[Senator] Joe Manchin (D WV) remains at the negotiating table [with his party’s leadership], despite deep concerns about President Joe Biden’s climate and social spending bill [a/k/a the Build Back Better Act].
After speaking with Biden on Monday afternoon, Manchin said he was still “engaged” in discussions. And as he left the Capitol, the key Democratic senator made clear he wasn’t ready to commit to voting for or against a bill that is still coming together behind closed doors.
From the White House, the President issued an executive order on improving customer service performed by government agencies. Federal News Network explains that
Jason Miller, the Office of Management and Budget’s deputy director for management, said the EO also directs agencies to coordinate work on services that reflect common life experiences, including turning 65 and planning retirement, having a child or applying for a small business loan. * * *
The executive order gives senior administration officials 90 days to select a limited number of these customer life experiences to prioritize across government. It requires Miller and other members of the President’s Management Council to update [Presidential senior advisor Neera] Tanden and White House Chief of Staff Ron Klain on progress made improving these customer life experiences every six months.
The EO also gives the General Services Administration six months to develop a roadmap of shared services that agencies can use to improve customer experience.
The administration specifically names Login.gov and the U.S. Web Design System, a set of templates meant to create a common look and feel for agency websites, as tools that all agencies should use to improve federal customer experience.
Here is a link to the White House’s press release on the Executive Order as found on performance.gov.
From the Affordable Care Act front, the Internal Revenue Services has released the final Affordable Care Act coverage reporting forms, 1095-B and 1095-C, along with the final instructions for those forms.
From the Office of Information and Regulatory Affairs’ website, we find that the federal government’s Fall 2021 regulatory agenda has been published. Here is a link to OPM’s Fall 2021 agency rule list. A chill went up the FEHBlog’s spine when he noticed that the ACA provider non-discrimination proposed rule mandated by the No Surprises Act will be published this month due to a statutory requirement. Cost curve up?
From the employer sponsored care front, Healthcare Dive reports that
— The average per-employee cost of employer-sponsored health insurance jumped 6.3% in 2021, as employees and their families resumed care delayed last year due to the pandemic, according to a new survey of employers from Mercer.
— That’s the highest annual increase since 2010. Health benefit costs outpaced growth in inflation and worker compensation through September, the employee healthcare and investment consultancy said.
— The findings raise questions of whether employers are experiencing a temporary correction to the cost trend following a minimal year-over-year increase of just 3.4% in 2020, or if they’re staring down the barrel of a new period of higher cost growth.
No doubt those questions can keep actuaries awake at night.
From the good COVID news department (yes it exists), STAT News informs us that
Paxlovid, Pfizer’s oral treatment for Covid-19, led to an 89% reduction in hospitalization and death in final data from a pivotal trial, the company said today, confirming the results of an earlier analysis.
The news should allay concerns that the efficacy of Pfizer’s pill would wane over time. Molnupiravir, a Covid-19 antiviral from Merck, appeared 50% effective in an interim trial analysis but fell to about 30% in the final tally. Both studies enrolled unvaccinated patients who were recently diagnosed with Covid-19 and had at least one risk factor for severe disease.
The next step for Pfizer is submitting the results to the FDA, which the company expects to do this month, and applying for an emergency-use authorization. The agency is yet to disclose whether it will convene a panel of expert advisers before deciding on Paxlovid.
Based on the President’s winter is coming plan, the FEHBlog’s bet is on the FDA approving the Pfizer drug without delay.
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors
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.
“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.
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.
From the Delta variant front, David Leonhardt in the New York Times Mornings column tries to place the pre-Thanksgiving increase in COVID cases in perspective. He encourages readers to recognize that it’s the cadre over 65 and particularly those in their 80’s and 90’s who are threatened by COVID.
Covid is the threat on many of our minds. But for most people under 65, the virus may present less risk than a car trip to visit relatives this week.
The situation is more frightening for older people, especially those in their 80s and 90s. For the oldest age groups, Covid presents a real risk even after vaccination. It appears to be more dangerous than a typical flu and much more dangerous than time spent riding in a vehicle, based on C.D.C. data.
As a result, older Americans need protection during a surge. (The same is also true of a small percentage of younger people with specific vulnerabilities to Covid, like organ-transplant recipients.) The most effective way to protect vulnerable people is through vaccination — not only of them but also of others who might infect them [e.g., initial vaccinations for children beginning at age 5 and young teenagers and boosters for fully vaccinated adults, after two months for the Johnson & Johnson vaccine and six months for the mRNA vaccines.]
STAT News reminds us that the FDA will consider granting emergency use authorization to the Merck anti-viral pill for treating early COVID next Tuesday. However,
[C]linical trials for both the Pfizer and Merck antivirals focused on unvaccinated people with at least one risk factor for developing severe Covid-19. Trial data, as disclosed by the drug companies, shows them to be remarkably effective: No patient in either study died after being treated with a course of antivirals.
But it might be difficult to get the drugs outside a clinical trial setting. Depending on the particular patient, it could involve four individual steps: recognizing symptoms, receiving a positive Covid-19 test result, being prescribed an antiviral by a doctor, and picking up the pills at a nearby pharmacy.
Each step could prove difficult, Gaffney said, beginning with the challenge of recognizing symptoms during winter, when early signs of Covid-19 might be easily written off as a cold, flu, or allergies. Even if patients do quickly suspect they have Covid, diagnostic tests are still sometimes hard to come by. Many of the patients who test positive won’t have primary care physicians. And perhaps worst: The antivirals are ideally taken just three days after symptom onset, meaning the four-step process can’t face any setbacks.
Of all the challenges patients will face when seeking the antiviral treatments, the lack of access to efficient testing is by far the largest. * * *
[Céline] Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration] suggested that some immunocompromised people, for instance, should be prescribed the antivirals preemptively, if they’re exposed to Covid but haven’t tested positive — eliminating a potentially burdensome step. * * *
Ideally, though, people who live outside congregate settings would be able to access the same level of service at retail pharmacies. Other fixes, Gounder suggested, could include issuing a “standing order” for the drugs — essentially, allowing an entire city or state’s population to receive the drugs without a prescription.
In other words, we are close to having a Flonase for COVID.
From the Delta variant vaccine mandate front, the Wall Street Journal reports that
The Biden administration on Tuesday filed an emergency court motion that seeks the immediate reinstatement of its rules requiring many employers to ensure their workers are vaccinated or tested weekly for Covid-19.
The Occupational Safety and Health Administration earlier this month formally issued the requirements, which apply to businesses with 100 or more employees. The rules cover roughly 84 million workers and are scheduled to take effect Jan. 4.
Also because the government contractor mandate requires contractors to verify its employees’ COVID vaccination status with supporting documents, the Society for Human Resource Management offers guidance on how employers can recognize fake vaccination cards.
From the tidbits department —
The Federal Times informs us that “Legislation introduced in the House Tuesday would not only establish credentials necessary for all future Office of Personnel Management directors, but also formally dictate the agency’s role in leading human resources through data-driven and modern policy. Under the bill, introduced by Rep. Gerry Connolly, D-Va., a nominee for OPM director would have to have prior human capital experience and be chosen without regard for political affiliation.”
The [independent dispute] system chosen by the Biden administration was expected to push insurance premiums down by 0.5% to 1%, the Congressional Budget Office estimated.
“Everyone has to give a little to get to a good place,” [HHS Secretary] Becerra said. “That sweet spot, I hope, is one where patients … are extracted from that food fight [between out of network providers and health plans]. And if there continues to be a food fight, the arbitration process will help settle it in a way that is efficient, but it also will lead to lower costs.”
The International Foundation of Employee Benefit Plans provides its insights into the new proposed rule on ACA reporting referenced in yesterday’s FEHBlog post. The proposed rule would provide:
— An Automatic 30-Day Extension of Deadline for Furnishing Statements Under Sections 6055 and 6056
— An Alternative Manner of Furnishing Statements Under Section 6055 During Taxable Years When the Individual Shared Responsibility Payment is Zero
Under the proposed alternative manner of furnishing, the reporting entity must post a clear and conspicuous notice on the entity’s website stating that responsible individuals may receive a copy of their statement upon request. The notice must include an email address, a physical address to which a request may be sent, and a telephone number that responsible individuals may use to contact a reporting entity with any questions.
The public comment period on this IRS proposed rule ends in roughly sixty days.
Govexec offers a helpful to-do list for the ongoing Federal Benefits Open Season from Nov. 8-Dec. 13
The National Active and Retired Federal Employees Association’s Federal Benefits Institute will have a variety of resources available during open season, including a live webinar series.
Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases:
Here is a link to the CDC’s weekly chart of new COVID hospital admissions which trended up by 5.4% from last week. However, the FEHBlog’s weekly chart of new COVID deaths has begun to trend down again.
Here’s FEHBlog’s weekly chart of new COVID vaccinations distributed and administered.
The vaccinations administered line continues to trend up. The CDC’s COVID vaccinations site now displays vaccinations administered to the age 5 to 11 group. Nearly 70% of the over age 12 population is fully vaccinated, and 97.5% of the age 65+ population has received at least one dose of the COVID vaccine. That’s impressive.
In Delta variant booster news, the CDC informs us that over one quarter of the age 50+ has received the booster. AHIP informs us that
Today the Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. This amendment expands the use of booster doses of both vaccines to include all adults at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also met today to discuss further clinical recommendations on the use of COVID-19 vaccine booster doses for adults. After reviewing the most recent safety and efficacy data of the Pfizer and Moderna booster doses, which showed the vaccines to be safe, the Committee unanimously (11-0) voted in favor of authorizing:
— A single COVID-19 vaccine booster dose is recommended for persons aged 18 and olderwho received an mRNA COVID vaccine primary series based on individual benefits and risks, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization (EUA).
— A single COVID vaccine booster dose is recommended for persons aged 50 and older who received an mRNA COVID vaccine, at least 6 months after the primary series, under the FDA’s EUA.
Any FDA-approved or authorized COVID-19 vaccine can be used for a booster dose, regardless of vaccine received for a primary series.
The committee emphasized that the top priority continues to be vaccination of the unvaccinated, and that potential side effects of vaccination, such as incidence of myocarditis and pericarditis, need continual monitoring as more data becomes available.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, signed off on a recommendation Friday evening to let all US adults get a COVID-19 booster shot.
The endorsement, following a unanimous vote by a panel of CDC advisors earlier in the day backing a third dose of a Moderna or Pfizer mRNA COVID vaccine, now means everyone over the age of 18 is eligible for a booster.
According the ACA FAQ 50, health plans now must covered vaccines administered to the expanded group.
Here is a link to the CDC’s weekly interpretation of its COVID statistics.
In other news / the “more”:
The Department of Health and Human Services announced today that “Today, the Biden-Harris Administration unveiled details about the establishment of a new federal advisory committee, the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. As mandated through the No Surprises Act, the GAPB Advisory Committee will be charged with providing recommendations to the Secretaries of Health and Human Services (HHS), Labor, and Treasury on ways to protect consumers from exorbitant charges and balance billing when using ground ambulance services. * * * Learn more about the GAPB Advisory Committee and the Federal Register Notice – PDF.”
Beckers Hospital News reports that “Insurers need more evidence of the clinical benefit of Biogen’s controversial Alzheimer’s drug Aduhelm before they start paying for it, Bloomberg reported Nov. 18. Bloomberg surveyed 25 of the nation’s largest insurers, and none of them deemed the drug “medically necessary.” Most indicated they view the drug as experimental and said they needed to see more evidence on the drug’s ability to slow cognitive decline.”
Govexec tells us that “About 90% of NASA employees have received at least one dose of a COVID-19 vaccination, according to agency data, but about 1,150 workers are seeking an exemption to President Biden’s governmentwide mandate.”
mHealth Intelligence informs us that “The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.”
The Wall Street Journal provides an overview of currently available and near future COVID treatments.
From the Delta variant vaccine front, the New York Times reports
The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.
The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.
Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.
Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.
From the Delta variant research front, the National Institutes of Health has announced that
Lung autopsy and plasma samples from people who died of COVID-19 have provided a clearer picture of how the SARS-CoV-2 virus spreads and damages lung tissue. Scientists at the National Institutes of Health and their collaborators say the information, published in Science Translational Medicine, could help predict severe and prolonged COVID-19 cases, particularly among high-risk people, and inform effective treatments.
From the Delta variant vaccine mandate front, Govexec tells us that
The White House will not back down from next week’s deadline for virtually all federal employees to prove they are vaccinated against COVID-19, despite calls for a delay. The federal workforce has until Nov. 22 to provide documentation demonstrating they are inoculated or to request an exemption under an executive order issued by President Biden.
From the opioid epidemic front, the Washington Post informs us that
The U.S. drug epidemic reached another terrible milestone Wednesday when the government announced that more than 100,000 people had died of overdoses between April 2020 and April 2021. It is the first time that drug-related deaths have reached six figures in any 12-month period. * * *
The new data shows thereare now more overdose deaths from the illegal synthetic opioid fentanyl than there were overdose deaths from alldrugs in 2016.
Fentanyl is many times more powerful than morphine, leading to more frequent fatal overdoses. It is increasingly laced into other drugs, such as cocaine, and counterfeit pills, killing some who consume it unknowingly.
During the worst of the pandemic, more users were alone, reducing the chances that other users or bystanders could call first responders in the event of an overdose, experts have said. * * *
The number of opioid prescriptions issued by health-care providers has declined sharply as the crisis continues.
Addiction preys on young and middle-aged adults, who make up the bulk of those with drug-related substance use disorder.
Compounding the problem is the fact as related by Sam Quinones in his recent book the Least of Us that while a lethal dose of heroin takes about 15 minutes to kill a person, a lethal dose of fentanyl will take a minute or two to do so. That’s hardly enough time to administer naloxone which can pull people back from the brink of death. The FEHBlog wishes that Pfizer and Merck could develop a pill to cure substance abuse.
From the Open Season front, Reg Jones in Fedweek offers thoughts on how to use the ongoing federal benefits open season to the readers’ advantage.
From the No Surprises Act front, Healthcare Dive reports that
A key sticking point [stemming from the tri-agencies’ independent dispute resolution interim final rule] is the arbitration process, and how the qualifying payment amount (QPA) — determined by a plan’s median in-network contracted rate for a geographic area — is used to arrive at rates for out-of-network providers.
The Association of Air Medical Services filed a lawsuit in federal [district] court [for the District of Columbia, No. 1:21-cv-03031] challenging the rules Tuesday, claiming reliance on a QPA strays from Congress’ intent when passing the law that “no single statutory factor receives special weight” in the arbitration process.
As the FEHBlog previously noted, the Texas Medical Association has filed a similar lawsuit in the Lone Star State.
The rules guiding the arbitration process are a form of consumer protection, 63 organizations representing patients, consumers, unions and employers said in a Tuesday letter.
An over reliance on out-of-network charges, particularly among Wall Street-backed providers, extracts maximum costs from patients, employers and health systems, thus driving up premiums and contributing to ever-rising healthcare spending in America, they said.
“As outlined in the interim final rule, it is only by reinforcing the QPA as the overriding and primary factor for determining final payment that the No Surprises Act can achieve the $17 billion in cost savings outlined by the Congressional Budget Office,” the groups wrote.
Amen
Also from the NSA front, the tri-agencies and OPM released an interim final rule implementing NSA Section 204’s burdensome yet aggregated prescription drug and healthcare cost reporting requirements imposed on health plans. The accompanying fact sheet explains
Summary of the November 17, 2021 IFC
This IFC requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including:
General information regarding the plan or coverage;
Enrollment and premium information, including average monthly premiums paid by employees versus employers;
Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers;
The 50 most frequently dispensed brand prescription drugs;
The 50 costliest prescription drugs by total annual spending;
The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year;
Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and
The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs.
The IFC provides that plan sponsors, issuers, and FEHB carriers generally will be required to submit this information aggregated at the state/market level, rather than separately for each plan. To ensure that the Departments and OPM are able to conduct meaningful data analysis and identify prescription drug trends, the IFC further provides uniform standards and definitions, including for identifying prescription drugs regardless of the dosage strength, package size, or mode of delivery.
Applicability Date and Comment Period
The CAA requires plans and issuers to begin submitting the required information to the Departments by December 27, 2021, and to submit this information by June 1 of each year thereafter. However, the Departments have announced that they will exercise discretion to provide temporary deferral of enforcement with regard to the December 27, 2021 and June 1, 2022 deadlines, and that they will not initiate enforcement action against a plan or issuer that submits the required information for 2020 and 2021 by December 27, 2022. OPM also will allow its FEHB carriers to report information for 2020 and 2021 by December 27, 2022.
Comments on this IFC are due at 5 p.m. on January 24, 2022.
Before long, health plans, and especially FEHB carriers, will be spending most of their time reporting data to the government.
From the Delta variant front, Medscape informs us that
“Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published Friday in the CDC’s Morbidity and Mortality Weekly Report.”
and
People who already have had COVID-19 may have more reason to get vaccinated, with new findings suggesting that vaccination after infection can boost protection. Under viral threat, the body first uses B cells to make antibodies against the invader, a process that can take up to 2 weeks. The immune system simultaneously creates memory B cells that can recognize the virus if it reappears and rapidly mounts a powerful secondary response.
In a series of shots, the first dose triggers the primary response. The follow-up doses activate the memory B cells, strengthening defenses against the pathogen.
These new results, published in Cell Reports, show that a SARS-CoV-2 infection, like a first vaccine dose, will elicit the primary response, as expected.
COVID-19 testing newcomer Detect aims to reset expectations for regular screening against the pandemic coronavirus—and it’s now received an FDA green light to move forward with its rapid, lab-quality test for repeated use in the home.
The company’s molecular diagnostic received an emergency authorization allowing it to be sold at retail stores over-the-counter. Equipped with a reusable analyzer and $50 cartridge-based tests, the system aims to produce results with PCR-level accuracy within one hour.
From the Delta variant mandate front, the Society for Human Resource Management reports that
The White House issued guidance on Nov. 1 that its Dec. 8 deadline for federal contractors to be vaccinated against COVID-19 isn’t set in stone, providing companies with the opportunity to educate workers past that date rather than fire workers who haven’t been vaccinated by then.
“A covered contractor should determine the appropriate means of enforcement with respect to its employee at a covered contractor workplace who refuses to be vaccinated and has not been provided, or does not have a pending request for, an accommodation,” according to the guidelines.
As federal contractors prepare to implement the vaccine mandate, many questions have arisen on timing, costs and related issues, which prompted the White House to release the new guidance.
Also today, OMB’s Office of Information and Regulatory Affairs concluded its review of the OSHA vaccination screening rule for private sector employers with 100 or more employees. This means that the rule should be released this week. Heavens only knows when the FAR Council will release its vaccine mandate rule for federal contractors.
Federal News Network offers an update on the federal employee vaccine mandate.
From the recognition department, Fierce Healthcare names ten women of influence in healthcare while Healthcare Dive points out that “Healthcare employees bore the brunt of the pandemic in the workforce. Women bore the brunt of the pandemic at home. Most nurses are both.”
In Affordable Care Act new, the IFEBP reports that “The Internal Revenue Service (IRS) issued the final 1094-B, 1095-B, 1094-C, and 1095-C forms that employers, plan sponsors and group health insurers will use to report health coverage to plan members and the IRS as required by the Affordable Care Act (ACA). IRS hasn’t released final instructions.” Links to the final forms are available at this link.
The FEHBlog was particularly struck by an in-depth article in the Wall Street Journal about a lower income man in his sixties who emptied his retirement plan to pay for hospital bills for his wife who was stricken with cervical cancer. How does this happen in the Affordable Care Act world. The FEHBlog is not blaming the law. Rather the FEHBlog believes that people from the hospital, the insurance company, etc. dropped the ball when they had a chance to help this now broken man. The woman’s adult daughter, presumably the man’s step daughter, created a Go Fund Me page. Isn’t that a red flag?
The Journal also reports from Capitol Hill that the President’s Hail Mary pass to score a legislative victory with the billion dollar infrastructure bill fell short.
The Mercer consulting company is offering a report on furious state legislative efforts this year to regulate prescription benefit managers in the wake of last December’s U.S. Supreme Court decision on ERISA preemption and such laws, which was favorable to the state legislatures. The laws in the FEHBlog’s view while well intentioned mainly raise administrative costs.
Govexec in an Open Season related article discusses the No Surprises Act provisions that take effect on January 1, 2022, for enrollees with primary FEHB coverage in the United States. The FEHBlog does expect that this law will achieve its objective of getting patients out of the middle of billing disputes between out of network providers and health plans in emergency care, ancillary care at hospitals and surgicenters and air ambulances. The article notes that “The new rules don’t apply to people with coverage through programs such as Medicare, Medicaid, the Indian Health Service, the Veterans Affairs health system or TRICARE, because these programs already have other protections against high medical bills.”
From the third quarter financial reporting front / telehealth front, Healthcare Dive tells us that
“Teladoc plans to take on financial risk for its offerings in the future, including its virtual-first primary service, in a bid to expand revenue per member, the CEO of the New York-based virtual care giant said Wednesday.
The telehealth vendor made that program, called Primary360, available nationwide earlier this month, and it will be available through CVS Health-owned payer Aetna and Centene’s marketplace plans in Michigan, Mississippi, South Caroline and Texas early next year. And Teladoc is also beginning to talk with health systems about using Primary360 as a white-labeled digital front door to care for their populations, CFO Mala Murphy told investors on a call.
In its third quarter financial results also released Wednesday, Teladoc beat Wall Street expectations on earnings and revenue, with a topline of $522 million, up 81% year over year due to strength in multi-product sales and behavioral health, management said. The 19-year-old vendor saw 3.9 million visits in the quarter, representing 37% year-over-year growth.”
From the Affordable Care Act front, Kaiser Health News reports that
The federal government’s effort to penalize hospitals for excessive patient readmissions is ending its first decade with Medicare cutting payments to nearly half the nation’s hospitals.
In its 10th annual round of penalties, Medicare is reducing its payments to 2,499 hospitals, or 47% of all facilities. The average penalty is a 0.64% reduction in payment for each Medicare patient stay from the start of this month through September 2022. The fines can be heavy, averaging $217,000 for a hospital in 2018, according to Congress’ Medicare Payment Advisory Commission, or MedPAC. Medicare estimates the penalties over the next fiscal year will save the government $521 million. Thirty-nine hospitals received the maximum 3% reduction, and 547 hospitals had so few returning patients that they escaped any penalty.
Here is a link to KHN’s online tool to look up hospitals to find out whether the hospital was assessed a 2022 penalty.
From the reports and studies department —
The Kaiser Family Foundation released its COVID vaccine monitor for October 2021.
The American Medical Association discusses a study concluding that, notwithstanding a tremendous amount of consolidation between health systems and providers, private practices continue to play a “big part” in primary care, which the FEHBlog finds reassuring.
From the beginning, it was clear that seniors’ lives would be turned upside down as a result of the coronavirus pandemic, but Humana’s survey of over 1,000 seniors reveal the severe toll the pandemic has taken on senior mental health and social health.
“Health plans should take particular notice, since it is critical to understand all the evolving needs of seniors – health, social and behavioral – as the industry increasingly moves toward models of ‘whole health’ senior care and coverage,” said Kathy Driscoll, senior vice president and chief nursing officer at Humana.
The survey reached 1,003 Americans ages 64 and older, nationwide. Kelton Global fielded the survey from September 14 to September 21, 2021.
One of the most striking results of the survey was that, despite the rise in mental and behavioral healthcare needs and the expanded access to telemental and telebehavioral services that the pandemic brought, only three percent of seniors had accessed mental healthcare.
The results run parallel with a separate Anthem study which found that mental healthcare claims dropped even though mental healthcare demand rose during the coronavirus pandemic.
However, the low rate of telehealth utilization for these specific demands does not mean that seniors were as hesitant to use telehealth for other health-related purposes. Seniors were far more likely to use telehealth in order to access wellness programming (84 percent) and a third of seniors used telehealth to connect with their providers.
From the Delta variant front, the New York Times reports that “The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday [this week] to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines.”
Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.
Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used.
The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.
If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with Covid — many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.
Fingers crossed on the pill.
From the hospital transparency front, Fierce Healthcare assesses a New York Times analysis of hospital pricing. Fierce Healthcare finds that cash prices can be lower than prices paid by insurers.
America’s Health Insurance Plans published a statement saying the attempt to look at the data “spotlights a lot of numbers with little context” and “often compares apples and oranges.”
Because of these complexities, the CMS rule does not help patients “shop for services” as intended, said Delphine O’Rourke, a healthcare attorney and partner at Goodwin Procter. “I, as a consumer, don’t know at the end of the day what I’m going to be responsible for,” she said.
To O’Rourke, it’s not surprising that at times, a hospital’s cash price is lower for a service. Since people paying cash price are generally a small segment of patients, she explained, and tend to be uninsured or undocumented, hospitals structure cash pay anticipating that it will be “challenging to collect,” O’Rourke said. (Earlier this year, the Wall Street Journal found that many times, patients who pay with cash are actually charged the highest price across hospitals.)
Be sure to listen to this week’s Econtalk episode during which Russ Roberts interviews Sam Quinones who wrote the FEHBlog’s favorite book of 2017, Dreamland. (While the book was published in 2015, the FEHBlog discovered it from a 2017 Econtalk episode.) This week Mr. Quinones discusses the tremendous impact of fentanyl on growing our opioid epidemic. He explains that dealers learned to lace fentanyl into non-addictive drugs like cocaine and meth thereby creating daily customers for them. Because Econtalk episodes last over an hour, you can find a transcript on the website. The FEHBlog has pre-ordered Mr. Quinones new book, the “Least of Us True Tales of America and Hope in the Time of Fentanyl and Meth,” which is available on Amazon for the Kindle at around nine dollars.
The U.S. House of Representatives and Senate continue to be engaged in Committee business and floor voting this week which should be a humdinger on Capitol Hill. The Wall Street Journal sums the situation up as follows:
Congress Heads Into Tumultuous Week Pressured by Converging Deadlines Government shutdown, debt ceiling loom as Democratic leaders plan votes on multitrillion-dollar spending ambitions
The Supreme Court prepares for the opening of its October 2021 term on October 4. Amy Howe informs us
The Supreme Court announced on Tuesday that oral arguments will follow a slightly different plan when the justices return to the courtroom for in-person arguments next month. Instead of reverting entirely to the traditional “free for all” format for asking questions, the justices will adopt a hybrid approach that sets aside time for the justices to take turns asking questions, just as they did when hearing oral arguments by telephone during the pandemic. The change appears to increase the chances that Justice Clarence Thomas, who was rarely heard in the courtroom but was an active participant in remote arguments, will continue to participate when in-person arguments resume.
How collegial.
We also can look forward to the Departments of Health and Human Services, Labor, and Treasury as well as OPM issuing the second big No Surprises Act interim final rule this week. The statutory deadline for releasing this rule concerning the independent dispute resolution process is Friday October 1.
From the Delta variant front
Both CVS Health and Walgreen’s have announced that their multitude of pharmacies are offering the Pfizer booster to all eligible folks.
If you noticed the articles recently reporting that the number of COVID-19 deaths in America exceeds the 1918 flu pandemic, check out this Health Affairs blog article from last April debunking this apples to oranges comparison.
In any event check out this Health Payer Intelligence article on three strategies for sustaining payer innovation momentum post-pandemic. “The coronavirus pandemic resulted in accelerated payer innovation and payers can continue that momentum by identifying opportunities, involving members, and using data effectively.”
Based on data from the Centers for Disease Control’s COVID Data Tracker, here is the FEHBlog’s weekly chart of new COVID cases for 2021:
The CDC observes “After experiencing a brief decline in COVID-19 cases, the United States is once again seeing an increase in cases in most of the country.”
Here’s a link to the CDC’s weekly chart of COVID hospitalizations which shows a drop in the seven day moving average.
Here’s the FEHBlog’s weekly chart of new COVID deaths for 2021:
Finally here is the FEHBlog’s weekly chart of COVID vaccines distributed and administered from the 51st week of 2020 through the 37th week of 2021, ending last Wednesday September 15.
There are 180.6 million fully vaccinated Americans, or 63.6% of the vaccination eligible population (age 12 and older) and 31 million more who are waiting for their second dose.
The Covid-19 vaccine made by Moderna Inc. is more effective at keeping people out of the hospital than those from Pfizer Inc. and partner BioNTech SE or Johnson & Johnson, new research indicates.
In a study published by the Centers for Disease Control and Prevention on Friday, researchers studied more than 3,600 adults who were hospitalized in the U.S. between March and August of 2021. They looked at people who were admitted to 21 hospitals who had at least one Covid-19 symptom and a positive PCR or antigen test, as well as patients who were admitted to a hospital who tested negative for Covid-19. They then compared their vaccination status and which vaccine they received.
The researchers found that the Moderna vaccine’s effectiveness against hospitalization was 93%, compared with 88% for Pfizer-BioNTech’s and 71% for J&J’s. The effectiveness of the Moderna and Pfizer-BioNTech vaccines also seemed to stand up better over time than that of J&J’s vaccine. The Moderna vaccine’s effectiveness against hospitalization dropped to 92% after 120 days, while Pfizer-BioNTech’s dropped to 77%. After just 28 days, the J&J vaccine’s effectiveness fell to 68%.
And the administrative suspense is over, STAT News tells us
An advisory panel to the Food and Drug Administration on Friday recommended against a booster dose of a Covid-19 vaccine for most Americans at this time — a major rebuke to the Biden administration — but voted unanimously to recommend one to Americans who are 65 or older.
The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom.
After seven hours of deliberation, members of the Vaccines and Related Biological Products Advisory Committee voted 16 to 2 against a proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older. The vote to recommend a booster to people 65 years and older — as well as people who are at risk of severe Covid — was 18 to 0.
It was not immediately clear who would qualify as high risk; fleshing that out will likely fall to the CDC’s advisory committee, the Advisory Committee on Immunization Practices.
You will be able to knock the FEHBlog down with a feather if acting FDA Commissioner Janet Woodcock overrules the advisory committee given the Aduhelm debacle earlier this year. Also the outcome strikes the FEHBlog as a reasonable Goldilocks solution to the thorny problem.
Speaking of the expensive Alzheimer’s Disease drug Aduhelm, Fierce Pharma reports that
Data collected from a survey of 74 neurologists collected at the start of the month found that at least two thirds of respondents anticipate having at least some patients on Aduhelm by March 2022, according to Spherix Global Insights’ newly launched drug report released on Thursday. That could result in “an estimated brand share substantially higher than that projected back in August,” the report found.
he results indicate increased signs of optimism, according to Spherix, with small increases in the prescriber base and number of new patients compared to the stagnant trends found in the first few months following Aduhelm’s June FDA nod. In Spherix’s mid-July report, only about one fourth (27%) of responding physicians had planned to prescribe Aduhelmin the next few months.
Biogen’s prospects should improve in the coming weeks, Spherix estimates. According to the report, the prescriber base will likely grow by nearly 50% within that time, which could lead to twice the number of new patient initiations when compared with August.
Despite the maelstrom of negative press Biogen’s accelerated FDA nod has garnered, one in seven newly diagnosed patients with the memory-robbing disease are considered potential Aduhelm candidates, Spherix said.
Therefore, Aduhelm’s long-term success “does not appear to be markedly limited by physician willingness to prescribe” the treatment or “clinical determination of patient eligibility.”
In HHS News —
Today, the Biden-Harris Administration announced a $2.1 billion investment to improve infection prevention and control activities across the U.S. public health and healthcare sectors. The Biden-Harris Administration, working through the Centers for Disease Control and Prevention (CDC), is investing American Rescue Plan funding to strengthen and equip state, local, and territorial public health departments and other partner organizations with the resources needed to better fight infections in U.S. healthcare facilities, including COVID-19 and other known and emerging infectious diseases.”
Also today a record breaking third Affordable Care Act notice of benefit and rate parameters notice for 2022 was finalized. Fierce Healthcare tells us that “For 2022, insurers will face an increase in the federally run marketplace user fee rate to 2.75% of their premiums and the state-run exchanges to 2.25%. That is a change from the user fee finalized on Jan. 19 under the Trump administration, which called for a user fee of 2.25% for the federal marketplace and 1.75% for the state-run exchanges. The rule would also extend the open enrollment period by 30 days for ACA signups, with the new deadline on the federally run exchanges being Jan. 15. Open enrollment for the federal exchanges still starts on Nov. 1. * * * CMS is also creating a new special enrollment period that targets low-income individuals through HealthCare.gov. The goal is to target people who could be eligible for boosted subsidies that were included in the American Rescue Plan Act but expire after the 2022 coverage year. Congress is debating whether to extend those subsidies as part of a $3.5 trillion infrastructure package.”
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