Posts Categorized: Winter 2015

IN THIS ISSUE: Winter 2015

cosgrove  Jerry Tichner Bio photo  Zick_Colin

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.

Opinion Pieces:

Telemedicine in Massachusetts: What Providers Need to Know
By George Leehan, Sarah Sossong, and Nathaniel Lacktman

The Medical Use of Marijuana and Legal Issues Associated with Physician Certification of Medical Marijuana Use by Qualifying Patients
By Jesse Alderman

BOOM! Aging Baby Boomers are Set to Cause an Explosion in Government Enforcement and Health Care Fraud and Abuse Investigations of Skilled Nursing Facilities
By Daniel C. LaPenta

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

Telemedicine in Massachusetts: What Providers Need to Know

 By George Leehan, Sarah Sossong, and Nathaniel Lacktman, Esq.

Introduction

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]

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The Medical Use of Marijuana and Legal Issues Associated with Physician Certification of Medical Marijuana Use by Qualifying Patients

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.

Background

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]

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BOOM! Aging Baby Boomers are Set to Cause an Explosion in Government Enforcement and Health Care Fraud and Abuse Investigations of Skilled Nursing Facilities

By  Daniel C. LaPenta, Esq.

IIntroduction

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.

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Policymaker Profile: Tom O’Brien

By Anna Gurevich, Esq.

Thomas More O’Brien is the General Counsel for the Massachusetts Department of Public Health (“DPH” or the “Department”) where he oversees a 45-person legal office.  As chief lawyer for the Department, Tom manages the legal affairs for the Department and is responsible for the interpretation and administrative enforcement of the Commonwealth’s public health laws (primarily M.G.L. c. 111 and portions of c. 112) and regulations.  The Department operates with more than 3,000 employees at fifteen locations including four public health hospitals, and performs a range of statutory functions including administration of vital records, licensure of health professionals (e.g., nurses), licensure of health providers (e.g., hospitals), surveillance to monitor food safety, and efforts to detect, prevent, and reduce infectious and environmental public health threats.

Prior to joining the Department in June of 2014, Tom was an Assistant Attorney General and Chief of the Health Care Division in the Office of the Attorney General of Massachusetts.   Tom successfully led the Health Care Division through significant policy work and litigation against numerous health plans, health care providers, and pharmaceutical companies returning tens of millions of dollars to Massachusetts.  He led the Health Care Division’s groundbreaking examination of health care cost trends and cost drivers. Tom started his career in public service in the Executive Office for Administration and Finance, where he helped launch the Office of Purchased Services that reformed the Commonwealth’s system for purchasing health and social services from private vendors.  Tom received a J.D. from Suffolk University Law School, an M.P.A. from the University of Massachusetts at Amherst, and a B.S. (mathematics) and a B.A. (English literature) from the College of Santa Fe.

Why don’t we start by you walking me through your background and experience before joining the Department of Public Health?

I joined DPH at the Department’s request this past summer. I came to the Department after 21 years at the Office of the Attorney General (“AGO”), where most recently I was the Chief of the Health Care Division within Attorney General Martha Coakley’s office. I was originally hired into the office by Attorney General Scott Harshbarger. So I had the pleasure of working with 3 attorneys general – Scott Harshbarger, Tom Reilly, then Martha Coakley. Prior to joining the AGO, which is now ancient history, I was in the Executive Office for Administration and Finance. I started there during the Dukakis administration after graduating with my Master in Public Administration, and worked there while I went to law school.

It sounds like you were significantly involved with government at the same time you decided to pursue law. What prompted you to become a lawyer?

That is a good question. I am not from a legal family, and I did not have a particular desire when I was in high school or college to go to law school. I am a career public servant, and it was always my intention to be in public service. Some might say (laughing), that with a name like Thomas More O’Brien, it is not surprising that I ended up a lawyer, and a lawyer involved in public service. I was still working on my college thesis when I started working as an intern for the Executive Office for Administration & Finance in the Dukakis administration. There, I worked with some outstanding attorneys who were not litigators- they were in practice as government officials. They recognized, whether it was for good or ill, that I had some of the same qualities that government attorneys had, with regard to how I looked at and analyzed issues. So the suggestion was made by multiple people that I should explore going to law school, which is what I did. In 1988, I started at Suffolk University, working during the day in the Executive Office and going to law school at night.  I relished that period of time. It was a lot of work, but it enabled me to see the Dukakis and then Weld administrations in action during the day, and then have the construct of the law reinforced at school in the evenings. When I graduated from law school it was my intention to stay with the administration, but multiple people suggested that I go to the AGO as a better opportunity to hone my legal skills. Twenty years later, I was still at the AGO, relishing the work. I have always been, in my career, proud to be an employee of the Commonwealth of Massachusetts.

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Health Law Case Brief: Robert Roe, et al vs. Children’s Hospital Medical Center

By Rachelle Rubinow, Esq.

In Robert Roe, et al vs. Children’s Hospital Medical Center,[i] the Supreme Judicial Court (SJC) ruled that a hospital employer does not owe a duty of care to the future patients of a former physician employee who had left its employ and was working for a different employer when that physician allegedly abused the plaintiffs.

In 1966, Children’s Hospital Medical Center (Children’s Hospital) hired Melvin Levine as a pediatric physician, a position he held until 1985, when he relocated to North Carolina and began working as a pediatrician at the University of North Carolina School of Medicine (UNC). In 2009, he surrendered his medical license amid allegations that he performed medically unnecessary genital examinations on several UNC patients. Two years later, eleven former UNC patients of Dr. Levine’s brought suit against Children’s Hospital in Superior Court. They alleged that Children’s Hospital failed to properly train, supervise, or discipline Levine during his employment at Children’s Hospital; knew or should have known that Levine was conducting inappropriate genital examinations of minors during that employment; and failed to report Levine’s conduct to various licensing authorities and UNC. The evidence used in support of the complaint included an allegation made by the mother of a former patient in 1967, as well as litigation brought in 1988, 2005, 2006, 2007, 2008, alleging similar conduct by Dr. Levine toward minor patients during his employment at Children’s Hospital.

Children’s Hospital moved to dismiss the plaintiffs’ complaint for failure to state a claim upon which relief could be granted. In response, the plaintiffs moved to amend, seeking to add an allegation that Children’s Hospital owed them a duty of care because it had a “special relationship” with Levine, and it knew or should have known that he posed a foreseeable risk of harm to future patients. In July 2012, the Superior Court granted Children’s Hospital’s motion to dismiss and denied the plaintiffs’ motion to amend. The plaintiffs appealed, and the SJC granted direct appellate review, with the only issue on appeal being whether Children’s Hospital owed a duty of reasonable care to the plaintiffs.

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Health Law Case Brief: Genereux et al. v. Raytheon Co.

By Alysson M .Gray, Esq.

On June 10, 2014, the United States Court of Appeals for the First Circuit (First Circuit) affirmed a ruling of the United States District Court for the District Court of Massachusetts (District Court) granting a motion for summary judgment in favor of the defendant in Genereux et. al. v. Raytheon Co.[i] The decision in Genereux results in a narrowing of protections extended to individuals exposed to dangerous substances during their employment. Although past precedent in Massachusetts signals that those exposed to dangerous substances during the scope of their employment may be eligible for employer-funded medical monitoring, the Court in Genereux held that a plaintiff must show evidence of a subcellular or physiological change in order to secure compensation for treatment.

The defendant, Raytheon, is a company based out of Waltham, MA that specializes in defense and security technology.[ii] The plaintiffs alleged that the defendant endangered the health of its employees and their families by negligently exposing them to beryllium[iii], a hazardous substance used in the manufacturing process at the Waltham plant. The plaintiffs sought a court order compelling the defendant to establish a trust fund that would provide for medical monitoring of beryllium sensitization (BeS) for two groups. The first class consisted “…of all persons who worked at the Waltham plant for at least one month prior to December 31, 1996.”[iv] The other group consisted “…of all persons who lived with members of the first class and thus were subject to take-home beryllium exposure.”[v] Employees already diagnosed with Chronic Beryllium Disease (CBD) were excluded from both classes. (more…)