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:
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. (firstname.lastname@example.org) 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.
By: Elta Mariani
Representative Jeffrey Sánchez has served as the Massachusetts State Representative for the 15th Suffolk District since 2003. In February 2015, he was appointed the House Chairman of the Joint Committee on Health Care Financing. Prior to this role, he served as the House Chairman of the Joint Committee on Public Health.
Representative Sánchez’s overall legislative agenda is driven in large part by the issues faced in his district– access and retention in education, public infrastructure development, workforce development, public health, and affordable housing. His healthcare work is focused on evidence-based health policy reform, particularly for underserved communities. He has worked to pass comprehensive reforms on compounding pharmacy practice and school nutrition programs, as well as expanded public health data sharing, enhanced practice for nurse midwives, and was instrumental in several key provisions of Chapter 224, the 2012 Massachusetts health care cost-containment law.
Before running for the House of Representatives, Sánchez worked in the Boston Mayor’s Office from 1995 to 2001. Prior to this work, Sánchez worked in San Diego as a financial management advisor and investment banker. He earned his Bachelor of Arts Degree in Legal Education from the University of Massachusetts, Boston, a Masters of Public Administration from the John F. Kennedy School of Government at Harvard University and is a current instructor at the Center for Public Health Leadership at the Harvard University TH Chan School of Public Health.
- What drew you to politics?
My mother was a community activist, and her area of focus was housing. We moved to Boston when I was a small child and lived in a housing project down the street from Harvard and Children’s Hospital. My mother was troubled by the Boston Housing Authority- its bureaucratic nature, how it treated people, and its failure to help many people find opportunities. She organized people, planned community meetings, was the head of a housing task force, and even sued and won against the Housing Authority (Perez v. BHA). Boston was a different city then. It was in decline. Now, the community where I grew up is thriving. My mother made some friends but her drive often challenged people, which I did not like when I was young. It wasn’t until later that I appreciated her activism and embraced public service myself.
- You have an MPA from Harvard. How has that helped you in your current role?
I attended the program after 15 years of government and finance work had left me feeling tired and defeated, and it became vocational training for me. The Kennedy School intellectualized things I had been working on. It helped me refine fundamental knowledge that I already had. Also, it put me in contact with the folks who are leading authorities. I initially wanted to work for a mutual fund company, but I managed to meet with Mayor Thomas Menino, and 20 years later here I am.
- How do you balance the agendas of various interest groups? Attorneys at firms have a duty of loyalty to their clients, and in-house attorneys to their companies, but as a legislator, don’t you have a duty to the entire public?
I listen to people. I ask enough probing questions until I get at what people really want. Then, I weave their ideas together and try to hopefully build something that people at opposite ends can appreciate and own together as opposed to holding on tightly to what they think is the solution. I have been a stock broker and an investment banker- I am done with selling. Now I am dealing with the business of people, and it is all about bringing people together for the goal of the public good. One of the biggest issues is poverty. Boston is cleaner, prettier, and more modern today, but it is still a challenging city for a lot of people.
My most valuable class from the Harvard Kennedy School was taught by Brian Mandell. It was a sort of “negotiations bootcamp” that helped me compartmentalize the challenges involving state and local finance, infrastructure investment, math and public policy, and accountability. We would work on things and then go over in class the pieces that would help make the best value for people.
- Tell me about the Joint Committee on Health Care Financing.
I was appointed to the committee in late February, and I had previously served on the Committee of Public Health for 6 years. In this prior experience I learned about how the government tries to address health in a group setting, and the mechanics of this setting (aka, how the delivery system operates). I worked on initiatives such as regulating compounding pharmacy and drugs and rewriting the determination of need statute to include market impact (region and Commonwealth as a whole) in Chapter 224. I worked with finance on the public payer side, MassHealth, and members of various communities. Some major issues were primary care, workforce issues, and insurance card use. I learned how to look at the healthcare system within the overall market economy, and ask what are things that impact it and how can we remedy certain issues.
Since healthcare reform began in 2006, these have continued to be big issues. 37% of the state budget is spent on healthcare in one way or another. Medicaid is $15 billion and growing. This matters because the economy health is linked to healthcare. Healthcare comprises 11-12% of the economy. The committee’s goal is to improve care delivery in a manageable and sustainable way.
- About how many bills does the committee address on a regular basis? How does the process work?
We get bills referred to us from any of 5 other committees- Financial Services, Public Health, Mental Health and Substance Abuse, Children and Families, and Elder Affairs. We usually begin a legislative session with around 150 bills.
Bills also come from constituents. If you have a good idea, you could go to your representative and the bill will get filed. Then, a clerk looks at the bill and determines where it goes. I don’t get to choose bills. The clerk gives them to my committee. Then I work with my Senate counterpart and if the bill gets traction, we will rewrite it until it is approved.
- Do bills often reflect changes occurring in surrounding states? For example, this summer Connecticut enacted new hospital legislation that seems to dissuade mergers, and New Hampshire enacted a paid sick time law. Does the committee actively watch such developments?
I have a fantastic research staff that makes sure everything I need to know crosses my desk. My staff is comprised of people with many different backgrounds including public health, business, and law.
- What is your view on elections and short terms for state representatives? Do they tend to keep political goals in line with those of the general populace, or are they a distraction from making real changes, due to worries about continued constituent support?
Nah. Every 2 years your name is on the ballot. If people like you and you are doing the right thing, you will get re-elected. If not, you won’t. The world of politics changes a lot. The new generation looks at things completely differently. You used to be able to get strong messages out, but now with phones and laptops, people are no longer attending community meetings. But that doesn’t mean people are not informed. As a politician, you need to put yourself into the new way of communicating to reach people. You still must hold on to fundamental strategies too, because people still go outside, but it is a balance.
- What role do you see lawyers playing regarding these challenges? What role ought they to play?
Lawyers exercise the right to have representation in many forms. Also, the legal community is very well represented in public affairs. I can talk to the head of an institution or organization, but they will always have a legal team that they depend on. Yes, lawyers and politicians both get a hard time for sometimes aggravating problems, but who said representation was going to be easy? The world is more complicated now than ever before, and lawyers and politicians are needed.
Massachusetts is a very dynamic state when it comes to healthcare policy, delivery, finance, and writing the tomes. Members of the bar make the difference because they are actively improving how we do things.
- Does the Open Meeting Law apply to you and if so, does it inhibit or aid decision-making?
The Open Meeting Law is pretty complicated. I can meet with people. Talking to people and learning from them is not covered. It is when I am making decisions that it matters. We have a public hearing on each bill (though the meeting to learn about it can be off-camera), where we incorporate co-chair comments and ask if there will be a motion to move the bill forward. Then if we get a motion, we talk to other members in a public meeting executive session before voting.
- Tell me something interesting about you that people do not generally know (a “fun fact”).
I wanted to go to law school and actually applied to BU and Suffolk Law, but ultimately Harvard Kennedy School was the best option for me. Also, I think it is funny when people ask what my plan is. My plan is going and talking to people about their plans. The people who are underserved and underprivileged need a voice.
- Is health care spelled as one word or two?
I usually spell it as one, but I think that it can be spelled either way. A piece of advice- always asks the question that you’re afraid to ask, because other people may be wondering the same thing.
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.
Meg Cosgrove, Jerry Tichner, Colin Zick
Co-editors, Health Law Reporter
Jerry, Colin and I are proud to bring you the Winter 2015 edition of the Health Law Reporter. The good news is that we can promise that this edition has nothing to do with the weather and will not comment upon the record snow or cold temperatures experienced by Boston this winter. Instead, this edition brings with it news of epic changes to the Massachusetts healthcare landscape as we move into spring. In this issue, George Leehan, Sarah Sossong and Nathaniel Lacktman cover the principal legal and regulatory issues associated with the current state of telemedicine in Massachusetts including licensure, scope of practice, credentialing and reimbursement issues. Jesse Alderman tackles the intricacies of physician certification of the medical use of marijuana for patients including the parameters associated with qualifying patients as having a “debilitating medical condition,” the requirements surrounding a physician’s certification that the benefits of medical marijuana outweigh the risks to the patient, and the criteria required to register as a certifying physicians with DPH. This article follows up on the Summer 2014 Reporter article discussing the legal issues confronted by Registered Marijuana Dispensary (RMD). Finally, Daniel LaPenta discusses the exposure of skilled nursing facilities to increased government enforcement due to the increase of Medicare-eligible beneficiaries from the “baby boom” generation.
We are also excited that Anna Gurevich from Beth Israel Deaconess Medical Center was able to spend some time with Tom O’Brien, the General Counsel of the Department of Public Health and the former Chief of the Health Care Division at the Office of the Attorney General. In her interview, Anna garnered insights from Tom regarding his role at DPH as well as his dedication to public service and the enforcement of the rule of law. This edition also includes summaries on two recent health law cases in Massachusetts—Barry Genereux, et. al. v. Raytheon Co. addresses employer responsibility for medical monitoring for employees exposed to dangerous substances and Robert Roe, et. al. v. Children’s Hospital Medical Center discusses whether a hospital owes a duty of care to allegedly abused future patients of a former physician employee.
On a final note, we wanted to extend our heartfelt thanks and appreciation to our former co-editor, David Sontag from Beth Israel Deaconess Medical Center for all of his hard work and dedication to the Reporter over the years.
Telemedicine in Massachusetts: What Providers Need to Know
By George Leehan, Sarah Sossong, and Nathaniel Lacktman
Policymaker Profile: Tom O’Brien
By Anna Gurevich
Health Law Case Briefs:
Robert Roe, et al vs. Children’s Hospital Medical Center
By Rachelle Rubinow
Genereux et al. v. Raytheon Co.
By Alysson M .Gray
By George Leehan, Sarah Sossong, and Nathaniel Lacktman, Esq.
Telemedicine is an exciting clinical delivery tool that offers real ways to address healthcare’s persistent problems of access, coordination, and efficiency. But with innovation comes unique legal considerations, and while some states have given significant thought to telemedicine, publishing robust laws or rules to guide adoption and promote reimbursement, Massachusetts laws and regulations have not addressed the area in depth.
And yet, despite the lack of robust regulatory standards or widespread commercial coverage of telemedicine in Massachusetts, many providers and hospital systems have taken the initiative and successfully embedded telemedicine into their patient care delivery models. The resulting dissonance between telemedicine policy and telemedicine practice is particularly evident in Massachusetts, where a number of legal hurdles continue to exist, serving to inhibit the widespread adoption of certain telemedicine options in Massachusetts despite the strong efforts of the provider community to push the technology forward. Written primarily with Massachusetts healthcare providers and legal counsel in mind, this article covers the principal legal and regulatory issues around telemedicine in Massachusetts – licensure, scope of practice, credentialing, and reimbursement.[i]
By Jesse Alderman, Esq.
This is the second article in a two-part series on the medical use of marijuana in Massachusetts. The first article addressed some of the issues associated with the opening of a registered marijuana dispensary (RMD). This article addresses issues associated with physician and clinician certification of the medical use of marijuana for patients.
The Massachusetts voters passed a ballot initiative in 2012 authorizing physician certification, patient use and commercial sale of medical marijuana consistent with a detailed regulatory framework for patients, physicians, caregivers and medical marijuana purveyors.[i] Chapter 369 of the Acts of 2012 – An Act for the Humanitarian Medical Use of Marijuana (the “Act”) – authorized the Department of Public Health (DPH) to license up to 35 RMDs in the Commonwealth and to promulgate regulations to implement the medical marijuana program.[ii]
The registration of RMDs has been slow and not without continuing controversy, but the opening of RMDs in Massachusetts appears now to be nearing fruition.[iii] In November 2013, after a multi-part application process – and numerous media reports questioning the rigor of DPH’s vetting of applications and the political connections of certain applicants – DPH provisionally selected 20 applicants (out of an initial pool of 181) to move to what it called a “verification phase” of the registration process.[iv] Additionally, DPH invited five applicants to reapply to operate RMDs in counties for which no applicant was provisionally selected.[v] During the “verification phase,” DPH further analyzed the accuracy of the 20 provisionally selected applications and disqualified nine of the applicants.[vi] On June 27, 2014, eleven applicants were invited to begin securing necessary approvals and otherwise establish fully operational RMDs subject to an “inspection phase” by DPH.[vii] Likewise on November 7, 2014, after reviewing resubmissions from invited applicants, DPH approved four more RMDs (from three separate applicants) to proceed to the inspection phase.[viii] DPH will not register an RMD until an applicant satisfactorily passes the inspection phase.[ix] The agency has said it expects the first dispensaries to open “this winter.”[x] To that end, DPH has now registered Alternative Therapies Inc. to grow medical marijuana in anticipation of opening its Salem dispensary within months pending final approvals; the applicant satisfactorily passed through DPH’s “inspection phase.”[xi]
By Daniel C. LaPenta, Esq.
Seventy years ago, the greatest generation stormed the beaches of Normandy and planted an American flag atop Iwo Jima’s Mount Suribachi. Stateside, the greatest generation supplied the boats, bullets, and beans necessary for success. In the twenty years that followed, the greatest generation spawned the “baby boomers,” who now present perhaps our nation’s greatest challenge: taking care of them. It is ironic that the most vulnerable among us are the sons and daughters of a generation that endured the Great Depression, defeated Nazism, and laid the groundwork for American’s economic surge. Attendant to that vulnerability is a health care system trying to care for them, profiteers ready to exploit them, and the government attempting to protect them.
This triad of players involved in health care for the elderly naturally implicates Medicare reimbursement for the services of skilled nursing facilities (SNFs).[i] With the rise of government spending on Medicare to meet the demands of the aging and retiring baby boomers, there is more opportunity for innocent errors, pervasive abuse, and outright fraud. The government will try to curb the waste of the tax dollar through increased oversight and enforcement. Trends since the passage of the Affordable Care Act (ACA)[ii] show that oversight of SNFs is a government priority. Recent enforcement actions display that reality with no signs of slowing. In particular, there appears to be a focus on the “quality of care” that SNFs must (statutorily) give to their residents. This will increase the compliance risk for the future of SNFs, exposing them to greater civil and even criminal penalties.