March 08, 2023

Credit: Politico

AT ODDS — Federal agencies may be working at cross purposes in their fight against the opioid epidemic, Krista and our Ben Leonard report.

The Biden administration is implementing a new law to make it easier to prescribe drugs to treat opioid use disorder — even as one of its agencies, the Drug Enforcement Administration, subjects the drug to such strict regulation that many are reluctant to dispense it.

That leaves doctors scrambling to stop people from dying in America’s unyielding opioid crisis, say Biden administration officials are working at cross purposes in their fight to reverse record numbers of fatal drug overdoses.

The administration is in the midst of enforcing a law enacted in December that eliminates a requirement that practitioners go through time-consuming training to prescribe buprenorphine, which helps wean patients from dangerous opioids. It also lifted restrictions on the number of patients doctors could treat with the drug.

But buprenorphine is itself an opioid, and the DEA controls its access — though a spokesperson said the agency supports the new law.

Still, the standing policies have dissuaded doctors from prescribing the drug and pharmacies from carrying it, leaving treatment advocates to call for more action.

WELCOME TO WEDNESDAY PULSE, where we’re hearing murmurs about what may — or may not — be in the White House’s budget proposal.

What whispers (or calls) are you hearing? Do you have an idea of what to expect? Let us know at dpayne@politico.com and kmahr@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Megan R. Wilson about a handful of small companies developing next-generation Covid-19 vaccines that hired lobbyists in hopes of winning contracts to fund research, manufacturing and testing and why the drugmakers are now abandoning K Street.

A message from PhRMA:

Insurers and PBMs don’t pay full price for your medicines. So why do you?  Insurers and PBMs get discounts on medicines. Surprised? These savings can reduce the cost of some brand medicines by 50% or more, but insurers and PBMs aren’t required to share these savings with you. What else don’t they want you to know?

IN CONGRESS
Chris Coons. Photo credit: Francis Chung/E&E News
Sen. Chris Coons acknowledges that making changes to Social Security will be one of the most difficult things Congress will have to do. | Francis Chung/E&E News

ALL BARK? Congress is talking about changes to Social Security and Medicare, but POLITICO’s Burgess Everett writes that there are plenty of reasons to be skeptical.

Delaware Democrat Chris Coons has a unique perspective as a bipartisan group of his fellow senators meet quietly about potential solutions to shore up Social Security’s long-term fiscal health.

Coons, a close ally of President Joe Biden who’s sat in on meetings of the bipartisan Social Security gang, openly admits that changing the popular entitlement “is one of the most difficult things for Congress to do.”

Sen. Bill Cassidy (R-La.) didn’t exude optimism either: “Is there ever a good time? The answer is always no,” he said.

The discussion comes after Biden unveiled a plan to keep Medicare solvent, as reported by POLITICO’s Caitlin Emma.

The plan — which will be in the president’s budget and require Congress’ approval — works by increasing the tax on those making more than $400,000 a year and closing loopholes that have kept wealthy business owners and earners from paying the tax, according to the administration.

Also key to the plan: strengthening Medicare’s negotiating power for drug pricing and allowing negotiations over more drugs.

One new detail about the budget: Former NIH Director Francis Collins, at a STAT event Tuesday, hinted the Biden administration’s Thursday budget will propose a “significant investment” into a national plan to cure hepatitis C, David reports.

MEDICARE MENTAL HEALTH ACCESS — A bill reintroduced in the Senate on Tuesday would ensure access to clinical psychologists across care settings for Medicare beneficiaries.

Sens. Markwayne Mullin (R-Okla.), Sherrod Brown (D-Ohio), Susan Collins (R-Maine) and Martin Heinrich (D-N.M.) are behind the legislation, called the Increasing Mental Health Options Act of 2023.

The sponsors said the bill would remove barriers to access by allowing Medicare to recognize clinical psychologists as independent providers no matter the setting.

MORE MENTAL HEALTH ON THE HILL — Rep. Lisa McClain (R-Mich.) will join the Bipartisan Mental Health and Substance Use Disorder Task Force as the fourth co-chair of the 130-member coalition.

She joins co-Chairs David Trone (D-Md.), Brian Fitzpatrick (R-Pa.) and Ann McClane Kuster (D-N.H.).

A message from PhRMA:

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LETTING K STREET GO — After years of lobbyists trying to push for more government money for next-gen Covid-19 vaccines, many small manufacturers funding the effort are giving up on making a dent in Washington, D.C., POLITICO’s Megan R. Wilson reports.

Several lobbyists, researchers and people in the biotech industry described dysfunction among the agencies that fund those types of projects and how, ultimately, leaning on K Street wasn’t the boon they had hoped it would be.

With Congress gridlocked on many pandemic prevention and preparedness efforts, the initial cash infusions fizzled.

Vaccines less dependent on being tailored to variants, as well as new ways to deliver vaccines, could be key in the future fight against Covid, several infectious disease experts believe.

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GLOBAL HEALTH
VACCINE IP FIGHT A WASTE OF TIME, GAVI BOSS SAYS — Carmen reports that some advocates and governments pushing at the World Trade Organization for an intellectual property waiver for Covid-19 vaccines was irrelevant in increasing developing countries’ access to the shots, Seth Berkley, CEO of Gavi, the Vaccine Alliance, said at a Center for Global Development event Tuesday in Washington, D.C.

“Vaccines are about know-how; they’re not about intellectual property,” he said. Without that know-how, there can be no technology transfer among companies and acceleration of vaccine production, Berkley added.

Berkley, who led the global Covid-19 vaccine equity effort COVAX, said he suspects some vaccine producers delayed Covid doses for COVAX to supply them to rich nations before poorer countries, and he would have appreciated help from activists putting pressure on companies on those issues instead of focusing on IP, which he doesn’t think was the barrier to increasing the pandemic’s vaccine supply.

ABORTION
WOMEN DENIED ABORTIONS SUE TEXAS — Five women who were unable to obtain abortions after experiencing serious pregnancy complications are suing Texas over its multiple near-total bans on abortions. The Center for Reproductive Rights, which is representing the women, says it’s the first lawsuit to be brought on behalf of pregnant people denied abortions since the Supreme Court overturned Roe v. Wade last summer, Megan Messerly reports.

In the lawsuit, filed in state court Monday evening, the women allege the state’s abortion ban violates their fundamental and equal rights as pregnant people under the state constitution. They say they were denied abortions even though their circumstances should have qualified them to obtain the procedure under a medical emergency exception to the state’s abortion restrictions.

Two Texas OB-GYNs, also named as plaintiffs, argue the state’s abortion ban violates their right to practice their profession and provide emergency abortions. The women and doctors are asking the court to clarify the scope of the exceptions to the state’s ban.

Three abortion bans are in effect in Texas: a so-called trigger ban, which prohibits abortion in nearly all circumstances; a pre-Roe criminal ban on abortions; and a ban after about six weeks of pregnancy, which is enforceable through civil lawsuits.

In response to the lawsuit, a spokesperson for Texas Attorney General Ken Paxton, a Republican, said he “is committed to doing everything in his power to protect mothers, families and unborn children, and he will continue to defend and enforce the laws duly enacted by the Texas Legislature.”

FLORIDA’S SIX-WEEK PROPOSAL — On Tuesday, Florida’s Republican-led legislature filed bills that would ban abortions after six weeks of pregnancy, POLITICO’s Arek Sarkissian reports.

The bills offer exceptions, including when the procedure is needed to save a patient’s life or when the pregnancy is the result of rape or incest.

The bills, if passed, would significantly tighten the state’s current 15-week ban by making abortions illegal two weeks after a pregnant person’s first missed period.

And passage seemed increasingly likely after Gov. Ron DeSantis told reporters he would sign the abortion bill into law should it pass the state’s legislature, where Republicans have supermajorities.

Also in Florida’s legislature …

LOOKING TO LOOSEN VAX REQUIREMENTS — Florida House and Senate Republicans filed bills Tuesday that water down requirements tied to state immunization records and offer protection for people who choose not to use vaccines, Arek reports.

The measure would stop the Florida Department of Health from requiring enrollment in the state immunization registry. The state Department of Health would also be forbidden from sharing any immunization records with interstate or federal immunization tracking systems. DOH oversees the Florida SHOTS registry, which preserves vaccine records that patients, parents, health care providers and schools can access.

STEP INSIDE THE WEST WING: What’s really happening in West Wing offices? Find out who’s up, who’s down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider’s guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won’t find anywhere else, subscribe today.

WHAT WE’RE READING
Workforce woes may mean we’re even less prepared for the next public health crisis than the last, Joanne Kenen writes for POLITICO.

Best Buy plans to be the newest player in in-home hospital care, CNBC’s Melissa Repko reports.

A message from PhRMA:

Insurers and their PBMs don’t want you to see that you could be paying more than they are for your medicines. Rebates and discounts can significantly lower what insurers and PBMs pay for medicines. These savings can reduce the cost of some brand medicines by 50% or more. But insurers and PBMs aren’t required to share those savings with you at the pharmacy counter.

They don’t want you to see that they use deductibles, coinsurance and other tactics to shift more costs on to you. Or that the three largest PBMs control 80% of the prescription drug market. Or that last year they blocked access to more than 1,150 medicines, including medicines that could have lowered costs for you at the pharmacy. 

PBMs and insurance practices are shrouded in secrecy, they need to be held accountable.