affected by the issues discussed here, they are not alone. Indeed, as attorney Christopher Watkins has stated, in no community is –
the welfare of children . . . served by breaking up families based on fear and stereotype. If we are truly concerned about the welfare of children, we should invest more money and energy in preventive services for families rather than in parental rights termination and foster care. Our conception of the parent or parents as individuals, standing alone, without help from the broader community, does children no service.
Robyn M. Powell is an Attorney Advisor at the National Council on Disability (NCD), an independent federal agency that advises the President and Congress on matters concerning people with disabilities. Ms. Powell has dedicated her career to disability rights and has previously served as the Disability Rights Program Manager at the Equal Rights Center, as Assistant Director for Policy and Advocacy at the Disability Policy Consortium, and Staff Attorney at Greater Boston Legal Services. While in law school, Ms. Powell interned for both the National Council on Disability and the Disability Law Center, the Massachusetts Protection & Advocacy agency. Ms. Powell is principal author of NCD’s Rocking the Cradle: Ensuring the Rights of Parents with Disabilities and their Children. As a national expert on the rights of parents with disabilities, Ms. Powell frequently presents on the topic and has been interviewed by various news outlets, including NPR, BBC, ABC News, and the Associated Press.
Ms. Powell holds a Bachelor of Science degree in Social Work from Bridgewater State University and a Juris Doctor from Suffolk University Law School.
 Meyer v. Nebraska, 262 U.S. 390, (1923).
 Pierce v. Society of Sisters, 268 U.S. 510 (1925).
 Id. at 535.
 See, Stanley v. Illinois, 405 U.S. 645 (1972); Smith v. Organization of Foster Families, 431 U.S. 816 (1977); Quilloin v. Walcott, 434 U.S. 246 (1978);Troxel v. Granville, 530 U.S. 57 (2000).
 National Council on Disability, Rocking the Cradle: Ensuring the Rights of Parents with Disabilities and Their Children (hereinafter “NCD Rocking the Cradle”) (September 2012) available at http://www.ncd.gov/publications/2012/Sep272012/. This article is adapted from NCD’s report.
 Michael G. Silver, Note, Eugenics and Compulsory Sterilization Laws: Providing Redress for the Victims of a Shameful Era in United States History, 72 Geo. Wash. L. Rev. 862, 864 (2004).
 Paul A. Lombardo, Medicine, Eugenics, and the Supreme Court: From Coercive Sterilization to Reproductive Freedom, 13 J. Contemp. Health L. & Pol’y and Policy 1, 3 (1996).
 Paul A. Lombardo, Three Generations, No Imbeciles: Eugenics, the Supreme Court, and Buck v. Bell (Baltimore, MD: John Hopkins University Press, 2008).
 Buck v. Bell, 274 U.S. 200, 208 (1927).
 Estate of C.W., 640 A.2d 427 (Pa. Super. Ct. 1994), cert. denied, 115 S. Ct. 1175 (1995).
 Vaughn v. Ruoff, 253 F.3d 1124 (8th Cir. 2001).
 Id. at 1129.
 The following states retain dangerous and offensive statutory language that authorizes a court to order the involuntary sterilization of a person with a disability: Arkansas (Ark. Code Ann. §20-49-101); Colorado (Colo. Rev. Stat. §27-10.5-130); Delaware (16 Del.C. §5712); Georgia (Ga. Code. Ann. §31-20-3); Maine (34-B M.R.S.A. §7010); North Carolina (N.C.G.S.A. §35A-1245); Oregon (O.R.S. §436.205); Utah (U.C.A. 1953 §62A-6-102); Vermont (18 V.S.A. §8705 et seq.); Virginia (Va. Code Ann. §54.1-2975 et seq.); West Virginia (W.Va. Code, §27-16-1 et seq. (uses especially offensive language regarding the best interests of society).
 Guardianship of Mary Moe, 960 N.E.2d 350 (Mass. App. Ct. 2012).
 Id. at 353.
 Id. at 355.
 Id. at 353.
 Carl H. Coleman, Conceiving Harm: Disability Discrimination in Assisted Reproductive Technologies, 50 UCLA L. Rev. 17, 24 (2002).
 Eric Schultz, Blind Independence Couple Gets Newborn Back after 57 Days, NBC Action News (July 21, 2010), http://www.nbcactionnews.com/dpp/news/local_news/blind-kansas-city-couple-gets-newborn-back-after-57-days.
 Loran B. Kundra & Leslie B. Alexander, Termination of Parental Rights Proceedings: Legal Considerations and Practical Strategies for Parents with Psychiatric Disabilities and the Practitioners Who Serve Them, 33 Psychiatric Rehabilitation Journal, 142, 143 (2009).
 Elizabeth Lightfoot et al., The Inclusion of Disability as a Condition for Termination of Parental Rights, 34 Child Abuse & Neglect 928 (2010); Maurice Feldman, “Parents with Intellectual Disabilities: Implications and Interventions,” in J. Lutzker (Ed.), Handbook on Child Abuse Research and Treatment (pp. 401–420) (New York, Plenum Press: 1998).
 NCD Rocking the Cradle, supra at 92.
 Lightfoot et al., supra at 930.
 See NCD Rocking the Cradle, supra at Appendix B, for a state-by-state analysis of dependency statutes and their inclusion of disability.
 Elizabeth Lightfoot & Traci LaLiberte, Parental Supports for Parents with Intellectual and Developmental Disabilities, 49 Intellectual and Developmental Disabilities 389 (2011).
 See generally, NCD Rocking the Cradle, supra at 83 et seq. While the goals of ASFA are laudable, the consequences can be devastating, especially for parents with disabilities and their children. For example, ASFA’s key provision, the “15/22 rule,” requires states to file a petition for TPR if a child has been in foster care for 15 of the most recent 22 months (even shorter time frames, defined by state law if the child is an infant), which is often challenging for parents with disabilities to comply with. In addition, although ASFA requires states to make “reasonable efforts” to preserve a family before moving the child to an out-of-home placement and to reunify the family if a child has been removed, the vagueness of this term, coupled with the unadapted services typically provided to parents with disabilities, often results in “reasonable efforts” not being fairly applied to parents with disabilities. Finally, ASFA allows child welfare workers to engage in concurrent two-track planning for children in out-of-home placement, which research shows is not equally engaged in for parents with disabilities.
 Id.; As NCD’s Rocking the Cradle, demonstrates, courts have resisted ADA defenses in child welfare proceedings or incorrectly held that the ADA does not apply to termination of parental rights proceedings.
 Id.; Beginning with the investigation into a report of child maltreatment, bias pervades the child welfare system at every step. Termination of parental rights generally hinges on “unfitness.” For parents with disabilities, demonstrating “fitness” can be insurmountable because of the significant speculation they face. Presumptions of unfitness are most obvious in cases where the parent has never actually had custody of the child, as illustrated by the above story of the Missouri parents.
 See generally, NCD Rocking the Cradle, supra at 83 et seq. An overarching lack of knowledge concerning parenting with a disability, particularly the use of adaptive parenting equipment or supports, often leads to child welfare workers and others engaged in custody determinations making uninformed decisions concerning capacity.
 Sara Olkon, Disabled Mom Fighting to Keep Her Son, Chicago Tribune (December 20, 2009), http://articles.chicagotribune.com/2009-12-20/news/0912190290_1_disabled-parents-custody-mom.
 Through the Looking Glass, Legal Program, Battle for the Rattle: A Soldier Mom Story of Custody Court, Disability, and Mothering, available at http://pwd-legalprogram.org/Battle-for-the-Rattle.html.
 Sarah Schulte, Disabled Single Mom Talks about Challenges of Raising Son, ABC 7 Chicago (May 4, 2011), http://abclocal.go.com/wls/story?section=news/local&id=8112269.
 See generally, NCD Rocking the Cradle, supra at 136 et seq.
 Ella Callow et al., Parents with Disabilities in the United States: Prevalence, Perspectives, and a Proposal for Legislative Change to Protect the Right to Family in the Disability Community, 17 Tex. J. C.L. & C.R. 9-42 (2011).
 Megan Kirshbaum et. al., Parents with Disabilities: Problems in Family Court Practice, 4 J. Ctr. for Fam. Child & Cts. 27, 37-38 (2003).
 See generally, NCD Rocking the Cradle, supra at 181 et seq.
 Brenda K. DeVries, Health Should Not Be a Determinative Factor of Whether One Will Be a Suitable Adoptive Parent, 6 Ind. Health L. Rev. 137, 141–142 (2009).
 NCD Rocking the Cradle, supra at 200.
 U.S. Department of State, “Statistics – Intercountry Adoption,” available at http://adoption.state.gov/about_us/statistics.php.
 See generally, NCD Rocking the Cradle, supra at 205 et seq.
 National Council on Disability, The Current State of Health Care for People with Disabilities (2009), available at http://www.ncd.gov/publications/2009/Sept302009.
 Coleman, supra at 20.
 Chris Watkins, Comment, Beyond Status: The Americans with Disabilities Act and the Parental Rights of People Labeled Developmentally Disabled or Mentally Retarded, 83 Calif. L. Rev. 1415, 1475 (1995).
By: Andrew S. Levine, Esq., Robert K. Blaisdell, Esq., and Kathleen A. Harrell, MPH
This is the first article in a two-part series on the medical use of marijuana in Massachusetts. This article addresses some of the issues associated with opening a registered marijuana dispensary (RMD). The second article will address physician and clinician issues associated with RMDs.
In November 2012, sixty-three percent of Massachusetts voters approved a ballot initiative allowing qualified patients with debilitating medical conditions to purchase and possess marijuana. This measure – An Act for the Humanitarian Medical Use of Marijuana, Chapter 369 of the Acts of 2012 – became law on January 1, 2013, making Massachusetts the eighteenth state in the nation (along with the District of Columbia) to approve the use of marijuana for medical purposes. The newly-enacted law eliminated state civil and criminal penalties for the possession of marijuana for individuals who are certified by a physician as having at least one statutorily-defined debilitating clinical condition, and who may benefit from use of the drug. Additionally, the law provided for the implementation of up to thirty-five medical marijuana treatment centers (MMTCs) across the Commonwealth. Furthermore, the law charged the Massachusetts Department of Public Health (DPH) with promulgating regulations for the implementation of treatment centers, which DPH now refers to as registered marijuana dispensaries (RMDs), and creating a policy framework for qualified patients to obtain written certification from physicians for medically-necessary marijuana. In early 2013, DPH carried out a public engagement process – through listening sessions, hearings, and a public comment period – seeking feedback on both the proposed regulations, as well as the overall selection process for RMDs. On May 8, 2013, the Massachusetts Public Health Council unanimously approved regulations that outline the registration process for qualifying patients, personal caregivers and certifying physicians; set forth a process for obtaining hardship cultivations; and define the operational aspects of RMDs.
On August 2, 2013, DPH launched the first of two phases in the RMD request for proposal process. During this initial phase, one hundred eighty-one applications were received by DPH with one hundred fifty-nine applicants moving on to the second phase. Shortly thereafter, DPH issued the second phase of the proposal process, with one hundred organizations submitting applications for review. These processes required applicants to manage local zoning requirements around leases for potential dispensaries, obtain support from their designated municipalities, adhere to state laws and regulations, facilitate suitability filings, and devise the necessary infrastructure to operate a sustainable RMD. Earlier this year, DPH issued the results of the two-phase process, and selected twenty dispensaries for provisional status, invited eight dispensaries to seek alternative locations, and denied seventy-two applications outright. Upon selection of the twenty applicants for provisional status, DPH staff began conducting a “verification phase” of the selected organizations, whereby DPH verified the accuracy of each application’s contents, such as letters of support, meeting with municipalities to confirm siting and local support, reviewing each applicant’s operational and leadership plans, and having applicants attest to all submitted application materials (for more information on the overall DPH process for RMDs, please see Exhibit 1). On June 27, 2014, DPH announced that eleven of the twenty RMD applicants advanced to the “inspection phase” of the selection process while the remaining nine were not selected to move forward. These eleven proposed dispensaries will bring ninety-seven percent of the Commonwealth’s population within thirty miles of a RMD, ensuring patient access to medical marijuana across the Commonwealth. Additionally, DPH also announced that five highly-scored applicants that were not selected in the first two-part process of licensing were invited to reapply for a license in any of seven unrepresented counties: Berkshire, Hampden, Franklin, Bristol, Suffolk, Nantucket and Dukes. Under a new timeline devised by DPH, these five applicants have until August 29, 2014 to submit their revised applications.
Local/Municipal Legal Issues
The most common difficulties faced by RMD applicants concern municipal and local legal issues, including meeting RMD siting requirements, obtaining local political and community support, ensuring that leadership can meet submitted timelines for opening, and complying with local zoning ordinances. In September 2013, shortly after submission of the first round of applications, a State House News Service analysis found that nearly one-third of all Massachusetts’ municipalities had placed temporary moratoriums on the implementation of RMDs (which many cities and towns still refer to as MMTCs). Since that time, most of these communities, as well as many others, have enacted zoning ordinances governing the siting of RMDs.
RMD siting requirements are governed by 105 CMR 725.000: Implementation of an Act for the Humanitarian Medical Use of Marijuana (the Regulations). The Regulations state that a RMD:
[S]hall comply with all local requirements regarding siting, provided however that if no local requirements exist, a RMD shall not be sited within a radius of five hundred feet of a school, daycare center, or any facility in which children commonly congregate. The distance is measured in a straight line from the nearest point of the facility in question to the nearest point of the proposed RMD.
The Regulations only control, however, when there is no local ordinance in place. And many of the cities and towns that have adopted ordinances that address specific siting requirements are more stringent than the DPH Regulations. For example, the City of Cambridge outlines, in Ordinance Number 1359, two overlay districts for RMDs. This ordinance also discusses appropriate dimensional requirements for a RMD building, parking and loading logistics, signage restrictions and special permit criteria. These are all common requirements that most cities and towns have within their RMD zoning laws that are not mandated by the Commonwealth.
Another common issue for most RMDs involves the proximity of dispensaries to places where children commonly congregate. In 2013, DPH issued its Guidance for Municipalities Regarding the Medical Use of Marijuana (updated December 13, 2013) (DPH Guidance). In its Guidance, DPH specified that the “500 feet restriction around areas where children commonly congregate” that is addressed in the Regulations is measured from “building to building rather than property line to property line.” However, DPH went on to say that:
[A] facility is not limited to a building. For example, a playground outside a school would be considered a facility where children congregate, so in that case the line would be measured from the edge of the playground to the nearest point of the building that would house the potential RMD. Also, a RMD may have a cultivation area, which would be considered a facility. In that case, the line would be measured from the edge of the fence surrounding the cultivation area to the facility where children congregate.
Some cities and towns take this a step further, measuring property line to property line without regard for whether the applicable structures are set back from property lines, making the standards for siting RMDs even more rigorous.
The DPH Guidance also defines a“facility in which children commonly congregate” as:
[D]ance schools, gymnastic schools, etc. if children commonly congregate there in a structured, scheduled manner. It includes facilities where services or programs targeting children or youth take place. It includes a private home housing a family day care center, but not a private home where children happen to live. It includes a city or town park, if the park includes play structures intended for use by children. It does not include other facilities, such as ice cream shops, where children may happen to congregate, but not in a structured, scheduled manner.
For this specific issue, DPH has stated that an analysis around the common congregation of children should consider “whether children congregate at any specific place according to a schedule, how often they congregate, and whether the purpose of congregating is an activity designed for or targeted to children.” In addition to the DPH constraints, many cities and towns have added their own restrictions, prohibiting RMDs from locating within close proximity to public parks, conservation land, or establishments that offer play groups or youth activities. To address this issue, most RMD applicants have reached out to local counsel within their city, town or district to ensure they understand specific siting requirements and are aware of any potential abutter issues.
RMDs also seek to garner community support and work with local municipalities to ensure access to appropriate public services, such as police, fire, and other emergency services – all of which are paid for, in part, by local taxes. Although RMDs are required to be nonprofit organizations under Massachusetts law, a nonprofit organization is not automatically a tax-exempt organization. Nonetheless, the MA Department of Revenue will decide whether these entities will be assessed a state tax and, if so, at what rate. Consequently, RMDs are entering into agreements with local cities or towns to make payments that can be put toward municipal services, known as Good Will Contracts or Good Citizen Agreements. These arrangements are similar to payment-in-lieu-of-taxes (PILOT) programs, and provide the municipality with appropriate monies for the dispensaries’ consumption of public services. However, these agreements can be challenging, both to devise and negotiate. For example, a RMD may want to be a “good neighbor” to its local city or town by providing the necessary monies needed to offset its utilization of local services, but this desire to work with local officials must be balanced against the need to run a sustainable organization. Moreover, most municipalities are seeking Good Citizen Agreements or some other form of financial support in the first year of operations; however, this type of monetary commitment when an organization is young can impact both the capital and operational budgets of the RMD. To help ensure an adequate response to a municipality that is also appropriate for the organization’s finances, applicants must devise realistic financial plans comprised of feasible budgets and rational implementation strategies.
State Legal Issues
RMDs also face various state compliance issues when opening a dispensary. For most organizations, this means devising continuous quality initiatives to ensure compliance with state laws and regulations. Currently, the selected applicants are working to operationalize dispensaries. Prior to receiving full licensure via DPH, the RMDs will need to provide DPH staff with policies and procedures addressing the following areas:
- Storage of marijuana;
- Descriptions of the various strains to be cultivated and dispensed;
- Procedures for recordkeeping and inventory protocols;
- Plans for quality assurance and appropriate product testing to eliminate contaminants;
- Staffing plans and staffing record compliance;
- Security plans;
- Emergency procedures including disaster plans, substance-free workplaces policies;
- A plan for the maintenance of confidential information;
- A description of RMD patient education activities;
- Standards and procedures to determine the price of marijuana including a sliding fee scale for patients with financial hardship;
- Diversion plans;
- Procedures for voluntary and mandatory recalls of marijuana;
- Procedures for ensuring damaged or deteriorated marijuana is segregated from the rest of the inventory and destroyed;
- Home delivery;
- Transfers of marijuana between dispensaries;
- Cultivation and distribution requirements; and
- Waste disposal.
In total there are fourteen pages of regulations devoted to operationalizing a RMD.
Devising an overall operational framework and a complete set of operating policies and procedures for this type of organization can be daunting, especially when it is within a new and developing industry. To help address this issue, many RMDs have formed relationships with dispensaries in other states that have been operating for many years, such as Maine or Rhode Island. The existing out-of-state dispensaries provide those MA RMDs with baseline information around devising policies and procedures. Other MA RMDs rely on consultants or previous experience to implement all the necessary steps to operate a dispensary. These compliance issues underscore the need for a strong leadership team at the RMD with healthcare and regulatory experience. This team should also include at least one individual whose sole focus is on regulatory compliance. Additionally (or alternatively), the RMD may want to contract with legal counsel to ensure that all local, state and federal laws are being met.
In addition to complying with the DPH Regulations, RMDs must also meet the legal requirements generally associated with running a state charitable organization. RMDs must be incorporated under M.G.L. ch. 180, known as the public charities statute, and “must operate on a non-profit basis for the benefit of registered qualifying patients.” The RMD must also “ensure that revenue of the RMD is used solely in furtherance of its non-profit purpose.”  To comply with these requirements, DPH expects that an RMD will be governed by a board of directors that will meet its duty of loyalty to the organization and its duty of care in carrying out their responsibilities. Directors must act in compliance with the organization’s bylaws and for the purpose of furthering the organization’s mission – to provide access to marijuana for eligible patients and their caregivers.
Additionally, RMD management must develop and implement appropriate policies and procedures for suitability checks on all employees, including criminal offender record information (CORI) and other appropriate background checks. All employees of a RMD are designated as dispensary agents, and as such, each RMD is required to adhere to these strict investigative procedures. By having these appropriate safeguards in place, RMDs can ensure that there are no internal security issues for the organization.
Federal Legal Issues
In addition to state regulations, RMDs also face compliance issues on the federal level. Federal law sometimes conflicts with state law, and what is permitted by the state may not be permitted by the federal government. While the federal law seems to be evolving to become more favorable to the operation of a dispensary, significant concerns still exist. For example, although many states have either de-criminalized or legalized marijuana, the cultivation, possession and distribution of marijuana for any purpose is still considered a federal crime. In August of 2013, in light of states passing legislation legalizing marijuana for medical use, the U.S. Department of Justice (DOJ) issued a memorandum to federal prosecutors providing guidance on the enforcement of marijuana laws under the Controlled Substances Act (CSA). This memorandum states that Congress has determined marijuana is a dangerous drug and that the distribution and sale of marijuana is a serious crime “that provides a significant source of revenue to large-scale criminal enterprises, gangs, and cartels.” Consequently, the DOJ remains committed to enforcing the marijuana laws under the CSA. Furthermore, the memorandum goes on to say that state laws authorizing the production, distribution and possession of marijuana affect the traditional joint federal-state approach to narcotics enforcement. Therefore, DOJ expects states to have established “strong and effective regulatory and enforcement systems that address the threat those [more lenient] state laws may pose to public safety.” Additionally, DOJ specifies that “in using their prosecutorial discretion, prosecutors should not consider the size or commercial nature of a marijuana operation alone as a proxy for assessing whether marijuana trafficking implicates the DOJ’s enforcement priorities.” Rather, marijuana cases should be reviewed on a “case-by-case basis and weigh all available information and evidence, including, but not limited to, whether the operation is demonstrably in compliance with a strong and effective state regulatory system.” Therefore it appears that the DOJ is seeking to enforce the CSA by ensuring that their enforcement priorities are met by state and local governments.
Similarly, many dispensaries are confronting additional issues posed by the U.S. Drug Enforcement Administration (DEA). To help ensure clinical compliance and the implementation of rigorous quality control plans, some RMDs employ or contract with a medical director to provide patients with information regarding the medical purpose of various strains of medical marijuana, and to answer questions that patients and consumers may have concerning the medical use of marijuana in general. However, the DEA has taken a position on clinicians involved with RMDs, specifically, physicians serving as medical directors. In June of 2013, DEA agents notified a few physicians serving as medical directors at RMDs in Massachusetts that they must either sever their ties with the organizations or relinquish their federal licenses to prescribe certain medications. In response, U.S. Representative Dana Rohrabacher (R-CA) sponsored a measure approved by the House last month to restrict the DEA from using its funding to impede state medical marijuana laws. Representative Steve Cohen of Tennessee and Representative Michael Capuano of Massachusetts each supported Rohrabacher’s bill and said that the DEA needed a clear directive concerning the medical use of marijuana. Additional details about the DEA’s position, as well as other issues related to physicians and the medical use of marijuana, will appear in the next Health Law Reporter as the second part to this series.
A second but equally important challenge for many dispensaries is the inability to open bank accounts to conduct business activities. In many states, including California, Colorado and Massachusetts, many larger banks have declined to work with dispensaries due to fears that various federal enforcement agencies will impose penalties for violating federal banking law. In January, U.S. Attorney General Eric Holder announced that his staff would review current banking rules to try to ease the apprehension that many lenders were having about doing business with RMDs. On February 14, 2014, the Department of the Treasury’s Financial Crimes Enforcement Network issued a guidance to clarify the Department’s “expectations” under the Bank Secrecy Act (BSA) concerning financial institutions seeking to provide services to marijuana-related businesses (Treasury Expectations). The Treasury Expectations outline the need for increased due diligence by financial institutions when working with marijuana-related entities. In its Expectations, the Treasury states the following:
In assessing the risk of providing services to a marijuana-related business, a financial institution should conduct customer due diligence that includes: (i) verifying with the appropriate state authorities whether the business is duly licensed and registered; (ii)reviewing the license application (and related documentation) submitted by the business for obtaining a state license to operate its marijuana-related business; (iii) requesting from state licensing and enforcement authorities available information about the business and related parties; (iv) developing an understanding of the normal and expected activity for the business, including the types of products to be sold and the type of customers to be served (e.g., medical versus recreational customers); (v) ongoing monitoring of publicly available sources for adverse information about the business and related parties; (vi) ongoing monitoring for suspicious activity, including for any of the red flags described in this guidance;and (vii) refreshing information obtained as part of customer due diligence on a periodic basis and commensurate with the risk. With respect toinformation regardingstatelicensureobtained in connection with such customerduediligence,a financial institution mayreasonablyrelyon theaccuracyofinformation provided bystatelicensingauthorities, wherestates makesuch information available.
Furthermore, the Treasury Expectations remind lending institutions of their on-going obligation to file suspicious activity reports (SARs) when the institution knows, suspects, or has reason to know that any customer, including a RMD, is engaged in illegal activity. The Treasury Expectations also outline red flags to distinguish priority SARS in RMDs. The Department makes it clear that isolated lapses in technical compliance are not enforcement priorities for the agency. Instead, the Treasury will take enforcement action when it identifies systemic or significant failures to comply with the BSA.
The aforementioned challenges are just a small number of the issues currently facing RMDs as they seek to operationalize all aspects of the dispensaries and open in the coming months. As discussed, the Fall issue of the Health Law Reporter will focus on physician-related issues and the implementation of RMDs.
Andrew S. Levine is a partner at Donoghue, Barrett & Singal, where he directs the firm’s Health Law Regulatory practice. Andrew counsels a broad range of healthcare providers on a variety of state and federal regulatory matters including Department of Public Health (DPH) licensure and Medicare certification proceedings; Determination of Need approvals for the transfer of ownerships of hospitals and ambulatory surgery centers; Determinations of Need approvals for hospital and nursing home construction projects as well for the acquisition of innovative services and new technology; DPH clinic and nursing home change in ownership proceedings; DPH architectural, plan review and licensure filings; state and federal agency quality of care enforcement actions; Medicaid rate and provider contracting issues; drug diversions; state and federal registration; Medicaid fraud investigations; and Board of Registration actions. He has represented clients in front of such agencies as the Health Policy Commission, the Office of Medicaid, the Department of Mental Health, the Executive Office of Health and Human Services, the Office of the Attorney General, the Executive Office of Elder Affairs and the Centers for Medicare and Medicaid Services.
Robert K. Blaisdell is a partner in Donoghue Barrett & Singal’s Health Law practice. He works with healthcare clients to provide general business and corporate legal services and guidance on a wide range of issues, such as regulatory and corporate compliance; vendor contracting; HIPAA; medical staff credentialing and peer review; healthcare fraud and abuse, including Anti-Kickback, Stark Physician self-referral and False Claims Act analysis; nursing home and assisted living facility representation (including MassHealth audit appeals, transfers/discharges, and evictions). He has also appeared before various oversight agencies, such as the Massachusetts Commission Against Discrimination, Board of Registration in Nursing and the Board of Registration in Medicine. Bob is experienced in general corporate law, employment law, and litigation.
Kathleen Harrell is a law clerk at Donoghue, Barrett & Singal within the firm’s Health Law practice. Kathleen has an extensive background in program development, public policy and strategic planning. She is a J.D. candidate at New England Law Boston (expected, 2015). In addition to her law and policy background, Kathleen holds a Master of Public Health degree from Boston University with dual concentrations in Health Law and Bioethics. She has written on diverse topics for a wide range of audiences, including action plans, issue briefs, and advocacy publications.
Mass. Dep’t of Pub. Health, Guidance for Municipalities Regarding the Medical Use of Marijuana (2013).
 Currently, twenty-three states and the District of Columbia have approved the medical use of marijuana.
 Mass. Dep’t of Pub. Health, Guidance for Municipalities Regarding the Medical Use of Marijuana (2013).
 A “debilitating medical condition” is defined as “[c]ancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn’s disease, Parkinson’s disease, multiple sclerosis and other conditions as determined in writing by a qualifying patient’s physician.
 Id. at 2.
 105 Mass. Code Regs. 725.000 et seq. (2014).
 Mass. Dep’t of Pub. Health, From Provisional to Final: A Rigorous Process for Registered Marijuana Dispensaries (2014), http://www.mass.gov/eohhs/docs/dph/quality/drugcontrol/medical-marijuana/medical-marijuana-flow-chart-for-dispensaries.pdf.
 Andy Metzger, Progress On Medical Marijuana Hits Local Hurdles Across Mass., State House News, Sept. 18, 2013, available at http://www.masslive.com/politics/index.ssf/2013/09/progress_on_medical_marijuana.html.
 City of Cambridge, Ordinance 1359 (2013) available at http://www.cambridgema.gov/~/media/Files/CDD/ZoningDevel/Amendments/Ordinances/zngamend_1359_medmarijuana.ashx.
 Mass. Dep’t of Pub. Health, Guidance for Municipalities Regarding the Medical Use of Marijuana (2013).
 Mass. Dep’t of Pub. Health, Frequently Asked Questions Regarding the Medical Use of Marijuana (2013).
 Id. at 5.
 RMDs will not be tax-exempt under federal law, however, and will still be subject to federal taxation.
 Mass. Dep’t of Pub. Health, Guidance for Municipalities Regarding the Medical Use of Marijuana (2013).
 105 Mass Code of Regs. 725.100(A)(1) (2014).
 21 U.S.C. 13 (2014).
 Memorandum from the U.S. Dep’t of Justice on Guidance Regarding Marijuana Enforcement (August 29, 2013) (on file with author).
 Id. at 2.
 Id. at 3.
 Kay Lazar and Shelley Murphy, Lawmakers Slam DEA For Targeting Mass. Doctors, Boston Globe, June 11, 2014, http://www.bostonglobe.com/lifestyle/health-wellness/2014/06/11/congressmen-fault-dea-for-intimidating-massachusetts-doctors/MOQlJBKtCeKFI6nK6RQJ6O/story.html.
 David Ingram, U.S. to Adjust Rules to Let Banks Handle Marijuana Money – Holder, Reuters, Jan. 23, 2014, available at http://www.reuters.com/article/2014/01/24/usa-marijuana-banking-idUSL2N0KY03D20140124.
 Dep’t of Treasury. FIN-2014-G001. Bank Security Act Expectations Regarding Marijuana-Related Business (2014).
 Id. at 2-3.
 Id. at 3.
By Samantha J. Morton, JD, Kirsten Meisinger, MD, Deborah Durant, JD, MA
Health care delivery is rapidly changing in response to a number of new pressures and reform movements, for which the dominant fee-for-service model has proven inadequate to address. Many new organizational structures are converging and spotlight the increased importance of the patient’s perspective and lived experience in healthcare delivery redesign. Accountable care organizations (ACOs), with their focus on management of value-based care and total cost risk, have a financial incentive to understand what patients need to become or stay healthy, and to structure care teams, delivery systems, and budgets around those realities. Complementing Massachusetts’ 2006 innovation of near-universal access to health insurance, the cost containment legislation signed in 2012 (Chapter 224 of the Acts of 2012, hereinafter referred to as “Chapter 224”) explicitly targets health disparities and provides that when setting up new payment structures, the system must engage in thoughtful risk adjustment methodologies to account for variation in the needs of populations that are more vulnerable to those disparities. Moreover, healthcare organizations that seek certification as patient-centered medical homes (PCMHs) must demonstrate that they provide a range of meaningfully consumer-oriented services, such as extended hours, patient-friendly materials, and improved care coordination for patients as they move across the healthcare spectrum. Additionally, several Massachusetts initiatives are pushing healthcare delivery systems to focus on behavioral health as a key driver of costs and to find ways to integrate primary mental healthcare across individual locations and larger health systems.
These developments – especially the economic pressures of new financing methodologies – have triggered a more robust dialogue about the role of the healthcare system in addressing both the biological and social determinants of health., Healthcare providers increasingly are expected to help patients get and stay healthy, as opposed to merely treating patients’ diseases. Since the socio-economic context within which people function impacts their health in myriad ways, institutions now disregard complex socio-economic drivers of poor health (and related healthcare costs) at their peril. As presciently noted in Malcolm Gladwell’s 2006 article in The New Yorker, Million Dollar Murray, a tiny percentage of patients (so-called “superutilizers”) generates a disproportionate amount of healthcare costs. Indeed in 2011, one percent of patients in Camden, New Jersey generated one-third of the city’s healthcare costs. The high cost of caring for our society’s most vulnerable people – combined with the already large and growing costs of care for people with chronic diseases like diabetes, heart failure and kidney failure – demand that health care institutions (a) control costs, but also (b) maintain high quality care, rather than limit care in the short-term and thus create higher costs down the road. It no longer is a sufficient risk stratification strategy to simply identify patients with chronic disease; the delivery system also must assess a range of risk factors – such as food and housing insecurity, interpersonal and community violence, social isolation, and mental illness – that predict complex needs and complex care, if the system is to thwart associated higher costs. These changes have the potential to align healthcare institutions in a new focus on the multi-dimensional determinants of health and chronic disease management; this kind of alignment could be a major force for health equity among populations that historically have been at highest risk for disparities in coverage, access to care, and health outcomes.
Against this backdrop, attorneys should revisit how the legal profession intersects with the healthcare system. While legal risk management activity in healthcare typically has focused on issues such as medical malpractice, HIPAA compliance, and myriad regulatory obligations, lawyers have an important role to play in helping healthcare stakeholders manage another set of risks that the system is just beginning to confront more systematically. These risks relate to a patient’s socio-economic context and increase health disparities, reduce healthcare workforce productivity and efficiency, and trigger high-cost events such as avoidable hospital readmissions. Many of these risk factors can be addressed, and some even prevented, through legal planning, guidance, and interventions.
2. Socio-Economic Context and Healthcare Delivery: Why Health Reform Matters
The drive to cut overall healthcare costs, exemplified in the federal Affordable Care Act, includes efforts to shift responsibility for increased costs back onto insurers and healthcare institutions via ACO structures. An ACO is a network of physicians and hospitals that shares financial and medical responsibility for providing coordinated, quality care to patients in a cost-effective manner. The underlying concept is that providers in an ACO will take on upside financial risk and/or downside financial risk in relation to defined patient outcome benchmarks. The ACO paradigm creates incentives for providers to develop delivery systems that maintain high quality care and to manage both short-term and long-term costs. Functionally, ACOs are incentivized to recognize the downstream costs of limiting access to prevention, care coordination services, medications, timely follow-up with primary care for acute problems, and behavioral health services.
In this new economic reality, to which payers and institutions are adapting, it will be critical to identify and address a broader range of barriers to care and health. Historically, clinical teams have been best positioned to prioritize internal “process” barriers such as inadequate access to follow-up appointments. However, many barriers to health and care confronted by patients are socio-economic, and the healthcare system is neither accustomed to having to address these complex issues, nor was it built to do so. Indeed, many of the highest-risk and highest-cost patients (so-called “superutilizers”) have a preponderance of unresolved, untreated or under-treated mental health diagnoses like depression and addiction. Mental Health Integration, frequently called Behavioral Health Integration (BHI), is now recognized as a crucial component of any successful ACO — with success defined as simultaneous improved health and decreased costs.
Massachusetts has long been a leader in the movement to increase access to healthcare through health insurance, and provides lessons for the rest of the United States in the steps healthcare should take to succeed in this brave new world. Indeed, the Massachusetts coverage expansion movement was sufficiently momentous to spur formation of global payment contracts in the Commonwealth several years ago. However, coverage expansion alone does not guarantee good health or meaningful access to healthcare services. This reality was recognized in Chapter 224:
In developing additional standards for ACO certification, the [Health Policy Commission] shall consider the following goals for ACOs: . . . (4) to promote alternative payment methodologies consistent with the standards developed by the commission and the adoption of payment incentives that improve quality and care coordination, including, but not limited to, incentives to reduce avoidable hospitalizations, avoidable readmissions, adverse events and unnecessary emergency room visits; incentives to reduce racial, ethnic and linguistic health disparities in the patient population; and in all cases ensuring that alternative payment methodologies do not create any incentive to deny or limit medically necessary care, especially for patients with high risk factors or multiple health conditions[.] (emphasis added)
. . .
The office of Medicaid shall ensure that alternative payment methodologies: (i) support the state’s efforts to meet the health care cost growth benchmark and to improve health, care delivery and cost-effectiveness; (ii) include incentives for high quality, coordinated care, including wellness services, primary care services and behavioral health services; (iii) include a risk adjustment element based on health status; (iv) to the extent possible, include a risk adjustment element that takes into account functional status, socioeconomic status or cultural factors; (v) preserve the use of intergovernmental transfer financing mechanisms by governmental acute public hospitals consistent with the Medical Assistance Trust Fund provisions in effect as of fiscal year 2012; and (vi) recognize the unique circumstances and reimbursement requirements of high Medicaid disproportionate share hospitals and other safety net providers with concentrated care in government programs. (emphasis added)
Chapter 224 acknowledges that individuals do not come to the healthcare system on equal footing, even if they all technically are insured. There is a range of other factors that must be accounted for to achieve health equity in the Commonwealth.
There is another reason insurance coverage is not sufficient on its own: the American healthcare system is historically underfinanced in the areas of care that advance prevention and decrease costs (primary care and care coordination) and overfunded in areas that can drive up costs without improving health (sub-specialty care and high-cost, often unnecessary, procedures or tests). In order to avoid a surge in healthcare costs from newly-insured but primary care naïve patients, ACOs in Massachusetts are expanding primary care services in the hope of improving the efficiency and quality of care delivered in primary care settings. These changes are described as the “Patient-Centered Medical Home Model” of care and focus on patients’ health needs outside of the traditional “one doctor and one patient in a room together” style of care.
The Patient Centered Medical Home (PCMH) describes a care delivery model that is organized with the needs of patients at its center. Concretely, this means:
- Enhanced prevention screenings and careful follow-up on identified risks and problems;
- Making care accessible beyond traditional “banker’s hours,” either by extending direct patient care into evening and weekend office hours, and/or providing 24 hour access to medical advice by phone or email;
- Generating patient-oriented educational materials regarding chronic disease self-management tips and so forth (accounting for among other things, the needs of low literacy patients and English Language Learners)
- Careful reconciling of patient-reported medication behaviors against what is noted in medical records; and
- Thoughtful care coordination, since no single physician, or even doctor-nurse team, can deliver this type of comprehensive care to a population (panel) of patients.
While the PCMH structure may seem like a one-size-fits-all solution, the complex dance of even a high-functioning PCMH team can quickly come undone by socio-economic factors entirely beyond the team’s control. For example, a patient may not be able to keep the necessary appointments due to a lack of transportation resources; the newest and best asthma medicines simply are not enough to counter the allergens in the substandard housing in which the patient resides; or the patient’s abusive partner prohibits him or her from having any further contact with healthcare professionals. Even in the realm of insured patients, those with chronic diseases frequently become overwhelmed by the monthly cost of even “low co-pay” medications; many of these patients either economize by buying medicines every-other-month or choose which ones to buy each month rather than take all of the recommended and necessary doses. Clinicians, understandably, are not equipped to solve these foundational problems.
Notably, the patient profiled in Gladwell’s Million Dollar Murray article was “non-compliant” because he lacked an apartment to pass out in after a bender, somewhere safe to manage his chronic disease of alcoholism. Housing instability is a key social determinant of health that shadows these highest-cost healthcare consumers. Significantly, health insurers in several states have recently undertaken new initiatives to subsidize affordable housing.
When a medical diagnosis is made, medical treatment teams rush to treat the problem and hopefully resolve the issue. When diagnosis of a socio-economic barrier to care/health is made, the healthcare team’s resources are limited. As the healthcare system now grapples with appropriate and feasible treatments for these causes (often root causes) of disease and high healthcare costs, we should consider how the legal profession can support these efforts.
3. Social Determinants of Health (SDH): A New Frontier in Medicine
Physicians and nurses have long been trained to take a patient’s medical history. But exploring a patient’s social history and context, — beyond tobacco and alcohol use, sexual behavior risk factors, and use of car seats for young children – is a relatively recent development. In fact, systematic clinical screening for domestic violence is a surprisingly recent phenomenon. Not only can conversations on topics such as income, personal safety, and immigration status be challenging, but many providers are understandably reluctant to screen for problemsfor which they may be unable to offer a remedy. However, since institutions no longer can ignore these predictors of poor health and high costs, efforts to develop standardized screening tools and practices for a range of key SDH are underway.
Healthcare institutions that have attempted to build infrastructure to address SDH – generally through increasing their allied health staff – have run up against a core challenge: under the dominant fee-for-service payment model, only clinical services are reimbursable by payers. Therefore, while a hospital could be reimbursed for clinical services provided to a patient by a licensed social worker (such as therapeutic counseling), it could not be paid for social worker efforts to connect patients to resources essential for day-to-day subsistence (such as SNAP benefits, housing subsidies, and more). To offset the costs of providing these additional services, some institutions have received philanthropic grant funding; however, this approach is not sustainable in the long-term.
In the last several years, the community health worker movement has spawned exciting pilot programs that integrate lay, culturally (and often linguistically) congruent outreach workers into healthcare teams to help patients overcome defined barriers to care. In addition, a number of pilots are underway that seek to improve post-discharge care management, including successful leveraging of community-based resources. Massachusetts again is a hotbed of innovation in this area. To date, integration of these new team members has had the most traction in chronic disease managementcontexts (as opposed to primary care), and to the extent this new workforce is helping to eliminate barriers to health insurance coverage. As these initiatives evolve, it will be important to connect the dots between (a) evidence of what exactly patients need to overcome barriers to care and health, (b) funding streams for community health work, and (c) the job description for this important workforce.
4. Big Problems Like SDH Demand Large Toolboxes
Medical institutions and professionals have developed their own unique set of problem-solving tools, which are essential to individual and population health. However, in this time of shifting paradigms, there is a greater recognition that the traditional toolbox is incomplete and collaboration with other disciplines will be important. The legal profession can leverage its long history of tackling some of thorniest challenges confronting our country’s most vulnerable people (particularly in the realm of civil rights enforcement) for populations at the highest risk of health disparities: people of color, people with disabilities, English Language Learners, the LGBTQ community, and more. Further, lawyers are trained in a number of distinct strategies – including but going beyond traditional litigation – that solve problems when patients confront health-harming social or environmental conditions. This suite of skill sets will only become more relevant in an accountable care-oriented healthcare landscape:
In healthcare, preventive law typically takes the form of compliance work, and is postured proactively – identifying legal risks before they convert into legal problems for a provider or institution. These same skills can be leveraged, productively, to support low-resource healthcare consumers who often interact with no less than ten powerful decision-makers simultaneously when attempting to access health-promoting benefits and services to which they are legally entitled. These interactions that comprise a person’s social ecology – with landlords, abusive partners, government agencies, and so forth – can have a profound impact on a person’s health trajectory. The healthcare sector should be fertile ground for proactive legal risk assessments for low-resource patients, since healthcare institutions increasingly will share an interest in anticipating and eliminating barriers to care and health.
While determining the origins of disease (“pathogenesis”) has long been the focus of medicine, understanding and cultivating the origins of health (“salutogenesis”) may in fact represent the bigger challenge – and certainly one in which people themselves should be engaged. As healthcare continues an important dialogue about whether its consumers are “people” or “patients”, patient-centered care delivery models may ask: what steps will empower people to participate themselves in addressing social determinants of health? Community lawyers have vast experience to share on this subject.
Community lawyering encourages attorneys to meaningfully engage community members in advocacy that affects their lives, and to engage in multiple strategies to achieve their goals (including but not limited to outreach, facilitative leadership, and campaign feasibility exercises). Community lawyers are the legal profession’s closest equivalent to community health workers, and the strongest legal community ambassadors for the healthcare notion of “patient engagement.” As patient-centered medical homes proliferate and providers operating in ACO environments re-balance expectations with patients regarding responsibility for disease prevention and management, community lawyers could be important allies in supporting patients who have been activated help manage their health.
Negotiation and Mediation
Although negotiation arguably is a critical life skill with which all people should be equipped to succeed, training and support for negotiation capacity largely has been vested in the legal and business professions. Many of the social barriers to care and health that result in a “stuck patient” or repeated avoidable readmissions could be addressed through thoughtful negotiation with a patient’s proposed long-term care facility, landlord, state agency worker, or school district. The legal profession has much to offer in this domain – not merely in serving as negotiators directly, but in helping to build negotiation skills in allied health professionals and patients themselves.
While negotiation involves dispute resolution directly between two or more parties, mediation positions a neutral party as mediator of such as disputes among parties. Again, the legal profession is host to a large supply of active mediators, but also can play a capacity-building role by sharing best practices on mediation techniques with lay and allied communities invested in this form of dispute resolution for people with health-impacting problems.
When all else fails, litigators are equipped to challenge rights violations in court proceedings. This can happen on behalf of an individual or a group of similarly situated individuals (class actions). In some contexts (e.g., eviction and imminent homelessness), this strategy functions like a legal “emergency room”, since the client is facing severe, life-changing consequences in the near-term. In other contexts (e.g., some consumer class actions), litigation can serve a preventive function, leveraging correction of past harms to ensure no future harm comes to a population going forward.
At their best, all of the above strategies can breed changes in public policy and law that are both just and health-promoting. As the socio-economic drivers of poor health are increasingly better documented and understood, the healthcare system may observe opportunities to influence policy domains that have long been considered unrelated to the practice of medicine and healthcare financing. Lawyers sited in healthcare-based general counsel and government relations teams are especially (though not exclusively) well-positioned to examine whether what looks like a “poverty law” issue is in fact a healthcare access and quality problem with damaging consequences not only for patients, but for a healthcare delivery system.
Some socio-economic problems are quickly amenable to the strategies noted above; many are not. When a care coordinator attempts to resolve a patient’s difficult barriers to care, s/he quickly will need to know whether or not current law presents a solution. If so, role-appropriate advocacy can begin. If not, this knowledge will allow value-based care teams to allocate their scarce resources wisely in the short-term – and then set long-term policy change agendas on the tougher issues.
4. Lawyering as a Health Intervention: Practical and Cultural Implications for the Profession
Social ecology is a new frontier for healthcare, and it may be useful to step back and look at the big picture. Initiatives designed to address SDH will be most impactful – for patients, for the healthcare system, and for communities – if their design is informed by the following considerations:
- Re-orienting healthcare teams to patients’ total context must start during their education and training. Would we expect an astronaut to learn a core skill set only after she’d already landed on the moon? Schools of medicine, nursing, social work, and dentistry (among others) are key partners in this critical patient-centered, public health-oriented re-alignment. But as the healthcare team expands and diversifies, it’s also essential that community college graduates heading to myriad careers in healthcare (as physician assistants and more) start their jobs with a comprehensive understanding of what drives a person’s health.
- Tackling SDH may require new workforce skills and role adaptation. Public policy has long demanded that clinicians provide medical certifications and support for patients in a range of high-stakes contexts connected to health inequities: disability benefit applications, utility shut-off protection letters, requests for health-related reasonable accommodation in housing, employment, and so forth. They’ve done so for years without much formal guidance, although these time-intensive responsibilities carry with them enormous practical and ethical and implications for both clinicians and their employers – and often “heat-or-eat” implications for the affected patients. The laws, regulations, and policies governing patients’ access to a range of health-promoting benefits and programs change frequently. Historically, keeping up with such matters has not been the province, or priority, of healthcare-based offices of General Counsel. Perhaps we will see an expansion of the General Counsel domain when it becomes clear that healthcare delivery systems directly benefit from many patients’ seemingly external legal claims (to,for example, a housing unit free of asthma triggers to which s/he can be quickly and safely discharged from an emergency room or inpatient ward).Meanwhile, greater emphasis on SDH has put Social Work teams under increased pressure to simultaneously differentiate into complex care management and expand their role in routine care management of the usual patient population – generally with no additional financial resources. And the relationship between social work and the community health workforce remains murky – synergistic for sure, but potentially competitive. It will be critical to ensure that existing skill sets and experience are wisely leveraged alongside productive innovation of institutional organizational charts.
- A successful population health strategy will demand social policy innovation alongside healthcare policy innovation. As patients’ medical and social complexities become more relevant to care delivery and healthcare financing, so do the public policies that drive these complexities. Integration of community health workers (and other allied team members) into specific health centers and hospital departments represents substantial progress, but focuses the intervention at the individual patient level. Perhaps as institutions’ interests continue to re-align with the interests of vulnerable patients, we may observe increased engagement among institutions’ Government Relations teams (often populated by attorneys) on matters that are known to be “root causes” of health inequities, such as the inadequate supply of affordable housing.
If the legal community is to play a different and productive role in the accountable, value-based, patient-centered healthcare landscape, it must:
- Rigorously assess the socio-economic risks confronting low-resource healthcare consumers (often civil rights violations) that simultaneously harm healthcare providers and insurers. These issues extend well beyond access to insurance coverage.
- Learn the healthcare system’s values, financing, vocabulary, and culture. We may use different words to describe our goals for patients/clients (“engagement” v. “self-efficacy” v. “empowerment”), but we often are talking about the same thing, and in fact pursuing the same goals.
- Embrace the depth of our lawyer’s “toolbox” even if it means adapting our individual lawyering styles and larger practice structures. Healthcare is re-examining whether its practices are truly “patient-centered” – perhaps this process will produce reflections that enhance client-centeredness in the legal profession as well.
Samantha J. Morton is Executive Director of Medical-Legal Partnership | Boston (MLP | Boston), the founding site of the national MLP network. She is outgoing co-chair of the BBA Delivery of Legal Services Section and a member of the BBA Health Law Section. Ms. Morton is a national expert on how legal strategies can be deployed to address social determinants of health, and how the healthcare and legal communities can better align promote health equity. Before joining MLP | Boston in 2003, she was an Associate at Hale & Dorr LLP and a judicial clerk for the United States District Court for the District of Maine. Ms. Morton is a graduate of Cornell University and the University of Michigan School of Law.
Kirsten Meisinger is Regional Medical Director at Cambridge Health Alliance (CHA) as well as Special Projects Coordinator for CHA’s Department of Family Medicine. She has practiced medicine at Union Square Family Health Center in Somerville since 1999, serving as Medical Director since 2008. Dr. Meisinger is a graduate of Brown University and Case Western Reserve University School of Medicine, and she completed her Family Medicine residency at Greater Lawrence Family Health Center. She has clinical appointments at Harvard Medical School and Tufts University School of Medicine, and serves on MLP | Boston’s Advisory Board.
Deborah Durant is a Staff Attorney at MLP | Boston and a member of the Practical Skills Committee of the BBA New Lawyers Section. A graduate of Tufts University and Suffolk University Law School, Ms. Durant complemented her law degree with master’s degrees in Urban and Environmental Policy and Planning & Child Development. Before joining MLP | Boston in 2013, she worked at Oracle Corporation.
See Suzanne Delbanco & David Lansky, The Payment Reform Landscape: Accountable Care Organizations, HealthAffairs Blog (Aug.5, 2014, 1:12PM), http://healthaffairs.org/blog/2014/08/05/the-payment-reform-landscape-accountable-care-organizations/.
 Mass. Gen. Laws ch. 224, § 60 (2012)
See Patient Centered Medical Home Resource Center, Agency For Healthcare Research And Quality, http://pcmh.ahrq.gov/page/defining-pcmh (last visited August 13, 2014).
See Michelle H. Soper & Brianna Ensslin, State Approaches to Integrating Physical and Behavioral Health
Services for Medicare-Medicaid Beneficiaries: Early Insights, Ctr. For Health Care Strategies, Inc. (2014), http://www.chcs.org/media/State_Approaches_to_Integrating_Physical_and_Behavioral_Health.pdf.
See William H. Foege, Social Determinants of Health and Health Care Solutions, Pub. Health Reports (2010), http://www.publichealthreports.org/issueopen.cfm?articleID=2477;see also Social Determinants of Health, Ctr. for Disease Control And Prevention (last updated Mar. 21, 2014), http://www.cdc.gov/socialdeterminants/FAQ.html.
 For purposes of this article, we will refer to three arguably distinct concepts – health, wellness, and disease prevention – as “health.” The authors recognize that there is not full consensus about these delineations within the healthcare and public health communities.
See Leonard Kish & Cyndy Nayer, Addressing Social Determinants of Health as Key to Health, Health Care, iHealthBeat (May 27, 2014),http://www.ihealthbeat.org/perspectives/2014/addressing-social-determinants-of-health-key-to-improving-health-health-care; see also Mollie Bloudoff-Indelicato, Poor Quality of Life May Affect Teens’ Diabetes Management, Reuters (June 10, 2014, 12:13 PM), http://mobile.reuters.com/article/idUSKBN0EL1PQ20140610?irpc=932 .
 Malcolm Gladwell, Million Dollar Murray, Gladwell.com (Feb. 6, 2006), http://gladwell.com/million-dollar-murray/ (via http://gladwell.com/category/the-new-yorker-archive/).
Atul Gawande, The Hot Spotters,The New Yorker (Jan. 24, 2011), http://www.newyorker.com/magazine/2011/01/24/the-hot-spotters?currentPage=all.
See Complex Care Innovation Lab, Ctr. For Health Care Strategies, Inc. (last visited Aug. 14, 2014), http://www.chcs.org/project/complex-care-innovation-lab/.
See Stephen Somers & Tricia McGinnis, Introducing Totally Accountable Organizations (TACO), Ctr. For Health Care Strategies, Inc. (last visited Aug. 14, 2014), http://www.chcs.org/resource/introducing-totally-accountable-care-organizations/; see Stephen Somers & Tricia McGinnis, Broadening the ACA Story: A Totally Accountable Care Organization, HealthAffairs Blog (Jan. 23, 2014, 11:59 AM), http://healthaffairs.org/blog/2014/01/23/broadening-the-aca-story-a-totally-accountable-care-organization/.
See Agency For Healthcare Research And Quality, 2013 National Healthcare Disparities Report, Ahrq Publ’n No. 14-0006(May 2014), http://www.ahrq.gov/research/findings/nhqrdr/nhdr13/2013nhdr.pdf.
See Fenton, Health Care’s Blind Side: The Overlooked Connection Between Social Needs and Good Health, Robert Wood Johnson Found.(Dec. 2011), http://www.rwjf.org/content/dam/farm/reports/surveys_and_polls/2011/rwjf71795.
Patient Protection and Affordable Care Act, 42 U.S.C. §§ 18001 (2010).
See Accountable Care Organizations (ACO), Ctr. For Medicare & Medicaid Serv. (last visited Aug. 15, 2014), http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ACO/index.html?redirect=/ACO.
Jenny Gold, FAQ on ACOs: Accountable Care Organizations Explained, Kaiser Health News (Apr. 16, 2014), http://www.kaiserhealthnews.org/stories/2011/january/13/aco-accountable-care-organization-faq.aspx.
See U.S. Dep’t of Health and Human Serv., Determinants of Health, HealthyPeople 2020 (last updated Aug. 15, 2014), http://www.healthypeople.gov/2020/about/DOHAbout.aspx#socialfactors.
See Jennifer DeCubellis and Leon Evans, Investing In The Social Safety Net: Health Care’s Next Frontier, HealthAffairs Blog (July 7, 2014, 9: 35AM), http://healthaffairs.org/blog/2014/07/07/investing-in-the-social-safety-net-health-cares-next-frontier/ ; see also Jennifer L. Huget, ‘Super-Utilizers’ Place Huge Burden On Health-Care System, The Washington Post (Oct. 22, 2012, 7:00 AM), http://www.washingtonpost.com/blogs/the-checkup/post/super-utilizers-place-huge-burden-on-health-care-system/2012/10/19/c62781ba-1a32-11e2-ad4a-e5a958b60a1e_blog.html.
See Kristin Jones, Untreated Mental Health Issues Key in Helping System’s “Frequent Flyers,” Rocky Mountain PBS I-News (May 9, 2014), http://inewsnetwork.org/2014/05/09/untreated-mental-health-issues-key-in-helping-systems-frequent-flyers/.
See Deborah Brown & Tricia McGinnis, Considerations for Integrating Behavioral Health Sciences Within Medicaid Accountable Care Organizations, Ctr. For Health Care Strategies, Inc. (July 2014), http://www.chcs.org/media/ACO-LC-BH-Integration-Paper-0709141.pdf.
See Sabrina Tavernise, Mortality Drop Seen to Follow ’06 Health Law, The New York Times (May 5, 2014), http://www.nytimes.com/2014/05/06/health/death-rate-fell-in-massachusetts-after-health-care-overhaul.html?_r=0.
See David Schultz, Study: Mass. Global Payment Approach Lowers Costs, Improves Care, Capsules: The Kaiser Health News Blog (July 11, 2012, 4:52 PM), http://capsules.kaiserhealthnews.org/index.php/2012/07/study-mass-global-payment-approach-lowers-costs-improves-care/.
 Mass. Gen. Laws ch. 224, § 15 (2012).
Id. § 261.
See Adele Kirk, Research Insights: Prevention and Health Reform, Academy Health (July 2009), http://www.academyhealth.org/files/publications/AH_RI_Health%20Care%20reform.pdf.
See State Innovation Models Initiative: Model Testing Awards Round One, Ctr. For Medicare & Medicaid Serv. (last visited Aug. 15, 2014), http://innovation.cms.gov/initiatives/state-innovations-model-testing/.
SeePatient Centered Medical Home Resource Center, Agency For Healthcare Research And Quality, http://pcmh.ahrq.gov/page/defining-pcmh (last visited August 13, 2014).
See Steven Reinberg, Costs A Barrier to Asthma Care For Some Kids, Health Day News (May 22, 2014), http://consumer.healthday.com/respiratory-and-allergy-information-2/asthma-news-47/costs-a-barrier-to-asthma-care-for-some-kids-688005.html.
 Malcolm Gladwell, Million Dollar Murray, Gladwell.com (Feb. 6, 2006), http://gladwell.com/million-dollar-murray/ (via http://gladwell.com/category/the-new-yorker-archive/).
See Cindy Mann, CMCS Informational Bulletin: Targeting Medicaid Super-Utilizers to Decrease Costs and Improve Quality, Ctr. For Medicaid & CHIP Serv. 9, 21, 27-28, 35 (July 24, 2013), http://medicaid.gov/Federal-Policy-Guidance/Downloads/CIB-07-24-2013.pdf.
See $22 Million UnitedHealth Group Investment Helps Fund Three New Affordable-Housing Communities in New Mexico, UnitedHealth Group (June 25, 2013),http://www.unitedhealthgroup.com/Newsroom/Articles/Feed/UnitedHealth%20Group/2013/0625AffordableHousingNewMexico.aspx; Matt Chaban, Housing For The Homeless – Built With Medicaid Money, NY Daily News (Oct. 8, 2013, 4:45 PM), http://www.nydailynews.com/new-york/bronx/housing-homeless-medicaid-money-article-1.1479796.
Social Determinants of Health, HealthyPeople.Gov (last updated Aug. 14, 2014), http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=39.
See U.S. Dep’t of Health and Human Serv., Screening for Domestic Violence in HealthCare Settings, ASPE Policy Brief (Aug. 2013), http://aspe.hhs.gov/hsp/13/dv/pb_screeningDomestic.pdf.
Chen Kenyon et al., Revisiting the Social History for Child Health, Pediatrics (Sept. 2007), http://pediatrics.aappublications.org/content/120/3/e734.full (via http://medical-legalpartnership.org/wp-content/uploads/2014/03/Revisiting-the-Social-History-for-Child-Health.pdf).
See Leonard Kish & Cyndy Nayer, Addressing Social Determinants of Health as Key to Health, Health Care, iHealthBeat (May 27, 2014),http://www.ihealthbeat.org/perspectives/2014/addressing-social-determinants-of-health-key-to-improving-health-health-care; Inst. of Med., Capturing Social and Behavioral Domains in Electronic Health Records: Phase I, The Nat’L Acad. Press (2014), http://www.nap.edu/openbook.php?record_id=18709; Social Screening Tools, Health Begins (last visited Aug. 18, 2014), http://healthbegins.ning.com/page/social-screening-tools; Erin R. Hager, Development and Validity of a 2-Item Screen to Identify Families at Risk for Food Insecurity, Pediatrics (Apr. 10, 2010), http://www.childrenshealthwatch.org/wp-content/uploads/EH_Pediatrics_2010.pdf.
See Randall R. Bovbjerg et al. The Expansion, Evolution and Effectiveness of Community Health Workers, The Urban Inst. (Dec. 2013), http://www.urban.org/UploadedPDF/413072-Evolution-Expansion-and-Effectiveness-of-Community-Health-Workers.pdf.
See Where Innovation Is Happening, Ctr. for Medicare & Medicaid Serv. (last visited Aug. 18, 2014), http://innovation.cms.gov/initiatives/map/index.html#state=MA&model=community-based-care-transitions-program; See also Health Care Innovation Awards, Ctr. for Medicare & Medicaid Serv. (last visited Aug. 18, 2014), http://innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/Massachusetts.html;J. Nell Brownstein et al., Addressing Chronic Disease Through Community Health Workers: A Policy And Systems-Level Approach, Nat’l Ctr. for Chronic Disease Prevention and Health Promotion 6-7 (last visited Aug. 18, 2014), http://www.cdc.gov/dhdsp/docs/chw_brief.pdf.
See J. Nell Brownstein et al., Addressing Chronic Disease Through Community Health Workers: A Policy And Systems-Level Approach, Nat’l Ctr. for Chronic Disease Prevention and Health Promotion 6-7 (last visited Aug. 18, 2014), http://www.cdc.gov/dhdsp/docs/chw_brief.pdf.
See Patricia A. Cuff, Establishing Transdisciplinary Professionalism for Improving Health Outcomes: Workshop Summary, Inst. Of Med. (Oct. 7, 2013), http://books.nap.edu/openbook.php?record_id=18398; Chen Kenyon et al., Revisiting the Social History for Child Health, Pediatrics (Sept. 2007), http://pediatrics.aappublications.org/content/120/3/e734.full (via http://medical-legalpartnership.org/wp-content/uploads/2014/03/Revisiting-the-Social-History-for-Child-Health.pdf).
See Thomas D. Barton, Preventive Law And Problem Solving: Lawyering for the Future (2009).
See Shriver Ctr., Community Lawyering, Sargent Shriver Nat’l Ctr. On Poverty Law (last visited Aug. 18, 2014),http://povertylaw.org/training/courses/community-lawyering.
By: Margaret Schmid, Esq.
Sarah Iselin is Senior Vice President of Strategy, Policy, and Community Partnerships and Chief Strategy Officer at Blue Cross Blue Shield of Massachusetts (“BCBSMA”). She is responsible for BCBSMA’s strategic services, including internal business consulting and strategic and business planning. She also leads the company’s corporate citizenship team. Earlier this year, Ms. Iselin took a leave of absence from BCBSMA to serve as the temporary Special Assistant to the Governor for Project Delivery to oversee fixes to the Massachusetts Health Connector. Prior to serving in her current role at BCBSMA, Sarah was President of the Blue Cross Blue Shield of Massachusetts Foundation.
Ms. Iselin is the former Commissioner of the Massachusetts Division of Health Care Finance and Policy where she managed and monitored critical phases of the implementation of the state’s landmark 2006 health care reform law, including the formation of the Health Safety Net, and the Fair Share, Free Rider, and Health Insurance Responsibility Disclosure requirements for employers. She also co-chaired the Special Commission on the Health Care Payment System which recently recommended a major overhaul in the way physicians and hospitals are paid. Prior to her appointment as Commissioner, Iselin worked on the development of statewide quality and safety initiatives for Blue Cross Blue Shield of Massachusetts. From 2001 to 2005, Iselin was the director of policy and research for the BCBSMA Foundation, where she played a key role in developing the BCBSMA Foundation’s Roadmap to Coverage initiative, which provided the framework for the states 2006 health reform law. Ms. Iselin earned a master’s degree in health policy and management from the Harvard School of Public Health and her undergraduate degree from the School of the Art Institute of Chicago.
1. You graduated from the School of the Art Institute of Chicago. Subsequently, you received your master’s degree from the Harvard School of Public Health. How did you find your way from the Art Institute into the world of healthcare?
I grew up on Capitol Hill in Washington, D.C., and both of my parents worked in and around the Hill for their entire careers. I am the product of an intensely political family; public service and social justice are issues that I have always been immersed in. Growing up and attending public school in D.C. in the 70s, I saw firsthand how poverty and drug problems can affect a community, and I became aware of how much inequality there is in the world. These experiences were formative and engendered a concern about community health as a social justice issue.
When I went to college, I initially pursued the interest that I had in art and art history, but I wasn’t too far down that path when I realized that I had a public services-oriented, social justice-oriented disposition, and I wanted to pursue this part of my interest professionally. After college, I moved to Boston, and upon the recommendation of a family friend, began working for the Visiting Nurses Association. I worked there for three years, and I found the work to be very interesting on an operational level as well as on a philosophical level. Healthcare is something that affects all people; at the beginning of life and at the end of life, we all have contact with the healthcare system. It’s also an area wherein you’re dealing with matters of inequity, inequality, quality, and access, and it hearkened back to my childhood concerns related to community health. Not surprisingly, my work at the VNA resonated with me, and I’ve been working in healthcare ever since. Fortunately, though, I haven’t had to give up my love of art entirely. I’m able to satisfy my creative urges in other ways; I have three young kids who require a lot of creativity.
2. You worked at BCBSMA early on in your career and then transitioned to the public sector as Gov. Patrick’s Commissioner of the state’s Division of Health Care Finance and Policy. Later, you went back to BCBSMA and most recently accepted a temporary appointment as Governor Patrick’s Special Assistant to help solve the problems plaguing the Massachusetts Health Connector. Generally speaking, what are your favorite aspects of working in the public and private sectors?
I’ve really enjoyed having a career where I’ve been able to move back and forth between the two sectors. I think my private sector experience has made me more effective as a public sector leader, and I think my public sector leadership experience has translated well in the private sector. I hope to have a career where I continue to have opportunities to work on both sides of the aisle.
More specifically, I think that the opportunities to innovate, to experiment, to understand the concerns, constraints, and needs of businesses makes the private sector an exciting place to work, and I am able to bring an appreciation those issues into government, which, in turn, I believe has helped to make me a much more effective public leader.
In terms of the benefits of working in the public sector, if you’re someone who is passionate about change, there’s nowhere else that you have the opportunity to drive broad-scale change the way you do when you’re working for the government. For me, there is nothing more gratifying than having the opportunity to work in conjunction with the legislature to improve the healthcare experience of the residents of the Commonwealth.
3. If everyone involved with the Health Connector from Day One was sitting around a table today, what do you think people might say that they would have done differently?
Looking back, I think that the state – not just the government but everyone in Massachusetts –underestimated the impact and challenge of implementing the Affordable Care Act because we had already successfully implemented our own health reform law and because our health reform law was the model for the national health reform law. However, as we got further down the path of ACA implementation and as the federal government began to issue regulations, it became clear how many things were actually different. And as is often the case, the devil is in the details.
In regard to the website project specifically, the common sentiment seems to be, ‘Well, you had a functioning website before, why is it so hard to adapt it to the ACA’s requirements?’ Folks don’t appreciate that it’s really an ‘apples to oranges’ comparison. Massachusetts’s original website was a tool that allowed people to compare health plans. The ACA drastically increased the website’s functionality requirements. Under the ACA, states’ insurance exchanges need to present various insurance options to consumers as well as have the capability to process online insurance applications, make immediate eligibility determinations, and ideally allow consumers to begin paying premiums. At the end of the day, the ambitions of our state, and the governance structure that we put in place to manage that project, and the vendor we picked, were not the right ingredients to be successful in launching that new website on schedule.
Though these are my own words, if we could go back and do everything over again, I think folks would agree that the project should have only ever had a single point of accountability; the tripartite governance structure involving the Commonwealth Connector Authority, MassHealth, and the University of Massachusetts Medical School was too cumbersome. Hindsight being 20/20, we also should have scaled back our ambitions for the first year roll-out given the tight timeframe, and we should have selected a different vendor partner to develop the software.
4. The revamped Health Connector is scheduled to be ready by Nov. 15 for consumers to enroll in new health plans for 2015 and Massachusetts is pursuing a “dual track” strategy. Can you outline some of the benefits and risks associated with each track?
When the Governor asked me to assist him in developing a plan for moving forward, I put together an Executive Steering Committee (consisting of ITD CIO Bill Oates, ANF Secretary Glen Shor, HHS Secretary John Polanowicz, Health Connector Executive Director Jean Yang, and MassHealth Director Kristin Thorn) to help in that process. Working in concert with Optum, we took a look at all of the options that we had including assessing whether we could stay the course with our original software vendor, CGI. We concluded that CGI could not get the software fixed and finished in time, and we recommended to the Governor that we part ways with CGI. Having made that threshold decision, we then assessed the following four options: (1) start over from scratch; (2) hire a new vendor to fix CGI’s partially-built software; (3) adopt the federal exchange; and (4) implement at a commercial off-the-shelf solution. We eliminated the first two options fairly quickly as being too risky. But the two remaining options also have risks, and to hedge our bets, we decided to pursue both.
Migrating to the Federally Facilitated Marketplace is challenging because Massachusetts offers a greater level of subsidy for residents with incomes below 300% of the federal poverty line, and the federal exchange isn’t designed to support that additional level of subsidy. And as we’ve all read in the paper, the federal site is not without problems. In addition, the State’s intention has always been to maintain its own, state-based exchange. We worried that if we adopted the federal exchange in Massachusetts, the state-based exchange would never become a reality. In sum, I’d characterize this option as having policy risks.
In terms of utilizing an off-the-shelf software solution, hCentive has received great reviews; it’s powering the exchanges in Colorado, Kentucky, and in New York. The company also has small business exchange functionality, and hCentive has just been selected by the federal government to power their small business exchange. Notwithstanding the foregoing, there’s technology risk associated with pursuing this path because while this software has a good track record in other states, our timeline is quite condensed.
5. Do you have a sense of the progress being made by hCentive on the state’s off-the-shelf software solution?
The Connector Board meets once a month and is closely monitoring the progress of both tracks. At the most recent board meeting, there was a live demonstration of the hCentive product. Based on hCentive’s most recent demonstration, I think folks are cautiously optimistic. Even though this track is not without risk, hCentive has been meeting all of its near-term milestones. One thing that is notable about the hCentive track is that the software will be able to accommodate the higher level of premium subsidy for Massachusetts residents, and it appears as if this feature will be ready for the Fall 2014 roll-out. We still have a long way to go, but I’m feeling cautious optimism on the hCentive front.
6. What advice do you have for individuals who do experience a disruption in health insurance coverage?
Massachusetts is committed to protect coverage for residents of the state, and has established a transitional coverage program to ensure that residents’ health care coverage is not affected by any glitches arising from the implementation of the exchange. By way of background, when things didn’t go as expected last fall, Massachusetts – with support from the federal government – created Transitional Coverage, which is a temporary Medicaid fee for service coverage program. Currently, around 200,000 people are enrolled in the Transitional Coverage program, and the federal government has extended the authorization to keep that program going through the end of the year. This means that people will be protected for the coming months, which is great news. However, because so many people will be moving from the Transitional Coverage program into permanent, ACA-compliant coverage programs, it seems imprudent to say that there won’t be any glitches. And even though it’s not looking like we’re going to have anywhere near the problems we had last fall, it’s still going to be a change, and in the beginning, it might be difficult for consumers to navigate.
8. What are some current challenges facing Massachusetts payors?
We’re living in a time of transition in the healthcare industry and there’s an incredible amount of pressure and demand to make healthcare more affordable. This is challenging everyone in the healthcare industry from health plans, to physician groups, to hospitals to figure out how to achieve a vision where quality, affordable healthcare is available to all people. Blue Cross Blue Shield Massachusetts is developing creative and innovative ways of managing these changes, particularly around the way we pay for healthcare services rendered to our members. But it’s a time of change, that’s for certain.
9. Do you think there should be more transparency related to the Attorney General’s settlement with Partners HealthCare?
That’s a hard question to answer. There has been a lot more transparency in this state than there might be in others. We have the Health Policy Commission, and the fact that there’s a venue in which this matter was discussed and reviewed is a great thing. But consolidation is one of the big changes that I was alluding to. The drive for more accountability related to healthcare spending is certainly a contributing factor to healthcare systems looking to integrate, collaborate, and in some cases, merge. Providers are under pressure to gain efficiencies, to coordinate care better, and to save dollars, and I think there’s a belief in some parts of the healthcare world that large systems are best equipped to realize these goals. But I think, too, that we don’t know the answer to that question yet. Nevertheless, I believe that the consolidation in Massachusetts’s healthcare marketplace foreshadows what we’re going to see happen in the rest of the country in the upcoming years.
10. Do you have any advice for any young lawyers who are interested in pursuing a path in healthcare policy?
I would encourage people who are interested in policy to pursue public service. I think that the experience and perspective one gains by working in the public sector is invaluable. And we need smart, committed folks to consider making public service part, if not all, of their career path. There’s really nothing like it, both the opportunities that it creates and the learning that you gain from working inside the system.
Maggie Schmid, Esq. is an associate at Donoghue, Barrett, & Singal, P.C.. Prior to working for Donoghue, Barrett, & Singal, Ms. Schmid interned at Massachusetts Executive Office of Health and Human Services. She also worked for the U.S. Department of Health and Human Services, Office of the General Counsel, Public Health Division during her third year of law school. Ms. Schmid received her law degree from The Catholic University, Columbus School of Law in Washington, D.C., where she was a Note and Comment Editor on the Journal of Contemporary Health Law and Policy. She received her undergraduate degree from Kenyon College.