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Reconsidering Health Care Fraud and Abuse Laws image

Reconsidering Health Care Fraud and Abuse Laws

Carmel Shachar (Executive Director)
JAMA

When financial incentives influence physicians’ clinical decision-making, there may be cause for concern. Not all inducements aimed at affecting the utilization of medical services, however, are ill-intentioned. At a…

For Many in the U.S., Prescription Drugs Still Unaffordable image

For Many in the U.S., Prescription Drugs Still Unaffordable

Tanzina Vega, interviewing Rachel Sachs (Former Academic Fellow)
The Takeaway

There were many notable moments at last week’s chaotic presidential debate, from President Trump’s refusal to condemn white supremacy to his swipes at Democratic nominee Joe…

Experts Uncertain If the President’s Drug Import Plan Will Save Consumers Money image

Experts Uncertain If the President’s Drug Import Plan Will Save Consumers Money

Roz Plater, quoting Rachel Sachs (Former Academic Fellow)
HealthLine

On average, people in the United States spend about $1,200 a year on prescription drugs. That’s more than anywhere else in the world. With copays and out-of-pocket costs soaring,…

‘Medical debt is a violation of human rights’ image

‘Medical debt is a violation of human rights’: At a Petrie-Flom event on medical debt, health experts and journalists raise serious concerns about the affordability of testing and hospital care

Chloe Reichel (Communications Associate)
Harvard Law Today

Medical debt “totally traumatizes people” and “discourages people from going anywhere near the health care system,” said Robert Yates, director of the Global Health Programme and…

Debt, Dignity, and Health Care image

Watch online now! Debt, Dignity, and Health Care: Guaranteeing Health Rights and Universal Health Coverage

March 27, 2020
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Online Viewing Couldn't join us during the webinar? Watch fully-captioned video of the sessions! Check out the conversation on Twitter: #debtdignityhealth! View some of the panelists' slide presentations below! …

Kept at the Hospital on Coronavirus Fears, Now Facing Large Medical Bills: Care was mandated by the government, but it’s not clear who has to pay.

Sarah Kliff
New York Times

[...] Patients in the United States regularly confront surprise medical bills that are hard to decode. Mr. Wucinski’s case suggests that those held in mandatory isolation for suspected coronavirus…

Lessons from Germany on Controlling Prescription Costs image

Video now available! Lessons from Germany on Controlling Prescription Costs

February 25, 2020
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Description To control the costs of prescription drugs, Germany combines immediate access to innovative drugs with price controls. The system assesses scientific evidence on the value of new drugs to…

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Book Talk: When Misfortune Becomes Injustice: Evolving Human Rights Struggles for Health and Social Equality

February 7, 2020
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Description When Misfortune Becomes Injustice (Stanford University Press, February 2020) surveys the progress and challenges faced in deploying human rights to advance health and social equality over the last thirty years,…

‘A Supercenter for health’: Walmart places a big bet on cheaper, less intimidating primary care

Megan Theilking
STAT

[...] Interviews with Slovenski and other leading Walmart health executives revealed new details about the company’s strategy for the clinics, which it sees not only as a low-cost, less…

U.S. health system costs four times more to run than Canada’s single-payer system

Melissa Healy
Los Angeles Times

In the United States, a legion of administrative healthcare workers and health insurance employees who play no direct role in providing patient care costs every American man, woman and child…

Hospitals Merged. Quality Didn’t Improve.: The quality of care at hospitals acquired during a recent wave of deal making got worse or stayed the same, new research found

Melanie Evans
Wall Street Journal

This article is behind a paywall. Harvard affiliates can access the full text via Hollis. The quality of care at hospitals acquired during a recent wave of deal making got…

Politically Trump’s Drug Importation Plan Looks Good On Paper, But It’s Unrealistic And Won’t Cut Costs, Critics Say

Kaiser Health News

KHN Morning Briefing: Summaries of health policy coverage from major news organizations For one thing, Canada doesn't produce enough drugs, nor does it seem to be on board with…

Some Big Health Care Policy Changes Are Hiding In The Federal Spending Package

NPR Staff
NPR

Congress is set to pass a $1.4 trillion spending package this week, which President Trump has said he'll sign. The legislation includes policy changes and funding increases that public health…

House passes major drug-pricing bill, a Democratic salvo in a showdown far from over

Lev Facher
STAT

WASHINGTON — House Democrats on Thursday passed sweeping legislation to lower prescription drug prices, marking the latest volley in a health care debate that has animated progressives, Republican lawmakers, pharmaceutical…

First Opinion: Do large pharma companies provide drug development innovation? image

First Opinion: Do large pharma companies provide drug development innovation?: Our analysis says no

Emily H. Jung (former intern), Alfred Engelberg, and Aaron S. Kesselheim
STAT

From the article: Large pharmaceutical companies oppose legislation being considered by Congress to lower the prices of prescription drugs. Reducing their revenues, they contend, will reduce their investment in drug…

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Eighth Annual Health Law Year in P/Review

December 6, 2019
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At the Petrie-Flom Center's eighth annual Health Law Year in P/Review, leading experts discussed major developments in health law and policy during 2019 and what to watch out for…

Hospital Groups Sue to Block Price-Transparency Rule: Health-care providers say disclosure requirement pushed by Trump violates First Amendment

Stephanie Armour
Wall Street Journal

This article is behind a paywall. Harvard affiliates can access it via HOLLIS. Hospital groups sued to block a Trump administration rule forcing them to disclose secret rates, for the…

Labor Unions Team Up With Drug Makers to Defeat Drug-Price Proposals: A low-profile group, financed by the pharmaceutical industry, has hired former union officials to oppose drug-price proposals around the country.

Katie Thomas
New York Times

House Speaker Nancy Pelosi’s bill to lower drug prices has the backing of many of the nation’s biggest labor groups, including the United Auto Workers, the…

Trump Administration Rule Would Make Hospitals Reveal Secretly Negotiated Prices With Insurers

Kaiser Health News

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Hospitals are already gearing up for a legal battle against the "radical proposal." Some experts say the rule…

Big study casts doubt on need for many heart procedures

Associated Press
STAT

PHILADELPHIA — People with severe but stable heart disease from clogged arteries may have less chest pain if they get a procedure to improve blood flow rather than just giving…

Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says: In an unexpected lawsuit, federal officials claim that Gilead Sciences willfully disregarded government patents on medicines necessary to end the AIDS epidemic.

Donald G. McNeil Jr. and Apoorva Mandavilli
New York Times

After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H…

Trump bets on Washington outsider to lead FDA amid political battles: The longtime cancer researcher will have a large role in Trump's agenda on vaping, drug prices and opioids.

Adam Cancryn and Sarah Owermohle
Politico

President Donald Trump is betting on a Washington outsider to navigate a series of hot-button health care issues at the center of his 2020 campaign: a vaping crisis, an ambitious plan…

15+ Years of PEPFAR image

15+ Years of PEPFAR: How U.S. Action on HIV/AIDS Has Changed Global Health

October 7, 2019
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Couldn't join us for the event? Check out some of the speakers' slide presentations and blog posts! Description In May 2003, the U.S. Congress passed bipartisan legislation authorizing a…

Health Law Workshop: Michelle Mello: Legal Strategies for Reining in 'Unconscionable' Prices for Prescription Drugs

September 23, 2019

Presentation Download the Paper: "Legal Strategies for Reining in 'Unconscionable' Prices for Prescription Drugs" About the Presenter Michelle Mello is a leading empirical health law scholar whose research is focused…

Book Launch: Transparency in Health and Health Care in the United States

September 16, 2019
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Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…

Patient Assistance Programs and Anti-Kickback Laws

By Katherine Kraschel, JD (Student Fellow Alumna) and Gregory Curfman, MD
JAMA

From the article: Patient assistance programs provide financial support to patients who cannot afford their prescription drugs. In this issue of JAMA, Kang et al1 describe troubling findings about independent…

The Ethics of Cancer Screening: When Should We Screen and When Should We Not?: A Health Policy and Bioethics Consortium

May 10, 2019

Description There is substantial debate over whether and how we should screen the general population to detect cancers such as breast, prostate, and colon cancer. The principle of early detection…

Providing Value and Redesigning Care for Serious Illness

April 26, 2019
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Description The shift to value-based care presents opportunities to improve care delivery for advanced illness. This panel featured thought leaders who identified key challenges and shared their visions for a…

Why Donald Trump needs Obamacare

Tami Luhby, quoting Rachel Sachs (Academic Fellow Alumna)
CNN

From the article: President Donald Trump wants to kill Obamacare, but it will be a lot harder for him to fulfill his own health care promises without the landmark health…

The Future of Health Care?: Medicaid Buy-In and State Trailblazing in Health Care

March 15, 2019
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Learn more about the "State Medicaid Buy-In Tracker" map here. Description States can be laboratories of health reform. States like Massachusetts and Oregon expanded coverage during previous periods of federal…

Pharma’s day in Congress: 'A hearing not a show'

Ned Pagliarulo and Andrew Dunn, quoting Rachel Sachs (Academic Fellow Alumna)
BioPharma Dive

From the article: "Criticism from several Republican senators was notable, namely in how similar the conservatives sounded to their Democratic counterparts. Lawmakers on both sides of the aisle were "advancing…

Petrie-Flom Center Seeks RA for Project on Drug Pricing

Petrie-Flom Center

Call for Applications: Research Assistant, Drug Pricing in the U.S. and Globally The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School seeks a Research…

Call for Applications: Research Assistant, Drug Pricing in the U.S. and Globally, Petrie-Flom Center, Harvard Law School

Deadline: January 25, 2019

Description: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School seeks a current Harvard graduate student to serve as Research Assistant in support of…

When is a Medical Treatment Worth $850,000? The Value of Luxturna and Gene Therapy Treatments: A Health Policy and Bioethics Consortium

December 14, 2018

Luxturna, a gene therapy treatment for a rare form of inherited blindness, was recently approved and administered for the first time to a patient at Massachusetts Eye and Ear in…

Seventh Annual Health Law Year in P/Review

December 7, 2018
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Description At the Seventh Annual Health Law Year in P/Review symposium, leading experts discussed major developments during 2018 and what to watch out for in 2019. Speakers covered hot topics including…

Transparency in Health and Health Care in the United States

Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)
Cambridge University Press

Read the full introduction online now! This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health…

Health Law Workshop: Anya Prince

November 19, 2018

Presentation Topic: "Gene Therapy's Field of Dreams: If You Build It, Will We Pay?" This paper is not available for download. To request a copy in preparation for the…

Health Law Workshop: Ameet Sarpatwari

November 12, 2018

Presentation Topic: "The U.S. Follow-On Biologic Market" This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich…

Provider Consolidation: Implications for Costs and Quality in Health Care Delivery: A Health Policy and Bioethics Consortium

November 9, 2018

In the last decade, the traditional conception of individual physicians or medical groups has been increasingly replaced by consolidation under academic medical centers and other national or regional administrative organizations.…

Drug Pricing Policies in the United States and Globally: From Development to Delivery

October 24, 2018
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Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #drugpricing and some of our speakers' slide presentations below! Description This one-day conference explored the current pharmaceutical pricing landscape…

Health Law Workshop: Zack Buck

September 24, 2018

Presentation Download the Presentation: "The Price of Universality: Sustainable Access and the Twilight of the ACA" About the Presenter Zack Buck specializes in health law, and his scholarship examines governmental…

Health Law Workshop: Matthew J. B. Lawrence

September 17, 2018

Presentation Download the Presentation: "The Social Consequences Problem in Health Insurance and How to Solve It" About the Presenter Matthew J. B. Lawrence is Assistant Professor of Law at Penn…

Limiting State Flexibility in Drug Pricing

Nicholas Bagley and Rachel E. Sachs (Academic Fellow Alumna)
NEJM

From the article: Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked…

Are Fraud and Abuse Laws Stifling Value-Based Care?

Carmel Shachar (Executive Director)
NEJM Catalyst

From the article: While health care delivery and financing should not be a free-for-all, designing the exemptions to explicitly conform to specific regulatory programs does not best serve the system.…

Drug Pricing Policy: HHS Introduces Step Therapy In Medicare Advantage

Rachel E. Sachs (Academic Fellow Alumna)
Health Affairs Blog

From the post: Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) took its latest action in the area of drug pricing. CMS gave Medicare Advantage (MA) plans the…

The Trump admin has another pretty good, pretty modest plan to lower drug costs

Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)
Vox

From the article: “My concern is that once again, the administration’s rhetoric is out of step with its actual policy moves,” Sachs said. “The administration…

Perspective: Will Courts Allow States to Regulate Drug Prices?

Christopher Robertson (Academic Fellow Alumnus)
NEJM

From the article: Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President…

Report blames gaming of patent system for high drug prices: Most drugs named are biologics, and manufacturing trade secrets make competition especially tricky, legal expert says.

Alaric Dearment, quoting W. Nicholson Price II (Academic Fellow Alumnus)
Med City News

[...] The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was released last week by the nonprofit Initiative for Medicines, Access and…

CMS’ plan to lower drug spending in Medicare Advantage

Brianna Ehley, quoting Rachel E. Sachs (Academic Fellow Alumna)
Politico Pulse

From the article: Some viewed the step as a bit of a letdown, since HHS Secretary Alex Azar has been touting more sweeping changes to drug prices in Medicare Part…

To Tame Prescription Prices, HHS Dips A Toe Into Drug Importation Stream

Rachel Bluth, quoting Rachel E. Sachs (Academic Fellow Alumna)
Kaiser Health News

From the article: This isn’t the first time officials have suggested importing drugs from other countries to find better prices. Bills have been offered in Congress to allow…

On the Human Right to Health: Statistical Lives, Contingent Persons, and Other Difficult Questions

I. Glenn Cohen (Faculty Director)
Human Rights, Democracy, and Legitimacy in a World of Disorder

Faculty Director I. Glenn Cohen has written a chapter in the fortchoming book "Human Rights, Democracy, and Legitimacy in a World of Disorder," (Cambridge University Press, edited by Silja Voeneky…

Medical Tourism: Once Ready for Takeoff, Now Stuck at the Gate

Richard Mark Kirkner, quoting I. Glenn Cohen (Faculty Director)
Managed Care

From the article: Consultants predicted it would be a major business. Large employers and insurers were experimenting with it. But medical tourism has not lived up to the heady expectations.…