REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

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Monday, Feb. 1, Health Law Workshop with Michelle Mello

HLS Health Law Workshop: Michelle Mello

February 1, 2016 5:00 – 7:00 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Presentation Title: “Reforming the Medical Liability System in New York: Outcomes of the New York State Medical Liability Reform and Patient Safety Demonstration Project.” To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.

Michelle M. Mello is Professor of Law at Stanford Law School and Professor of Health Research and Policy at Stanford School of Medicine. She is a leading empirical health law scholar whose research is focused on understanding the effects of law and regulation on health care delivery and population health outcomes. She holds a joint appointment at the Stanford University School of Medicine in the Department of Health Research and Policy. Continue reading

TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium


MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West AB 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

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TOMORROW, 1/20! A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part II)

Special guest post by Nicholas J. Diamond

In Part I, I argued that the Affordable Care Act (ACA), while a monumental step toward improving health care in the U.S., does not fully advance the right to health in a few key respects. Responding to shortcomings in the ability of the ACA to fully advance the right is, in my view, a matter of coalescing domestic health policymaking around the right to health.

Full advancement of the right to health in the U.S. requires a normative commitment to the content of the right as articulated in General Comment 14 and related instruments. This commitment requires internalization of human rights-based norms in domestic health policymaking. Such a commitment would not only encourage the consensus required to design appropriate domestic health policies, but also provide valuable guiding principles to shepherd implementation.

Given the current political climate around the ACA, coupled with an ongoing Presidential election, statutory amendment of the ACA in order to more fully advance the right to health is highly unlikely. What is more, reliance on the rulemaking process to advance the right to health, absent an appropriate statutory foundation, would be misplaced because agency rulemaking authority is itself a statutory construct.

In the alternative, ratification of the International Covenant on Economic, Social and Cultural Rights (ICESCR) could provide just such a commitment. The U.S. is, however, very unlikely to ratify the ICESCR as an Article II treaty. Historically, the U.S. has been reluctant to commit to international human rights instruments and the current Administration has expressed its intention not to pursue ratification (at least as an Article II treaty). Absent ratification, through which international norms are internalized in national policies, it remains unlikely that the right to health becomes a guiding norm in U.S. health policymaking. Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I)

Special guest post by Nicholas J. Diamond

The right to health has played a significant role in global health fora since the World Health Organization first identified the “enjoyment of the highest attainable standard of health” as a “fundamental right of every human being without distinction of race, religion, political belief, economic or social condition” in 1946. Twenty years later, the International Covenant on Economic, Social and Cultural Rights (ICESCR) would set out the right to health in a binding international instrument. Subsequent guidance in 2000 from the United Nations Committee on Economic, Social and Cultural Rights, referred to as General Comment 14, clarified the content of the right to health, as well as articulated four elements—availability, accessibility, acceptability, and quality—that constitute the right.

Despite widespread support in the international community, the U.S. has not ratified the ICESCR. Many have argued that the Affordable Care Act (ACA) is doubtless a significant step toward realization of the right to health in the U.S. Indeed, its design speaks directly, to varying degrees, to each of the four elements of the right to health. While I acknowledge the significance of the ACA in advancing the right to health in the U.S., there are at least three reasons to doubt its ability to fully advance the right. Continue reading

Medicaid and Access to Health Care Services

Centers for Medicare and Medicaid Services Washington Headquarters

Centers for Medicare and Medicaid Services Washington Headquarters, Hubert H. Humphrey Building

Last week Health Affairs released a new article that surveyed low-income individuals in Kentucky and Arkansas, two states that expanded Medicaid coverage to all people under 138 percent of the federal poverty level in 2014. They survey, led by Harvard professors, Robert Blendon and Ben Sommers, found that people in these states reported lower rates of problems paying medical bills and forgoing care or prescriptions due to cost. Additionally, the number of people that reported seeing a physician for a checkup and management of chronic conditions increased in Kentucky and Arkansas. All of these responses are indicators of having access to health care.

The results seen in Kentucky and Arkansas are in stark contrast to the survey results in Texas, which has elected not to expand Medicaid coverage. Texas has seen no change in an individual’s ability to pay for medical services and an increase in people forgoing health care coverage. This comparison indicates that expanded Medicaid coverage improves a person’s access to medical care.

But this isn’t the first time Medicaid has been shown to score well in measures of access to health care services for low-income individuals. Contrary to the rhetoric of politicians and the logic that Medicaid’s low reimbursement rates mean people have fewer choices of physicians, evidence to date has suggested that some of these arguments may be exaggerated.

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Realizing the Potential of Accountable Health Communities

Michael Anne Kyle

The recent $157 million commitment from the Centers for Medicare and Medicaid Innovation (CMMI) for a new “Accountable Health Communities” test model is most welcome. This is major step for the agency in recognizing the significance of social determinants of health in improving outcomes and costs. A New England Journal of Medicine article accompanying the funding announcement does an excellent job of highlighting the extent to which social conditions affect health outcomes and costs.

The program will invest in 44 communities over five years in three progressively advancing tracks: “increasing awareness”, “providing assistance” and “aligning partners”. Evaluation (perhaps proof of concept is more apt) is an important aspect of the model: the goal is not only to find out whether social service linkages affect health outcomes, but what types of interventions work. The awareness and assistance tracks each involve randomizing patients to usual care or an intervention; in the case of awareness, this is information about relevant social services, and in the case of assistance, the patient is provided navigation to facilitate the connection. The alignment track provides navigation, and will not involve randomization; instead, outcomes in these communities will be measured against a matched control site.

The CMMI vision of AHCs (another new acronym, gulp!) reflects emerging trends in health care and antipoverty work. The funding announcement credits initiatives like Health Leads for inspiring the low-touch (e.g., awareness) pathways. The alignment track, meanwhile, aligns very nicely with the work of emerging Medicaid Accountable Care Organizations in states like Minnesota, Colorado, and New Jersey.

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UPDATED AGENDA: Fourth Annual Health Law Year in P/Review, January 29!


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

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Cost Control’s Growing Complexity

By Zack Buck

A paper entitled “The Price Ain’t Right? Hospital Prices and Health Spending on the Privately Insured” has a number of health policy experts talking this week. Authors Zack Cooper, Stuart Craig, Martin Gaynor, and John Van Reenen—as part of the Health Care Pricing Project—present new findings demonstrating that geographic areas with low Medicare costs and geographic areas with low private insurance costs are nearly completely unrelated. That is, locales with comparatively low Medicare costs are not necessarily areas with comparatively low costs for care paid for by private insurers. Though stunning, this lack of relation between the two metrics does make sense; the report notes that Medicare’s costs are largely driven by the amount of provided care and services, whereas care paid for by private insurance is largely affected by the price at which the care is set by each hospital. (Kevin Quealy and Margot Sanger-Katz of the New York Times have a number of interesting graphs and charts that reflect the study’s findings here.)

Indeed, before the study, and because of a dearth of private insurance pricing data, many simply believed that locales that were cheaper for Medicare were cheaper for private insurance—that is, areas that were great stewards of Medicare funds were likely efficient for private insurers as well. But this new paper demonstrates that this is not true. The two metrics are completely separate.

At the risk of overstating it, this finding could drastically change the paradigm for controlling health care costs going forward. The paper got the attention of Atul Gawande, who noted its importance in an article for The New Yorker. There, Gawande revisits the story of McAllen, Texas, which focused on exploding Medicare costs largely driven by large volume. (I even look at the McAllen story in a forthcoming article here because of its fascinating impact on cost control for Medicare.)

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Bioethicist Art Caplan: Cruz or FDA – Who do you trust with your health?

Bill of Health contributor Arthur Caplan and his colleagues have a new piece up on The Hill Blog:

Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. […]

Read the full post here.

Bill Sage Webcast on Health Law v. Health Policy

As part of the Regulatory Science series at University of Arizona:
Health Law and Health Policy: A Frictional Account
William M. Sage, MD, JD, University of Texas
Today 12/2 — Noon (AZ Time) / 2pm Eastern / 11am Pacific
The talk will be webcast live, and available as an archive:

https://streaming.biocom.arizona.edu/event/index.cfm?id=26074

Participants in the live webcast will have the opportunity submit questions and comments.  Please do!

Kentucky Continues to Inform Health Policy

By Matt Ryan

Following the Supreme Court’s decision in NFIB v. Sebelius, states have had the option whether to expand Medicaid or not. As of this writing, 30 states and the District of Columbia have expanded Medicaid. Kentucky was the only Southern state that decided to expand Medicaid and run their own exchange. The decision brought great success. Under Democratic Governor Steve Beshear, Kentucky saw their uninsured population drop by 10.6% from 2013 to 2014. As Governor Beshear put it, Kentucky was the “poster-child for the implementation of the ACA.”

Last month, Kentucky elected Matt Bevin governor. Mr. Bevin, a Republican, had promised to dismantle Medicaid and the insurance exchange. When asked about Medicaid early in his campaign, Mr. Bevin responded, “No question about it. I would reverse that immediately.” Many feared that Mr. Bevin’s election put Medicaid in critical condition. But since his election, Mr. Bevin has shifted his position.

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Premiums in Medicaid: The (not so) Recent Trend

By Emma Sandoe

Requiring Medicaid beneficiaries to pay premiums and other cost-sharing for medical services is not new to the Medicaid expansion debate. Premiums were introduced as part of the Tax Equity and Fiscal Responsibility Act of 1982. Previously, states were prohibited from imposing enrollment fees, premiums, or deductibles for any categorically eligible individual in the Medicaid program. This law allowed states to implement minimal cost-sharing for waiver demonstrations, but prohibited states from denying medical care due to an inability to pay.

Since this law was passed, the Centers for Medicare & Medicaid Services (CMS) has clarified that certain populations including pregnant women and children were exempt from most cost-sharing. Additionally, certain services are exempt from copayments and coinsurance entirely. The maximum amount that can be charged varies based on wage and type of service and where the beneficiary seeks treatment.

Prior to Indiana’s 1115, approved in 2014, CMS did not allow state waivers to charge premiums to individuals making under 50% of the federal poverty line (FPL). Indiana’s expansion plan is unlike any other state’s waiver plans. It requires individuals to pay a “monthly contribution” of $1 a month or 2% of a family’s income which ever is greater. When a beneficiary that has been paying these monthly contributions uses medical services, they are not required to pay co-payments. Previously, Indiana lowered the income eligibility for premiums during its 2013 waiver when it required premiums for individuals making between 50-100% of FPL. Arkansas and Iowa saw that precedent set by Indiana and lowered their cost sharing levels from 100% of FPL to 50%. Continue reading

The Good, the Bad, and the Ugly: Physician Coverage under the ACA

By Elizabeth Guo

A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.

Here’s where it gets ugly.

Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.

The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Continue reading

House of Reps v. Burwell: A Case Worth Following

By Matthew Ryan, Harvard Health Law Society

With the final judgment in King v. Burwell this summer upholding federal subsidies for health insurance, many legal analysts believed that lawsuits against the Affordable Care Act had ended. But the House of Representatives had other plans. In July of 2014, the House of Representatives voted on partisan lines to sue President Obama for overstepping his constitutional bounds. The House alleged that the President did not faithfully execute the Affordable Care Act with regard to two executive actions. First, the Obama Administration authorized payments to insurance companies to assist with cost sharing. The House argued Congress never appropriated these funds. Second, the House alleged that the Obama Administration unlawfully delayed the employer mandate at a $12 billion cost to taxpayers.

In September, the United States District Court for the District of Columbia cleared a major hurdle for the House: the court granted standing to the plaintiffs for their challenge to the Administration authorizing cost sharing funds without Congressional appropriation. The court did not grant standing with regards to the employer mandate implementation. Continue reading

China to Reform Review and Approval Process for Drugs and Medical Devices

China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August 9, the State Council issued the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices (RAP Opinions). Since several key reform measures initiated by the RAP Opinions involve amendments to China’s Drug Administration Law, the State Council must receive the authorization of the NPC. If the authorization is approved by the NPC, the reform of China’s RAP will be accelerated.

The direct pressure for reform comes from the very serious backlog for RAP in China. As of August, there was a backlog of 21,000 applications, and large backlogs have appeared repeatedly in the past decade. For example, there was a backlog of 17,000 in 2005 and a backlog of 27,000 in 2008. These backlogs attract more and more criticism, both from companies and patients. Patients, unable to benefit from a new drug, especially those made by foreign companies and that have proven successful and effective in other territories, have suffered. Some patients have to either rely on  smuggled drugs or conduct expensive medical tourism. Now, the State Council seems determined to reform the broken RAP system completely, with the following key reforms:

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The Once and Future Cadillac Tax

cadillacOver the last few weeks, health economists have been defending the often politically friendless “Cadillac Tax.” This policy, as part of the Affordable Care Act, will begin taxing certain generous health insurance plans starting in 2018. Since World War II, the IRS has held that employer-sponsored health insurance should not been taxed, costing the federal government $329 billion in lost federal revenue. But, the most pivotal decision in the tax exemption status of employer-sponsored health insurance took place in 1954, not during World War II.

In 1954, when Congress extended the World War II provisions into permanent tax law, Congress decided to do away with the limits imposed on the tax-free status of health insurance. In essence, Congress has already repealed the Cadillac tax back when you could buy a new Cadillac for $5,000.

The Introduction of the Tax:

As part of the World War II price and wage controls, President Roosevelt’s National War Labor Board first put limits on wage increases and would not allow wages to increase greater than 15 percent of 1941 rates. Enterprising employers began offering health insurance coverage to recruit workers, because enticing workers with higher wages was not permitted. This forced the hand of the Board to address the tax status of health insurance.

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Which state will be the next to expand Medicaid?

The last week has yielded significant progress in several states currently debating Medicaid expansion. Thirty-one states and DC have already expanded the program, made an option for states due to the Supreme Court’s NFIB v Sebelius decision. Many state legislatures are coming back into session from summer recesses bringing into focus discussions on the budget implications of Medicaid. Additionally, as we approach a looming Presidential election with expected high voter turnout, politicians have an opportunity to push for the expansion to gain support from certain stakeholders. While significant action is needed in each of these states before any Medicaid expansion legislation is passed or their governors act to implement their plans, it is worth keeping an eye on all of these states in the coming months.

Utah- It has been over a year and a half since Governor Herbert announced his support for Medicaid expansion. This week, details of the new plan, UtahAccess+, have been released. The plan, formulated by the Governor and Republican legislative leaders, is similar to the Healthy Utah plan that was passed the Utah Senate but was struck down in the House with the exception of the financing model which puts the burden on providers that would benefit from additional funds through expansion.

Louisiana- This is one of the more surprising states to appear on a list of upcoming states to expand Medicaid, however the tides may be shifting in this largely conservative state. Louisiana is in the process of electing a new governor as Presidential candidate Bobby Jindal is ineligible due to term limits. All four candidates have indicated some level of support for expansion (to varying degrees) since April. These candidates’ positions reflect the push by business groups in the state which have called for expansion, as well as the recent legislative change that gave the new governor the necessary state authority to expand in the first months in office.

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Presidential Campaigns Focus on Drug Costs

By Katherine Kwong

Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.

In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.

Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.

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