“This provides an opening,” said Elizabeth Fowler, executive vice president for programs at the nonpartisan Commonwealth Fund. “Maybe it’s a bargaining chip with the industry.”
Biden likes the idea of bringing high U.S. drug prices more in line with other countries’ lower prices.
This is the core idea in the “most favored nation” rule Trump announced on Friday. It will tie the prices of drugs in Medicare Part B to the lower prices in other developed countries, many of which negotiate those prices directly with drugmakers.
This approach — of linking high-cost U.S. drugs to an international index — is one that has been embraced by many Democrats. Last year, House Democrats passed a bill allowing the federal government to negotiate lower Medicare drug prices. The bill, H.R. 3, uses an index of prices in six other countries as a price ceiling for the United States.
Implemented a most favored nation rule represents a major shift in the way the federal government sets prices for drugs in the Medicare program and could result in significant payment cuts for drugmakers.
During his campaign, Biden proposed creating an independent panel to recommend prices for new drugs that lack competition and are provided through Medicare and marketplace plans. The panel would consider other countries’ prices in making its recommendations.
Yet it’s not entirely clear how the Biden administration will handle Trump’s rule.
For one thing, the Trump administration skipped the normal rulemaking process, which requires weeks for public comment. Instead, it issued what is known as an “interim final rule” — a move typically only reserved for rules that need to go into place quickly.
That could make it difficult for the Biden administration to defend the policy in court if the pharmaceutical industry sues over the rule. The rule also relies on the government’s authority to experiment with Medicare payments, but the Trump administration wrote it so broadly that it reads more like a fundamental change to the overall program. That could be another weakness drugmakers could emphasize in court.
Still, the Biden administration may decide to stick with the interim final rule. Or, it could choose to walk it back and issue its own rule laying out an international price index. Representatives for Biden didn’t respond to a question about how the president-elect will handle it.
Either way, the situation will soon be out of the hands of Trump appointees, who will be replaced by Team Biden in two months.
“These initial rules will not be finalized under the Trump administration, so the Biden team will have a chance to finalize or not finalize based on what is consistent with their view,” Andy Slavitt, administrator of the Centers for Medicare and Medicaid Services under President Barack Obama, told me.
Biden is less enthused about another Trump administration rule — this one banning drug rebates.
Trump announced another major regulation on Friday, finalizing a ban on drug rebates in the Medicare program. It is slated to go into effect on Jan. 1, 2022.
This rule is hated by pharmacy middlemen who collect the rebates but often don’t pass on the savings to consumers. The rebates are part of an opaque and convoluted price negotiation system, in which consumers can find it impossible to discover the actual price of a drug, let alone shop around for the best value.
Like the “most favored nation” policy, the aim of the rebates ban is to ultimately lower drug prices. But the administration abandoned that effort last year, when its own analysis showed such a ban would actually raise premiums in Medicare. That’s because health insurers, who increasingly own pharmacy benefit managers, probably would hike premiums to cover some of their losses from lost drug rebates.
If the Biden administration takes steps to reverse the rebates rule, it would be driven by that same concern.
“The rebate rule, I think, is viewed by most Democrats as a windfall for pharma and not for patients,” Fowler told me. “I cannot see that rule going forward…I think they would take steps to reverse it.”
Biden will be taking the reins from a GOP president who was unusually willing to go after the pharmaceutical industry.
Trump has not shied away from publicly slamming the drug industry for prices that are higher than anywhere in the world. Two years ago he promised to roll out the most favored nation rule, vowing it would have widespread effect on drug costs.
But then his administration dragged its feet amid heavy opposition by the industry and skepticism among Republican lawmakers. When Trump lost the election, many had assumed the effort would fall by the wayside, considering it’s atypical for presidents to implement controversial policy changes via executive order just before leaving office.
Yet the president — recently fueled by anger at Pfizer for announcing promising coronavirus vaccine data after Biden was declared the winner — rolled out the interim regulation on Friday. He paired it with a final rule banning drug rebates.
“Although the administration had discussed both ideas for several years, Trump health officials still found themselves rushing to get the rules finalized because of significant internal feuding over the proposals,” my colleague Yasmeen Abutaleb reports.
“Trump introduced both rules again in July as executive orders, but legal experts questioned whether they went through proper rulemaking processes and said those questions left them particularly vulnerable to legal challenges.”
A third drug maker says its coronavirus vaccine is highly effective.
The University of Oxford and the British-Swedish pharmaceutical giant AstraZeneca said its vaccine is up to 90 percent effective when administered at a half dose and then a full booster dose a month later. Pfizer and Moderna announced similarly promising results in the last two weeks.
“The Oxford-AstraZeneca vaccine is likely to be cheaper than those made by Pfizer and Moderna, and the British vaccine does not need to be stored at subzero temperatures, but can be kept in ordinary refrigerators in pharmacies and doctor’s offices,” William Booth and Antonia Noori Farzan report.
“The Oxford-AstraZeneca team said in a video conference with journalists that their vaccine’s average efficacy was 70 percent, reflecting the disparate results from two different dosing regimens,” they write. “When two full doses were given at least one month apart, efficacy fell to 62 percent. But it rose to 90 percent when a subjects received only a half dose, followed with a full dose one month later.”
The first coronavirus vaccine shots could come by Dec. 12.
The Food and Drug Administration’s coronavirus vaccine advisory committee is set to meet on Dec. 10 to discuss Pfizer and BioNTech’s application for emergency use authorization for their coronavirus vaccine. If approved, vaccines could be shipped to states within 24 hours, Moncef Slaoui, the head of Operation Warp Speed, the federal government’s coronavirus vaccine program, told CNN on Sunday.
Pfizer and BioNTech applied for emergency authorization on Friday after they said that a final analysis of data from clinical trials showed their vaccine to be 95 percent effective. Biotechnology company Moderna has released similarly promising early results and is expected to apply for emergency authorization before the end of the month.
Ashish Jha, dean of Brown University School of Public Health:
Slaoui also said in a separate interview with NBC’s Chuck Todd that he did not anticipate challenges in handing off the vaccine process once the Biden administration took office. The operation is “isolated from the administration, from the political environment and the political context,” Slaoui said. “All decisions are made, the train is running, whether one administration or the other doesn’t, frankly, make a difference.”
Still, approval of a vaccine is only the first step. State and local health departments must figure out how to distribute a vaccine, and some public health officials worry that the storage and use requirements for the Pfizer vaccine could lead to some scarce shots going to waste, Politico reports. The vaccine must be kept in ultracold storage and once a vial of the vaccine — enough to make five doses — is thawed it must be used within six hours, a potential challenge for small clinics and rural areas, which might see fewer patients seeking vaccinations.
The experimental coronavirus treatment given to Trump has gained FDA emergency use authorization.
The drug made by Regeneron Pharmaceuticals is designed to prevent people infected with the coronavirus from developing severe illness and was given to Trump when he was treated for covid-19 last month, The Post’s Laurie McGinley and Carolyn Y. Johnson report. But the treatment, which is time-consuming and complicated to make, is expected to be in short supply.
The drug is a cocktail of two monoclonal antibodies, a type of treatment that mimics the body’s natural defenses to a virus. It’s the second drug of this type to be cleared by the Food and Drug Administration after Eli Lilly & Co.’s drug received authorization earlier this month.
“Regeneron executives said on the company’s earnings call in early November that they project having enough doses for 80,000 patients by the end of November, and 300,000 total doses by the end of January,” Laurie and Carolyn write.
With the U.S. approaching 200,000 coronavirus cases a day, health care providers expect shortages, and some doctors worry that the treatments won’t find their way to the communities that most need them. An additional challenge comes from the fact that the treatment must be administered by intravenously, potentially requiring health care providers to set up separate infusion spaces to ensure that contagious coronavirus patients don’t receive infusions alongside people with compromised immune systems in infusion centers.
Ahh, oof and ouch
AHH: Top public health experts are ramping up pleas for people to reconsider holiday travel.
Anthony S. Fauci, the country’s top infectious-disease expert, told CBS News’s “Face the Nation” that although he understood “covid fatigue,” people traveling over the holidays and ignoring public health advice would “get us into even more trouble than we’re in right now.” The warning came as more than 80,000 Americans are hospitalized with covid-19.
Holiday travel is surging. More than 1 million people passed through the nation’s airports on Friday. Although that is less than half of the 2.5 million people who traveled through U.S. airports in 2019, it represents the second-highest single-day rush of airline passengers since the start of the pandemic, Derek Hawkins and Hannah Knowles report.
Experts caution that a negative coronavirus test is not a greenlight for socializing, especially indoors. Tests are only a snapshot in time, and even with the more accurate PCR tests, people infected with the coronavirus can receive a negative result, especially if they take the test soon after exposure but before the virus builds up in the body.
In an informal survey of 670 epidemiologists, the New York Times found that only 6 percent said they would feel comfortable spending time indoors without precautions after receiving a negative test.
OOF: The smallest health-care providers have the hardest time finding protective gear.
“Most U.S. hospitals and health systems have, over the pandemic’s nine months, stitched together systems and improvisations to acquire masks, gowns, gloves and other personal protective equipment,” The Post’s Amy Goldstein reports. “Yet many small health-care and social-service settings continue to suffer from shortages they expect to grow worse.”
Small doctors’ offices, AIDS clinics, homeless shelters and small rural hospitals lack the market power to compete with larger medical institutions and are among those struggling to find equipment to protect their workers. But politicians who have spoken about PPE have usually not mentioned the two-tiered system, which defines access to equipment.
Get Us PPE, a group that collects and distributes donated supplies, has fulfilled 12 percent of the requests that it gets for protective equipment, and that number is dropping quickly as the need for equipment amid surging cases outstrips the supply.
OUCH: Trump skipped out on a pandemic preparedness session during the G-20 summit.
“Major leaders among the world’s 20 largest economies delivered video messages for the virtual session on pandemic preparedness, including the leaders of Saudi Arabia, France, Germany, Italy and South Korea,” CNBC’s Emma Newburger reports of Saturday’s session. “Trump did not deliver a message for the event, and there did not appear to be any American presence in the session.”
Trump skipped part of Saturday’s Group of 20 summit to play golf at the Trump National Golf Club in Sterling, Va.
Unlike other world leaders, Trump made no promises during the summit about equitable global vaccine distribution. The United States is not part of COVAX, the World Health Organization’s plan to ensure that lower-income countries receive vaccines.
More in coronavirus
The Senate held a hearing on hydroxychloroquine, despite studies showing it is ineffective against the coronavirus.
The Senate Homeland Security Committee on Thursday “spent more than two hours revisiting discussion about hydroxychloroquine as a potential covid-19 treatment — a debate that leading health experts say was settled months ago,” The Post’s Marisa Iati reports.
Chairman Ron Johnson (R-Wis.) called a panel of witnesses who have publicly supported use of the antimalarial drug to combat coronavirus, despite the fact that the Food and Drug Administration withdrew its emergency use authorization for the drug and a randomized clinical trial found the treatment no more effective than a placebo.
Hydroxychloroquine was widely touted by Trump and allies as a treatment for the virus, but top health officials in the administration, including Anthony S. Fauci and Deborah Birx, have said it is ineffective.
Johnson accused the medical community of having “censored” evidence that the antimalarial drug is effective and posited that doctors and experts might have backed another drug, remdesivir, because it was more expensive and would bring more money to drug companies.