HEALTH CARE BRIEFING: GOP Senators May Invoke Byrd on Drug Bill

Groups that want commercial health plans to benefit from legislation under consideration that would allow Medicare to negotiate drug prices are worried that some Senate Republicans may try to sabotage their efforts in an attempt to kill the legislation.

Congressional Democrats are in agreement that commercial plans should be able to pay the same amount for drugs as Medicare pays as well as limit drug price increases to inflation.

But James Gelfand, senior vice president of health policy for the ERISA Industry Committee, which represents large employers on benefit issues, said in an Aug. 3 press call that, “We are starting to hear rumblings” about a group of GOP senators considering a “Byrd rule challenge to provisions that would apply protections to the commercial market.”

The Byrd rule, named after the late Senator Robert Byrd (D-W.Va.), restricts what can be included in reconciliation legislation, which the drug provisions are expected to be included in this fall, to budget provisions. “They will attempt to put a poison pill into the bill by potentially making it pass on devastating cost increases to employers,” he said. “We are confident that language can be written in such a way that it would survive a Byrd bath,” he said, referring to the process that text is weighed for its adherence to the Byrd rule.

“That may require some creative approaches to how you allow an employer to use a price that is negotiated by Medicare, or how you penalize drug companies that raise costs for employers faster than the economy grows,” Gelfand added.

Gelfand said he doesn’t know which GOP senators are likely to take the lead on such an attempt. Employers are worried about the cost of biological drugs coming onto the market, and they worry that if their health-care plans aren’t allowed to benefit from Medicare drug prices, pharmaceutical companies will raise commercial prices even higher to make up for lost Medicare sales, Sara Hansard reports. Read more on the commercial health plan effort in this Aug. 3 story.

Happening on the Hill

Schumer Puts Infrastructure on Path to Passage: Senate Majority Leader Chuck Schumer (D-N.Y.) moved to wrap up a days-long debate on a $550 billion infrastructure package, setting up the Senate for a Saturday vote to approve the largest infusion of cash for roads, bridges and other domestic projects in decades.

Schumer on Thursday teed up a procedural vote on that would limit further debate on the bipartisan measure when the Senate reconvenes on Saturday. Schumer attempted to move more quickly and vote last night, but last-minute disagreements on amendments held up progress.

Among the unresolved issues is how to modify a provision of the bill dealing with reporting requirements for cryptocurrency transactions for tax collections. The cryptocurrency industry said the original version of the bill unfairly targeted them and was too broad in scope.

Another pending amendment would allow state and local governments to use up to 30% of their unspent Covid relief funds on infrastructure projects. Sen. John Cornyn (R-Texas), who sponsored the change with Sen. Alex Padilla (D-Calif.), said he bargained with the Biden administration on the change, which would free up between $80 billion and $100 billion for projects. But it has yet to be scheduled for a vote. Read more from Steven T. Dennis, Laura Litvan and Laura Davison.

BGOV OnPoint: Democrats Push to Expand Medicare

Senate Bill Seeks to Prepare for ‘Disease X’: The U.S. could have vaccines, therapies and other medical countermeasures ready for future disease outbreaks under a Senate bill introduced yesterday. The measure from Sen. Tammy Baldwin (D-Wis.) would provide $2 billion to the Biomedical Advanced Research and Development Authority over four years, starting in fiscal 2022, to establish a Disease X program aimed at developing responses to unknown disease threats.

Currently there are no sustained programs, strategies or funds dedicated to medical countermeasures for previously unidentified diseases. “Infectious disease outbreaks now occur three times more often than they did 40 years ago. The next pandemic, driven by an unknown Disease X, will come,” Baldwin said in a statement. Read more from Jeannie Baumann.

Warren Blasts Juul as FDA Mulls Vaping Fate: E-cigarette manufacturer Juul is mounting an “egregious” and “deeply disturbing” marketing campaign ahead of an FDA decision on whether to allow its products to remain on the market, Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) said in letters to regulators. They urged the FDA to review Juul’s ad campaign and called on the FTC to take action against Juul’s “baseless claims” about its product’s safety, Catherine Larkin reports.

Finance Panel Targets Mental Health Care Access: Senate Finance Chairman Ron Wyden (D-Ore.) and top Republican Mike Crapo (Idaho) launched an effort to develop bipartisan legislation to address barriers to mental health care in the U.S., they said in a statement. The senators asked committee members in a letter for input on issues related to behavioral health workforce shortages, data reporting and oversight, and access to telehealth services for behavioral health. Read their letter here.

The Coronavirus Pandemic

Vaccine Cash Spurs Call for Study on Trial Perks: Cash, lottery tickets, and other prizes to galvanize vaccinations underscore the need for more research to understand if and how payments impact other individual decisions to help boost public health, such as participating in a clinical trial. “We’re sort of at a loss in terms of data. We need data on how it works and how well it works,” said Christine Grady, bioethics chief in the National Institutes of Health Clinical Center.

Clinical trial researchers have to work hard to recruit enough volunteers who are willing to test the safety and efficacy of a new medical product in their own bodies. It’s even more difficult to create a trial pool that adequately represents racial, gender and ethnic minorities, which then clouds the picture for how well the medicine works in those groups. If studies show that payment after participation boosts diversity in trials, it would be a boon to understanding treatment in underserved groups.

The ultimate goal is to democratize clinical trials and eliminate health disparities. “We should be playing the long game, and the long game is how can we improve diversity writ large in clinical trials?” said Terri Laws, a bioethicist at the University of Michigan. “Because that’s when we know that we really have the democratization of medicine.” Jeannie Baumann has more.

Moderna Nears Application for FDA Approval: Moderna said its coronavirus vaccine remained 93% effective through six months after the second dose, as it reported second-quarter earnings and revenue that beat expectations. A final report of the company’s late-stage study, described in a statement yesterday, suggests the vaccine’s protection remains stable long after recipients completed the two-dose course. It said it’s close to applying for full federal approval this month. Robert Langreth and Riley Griffin have more.

J&J Vaccine Effective Against Delta in South Africa Trial: Johnson & Johnson’s Covid-19 vaccine helps prevent severe disease among those infected with the delta variant, according to a trial involving almost 480,000 health workers in South Africa. The study, known as Sisonke, provides the first large-scale evidence that the J&J vaccine works against this dominant variant, according to trial co-lead Glenda Gray. It’s probably more protective against delta than it was with the earlier beta strain, she said in a presentation Friday. Read more from Janice Kew and Antony Sguazzin.

Florida’s Oxygen Woes Foreshadow Supply Shortages: Struggles in Florida to get hospitals enough oxygen for influxes of Covid-19 patients are likely a harbinger of heightened medical supply shortages nationwide as coronavirus cases persist and the delta variant rages. Health centers in the state are grappling with shortages of drivers who can transport oxygen, a critical resource for hospitalized Covid-19 patients, and restrictions on how long they can be on the road. Industry professionals expect similar obstacles to expand around the U.S. for other essential supplies. Read more from Shira Stein.

Hospitals Must Track Staff Vaccination Rate: Hospitals will be required to track and report Covid-19 vaccination status for their health-care personnel to comply with a rule from the Biden administration. The requirement, contained in a wide-ranging hospital payment rule (RIN 0938-AU44, 0938-AU56), is an effort to “support public health tracking and provide patients, beneficiaries, and their caregivers important information to support informed decision making,” according to the Centers for Medicare & Medicaid Services. Read more from Allie Reed.

More on the Coronavirus:

Global Coronavirus Headlines:

What Else to Know

Biden’s New Eviction Ban a Legal Risk: Biden quelled for now a brewing confrontation with progressive Democrats with a new moratorium on evictions from the CDC during the pandemic, but the order invites a legal fight with high-stakes consequences for public health that the government may well lose. Attorney General Merrick Garland said yesterday that the Justice Department will “vigorously” defend the renewed evictions moratorium and will also work with state court leaders to find “diversion strategies” to keep people in their homes. He said the potential eviction of millions of tenants could exacerbate the nation’s ongoing health crisis.

If a legal challenge gets to the Supreme Court before the eviction ban expires, the administration risks conservative justices using the case as an opportunity to curtail broad powers the CDC has exercised during the pandemic, said Lindsay Wiley, Director of the Health Law and Policy Program at the American University Washington College of Law. Read more from Nancy Cook, Billy House and Jennifer Epstein.

Tennessee’s Abortion Delay Law Upheld: Tennessee may impose a 48-hour delay on women seeking abortions, after a divided en banc Sixth Circuit said yesterday the state’s mandatory waiting-period law is constitutional under the Supreme Court’s Planned Parenthood v. Casey decision. The law doesn’t unduly burden “a large fraction of women” in the state seeking to terminate a pregnancy before viability, and Tennessee has a legitimate interest “in protecting the life of the unborn” and ensuring that women give “informed and deliberate” consent, the appeals court said. Read more from Kathleen Dailey.

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To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Sara Hansard in Washington at shansard@bloomberglaw.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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