Congress holds Covid hearings — Biden hikes Medicare payments for Covid shots — CMS delays device rule

From: POLITICO's Prescription Pulse - Tuesday Mar 16,2021 04:02 pm

Mar 16, 2021

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By Sarah Owermohle and David Lim

Presented by the Partnership for America’s Health Care Future

With Susannah Luthi, Brianna Ehley and Emily Martin

On Tap

— Congress holds Covid hearings with first appearances from Biden officials.

— Biden hikes Medicare payments for Covid shots to get more providers on board.

— CMS delays device rule, disappointing industry.

It’s Tuesday, welcome back to Prescription Pulse, where both of your authors are celebrating birthdays, one got a bike and the other is taking suggestions for self-gifting. Send birthday and pharma tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim).

A message from the Partnership for America’s Health Care Future:

American families deserve access to high-quality, affordable health coverage and care to help them get healthy and stay healthy. Let’s build on and improve what’s working and fix what’s broken in health care – not start over with an unaffordable, new government-controlled health insurance system like the public option. Learn more.

In Congress

CONGRESS HOLDS COVID VACCINE HEARINGS — Committees in both the House and Senate meet this week to discuss coronavirus vaccines and the federal effort to respond to the pandemic.

WEDNESDAY: The president’s chief medical adviser Anthony Fauci, FDA’s top vaccine official Peter Marks and CDC Director Rochelle Walensky appear before the House Energy and Commerce subcommittee on Oversight and Investigations. The three will discuss President Joe Biden’s vaccination efforts, particularly the goal to have broad access to shots by May.

THURSDAY : The same trio is joined by David Kessler, chief science officer for the Covid-19 response and a former FDA commissioner, to testify before the Senate HELP committee on the federal pandemic response.

This is the first time that Biden’s senior health officials will appear before congressional committees, though Fauci has been a fixture of coronavirus hearings since last year. Marks will appear for FDA as the Biden search for a permanent commissioner drags on and HHS nominee Xavier Becerra awaits a final Senate vote this week.

Possibly on the agenda: Biden announced recently that he wants all American adults to be eligible for vaccines by May 1, a goal that states are cautiously optimistic about hitting, as our Rachel Roubein reported.

There are also likely to be questions about early roll out of the Johnson & Johnson single-dose vaccine and when the government thinks all promised doses will be delivered. Another vaccine on top of minds lately is AstraZeneca’s candidate. Health officials say the drugmaker could file with FDA next month, but its shot is the subject of increasing health concerns in Europe (more on that below).

The day before Senate HELP’s coronavirus hearing, the panel will also vote to advance the nominations of Surgeon General pick Vivek Murthy and prospective assistant health secretary Rachel Levine.

SANDERS PREPS DRUG PRICING HEARING — Sen. Bernie Sanders (I-Vt.) will convene a hearing on U.S. drug prices next week. The HELP subcommittee he chairs will focus on the prices Americans pay for drugs compared to the costs for people abroad, Susannah Luthi writes.

Sanders, who campaigned on drug pricing reform along with Medicare for All during his presidential campaign, will lead the hearing on March 25 in the HELP subcommittee on Primary Health and Retirement Security, according to Senate staffers.

The hearing is expected to riff on a theme that both progressives and Donald Trump agreed on: American medicines are priced too high, especially in light of the costs in similar economies. That argument was central to one of Trump’s key drug reform pledges — tying payments for Medicare drugs to the lowest price set for comparable nations — that ultimately resulted in a last-minute regulation that’s on hold in federal court. The Biden administration hasn’t yet signaled how it will handle the Trump policy, whose goal resonates with many Democrats.

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Coronavirus

BIDEN HIKES MEDICARE PAYMENTS FOR COVID SHOTS — The Biden administration is nearly doubling Medicare payment rates to providers administering the Covid-19 vaccine in a bid to boost the number of providers giving the shots.

The change takes effect immediately and bumps up rates from around $23 per shot to $40 for two-dose vaccines. The rate will increase from $28 to $40 for a single-shot vaccine, like the one from Johnson & Johnson, Brianna Ehley reports.

“This will make it easier for more health care providers to get out into communities and give more Covid shots to people in need,” senior White House adviser Andy Slavitt said during a Covid task force briefing, adding that the reimbursement bump will help increase vaccination rates among hard-to-reach populations.

Slavitt also announced that the administration will fully cover all Medicaid and CHIP beneficiaries’ Covid shots, as mandated by the $1.9 trillion stimulus President Joe Biden signed into law last week.

CDC: MOST ADULTS GETTING THEIR SECOND SHOTS —The vast majority of adults who received the first of two shots of a Covid-19 vaccine completed the series within the recommended time period, according to CDC data on the first two months of the vaccination rollout.

Roughly 88 percent of people surveyed who received their first shots also got their second, while 8.6 percent had not received the second dose but were still within the allowable time frame to receive it. And among people surveyed who received a second dose, nearly 96 percent got the shots within the recommended time frames.

But disparities remain. The study found the percentage of people who missed their second doses was highest among American Indian/Alaska Natives, as well as people aged 16 to 44.

MEDICAL DEVICES

CMS DELAYS BREAKTHROUGH DEVICE COVERAGE RULE — CMS announced Friday it is delaying the implementation of a Trump-era regulation that would automatically give four years of Medicare coverage to breakthrough-designated medical devices with FDA marketing authorization.

CMS is asking for public comment on if the rule should be implemented, revised or rescinded — especially in light of data the agency said indicates that there may be greater numbers of breakthrough-designated devices than the public originally understood.

AdvaMed CEO Scott Whitaker tweeted he was “disappointed” that CMS delayed the rule but expressed confidence it “will ultimately be implemented.” But Peter Bach, director of the Memorial Sloan Kettering’s Center for Health Policy and Outcomes, described the decision as “a smart move to re-examine ceding coverage authority to a regulatory path at FDA not designed to evaluate [if such devices are] reasonable and necessary.”

FDA: POTENTIAL FALSE POSITIVES FROM ROCHE COMBO TEST — Flu and Covid-19 tests run on Roche’s cobas Liat System may be prone to false results, FDA said in a Friday letter to health care providers. Two issues may be related to the issue the letter says: assay tubs that may sporadically leak and occasional abnormal PCR cycling in reaction tubes.

STRYKER STAR ANKLE HAS HIGHER RISK OF BREAKING — FDA announced Monday that Stryker’s Scandinavian Total Ankle Replacement device has a “higher than expected” risk of breakage. A long-term post-approval study found that 13.8 percent of devices had a fracture eight years after implantation — several of which happened within three to four years.

“This higher fracture rate and earlier than expected occurrence are concerning when compared with other comparable total ankle replacement devices, and may also be underestimated as two polyethylene fractures were not diagnosed until surgical exploration in this study,” FDA’s safety communication states.

Eye on FDA

FDA LAUNCHES EUA ADVERSE EVENT DASHBOARD — The FDA on Monday launched a public dashboard that lists adverse event reports for Covid-19 drugs and biologics that are authorized on an emergency basis.

As of March 11, 8,627 reports have been submitted: 5,605 in 2020 and 3,022 in 2021. But FDA cautions that the data “cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with drug products.”

GET DAILY REGULATORY UPDATES STRAIGHT TO YOUR INBOX: AgencyIQ’s daily newsletter, FDA Today, provides actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today.

Industry Intel

ROCHE SIGNS AGREEMENT TO BUY GENMARK FOR $1.8B — Swiss diagnostics maker Roche announced Monday it has agreed to acquire GenMark Diagnostics for approximately $1.8 billion. The deal is expected to close in the second quarter.

Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

— A new bill is aimed at speeding up rare disease drug reviews. The bill introduced last week, the STAT Act , calls for the creation of a center of excellence at the FDA focused on rare diseases, as well as a new advisory committee exclusively focused on rare diseases. The bill also calls for the FDA to come up with recommendations on how to address ultra-rare diseases and facilitate communications between drug developers and insurance companies.

— How are Covid-19 vaccines regulated around the world? AgencyIQ has pulled together this extensive resource explaining how different countries and regions, from the U.S. to Canada, Australia and the EU, are approaching the regulation of new vaccines using emergency authorities.

Pharma Worldwide

U.S., PACIFIC PARTNERS TO SEND VACCINES TO ASIA — The United States, Japan, India and Australia have formed a partnership meant to flood Asian and Pacific island nations with “at least” 1 billion Covid vaccine doses by 2022, POLITICO’s Ryan Heath reports.

The Quad Vaccine Partnership includes an Indian production drive to deliver the billion extra doses by the end of 2022, but the alliance is joining the vaccine global diplomacy game late since China and Russia have already been delivering donated doses to more than 50 countries.

The Quad will also need to navigate carefully with COVAX, which has begun delivering the first 300 million of a planned 2 billion doses to mostly low and middle-income countries.

ASTRAZENECA WOES IN EUROPE GROW — Several more EU countries have paused, permanently or temporarily, distribution of the AstraZeneca coronavirus vaccine as concerns about its potential linkage to blood clots grow, POLITICO EU reports.

Ireland suspended all jabs on Sunday, with the deputy chief medical officer cautioning that no conclusion has been reached on a link between the shot and any clotting incidents. Germany followed suit on Monday, with France later pausing jabs for only 24 hours. Each country’s official stipulated that the pause was a precautionary measure.

French President Emmanuel Macron, and other European officials, said they are pausing inoculation until Tuesday afternoon, when the European health authority, the European Medicines Agency, is expected to publish new guidance on the AstraZeneca vaccine.

Quick Hits

— Tens of millions of doses of AstraZeneca’s vaccine are sitting in American manufacturing facilities, while countries that have authorized its use beg the White House for access, The New York Times reports.

— Chilean officials say the secret to the country’s success in vaccinating more than 25 percent of its population after being among the world’s hardest-hit nations is early negotiations with vaccine producers, AP reports.

— Sanofi said it has started human trials for its second Covid-19 vaccine, made from mRNA, after delaying the release of its other candidate, Forbes reports.

— WHO issued emergency use authorization for Johnson & Johnson’s vaccine, paving the way for its use in the United Nations’ international vaccine distribution effort, The Hill reports.

Document Drawer

FDA is reopening the comment period for a draft guidance on best practices in developing proprietary names for nonprescription drugs.

FDA is reopening the comment period for a docket on the listing of patent information in the Orange Book.

FDA announced a virtual public meeting on May 18 and 19 to discuss the risk of medication errors related to drug container labels.

Eli Lilly published in the New England Journal of Medicine the results of early clinical trials of its experimental drug, donanemad, which showed that it could slow the cognitive decline of patients with Alzheimer’s disease.

A message from the Partnership for America’s Health Care Future:

A recent poll on America’s health care future found that a majority of voters prefer building on and improving our current health care system, rather than starting over with the public option. And more than 70% of voters would be unwilling to pay more in taxes to finance the public option.

Let’s build on and improve what’s working in health care where private coverage, Medicare and Medicaid work together to provide access to the health coverage and care American patients deserve – not start over with a new government-controlled health insurance system, like the public option, that American families can’t afford. Learn more.