Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

Read More

Defining and Establishing Goals for Medicare for All

It is increasingly difficult to find a Democratic presidential hopeful who has not paid at least some lip service to “Medicare for all.” Indeed, ignoring this popular rhetoric would likely be political suicide for Democratic candidates.

In one poll, 73 percent of registered Democrats said they were more likely to vote for a presidential candidate who supported a Medicare for all health care policy. In response to the popularity of Medicare for all, House Democrats launched an official Medicare for All Caucus, with about 70 members.

Medicare for all, however, means many things to many people. As the fight to become the Democratic presidential candidate unfolds in 2019, it will be important to see how this term gets defined.

Many take Medicare for all to be policy shorthand for health or health care being a human right, entitling individuals to certain services and obligating the government to support access to health care.

For example, the Center for American Progress toted its proposal, Medicare Extra for All, by arguing that health care constitutes a right, as opposed to a privilege. Presidential hopeful U.S. Senator Elizabeth Warren (D-Mass.) similarly released a statement justifying her support of a Medicare for all bill by stating that “health care is a basic human right.”

Read More

mouse eating cheese

Stopping Nibbles around the ACA: Advocacy Organizations File Suit

Once it became clear that Congress did not have the appetite to repeal the Affordable Care Act (ACA), the Trump administration has pursued a strategy of “nibbling” around the edges of the ACA through regulations and rule making.

One of these nibbles included an expansion of short-term limited duration insurance (STLDI) plans, insurance schemes which a group of representatives called “junk plans” in an open letter to the National Association of Insurance Commissioners last month and which California may soon ban altogether by the end of September.

Recently, several organizations, including the Association for Community Affiliated Plans (ACAP), National Alliance on Mental Illness (NAMI), Mental Health America, American Psychiatric Association (APA), AIDS United, National Partnership for Women & Families, and Little Lobbyists, filed a suit to block the implementation of STLDI plan expansion and mitigate the impact it will have on the health insurance marketplaces.

Read More

Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy.

In two high profile cases in 2011 and 2015, Kavanaugh upheld key parts of the Affordable Care Act (ACA). But these cases, taken out of context, are misleading. They should not distract anyone evaluating his long record, nor overly inform how he might decide in future cases when it comes to health care.

Besides his record on reproductive health — which is controversial and is already creating significant opposition to his confirmation — Kavanaugh has exhibited strongly-held ideas about the relationship of the courts to government agencies and bureaucracies that carry out most of American public policy, also known as “the administrative state.”

Read more at WBUR’s Cognoscenti

Setting Hard Limits: A Federal District Court Puts up Major Hurdle to the Reworking of Medicaid in Stewart v. Azar

Since the Republican controlled Congress failed to repeal the Affordable Care Act in 2017, the Trump administration has been trying to implement its more conservative vision of Medicaid through waivers. On June 29, 2018, however, the D.C. federal district court issued a decision in Stewart v. Azar which would make it significantly more difficult for an administration to rework Medicaid without a congressional mandate.

This case, should it survive subsequent appeals, will represent an important turning point in the ability the Department of Health and Human Services has to shrink or undermine Medicaid through the use of administrative waivers.

Read More

OK, Now What? Health Care Reform Next Steps

By Carmel Shachar

The latest push to repeal at least some aspects of the Affordable Care Act (ACA) died late into Thursday, July 27, 2017 when John McCain (R-AZ) joined Lisa Murkowski (R-AK) and Susan Collins (R-ME) to vote against a much stripped down repeal bill.  This dramatic moment has been replayed over and over again by health policy wonks and on cable TV.  However, now that we have all “watched the show” a pressing question is unavoidable: What happens next?

Next Steps for Congress

The failure to pass repeal and replace (in the form of the Better Care Reconciliation Act), complete repeal (in a variation of the Obamacare Repeal Reconciliation Act), or skinny repeal (in the form of the Health Care Freedom Act), suggests that Congress may have to resort to something previously considered unthinkable: bipartisan action.  Indeed, soon after Senate Republicans failed to pass a health care bill, Senate Democratic leader Chuck Schumer (R-NY), stated that “[o]n health care, I hope we can work together to make the system better in a bipartisan way.” Read More