Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

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What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

Sponsored by the Center for Health Law Policy and Innovation, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the Harvard Health Law Society, all at Harvard Law School.

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School 

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

Continue reading

What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

Sponsored by the Center for Health Law Policy and Innovation, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the Harvard Health Law Society, all at Harvard Law School.

Petrie-Flom Panelists Contribute to new Guiding Framework for Designing and Implementing Serious Illness Programs

By Mark Sterling

As part of the Project on Advanced Care and Health Policy, the Petrie-Flom Center hosted two convenings on Critical Pathways to Improved Care for Serious Illness.  Through roundtable discussions and working sessions at these convenings, expert panelists reviewed innovative programs designed for the aging population with chronic illnesses, focusing on those with declining function and complex care needs.  These convenings contributed to the development of a framework to guide healthcare providers in developing and scaling programs to deliver high quality care to individuals with serious illness, which is of increased importance given the growth of this population and the development of alternative payment models.  The convenings were held in March and June, and the panelists, agendas, slide decks, and related program materials remain available on the Petrie-Flom website (Session 1 & Session 2).

C-TAC, which collaborates with Petrie-Flom on the Project on Advanced Care and Health Policy, now has published a Report, Toward a Serious Illness Program Design and Implementation Framework, to help providers develop, replicate, and scale programs across a variety of serious illness populations and settings.  The Report’s Framework provides steps to allow healthcare organizations to assess evidence-based options for each facet of care model design and implementation.  As noted in the Report, the Framework is designed to:

  • Inform serious illness program development, replication, and scaling;
  • Integrate with care model payment design;
  • Inform care model and proforma simulator development;
  • Inform other aspects of design and development such as policy, standardized measurement, and regulatory analysis.

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Recovery Navigators: How an Overlooked ACA Program Could Be a Tool in Addressing the Opioid Crisis

By Matthew J.B. Lawrence

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Research indicates that one of many challenges in addressing the opioid epidemic is getting people who are theoretically eligible for government-funded drug abuse treatment through CHIP or Medicaid to actually make use of those programs when their sickness or circumstances give them a window of opportunity to try to get help. The hassle of actually enrolling in these programs—knowing they are there, filling out the paperwork, having access to available information, and having the patience to navigate the process—is one impediment. The ACA’s sometimes-overlooked “Navigator” program could help. The ACA provision creating the program is broad enough for HHS to use it to award grants to community groups to serve as recovery navigators, enrolling addicts in Medicaid, CHIP, or Exchange coverage for substance abuse treatment.

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EPSDT: The little known acronym that helped millions of children

By Emma Sandoe

This year marks the fiftieth anniversary of the passage of the legislation that created the Early Periodic Screening, Diagnostic, and Treatment (EPSDT) program. The program requires states to provide screening and treatment to Medicaid eligible low-income children under the age of 21. In 2014 an estimated 40 million American children, or nearly one in every two kids, were eligible for this program. The Republican Obamacare repeal bills, the American Health Care Act (AHCA) and Better Care Reconciliation Act (BCRA) gives states the option to end this program for certain kids. EPSDT has improved the lives of millions of children and families in the Medicaid program over the last 50 years and has incidentally improved care for many millions more Americans.

As part of the first bill that made changes to Medicaid, this policy would become one of the most significant developments in the history the public health insurance program. Medicare and Medicaid were passed and signed into law in July of 1965 under the Medicare Act of 1965. A year later, the Medicaid program began to be implemented in states that took up the option. By the end of 1967, 38 states had opened their Medicaid programs to enrollment and begun providing services to low-income single-parent families and elderly and disabled individuals. Despite these coverage gains and medical treatment, many low and moderate-income children in two parent households lacked access to medical care. EPSDT was the first of many significant Medicaid coverage expansions to children. What was unforeseen at the time was the way that the benefits of EPSDT have been felt across the health care system and broader population. Continue reading

Keeping an Eye on the Eleventh

By Zack Buck

A particularly noteworthy health care fraud case—one that could have a major impact on the falsity requirement of the Federal Civil False Claims Act (FCA)—awaits a decision from the Eleventh Circuit as we enter the second half of 2017.  U.S. v. AseraCare, a case that could determine whether “objective falsity” and not only a “difference of opinion” is required for FCA liability, had oral arguments in mid-March in front of the Eleventh Circuit, and has been called a “case to watch” in 2017.  A decision is still forthcoming.

AseraCare was particularly notable because the FCA claim—which was alleged against the corporate hospice provider for allegedly fraudulently certifying individuals for hospice eligibility among other alleged claims—was abruptly dismissed in the Northern District of Alabama in 2016.  Rejecting the claims because the government failed to prove that the claims at issue were objectively false, Federal District Court Judge Judge Karon Owen Bowdre found that the government only proved that a clinical disagreement existed as to whether or not the patients should have been certified as hospice-eligible, which was insufficient to prove a false claim under the FCA.  According to the court, allowing the government to prove that a FCA action could be maintained based only upon the government’s disagreement with the defendant’s clinical judgment would allow the government to “short-circuit” the FCA’s falsity requirement. Continue reading

New Drug Pricing Bill from Democrats Balances Innovation, Access

By Rachel Sachs

Yesterday, a group of 20 Democrats in both the House and Senate introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug costs while increasing innovation and promoting transparency.  The bill aims to accomplish a number of different goals, and in this post I’ll go through the different functions it serves and consider some notable provisions.  For those who are interested, here’s a provision-by-provision summary.  This is going to be a very long post, so I apologize in advance.

On the whole, I think there’s a lot to like in this bill, particularly in its promotion of innovation and in the way in which it seeks to curtail bad actors within the industry.  However, I don’t agree with all of its provisions (as you’ll see) and I view some of its proposals as kludge-y solutions to kludge-y problems our complex system has created.  I’m not yet sure whether I see that as a bad thing, to be clear – it works to create meaningful change within a system that was cobbled together over decades, mostly accidentally.  But it isn’t the platonic ideal of a value-based pricing system, or anything similar.

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Medicare Advantage Might Have Potential — If Companies Play Fair

By Shailin Thomas

Medicare Advantage was introduced as a mechanism for capturing some of the oft-extolled efficiencies of the private health insurance market. Instead of paying providers for services directly, as in traditional Medicare, the government pays Medicare Advantage insurers a predetermined, risk-adjusted amount of money per patient to cover all medical expenses for the year. The risk adjustment ensures that companies insuring Medicare Advantage patients with chronic diseases — who will likely need more intensive, expensive care — receive additional funds to help cover those costs. For each qualifying condition a patient has, the Medicare Advantage plan receives on average an additional $3000 annually.

While the risk adjustment of Medicare Advantage payments was well intentioned and economically rational, it appears to have opened up an avenue for significant abuse on the part of Medicare Advantage insurers. The Department of Justice recently joined a lawsuit against UnitedHealth, a large provider of Medicare Advantage plans, for allegedly defrauding the government out of hundreds of millions, if not billions, of dollars. The complaint alleges that UnitedHealth “upcoded” its risk-adjustment claims by submitting for conditions patients did not actually have and refusing to correct false claims when it discovered or should have discovered them. In essence, the company allegedly realized it could extract more money out of the government by making the patients it covers appear sicker than they actually are, and took full advantage of that.

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Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading

All-Payer Claims Databases After Gobeille

By Gregory Curfman

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

ACA Repeal and the End of Heroic Medicine

By Seán Finan

Last week, I saw Dr Atul Gawande speak at Health Action 2017. Healthcare advocates and activists sat around scribbling notes and clutching at their choice of whole-food, cold-pressed, green and caffeinated morning lifelines. Gawande speaks softly, lyrically and firmly; the perfect bedside manner for healthcare advocates in these early days of the Trump presidency. He calmly announced to the congregation that the age of heroic medicine is over. Fortunately, he continued, that’s a good thing.

Gawande’s remarks echoed a piece he published in the New Yorker. He writes that for thousands of years, humans fought injury, disease and death much like the ant fights the boot. Cures were a heady mixture of quackery, tradition and hope. Survival was largely determined by luck. Medical “emergencies” did not exist; only medical “catastrophes”. However, during the last century, antibiotics and vaccines routed infection, polio and measles. X-rays, MRIs and sophisticated lab tests gave doctors a new depth of understanding. New surgical methods and practices put doctors in a cage match with Death and increasingly, doctors came out with bloody knuckles and a title belt. Gradually, doctors became heroes and miracles became the expectation and the norm. This changed the way we view healthcare. Gawande writes, “it was like discovering that water could put out fire. We built our health-care system, accordingly, to deploy firefighters.”

But the age of heroic medicine is over. Dramatic, emergency interventions are still an important part of the system. However, Gawande insists that the heavy emphasis on flashy, heroic work is misplaced. Much more important is “incremental medicine” and the role of the overworked and underappreciated primary care physician.

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Judy Solomon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week we discussed the future of the ACA with Judy Solomon of the Center for Budget and Policy Priorities. Judy is Vice President for Health Policy at CBPP, where she focuses on Medicaid and the Children’s Health Insurance Program. She is also an expert on issues related to the implementation of the ACA, particularly policies to make coverage available and affordable for low-income people.

As new alternatives to the ACA emerge, we discussed the wide range of policies that may be in the offing for state Medicaid waivers. CBPP has a fascinating and up-to-date series of posts on the transition from Obamacare to Trumpcare. Follow Judy on Twitter at @JudyCBPP, which includes links to her insightful blog posts and a number of other critical developments in health policy.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Well-rested versus well-trained doctors: New twist in debate over resident duty hours (Part II)

By Brad Segal

When people fall acutely ill, they deserve a non-sleep deprived doctor—but they also deserve an adequately-trained doctor. There are only so many hours to the day, and so in medical education a resident’s need for self-care must be balanced against the need for maximum clinical exposure. Since 2003, when restrictions to resident duty hours were first enacted, there has been disagreement about how to best navigate the tension. Recently, the debate resurfaced when the Accreditation Council for Graduate Medical Education (ACGME) proposed a change to the policy governing resident duty hour limits. Perhaps the most surprising part of the announcement was that their proposal increased the time limit that interns (first year residents) can care for patients without sleep. The policy ACGME enacted in 2011 had capped interns at 16 hours on-call, and the proposal increases the limit to 28 hours.

In my prior post I raised arguments for and against the proposed changes to duty hour limits. Here I will unpack the conclusions and limitations of the best empirical evidence available to ACGME: the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Published in the New England Journal of Medicine (NEJM) in 2016, the FIRST Trial randomized 117 surgical residency programs nationwide to have either “standard” duty hour policies, which included the current 16-hour cap on interns, or “flexible” policies, which reflect the recent ACGME proposal. Data were collected from July 2014 to June 2105. The sister-study involving medical residencies nationwide has regrettably not yet published.

The FIRST Trial warrant close attention because, like a Rorschach test, different people see different things in the data. For instance, take the finding that neither group caused significantly more or less harm to patients, though shorter duty hours were associated with more handoffs of patient responsibility. Taken at face value, these results neither clearly bolster nor contradict the proposed duty hour changes; yet they are used to both support and undermine the tentative changes to ACGME policy. The study’s first author told NPR that, “We believe the trial results say it’s safe to provide some flexibility in duty hours.” On the other hand, an editorial published in NEJM alongside the study argues that, “The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care.” Is there a right conclusion to draw from the study? Continue reading

Over Before It Started: CMS Abandons New Payment Pilot

By Zack Buck

With little fanfare, last month, the Centers for Medicare and Medicaid Services (CMS) abandoned its proposal to begin a payment pilot in which Medicare Part B would change the way it pays for pharmaceutical drugs.  As I blogged about last March, under the proposed pilot, providers’ payments would be changed from the Average Sales Price (ASP) plus 6 percent of drugs’ costs (ASP+6), to ASP plus 2.5 percent of the drugs’ costs plus a flat fee per drug per day (of $16.80). This new proposed pilot would have been time-limited, and would have allowed officials to observe the effects of such a reimbursement change on prescribing patterns in an effort to cut Medicare’s substantial drug costs.

Following an outburst of negative reaction from Medicare’s providers, the pharmaceutical industry, and Congress (including the new nominee to be Secretary of Health and Human Services Tom Price), CMS announced in December that more than 1300 public comments were submitted in reaction to the proposal.  And following November’s election and the public comments shared with CMS, the agency announced that it had decided that “the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time.”

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