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Farewell to the X waiver


With Ben Leonard, Daniel Lippman, Carmen Paun and Megan R. Wilson

AN END OF AN ‘X’ ERA — In a ceremony today at the White House, the Biden administration will mark the end of the so-called X waiver requirement, a move that federal officials, lawmakers and public health experts hope will open up access to a drug proven to dramatically reduce the risk of fatal opioid overdoses.

The backstory: For years, doctors who wanted to prescribe buprenorphine — a partial opioid and controlled substance — to patients with opioid use disorder had to undergo special training and seek additional permission from the federal government.

Getting an X waiver was a time-consuming process that both discouraged doctors from prescribing the drug and created an unhelpful stigma around the medication, advocates say.

“You could prescribe as much Oxycontin as you wanted without additional training, without an additional waiver,” Libby Jones, project director of the Overdose Prevention Initiative, recently told Krista. “But in order to treat someone and provide a medication that prevents you from overdosing, you had to go through this extra step.”

Meanwhile, as deaths from opioid overdoses reached record numbers, access to buprenorphine remained elusive: Just 11 percent of people diagnosed with opioid use disorder received FDA-approved medication in 2020.

Enter the MAT Act: The Mainstreaming Addiction Treatment (MAT) Act, which eliminates the X waiver, among other measures, was first introduced in Congress in 2019. But it gained broad bipartisan support in the last Congress and was endorsed by hundreds of organizations before it was added to the year-end omnibus bill passed in December.

Practitioners who want to prescribe buprenorphine to their patients will still be required to get a DEA license, as they would any other controlled substance like morphine or Xanax. But they won’t have to face additional administrative requirements that have slowed down patient access to the drug for years.

“For too long, federal barriers, which are rooted in stigma, have impacted access to lifesaving opioid use disorder treatment,” Sen. Maggie Hassan (D-N.H.), a MAT Act sponsor, said in a statement Monday. She’s set to speak at today’s ceremony, which starts at 11:30 a.m. “I am looking forward to joining advocates and law enforcement to underscore the importance of eliminating the outdated X-waiver requirement, which will help get more people on the road to recovery.”

WELCOME TO TUESDAY PULSE — Rhode Island police are helping a 10-year-old who sent a half-eaten cookie and gnawed carrots into her local department for DNA testing on Dec. 26. This seems to me to present a moral conundrum to the cops, but they are all in. Send your news and tips to [email protected] and [email protected].

TODAY ON OUR PULSE CHECK PODCAST, Ruth Reader talks with Adam Cancryn about Jeff Zients, the White House’s former Covid czar who’s set to become President Joe Biden’s new chief of staff, and how the managerial prowess he showed in his first stint there will be put to the test.

PRESENTING … THE TOP HEALTH LOBBYING SPENDERS OF ’22! Pharmaceutical interests dominated the top of the charts for advocacy spending, foreshadowing another substantial year ahead for the industry, Megan reports.

Using year-end disclosures to tabulate which companies and groups shelled out the most cash to lobby the federal government last year, Megan found that 42 percent of the 76 health care organizations that reported spending $2 million or more on lobbying in 2022 were drugmakers, pharma industry groups and pharmacy benefit managers.

Here are the top 15 health lobbying spenders:

A MOVE TO AN ANNUAL COVID SHOT? The FDA’s Vaccine and Related Biological Products Advisory Committee will vote Thursday on whether to recommend that the agency update its Covid-19 primary vaccine series to include bivalent shots, POLITICO’s Katherine Ellen Foley reports.

Committee members will also discuss whether to update the primary vaccine series for healthy adults to consist of only one shot, instead of multiple, and how manufacturers should generate future Covid-19 boosters.

At this point in the pandemic, the FDA notes, the evolution of SARS-CoV-2 appears to be similar to the flu, for which the vaccine is updated annually.

The FDA anticipates discussing the most widely circulating strains at least every year, with the hope of convening its advisers in June for reformulated boosters to be available by September.

FIRST IN PULSE: TRANSPARENCY PUSH — The Connected Health Initiative, along with close to 100 other health care groups, is raising concerns over a Contractor Advisory Committee’s lack of transparency concerning a meeting next month about remote patient monitoring, Ben reports.

The groups, including the American Medical Association, Teladoc, the Alliance for Connected Care and Roche Diagnostics, said in a letter sent Monday afternoon to Novitas Solutions that the meeting of Medicare Administrative Contractors, which process claims, should allow more engagement.

“We are concerned by the lack of transparency surrounding this meeting — including the agenda, guests/subject matter experts, topics, types of evidence being assessed, process (prior to/during/after the meeting), and the possible outcomes,” the letter said. “We openly question why the meeting will only be limited to the opinions of formal discussants/panelists via pre-distributed questions.”

Novitas Solutions, which is leading the meeting, said in a comment to POLITICO that the Contractor Advisory Committee meeting “is an all-Medicare Administrative Contractor (MAC) CAC meeting” and “the agenda and registration for all interested parties will be available at least two weeks prior to the meeting.”

THE NEW CDC HIRE ON THE ‘T’ WORD— Nirav Shah, the outgoing director of the Maine CDC who has been tapped as the new principal deputy director of the national agency in Atlanta, told the news call-in program “Maine Calling” on Monday that restoring public trust in public health officials would be a focal point of his new job.

“The U.S. CDC has a long ways to go to regaining some of the trust of a lot of people in the United States,” said Shah.

“Half the people in the country right now think we did way too much during Covid, and the other half think we didn’t do nearly enough,” he said. “Finding a middle ground through repeated conversations is going to be tough.”

Watch the full interview here.

CALLING ON CONGRESS TO CURB CONSOLIDATION — Several patient and health advocacy groups, including Families USA and the American Academy of Family Physicians, sent a letter to congressional leadership asking for action to control health care consolidation and boost price transparency across the market.

The letter, from the Consumers First alliance, lays out policies the groups see as possibilities amid a divided Congress, including:

— Preventing consolidations in health care, especially among providers and insurers, that could hinder market competition

— Ensuring the FTC has the resources to fight mergers and acquisitions deemed unfair

— Making pricing and health data more accessible to consumers and promoting transparency

— Implementing site-neutral payment policies across the board

WHO JUGGLING SCORES OF GLOBAL HEALTH CRISES — The World Health Organization asked the world on Monday for $2.54 billion to respond to the numerous concurrent health emergencies around the globe, Carmen reports.

The WHO said it’s responding to 54 simultaneous crises, including devastating floods in Pakistan; severe food shortages in the Sahel in northern Africa; several wars in Europe, the Middle East and Africa; cholera outbreaks in 30 countries; and an ongoing global pandemic. Nearly a dozen crises are classified as the most severe, according to the organization’s ranking.

“More people than ever before face the imminent risk of disease and starvation and need help now. The world cannot look away and hope these crises resolve themselves,” WHO boss Tedros Adhanom Ghebreyesus said, urging donors to be generous and help the WHO save lives.

Beverly Hart joins the Leukemia & Lymphoma Society as director of federal affairs. She previously was legislative director for Rep. Dean Phillips (D-Minn.).

The Campaign for Tobacco-Free Kids named John Bowman as executive vice president for U.S. programs. He most recently served as managing director of government affairs for the Natural Resources Defense Council.

Our colleagues in Florida write about the state Supreme Court decision to take up a challenge to Florida’s 15-week abortion ban.

In China, where the population is shrinking, some are calling for a government campaign for more babies, but women want to maintain the right to choose, The Washington Post reports.

The Wall Street Journal reports on how the high turnover in the in-home caregiver industry is impacting patients.

The Associated Press reports that the U.S. military has indicated a possible link between several military officers’ blood cancers and their previous work at a nuclear missile base in Montana.

And finally, if you’ve been following Vice’s gripping podcast on Havana Syndrome, the final four episodes dropped at midnight Tuesday.



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