Becerra to defend Biden’s budget blueprint — FDA ignites debate with approval of Alzheimer’s drug — HHS and Texas tussle over facilities for migrant children

From: POLITICO Pulse - Tuesday Jun 08,2021 02:06 pm

Jun 08, 2021

Presented by the Pharmaceutical Care Management Association

With Rachel Roubein

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Quick Fix

— Health and Human Services Secretary Xavier Becerra appears this morning before the House Ways and Means Committee to discuss the president’s proposed health care budget for 2022.

— The FDA approved the first new treatment for Alzheimer’s disease in nearly two decades — despite experts’ warnings that there isn’t clear evidence that the drug works.

— HHS warned Texas it could take legal action if the state shuts down facilities tasked with caring for migrant children.

WELCOME TO TUESDAY PULSE — Hot on the heels of an FDA advisory not to eat cicadas, the D.C. invaders are literally showing up on weather reports. Send cicada-free recipes and tips to sowermohle@politico.com and Adam at acancryn@politico.com.

A message from the Pharmaceutical Care Management Association:

The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by monthly premium increases, is for Congress to quickly repeal the rebate rule outright.

Driving the Day

BECERRA TO TESTIFY ON BIDEN’S BUDGET — President Joe Biden is proposing a more than 23 percent boost in HHS funding, including extra cash for the Centers for Disease Control and Prevention, as well as for the National Institutes of Health, where the president envisions a new institute aimed at cancer, Alzheimer’s disease and diabetes.

Biden’s budget request generally steers clear of potentially touchy policy changes such as drug pricing reforms and proposals to expand Medicare eligibility. Still, Becerra could face questions on proposed boosts for typical health spending, let alone the hot-button issues Biden’s wish list does touch, such as his wish to double investments in gun violence prevention research and more than double funding for refugee aid, with $3.3 billion for assisting unaccompanied minors at the border.

FDA IGNITES DEBATE WITH APPROVAL OF ALZHEIMER’S DRUG — Biogen’s aducanumab, or Aduhelm, will be sold at roughly $56,000 a year.

Yet controversy follows the drug; it showed no benefit in a late-stage trial, but then Biogen re-analyzed the data and said it was likely effective. That was not enough to satisfy many drug development experts — or the FDA’s panel on neurological therapies, which voted in November not to approve the medicine.

FDA cleared aducanumab via an accelerated approval pathway, meaning the agency could revoke the drug’s approval down the line if real-world results do not demonstrate its efficacy. pan out. But that rarely happens, even if post-approval studies of aducanumab are still a long-time coming: Another FDA panel, on cancer therapies, held a meeting in April on this very issue, and voted to keep several drugs on the market despite thin evidence that they work for certain tumors. Acting FDA Commissioner Janet Woodcock defended the accelerated pathway in an interview with POLITICO at the time.

Biogen has roughly nine years to provide solid answers, CEO Michel Vounatsos told CNBC’s “Power Lunch” on Monday. “We are committed to deliver the data as soon as we can, obviously,” he told CNBC’s Meg Tirrell.

The next hurdle: Medicare. The Centers for Medicare and Medicaid must now weigh in on the therapy, which will determine how accessible it will be for millions of qualifying adults.

That could begin by CMS launching a Medicare National Coverage Determination, a monthslong process to create a national standard for how and when the drug is covered, Rachel Roubein writes. It’s a process that controversial or pricey medicines generally have to go through.

A CMS spokesperson told Rachel that the agency is reviewing the FDA’s decision regarding aducanumab. “Today’s milestone provides hope to families, caregivers and the older Americans living with Alzheimer’s who rely on Medicare for health coverage,” they said.

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HHS AND TEXAS TUSSLE OVER FACILITIES FOR MIGRANT CHILDREN — The federal health agency on Monday sent a letter to Texas Gov. Greg Abbott, asking whether the governor’s recent ban on child care facilities for migrant children in the state will pertain to dozens of federally-managed facilities in the state.

Backstory: Abbott proclaimed on May 31 that the state would “discontinue state licensing of any child-care facility in this state that shelters or detains unlawful immigrants or other individuals not lawfully present in the United States under a contract with the federal government.”

But HHS is responsible for 52 state-licensed facilities that care for such children in Texas, Deputy General Counsel Paul Rodriguez wrote in a letter, in which he sought to clarify by the end of the week whether grantees under the HHS program could retain their licenses to operate — and threatening legal recourse.

“HHS is consulting the U.S. Department of Justice and intends to pursue whatever appropriate legal action is necessary to ensure the safety and wellbeing of the vulnerable youth that Congress entrusted to [the Office of Refugee Resettlement],” he wrote.

ICYMI: BLACK AMERICANS’ VACCINATION RATE LAGS — Per federal data, less than a quarter of Black Americans have received their first Covid-19 shot as of June 7, further evidence of a weekslong stagnation that has defied the government’s ramped-up effort to accelerate vaccinations and reach the nation’s most vulnerable communities, Adam reports.

This trend line worries health officials and experts, who say the immunization drive is running into a particularly complex web of distrust, outreach challenges and stubborn barriers to access. The White House has already assigned several Covid-19 response officials to focus on equity issues, in addition to creating an outside task force. But while Biden’s latest vaccination push has shown signs of success among Hispanic Americans—who show a sharp spike in vaccination rates this past month—the government’s outreach has yet to gain similar traction among Black communities.

In Congress

TODAY: PURDUE FOUNDERS BACK IN THE HOT SEAT — The bankrupt Oxycontin maker will be central to a House Oversight Committee hearing this afternoon where state attorney general will testify in favor of the SACKLER Act, named for members of the Sackler family, who built the company. Purdue’s widely used painkiller became a poster drug for the devastating opioid epidemic.

The law would prevent people like Sackler family members from escaping liability in a range of government-filed lawsuits pertaining to the epidemic. Idaho Attorney General Lawrence Wasden, a Republican, and Massachusetts Attorney General Maura Healey, a Democrat, will testify. Wasden has endorsed the bill, which is sponsored by Oversight Chair Carolyn Maloney (D-N.Y.), but no Republicans in Congress have signed onto the bill.

SENATE PASSES BILL TO AID DIRECTED-ENERGY ATTACK VICTIMS — The Senate on Monday unanimously passed a bill that would boost medical care for American diplomats and spies who develop mysterious brain injuries from suspected directed-energy attacks, Andrew Desiderio reports.

POLITICO first reported in April that, behind closed doors, administration officials had grown increasingly worried about the vulnerability of Americans to these suspected attacks. Andrew and our own Erin Banco reported last week that potential victims are being referred to NIH for care and review.

The Intelligence Committee has heard from several victims of the mysterious attacks who have had to “battle” with the federal government to get sufficient medical treatment, said Sen. Susan Collins (R-Maine), who drafted the legislation with Intelligence Chair Mark Warner (D-Va.)

Names in the News

Jon Blum is the new principal deputy commisioner at CMS according to a LinkedIn update. He mostly recently helmed Medicare work at Health Management Associates and was previously a CMS principal deputy administrator during the Obama adminsitration.

Former HHS Secretary Alex Azar joins the Aspen Health Strategy Group as an ex-officio in capacity, becoming the seventh former secretary to join the Aspen Institute sub-group led by Obama-era HHS chief Kathleen Sebelius. This is the first position Azar has taken since his stint as Trump’s top health official.

Sarah Lueck is now new vice president for health policy at the Center on Budget and Policy Priorities, where she will lead the group’s work on Medicaid, the Affordable Care Act and other health issues. Lueck was previously a journalist at The Wall Street Journal, reporting about health policy and legislation.

In memoriam: Donald Will Moran , a Washington health policy veteran, died on May 11. Moran served in President Ronald Reagan’s budget office and went on to consult on health policy, eventually founding The Moran Co. and playing a key role in the discussions that shaped the Medicare drug benefit.

Schroeder Stribling will be the next CEO of Mental Health America at the end of June, taking over for Paul Gionfriddo, who is retiring. Stribling spent 18 years at the D.C. housing nonprofit N Street Village, where she most recently was CEO, and began her career in social work.

A message from the Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

What We're Reading

Two medical schools — one nonprofit, the other for-profit — are jockeying to be the first to open in Montana, highlighting the debate about for-profit medical learning, writes Kaiser Health News’ Victoria Knight.

Five Iowa nursing homes have spent years on the government’s worst-in-nation list, but nationwide oversight of such facilities was cut by more than half in 2014 due to limited CMS staffing and funding, Iowa Capital Dispatch’s Clark Kauffman reports.

The federal government often gives less aid to Black disaster survivors compared to their white neighbors, even as global warming worsens environmental and health disasters, The New York Times’ Christopher Flavelle writes.

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