Congress returns from the holiday weekend tomorrow for Committee business and floor voting. The Wall Street Journal reports that

Democrats will sort through a heavy pile of to-do items when they return to Washington, including ironing out disagreements over their Build Back Better bill, keeping the government funded and boosting the debt limit before the U.S. runs out of money to pay its obligations.

The party’s $2 trillion education, healthcare and climate package, which passed the House before the Thanksgiving recess, now heads to the 50-50 Senate, where Senate Majority Leader Chuck Schumer (D., N.Y.) is hoping to approve the legislation before Christmas.

Senate Democrats need to reach unanimous agreement on the policy proposals and work through expected procedural challenges, both of which could mean changes to the package. * * *

Republicans blocked an attempt to vote on a bipartisan slate of 20 amendments to the National Defense Authorization Act, a $777.9 billion annual defense-policy bill, before leaving for Thanksgiving break. Democrats set up a procedural vote Monday at a 60-vote threshold on a substitute bill that has GOP amendments. If 60 senators agree to move forward, final passage could happen soon.

Meanwhile, funding for current government programs runs out after Friday, Dec. 3, giving lawmakers just days to pass legislation preventing a government shutdown. Some Democrats have pushed for a very short-term extension of government funding, possibly through Dec. 17, while Republicans are seeking an extension that lasts into 2022.

Some Republicans have signaled that they would accept holding funding for existing government programs flat for the fiscal year, which would preserve funding levels negotiated under the Trump administration. Democrats want to increase funding levels.

Prof. Katie Keith, writing in the Health Affairs blog, provides an overview of the healthcare provisions found in the version of the Democrat’s $2 trillion social and climate oriented budget reconciliation bill, a/k/a the Build Back Better bill which is now pending before the Senate as noted by the Wall Street Journal above. Two of the bill’s provisions would impact group health plans, presumably including FEHB plans:

“Beginning with the 2023 plan year, group health plans and insurers offering individual or group health insurance coverage would be required to cover certain insulin products on a pre-deductible basis and with limited cost sharing. Cost sharing would be capped at $35 or 25 percent of the negotiated price, whichever is lower, for a 30-day supply of insulin. Any associated out-of-pocket costs would be counted towards a consumer’s annual deductible and out-of-pocket maximum. CBO estimates that these new requirements will cost, on average, $2 billion annually. * * * The legislation would define both “insulin” and “selected insulin products” and makes clear that plans and insurers could charge higher cost sharing for products that do not meet these definitions. Higher cost sharing could also apply if a consumer receives the selected insulin products from an out-of-network provider.”

The Wall Street Journal adds that “[The Senate Majority Leader] Mr. Schumer said at a press conference in New York last weekend that the insulin cap could face procedural problems.”

The other Build Back Better bill’s provision affecting group health plans would require insurers and prescription benefit managers to semi-annually report to employers and other plan sponsors on prescription drug spending in their health plans.

The report would reflect information on dispensed drugs, utilization, costs, out-of-pocket spending, drug manufacturer copay assistance, and compensation paid to brokers and other consultants, among many other data elements laid out in the law. The law would impose civil monetary penalties for violating these requirements, and insurers and PBMs could not enter into contracts with gag clauses that prevent these disclosures.

Group health plans, insurers, and PBMs could restrict public access to cost data but would have to disclose reported information to federal officials. Federal agencies would also be required to develop separate, more limited reporting requirements. This requirement would go into effect for plan years that begin on or after January 1, 2023.

This reporting requirement seems to duplicate Section 204 of the No Surprises Act. Speaking of unnecessary complexity, health plan expert Robert Moffitt reminds us in the Hill that Congress has not yet bothered to repeal the dormant MultiState Plan Program provisions in the Affordable Care Act.

As explained in this KFF article, the Build Back Better bill also would allow the federal government authority to negotiate certain drug prices for the Medicare program, and moreover Section 8926 of the Build Back Better bill (HR 5376) would require FEHB plans to participate in this “fair price negotiation program.”

From the Delta variant front, we learned on Friday that the Delta variant has a new competition named the Omicron variant. The Wall Street Journal explains that

The WHO designated the strain a “variant of concern,” formally alerting health authorities around the world to the extra risks it appears to carry. To qualify as a variant of concern, a new virus strain has to be proved to be more contagious, lead to more serious illness or decrease the effectiveness of public-health measures, Covid-19 tests, treatments or vaccines.

Other variants of concern include the Delta variant, which is now dominant world-wide, and the Alpha variant, which drove a deadly wave of infections across Europe and the U.S. last winter and spring.

STAT News adds that

“Right now there are many studies that are underway,” Maria Van Kerkhove, the World Health Organization’s technical lead on Covid-19, said Friday. “There is a lot of work that is ongoing in South Africa and in other countries to better characterize the variant itself, in terms of transmissibility, in terms of severity, and any impact on our countermeasures, like the use of diagnostics, therapeutics, or vaccines. So far, there is little information, but those studies are underway, so we need researchers to have the time to carry them out.”

She added: “It will take days to weeks for some of these studies to be undertaken.” * * *

For now, perhaps the most pressing questions about Omicron are: Is it more transmissible than even the Delta variant, and if so, how much? And to what extent can it evade immune protection generated by earlier infections or vaccines?

On the transmissibility question, experts will watch closely to see how Omicron continues to play out in South Africa and elsewhere. * * *

With new variants, vaccines can lose a step at blocking infections — particularly if the antibodies they elicit aren’t able to recognize the virus as well — but still largely maintain their ability to guard against severe disease and death because of the broader immune response, including T cells. This has happened already to varying degrees with other variants, to the greatest extent with the Beta variant and even to some extent with Delta. It’s also possible that if there’s a greater degree of immune escape, a higher percentage of breakthrough cases will lead to serious outcomes. That wouldn’t point to complete vaccine failure — but it would point to reduction in vaccine effectiveness.

In other news —

• Healio informs us that

The obesity rate among emerging adults — who researchers defined as individuals aged 18 to 25 years — increased more than 26 percentage points over a 42-year span, National Health and Nutrition Examination Survey data show. * * * *

“Emerging adulthood may be a key period for preventing and treating obesity given that habits formed during this period often persist through the remainder of the life course,” Ellison-Barnes and colleagues wrote. “There is an urgent need for research on risk factors contributing to obesity during this developmental stage to inform the design of interventions as well as policies aimed at prevention.”

• The Federal Employee Benefits Open Season ends two weeks from tomorrow, December 13, 2021.

• Precision Vaccinations reminds us that an FDA advisory committee will meet on Tuesday November 30 to “discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.” The New York Times adds that

In briefing documents posted to the F.D.A.’s website on Friday, agency reviewers did not take a position on whether the drug should be authorized, though they found that the clinical trial data did not show any major safety concerns and that the drug was effective in preventing severe disease. * * *

Merck’s initial estimate that the drug reduced hospitalization and death by 50 percent came from an early look at results from 775 study participants. The updated figure announced on Friday came from more than 1,400. In the final analysis, the participants who received molnupiravir had a 6.8 percent risk of being hospitalized, and one patient died. Those who received a placebo had a 9.7 percent risk of being hospitalized, and nine died.

Dr. David Boulware, an infectious disease researcher at the University of Minnesota, said he expected the drug would still receive emergency authorization. If the expert committee endorses it and the F.D.A. heeds the recommendation, the treatment could be authorized in the United States as soon as next week.

“The reduction in hospitalization is a little bit less, but there is still a big mortality benefit if you start early,” he said.