ACA tax credits on ice. BIOSECURE on tap.

The White House last week was close to proposing an extension of expiring ACA premium subsidies, but that fell apart when House Republicans pushed back.

The prospects of a deal on the credits is up in the air, and the enrollment period for ACA health insurance plans that take effect on Jan. 1 ends in two weeks. Senate Majority Leader John Thune (R-S.D.) agreed to give Democrats a floor vote on the premium-subsidy bill of their choosing on Dec. 15. Republicans also could offer their own bill if a bipartisan compromise can't be reached. In that case, both bills would almost surely fail.

Senate health committee Chair Bill Cassidy (R-La.) scheduled a Wednesday hearing aimed at finding a compromise to extend the credits. Cassidy supports converting expiring tax credits into pre-funded ACA health savings accounts, but many of his fellow Republicans disagree with that approach.

The number of GOP senators who would support an extension of the credits is difficult to pin down because there is no Republican plan, and their backing depends on the details.

Meanwhile, the House might release details of legislation to restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies. The BIOSECURE Act was included in the Senate-passed National Defense Authorization Act. BIOSECURE was not included in the original version of the House's NDAA, but it is expected to be added in. A vote on the NDAA will likely take place this month.

foreign drug prices

'Quid' pro quo

The United Kingdom has agreed to pay more for medicines to avoid U.S. pharmaceutical tariffs, Daniel Payne and Andrew Joseph report.

The Trump administration has been critical of what it calls "free rider" countries since the president's first term, and President Trump has promised to get other countries to pay more for medicines while lowering prices domestically.

To succeed, Trump will need to get several other countries to take similar actions. U.K. health officials have said the country risks losing pharmaceutical industry investment if it doesn't pay more for drugs. Multiple major drugmakers have paused or halted major developments in the country in recent months.

Read more about the details of the agreement in principle.

medicare drug price negotiation

Medicare quietly discloses negotiated drug prices

The Trump administration last Tuesday evening unveiled the prices for 15 drugs that were the subject of the second year of Medicare negotiations, saying it saved $8.5 billion, or 36%, compared to what it would've paid last year had the negotiated prices been in effect, Elaine Chen and I reported.

The timing and process of announcing the negotiated prices seemed designed to avoid attention, unlike the splashy announcements that accompanied drug pricing deals with individual companies.

Curiously, the Medicare negotiated price for Novo Nordisk's semaglutide is slightly higher than the price Novo voluntarily agreed to in the same program as part of its deal with the administration. Read more.

fda

When an internal email is a press release

The FDA's top vaccine regulator asserted in an email to staff on Friday that the Covid-19 vaccine caused at least 10 deaths in children and called for changes to the way the agency regulates vaccines, Matthew Herper and Helen Branswell report.

Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, didn't provide evidence to support that claim or say much about how he plans to change vaccine regulations.

Internal agency emails are typically not an avenue for major policy announcements or revisions to product safety profiles. Jesse Goodman, who led CBER during the George W. Bush administration, said Prasad's memo was "destined to go externally," given that it was emailed to the entire center. Goodman said such a "really extraordinary" claim would normally be subject to a detailed scientific analysis and be presented "at an appropriate forum."

medicare advantage

$13 billion

That's how much Medicare Advantage plans stand to gain over nearly a decade from changes that the administration proposed to an MA bonus program, according to Bob Herman.

Medicare Advantage plans that score well on the program's star-rating program get lucrative bonuses.

Read more from Bob about the changes that the administration is proposing to that program that would benefit insurers.

pediatric research

House passes pediatric cancer drug bill

The House on Monday passed a bill to improve research on childhood cancer drugs. The Senate still needs to pass the legislation before it would be sent to the president for his signature.

The FDA already has the authority to make drug companies study drugs individually in children. The House bill would authorize the agency to require that new drugs be tested in combination with cancer drugs already on the market.

The bill would give the agency more tools to ensure that companies follow through on pediatric research, and it would renew a program that provides priority review vouchers to companies that develop treatments for rare pediatric diseases.

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