U.S. Capitol Building at Night

Advantages of Using the Congressional Review Act to Revoke Health Care Waivers

By Matthew B. Lawrence

The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.

Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.

Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).

In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.

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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Map of United States made up of pills.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj PatelandAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of September. The selections feature topics ranging from commentaries on political pressures and questions of integrity facing the FDA, to a critique of the financial incentive structure for antibiotic development, to an estimation of how much NHS England would spend if it paid U.S. Medicare Part D prices. A full posting of abstracts/summaries of these articles may be found on our website.

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A calculator, a stethoscope, and a stack of money rest on a table.

Telemedicine is No Cure for Fraud and Abuse

By Vrushab Gowda

The exponential growth of telehealth in recent years has revolutionized the delivery, access, and cost of care. Unfortunately, it is not immune to the fraud and abuse that divert nearly $70 billion from the health care system annually.

A rise in suspect practices has been accompanied by a concomitant escalation of Department of Justice (DOJ) enforcement, sending a clear signal to would-be fraudulent actors.

The ongoing Operation Rubber Stamp is one such enforcement thrust. A joint initiative of the of the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS), it targeted an extensive network of telemedicine fraud totaling over $4.5 billion in false claims and yielding thirty guilty pleas to date.

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Person typing on computer.

Telehealth Policy Brought to the Fore in the COVID-19 Pandemic

By Vrushab Gowda

The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity (e.g., minimizing infection risk, conserving thinly stretched healthcare resources, reducing cost) as well as of innovation.

Telehealth services have surged in recent months; in April alone, they constituted over 40 percent of primary care visits nationwide and over 73 percent of those in Boston. “Increasing Access to Care: Telehealth during COVID-19,” a recent publication in the Journal of Law and the Biosciences, dissects the issues that have accompanied the growth of telehealth and identifies further areas of potential reform.

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Suboxone.

Obstacles and Advances to Accessing Medication for Opioid Use Disorder

By Marissa Schwartz

Medication for Opioid Use Disorder (MOUD), sometimes referred to as Medication-Assisted Treatment (MAT), is a life-saving, evidence-based treatment method considered the gold standard for addressing opioid use disorders. Unfortunately, however, there are a number of barriers — both legal and cultural — that prevent some patients from accessing the treatment they need.

MOUD combines the use of prescription medications (like buprenorphine, methadone, and naltrexone) with counseling and behavioral therapies to provide comprehensive treatment in an inpatient or outpatient setting.

Due to stigma toward MOUD from patients and providers, as well as an overall lack of providers certified to dispense MOUD, there are currently more prescribing rules in the U.S. for the drugs used in MOUD, like buprenorphine, than for opioids. Major legal barriers include provider limits on the number of patients to whom they can offer MOUD, restrictions on which facilities can provide in-patient MOUD treatment, and insurance pre-authorization requirements.

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Health care workers in personal protective equipment attend to a patient.

Value-Based Reimbursement Can Decrease Spending on Medicare During COVID-19

By Sravya Chary

Since the start of the COVID-19 pandemic, the virus’ disproportionate threat to the Medicare patient population has been widely discussed and acknowledged. In light of the public health crisis and an increasing financial burden placed on entities involved in Medicare cost sharing, a value-based Medicare system would not only reduce costs, but also better protect the elderly and chronically ill during the pandemic.

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Young male doctor in telehealth concept

Telehealth amid COVID-19: What Health Care Providers Should Know

By Adriana Krasniansky

COVID-19 stands to be a watershed moment for telehealth adoption within the U.S. healthcare system.

In response to the COVID-19 pandemic, the Trump administration and the Centers for Medicare & Medicaid Services (CMS) (part of the Department of Health and Human Services, or HHS) announced expanded Medicare telehealth coverage for over 80 health services, to be delivered over video or audio channels. Additionally, the HHS Office for Civil Rights (OCR) announced it would waive potential Health Insurance Portability and Accountability Act (HIPAA) penalties for good faith use of telehealth during the emergency. Both measures are designed to enable patients to receive a wider range of health care services remotely, reducing clinical congestion and limiting transmission of the virus. 

In the midst of this emergency situation, health care providers can take measures to consider the ethical and legal aspects of tele-practice as they get started. This article is a short primer to help medical professionals understand telehealth in this moment, navigate regulations and technology practice standards, and choose technologies to support quality patient care. Read More

a crowd of people shuffling through a sidewalk

Lost in the Shuffle: The Impact of COVID-19 on Immigrants in Need

The recommendations for healthy people who have symptoms consistent with COVID-19, the illness caused by the corona virus called SARS-Co-V2, is to stay at home, get plenty of rest, drink fluids and control fever and body-aches with a non-steroidal medication. For people with pre-existing medical conditions, the elderly or those with more serious symptoms, an evaluation by a healthcare provider is warranted. This is a reasonable recommendation given that for most healthy people, the symptoms are uncomfortable but not life-threatening. There is a population however, that regardless of the severity of their illness, may stay at home and not seek medical care, even when things are serious. Fear of arrest and deportation is a real issue for undocumented immigrants and calling an ambulance or going to a hospital can put them at risk for these actions. The result is that some very sick people may not seek appropriate medical care. In addition, they may be taken care of by people that don’t have the appropriate personal protection, putting even more people at risk.

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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Medicare for the Poor

By David Orentlicher

While Medicare-for-All has proved controversial, every Democratic presidential candidate should embrace one of its key elements—folding the Medicaid program into the Medicare program. That would be much better for patients, doctors, and hospitals. It also would be much better for public school children.

Medicare would be a much better program for patients, doctors, and hospitals in several ways. Lower-income families suffer because Medicaid is a federal-state partnership, and some states have stingier Medicaid programs than do other states. In particular, Florida, Texas, and twelve other states have not signed up for the Affordable Care Act’s Medicaid expansion, leaving more than two million lower-income Americans uninsured. Under our current Medicaid system, access to health care for the indigent depends where they live. Folding Medicaid into Medicare would give the poor access to health care in every state.

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