Thursday Miscellany

Rx coverage

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Omnicron and siblings front, the Wall Street Journal reports encouraging news.

The Omicron BA.2 variant has dominated new infections in the U.S. for weeks without setting off a major surge so far, raising hopes among some public-health experts that the nation might dodge a more significant hit.

BA.2 is in particular affecting the Northeast, where virus concentrations in wastewater are rising alongside reported infections in such places as New York, Washington, D.C., and Philadelphia. Concern about BA.2 prompted Philadelphia to restore an indoor-mask requirement and U.S. authorities to extend mask mandates for airplanes and other forms of transportation.

Still, BA.2 hasn’t yet caused the rise in hospitalizations some doctors said they would have anticipated. Disease experts say some combination of immunity from Covid-19 vaccinations and a severe wintertime surge, aided by springtime weather drawing people outdoors, might be keeping the virus at bay.

MedPage Today informs us

A booster dose of the Pfizer-BioNTech COVID-19 vaccine was safe and produced an immune response in kids ages 5 to 11, including against the Omicron variant, the companies said on Thursday.

These data came from two sources: the phase II/III clinical trial on 140 children ages 5 to 11 who received a booster dose at least 6 months after their two-dose primary series, and a subgroup of 30 kids in whom response against Omicron was studied specifically. In this subgroup analysis, there was a 36-fold increase in neutralizing antibody titers compared with levels seen after the two-dose primary series, the companies reported.

The companies plan to submit a request to the FDA for an emergency use authorization (EUA) for a third dose for this age group “in the coming days.” The agency previously authorized a two-dose primary series of the 10 μg formula for this age group in October 2021.

Health IT Analytics tells us, “When comparing groups that experienced the worst effects of COVID-19, a study published in Public Health Nursing found that the pandemic had a significant impact on those who exhibit high social vulnerability, leading them to have the highest mortality levels.” This finding illustrates the importance of resolving health disparities.

On a related note, Govexec reports

More than 90 federal agencies released their first-ever equity action plans on Thursday, laying out more than 300 strategies to better help underserved communities. This follows an executive order President Biden issued on day one of his administration, which directed agencies to conduct equity assessments of their top three to five high-impact services for Americans to determine where there were systematic barriers. These findings helped agencies develop their plans.

“Taken together these 300 actions demonstrate what it means to take a whole-of-government approach to advancing equity,” said a senior administration official on a background briefing call. “For the first time Americans will see a full picture of what it looks like for the entire federal government to advance equity at once.”

For example, Health and Human Services Department plans to better help individuals with limited English proficiency access federal health programs; the General Services Administration seeks to assess the impact on communities of its vast real estate portfolio; and the Office of Personnel Management looks to invest in data to look at potential barriers in the federal hiring process.

In a significant development from the No Surprises Act front, the Affordable Care Act regulators issued helpful Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties and Certified IDR Entities. The new guidance no longer treats the Qualifying Payment Amount as a rebuttable presumption. This action strongly suggests that the QPA’s rebuttable presumption status will be removed from the “final, final” version of the IDR rule. That regulation is due out next month. However, the rule does not yet appear on the OMB Office of Information and Regulatory Affairs’ list of rules currently being subjected to their oversight.

In other regulatory news, the International Foundation of Employee Benefits Plans alerts us, ​

The Department of Justice (DOJ) released guidance including frequently asked questions (FAQs) on how the Americans with Disabilities Act (ADA) protects individuals from discrimination when they are being treated for and recovering from opioid use disorder (OUD).

From Capitol Hill, EndPoint News reports

A group of 30 bipartisan lawmakers sent letters to 7 naloxone manufacturers, calling on them to apply for over-the-counter status for their opioid overdose antidotes and open up supplies further as the opioid crisis continues in the US with record levels of overdoses and deaths.

Citing a Massachusetts study that found substantially increased access to naloxone reduced opioid overdose mortality rates by 46%, the senators and representatives called on Pfizer, Teva Pharmaceuticals, Adamis Pharmaceuticals, Akorn, Amphastar Pharmaceuticals, Emergent BioSolutions, and Hikma Pharmaceuticals to “submit applications to make naloxone available over the counter without delay.”

Currently, there are three FDA-approved forms of naloxone — injectable, auto-injector and nasal spray — and all three currently require a prescription, but in most states and the District of Columbia pharmacists are allowed to dispense naloxone under a standing order, meaning they don’t actually need individual prescriptions. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers.

Good idea. The HHS Secretary Xavier Becerra extended the opioid epidemic public health emergency for another 90 days earlier this month.

From the healthcare business front, Healthcare Dive reports on UnitedHealth Group’s 1st Quarter 2022 financial results.

UnitedHealth is bullish on completing its controversial acquisition of data analytics firm Change Healthcare, despite legal action from the Department of Justice to block the deal.

UnitedHealth’s extended agreement with Change “reflects our firm belief in the potential benefits of this combination to improve healthcare and in our ability to successfully overcome the challenge to this merger,” Chief Operating Officer Dirk McMahon told investors on a Thursday morning call regarding first-quarter financial results.

The Minnetonka, Minnesota-based healthcare behemoth beat Wall Street expectations for earnings and revenue in the quarter, with a topline of $80.1 billion, up 14% year over year due to double-digit growth at health services arm Optum and payer business UnitedHealthcare. Net earnings were $5.1 billion, up 3% year over year. UnitedHealth raised its full-year guidance following the results.

STAT News adds

The Omicron surge didn’t lead to an explosion of medical claims at UnitedHealth Group, which contributed to higher-than-expect profits. UnitedHealth ended the first three months of the year with more than $5 billion of profit on $80.1 billion of revenue. The company’s medical loss ratio, which shows the percentage of insurance premiums that were spent on medical claims, was 82% — higher than 80.9% in the first quarter of 2021, but less than what Wall Street expected.

From the miscellany department

  • The ICD 10 Monitor discusses “two extremely encouraging studies in terms of the content coverage and feasibility of replacing ICD-10-CM with ICD-11.”
  • BioPharma Dive reports “AbbVie and Genmab said treatment with their dual-acting antibody epcoritamab led to responses in nearly two-thirds of patients with lymphoma, announcing on Wednesday that their clinical trialsurpassed its benchmark for success. The partners will now take the data to the Food and Drug Administration and other regulators to determine whether it’s good enough to formally submit for approval.”
  • Health Data Management offers useful insights into the ongoing TEFCA launch.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

Beckers Hospital Review informs us

The World Health Organization on April 11 said it is monitoring two new “sister variants” of the original omicron strain dubbed BA.4 and BA.5, according to global news network WION.

Whither BA.3?

A lot of news sources are offering reports on Stealth Omicron. We learn from the AP that Stealth Omicron is another sibling of BA.2.

It was given the “stealth” nickname because it looks like the earlier delta variant on certain PCR tests, says Kristen Coleman at the University of Maryland School of Public Health. The original omicron, by contrast, is easy to differentiate from delta because of a genetic quirk.

BA.2 is “now the dominant coronavirus version in the U.S. and more than five dozen other countries.”

From the Health and Human Services Department, we find an account of “Secretary Becerra and HHS Leaders Celebrating Black Maternal Health Week 2022.”

From the Centers for Disease Control department

  • The CDC explains how diabetics can keep eating the cultural foods to which they are accustomed by taking a few preparation twists.
  • Neisseria gonorrhoeae (gonorrhea), a common sexually transmitted infection (STI) that can result in life-threatening ectopic pregnancy and infertility, leads to more than an estimated half a million drug-resistant infections in the United States each year.
  • With health departments in two states, CDC is expanding drug resistant-gonorrhea surveillance beyond traditional STI clinics and into emergency departments, where more people are seeking STI care.
  • From 2018 through 2019, nearly one-third (29%) of patients with positive tests from the North Carolina site were diagnosed at emergency departments, and drug resistance testing uncovered eight cases of gonorrhea less likely to be successfully treated by one of two drugs in the recommended first line treatment at that time.
  • Bloomberg adds “After sexually transmitted diseases fell during the early months of pandemic lockdowns and social distancing, the U.S. saw a resurgence of some of the most common infections through the end of 2020, according to a report.”

From the U.S. Preventive Services Task Force front, the Wall Street Journal tells us

All children should be screened for anxiety starting as young as 8 years old, government-backed experts recommended, providing fresh guidance as doctors and parents warn of a worsening mental-health crisis among young people in the pandemic’s wake.

The draft guidance marks the first time the U.S. Preventive Services Task Force has made a recommendation on screening children and adolescents for anxiety. The task force, a panel of independent, volunteer experts that makes recommendations on matters such as screening for diabetes and cancer, also reiterated on Tuesday its 2016 guidance that children between ages 12 and 18 years old should be screened for major depressive disorder. 

“What the pandemic has done is, it exacerbated a pre-existing issue,” said Nasuh Malas, director of pediatric consultation and liaison psychiatry services at C.S. Mott Children’s Hospital in Ann Arbor, Mich., who isn’t on the task force. “These guidelines are a preliminary step to many, many steps that we need to take nationally as a community of people who are concerned about our youth.”

STAT News adds

After staying flat for a decade, the overdose death rate among U.S. adolescents nearly doubled from 2019 to 2020 — an alarming climb that continued into 2021, a study in JAMA shows. It’s not a surge of 14- to 18-year-olds using drugs, researchers said. If anything, survey data indicate that fewer teens experimented with drugs during the pandemic. Rather, a main factor is the supply of increasingly deadly drugs, one that has driven overall overdose deaths to more than 100,000 per year and has now trickled down to adolescents. What teens may think is an opioid painkiller or Xanax diverted from the legal supply is now more likely to be a counterfeit tablet containing fentanyl or similar synthetic opioids. “Drug use is becoming more dangerous, not more common” among adolescents, study co-author Joseph Friedman told STAT’s Andrew Joseph. Read more.

From the antibiotic overuse front, the American Journal of Preventive Medicine informs us “Unnecessary prescription of antibiotic prophylaxis by dentists continues to be common. Antimicrobial stewardship strategies are needed to improve prescribing by dentists.” No bueno.

Also in the no bueno department, Healthcare Dive calls our attention to a Lown Institute report

— U.S. nonprofit hospitals often get tax breaks worth far more than they spend on charity care and community investment, according to a new report from the Lown Institute. Prominent systems such as Providence, Trinity Health, Mass General Brigham and the Cleveland Clinic had some of the largest of these “fair share deficits,” the healthcare think tank said.

— The Lown Institute found 227 of the 275 hospital systems it studied spent less on charity care and community investment than the value of their tax exemptions. The fair share deficits of all hospital systems studied totaled $18.4 billion, which the institute argues could have been used to address health equity, housing, food insecurity and other local needs.

— Many of the hospital systems also received hundreds of millions of dollars in grant funding through the Coronavirus Aid, Relief, and Economic Security Act in 2020. The 275 systems examined operate more than 1,800 hospitals nationwide.

From the Rx coverage department. Drug Channel assesses the recent CMS Office of Actuaries report projecting U.S. healthcare spending.

The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare. (See links below.) These data provide our first official look at post-pandemic U.S. healthcare spending. 

As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending. What’s more, taxpayers—via Medicare and Medicaid—will continue to crowd out the private insurance market. One bright spot: consumers will account for an ever-smaller share of drug spending. 

Thus, the government actuaries expect that pharmaceuticals will not be the key driver of U.S. healthcare spending growth. Will someone tell our elected officials?

Here are tidbits that also follow up from stories in recent FEHBlog posts

  • Fierce Healthcare reports that the bipartisan bill to control the price of insulin to consumers will “ensure that plans and PBMs ‘cannot collect rebates, which drive up drug costs at the point of sale, on insulins that roll prices back to 2006 or equivalent levels,’ the release said.” 
  • Healthcare Dive reports that part of the Administration’s efforts to control medical debt includes the following

The Biden administration laid out a four-point plan to reduce America’s medical debt on Monday, including having the HHS dig into how providers’ billing practices impact care access and affordability.

Under the plan announced by Vice President Kamala Harris, the HHS will request data from 2,000 providers on their bill collection practices, lawsuits against patients, financial assistance offerings, debt buying practices and more. The HHS will use this information in grant determinations, and to shape data and policy recommendations to the public.

The department will also share potential violations with enforcement agencies.The White House is also guiding federal agencies to stop using medical debt as an underwriting factor in credit programs where possible

  • Health Payer Intelligence discusses AHIP’s comments on the CDC’s draft, revised opioid prescription guidelines.

Finally here are some OPM and USPS tidbits

  • Govexec offers an interview with the Postmaster General Louis DeJoy.
  • Federal News Network tells us

The Office of Personnel Management issued a second round of guidance to agencies on Tuesday, outlining several ways agencies should make employees more aware of their collective bargaining rights.

OPM’s guidance also directs agencies to quickly process requests to pay union dues through payroll deductions, and train managers and supervisors on how to remain neutral during union organizing campaigns.

OPM Director Kiran Ahuja, in a blog post, said the guidance is part of the administration’s focus on making the federal government a model employer in a competitive labor market.

Monday Roundup

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill —

Roll Call informs us

The House Appropriations Committee is tentatively planning to take up its fiscal 2023 spending bills in June, teeing up potential floor votes in July, according to people familiar with the schedule.

Subcommittees would mark up their 12 annual bills from June 13 to June 22. The full committee would hold its markups from June 22 through June 30.

The top four appropriators in the House and Senate, known as the “four corners,” are expected to meet shortly after the two-week recess this month to begin discussions aimed at reaching a bipartisan agreement on overall discretionary spending levels for the fiscal year that begins Oct. 1.

STAT News tells us

A bipartisan group of four key lawmakers unveiled a long-shot policy that aims to alleviate one of the American health care industry’s most embarrassing problems: mind-bogglingly high prices for insulin, a drug millions of Americans need to survive.

The policy outline released Monday is a reboot of a three-year-old bill introduced by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). It would dangle a carrot for drugmakers to lower their list prices. Insurers and middlemen wouldn’t get to keep fees for diabetes drugs — but only if drugmakers lower list prices for drugs back to 2006 levels. It would also make sure patients with Medicare or private insurance don’t pay more than $35 per month for their insulin, though it would not offer the same protection to the uninsured.

Federal News Radio follows up on last week’s Senate confirmation of Kristin Boyd to be the first Senate-confirmed OPM Inspector General in over six years.

From the Omicron and siblings front —

Fierce Healthcare calls attention to a Commonwealth Fund report on the efficacy of Covid vaccines

COVID-19 vaccinations have blunted the worst waves of the pandemic, preventing millions of deaths, limiting strain on the U.S. healthcare system and producing “substantial cost savings” in healthcare spending, according to new estimates published Friday by the Commonwealth Fund.

From the first authorizations in December 2020 through March 2022, COVID-19 vaccination was estimated to have averted roughly 2.3 million deaths and 66.2 million additional infections, per the analysis.

Further, the push for shots in arms was found to have prevented 17 million hospitalizations in the U.S. and saved the country’s healthcare system just shy of $900 million in total spending, notwithstanding the country’s savings related to workplace absences and deaths.

The Wall Street Journal reports

The risk of developing inflammatory heart conditions after Covid-19 vaccination is relatively low, two large studies found, especially when compared with the heart-related risks from Covid-19 disease itself and from vaccines against other diseases [such as the flu].

“The overall message is that you can never consider risk in isolation,” said Jason Perry Block, an associate professor at Harvard Medical School and a co-author of the CDC’s analysis.

Concerns over potential side effects from Covid-19 vaccines are one reason some eligible adults in the U.S. say they haven’t gotten the shots, according to public-opinion surveys. About 70% of eligible Americans have been fully vaccinated against Covid-19, according to the CDC.

In considering the cardiac risks associated with Covid-19 vaccines, Dr. Block said people “also have to consider the risk on the other hand. If you don’t get vaccinated and do get infected, the risk is higher of cardiac complications.”

From the Covid vaccine mandate front —

A federal district court in Georgia preliminarily enjoined the federal government’s vaccine mandate on its contractors. The federal government appealed to the U.S. Court of Appeals for the 11th Circuit. The appeal was argued before a panel of three judges last Friday. Federal News Network adds

A three-judge panel from the U.S. Court of Appeals for the 11th Circuit says it remains unclear whether the Biden administration has the authority to impose a COVID-19 vaccine mandate on federal contractor employees.

The administration told the court last Friday that federal contracting law gives the president broad authority to set the terms of the federal government’s contracts, including making sure contractors have enough healthy employees to complete their contracts with agencies on time.

The judges,  however, repeatedly said during oral arguments that the federal government has a high bar to clear, in order for the court to overturn a lower court’s injunction barring the administration from enforcing the mandate.

The 11th Circuit likely will issue its opinion next month.

The Hill reports on the latest developments in the federal government’s vaccine mandate on its workforce.

The Biden administration on Monday asked a federal appeals court to clear a procedural hurdle that remained after a key legal victory last week and allow the administration to quickly resume enforcement of its COVID-19 vaccine mandate for federal employees.  

The request to the U.S. Court of Appeals for the 5th Circuit, if granted, would effectively reinstate the public health policy after it was put on hold across the country in January by a federal judge in Texas.

* * *

The administration’s request Monday would move up the timeline for the panel’s judgment to take effect, which is currently not set to occur until May 31. 

From the SDOH front, Health Payer Intelligence informs us

UnitedHealthcare announced that it will expand a program to advance maternal health equity in for minority communities in North Carolina.

“Access to quality maternal health care will help close the gap on health inequity in our state,” said Anita Bachmann, chief executive officer of UnitedHealthcare Community Plan of North Carolina. “We are honored to partner with Mountain Area Health Education Center and SistasCaring4Sistas of North Carolina to address disparities and outcomes with the expanded doula program.”

The payer partnered with the community-based organization SistasCaring4Sistas to expand access to the organization’s program, Doulas for Social Justice.

From the Aduhelm front, Fierce Healthcare reports on payers’ cheerful reaction to last week’s CMS Medicare coverage decision of that expensive drug only at the clinical trial level. “We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP.”

From the miscellany department

  • The Wall Street Journal reports about “New apps and telehealth services [that] are providing women in middle age more access to health expertise, education and support to help them during menopause [such as MenoLife].”
  • The Department of Health and Human Services shares Secretary Becerra’s remarks at the White House Medical Debt Event with Vice President Harris. Here is a link to the Administration’s fact sheet describing new actions to lessen the burden of medical debt and increase consumer protection. According to the fact sheet,

These actions will help:

Hold medical providers and debt collectors accountable for harmful practices;

Reduce the role that medical debt plays in determining whether Americans can access credit – which will open up new opportunities for people with medical debt to buy a home or get a small business loan;

Help over half a million of low-income American veterans get their medical debt forgiven; and,

Inform consumers of their rights.

  • Medpage offers an interesting account of how a doctor is trying to make sure that his patients get the medical screening tests that they need.

Friday Stats and More

David Ermer–ACA, Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021, a low points of cases and death, and the 14th week of 2022, another lull but not quite as low.

The CDC’s Weekly Review of its COVID statistics issued today notes “The current 7-day daily average for March 30–April 5, 2022, was 1,406. This is a 10.3% decrease from the prior 7-day average (1,567) from March 23–29, 2022.”

Here’s the FEHBlog’s weekly chart of Covid vaccinations administered and distributed since the beginning of the Covid vaccination era through this week, again using Thursday as the first day of the week.

The administration of Covid vaccines popped us this week. Over 75% of the U.S. population aged 18 and older are fully vaccinated. Nearly half (48.6%) of that cadre is boostered. The Weekly Review’s commentary discusses the importance of vaccinating children.

COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history, and adverse events are rare. Vaccinating children is the single best way to protect them from severe illness associated with COVID-19. 

From Capitol Hill, the Wall Street Journal reports

Senators had also hoped to move forward on the coronavirus vaccines and treatments package, but progress quickly bogged down over Republican efforts to amend the bill to extend a pandemic-era immigration policy called Title 42—which allows Border Patrol agents to quickly turn away migrants at the southern border—with some Democrats siding with the GOP. Senators said they ran out of time, and the break could help end the logjam, even if it means the aid will need to wait at least several weeks.

“We’ll see where the discussions go, but my assumption is during the course of the break they’ll be some conversations between people who are interested in advancing it and see if we can make any headway on coming up with a process,” said Sen. John Thune (R., S.D.) on the Covid aid.

“I don’t think we’re leaving anything hanging up in the air that we’re not going to be able to continue to work with afterwards,” said Sen. Angus King (I., Maine), who caucuses with Democrats.

Congress is on State / District work periods for the next two weeks.

From the Rx coverage front, Health Affairs offers a fascinating article leading with an HHS Inspector General report on biosimilar drug use in the Medicare Part D program. The article blossoms into a broader look at biosimilar use in America. For example,

Last fall, two academics from the USC Schaeffer Center for Health Policy & Economics and the University of Chicago Harris School of Public Policy analyzed the available biosimiliars and found these were, on average, 30% less expensive than the underlying brand-name biologics. This represented a savings of about $665 off the average price.

Perhaps the biggest boost, though, will occur when biosimilar versions of Humira begin entering the U.S. market next year. This is expected to kick-start a wave of increased biosimilar usage between now and 2027, by which time the worldwide market should roughly double to $20 billion, according to Bernstein analyst Ronny Gal.

“The savings we identified with increased biosimilar use, while modest, could be significant once biosimiliar versions of Humira come on the market,” said [Melissa] Baker [from the HHS Office of Inspector Genera]. “Part D spending for Humira is in the billions of dollars.” The HHS OIG report noted that Humira and Enbrel accounted for more than $5 billion in Part D spending and nearly half of Part D spending on biologics in 2019.

From the Aduhelm front, Fierce Healthcare tells us

Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.

FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.

“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.

From the mental healthcare front, Health Payer Intelligence informs us

CVS Health and its payer arm, Aetna, aimed to make strides in the healthcare industry in 2021 by delivering affordable healthcare services to members, increasing access to virtual and mental healthcare, and implementing initiatives to advance health equity, according to the payer’s 2021 Environmental, Social, and Governance (ESG) report. The report reflects data from January 1 to December 31, 2021.

Well done.

Finally, the FEHBlog ran across this helpful Kaiser Family Foundation preventive services tracker website.

The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services.  As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date.

This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.

For more information, see the fact sheet Preventive Services Covered by Private Health Plans under the Affordable Care Act.

This tracker also applies to FEHB plans. Thanks, KFF.

Thursday Miscellany

David Ermer–CMS, Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Capitol Hill front, today, the Senate took the following action

PN1166: Krista Anne Boyd, of Florida, to be Inspector General, Office of Personnel Management– Considered by Senate.– Confirmed by the Senate by Voice Vote.

And just like that, OPM has a Senate-confirmed Inspector General for the first time in over six years. The FEHBlog wishes Inspector General Boyd good luck.

The President issued a statement on World Health Day, which was celebrated today.

From the Omicron and siblings front —

  • The Centers for Medicare Services released an updated Toolkit on Covid Vaccines for health insurers and Medicare Advantage plans.

A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.

The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand. 

From the Rx coverage front —

STAT News reports

Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.

The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.

The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.

But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.

They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.

Here is a link to the CMS fact sheet on this decision.

U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.

From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.

From the healthcare business front, Fierce Healthcare informs us

[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.

At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.

The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”

In sad news, the Wall Street Journal reports

Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.

Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.

St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.

Centene offers FEHB HMO coverage through its Health Net subsidiary. RIP.

Weekend Update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

This week, the House of Representatives and the Senate will be in session for flooring voting and Committee business. In addition, the House and the Senate will be taking District and State work breaks for two weeks beginning next Monday.

From the Omnicron and siblings front, the New York Times Well column advises on preparing now for the next surge. Of course, as we lawyers say, the Times is assuming facts not in evidence. Nevertheless, given the huge Omnicron surge last winter, an ounce of prevention may become a pound of cure.

Last week, Bloomberg updated its Covid resiliency ranking of the world’s countries. The U.S ranks 24. Norway, the United Arab Emirates, and Ireland hold the top three spots. Mainland China ranks 48, and Russia and Hong Kong have the last two spots, 52 and 53.

From the Rx coverage front, STAT News brings us up to date on the Mark Cuban Cost Plus Drug Company.

Mark Cuban’s drug company started with an ambitious premise: to circumvent middlemen to offer cheaper costs to patients.

To do so, the company has had to grapple with which parts of the supply chain to develop themselves, and which to outsource using unusually transparent contracts, Mark Cuban Cost Plus Drug Company Founder and CEO Alex Oshmyansky said Thursday at STAT’s Breakthrough Science Summit.

“We decided that the only way to really ensure that pricing for our products actually reaches the patient, the most important part at the end of the day, was to build essentially a parallel supply chain,” Oshmyansky said.

But the company’s ambitions to entirely recreate the pharmaceutical supply chain have started smaller in the process of exploring what’s possible, and what’s profitable.

For example, instead of manufacturing many drugs to sell them cheaply, the company is choosing to focus on manufacturing drugs in shortage to ensure there’s a market for them, and working directly with existing generic manufacturers to keep costs down.

“​​We basically said, ‘Hey, why don’t we, instead of going through the effort of manufacturing these products ourselves, why don’t we just purchase them and just sell them close to their actual price?’” Oshmyansky said.

A lofty plan to create their own pharmacy benefit manager has also been shelved for the moment, though Oshmyansky insisted it’s not off the table entirely. Instead of creating its own PBM, the company instead chose to whitelist PBMs that behave well for the moment.

From the health plan front —

  • OPM and AHIP will hold the annual FEHB Carrier Conference later this month. Recently AHIP posted the conference agenda. In addition, the early registration discount ends on Friday, April 8.
  • Last week, AHIP provided a lengthy list of health insurer actions to address social determinants of health. Bravo.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid data tracker and using Thursday as the first day of the week, here are the FEHBlog weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 13th week of 2022:

The CDC weekly review of its Covid data adds

Currently, there are 19 (0.59%) counties with a high COVID-19 Community Level, 146 (4.53%) counties with a medium Community Level, and 3,059 (94.88%) counties with a low Community Level. This represents a slight (−0.84%) decrease in the number of high-level counties, a moderate (−2.73%) decrease in the number of medium-level counties, and a corresponding (+3.57%) increase in the number of low-level counties. Twenty-seven (48.21%) of 56 jurisdictions had no high- or medium-level counties this week. To check your COVID-19 community level, visit COVID Data Tracker.

* * *

The current 7-day daily average [of new Covid hospital admissions] for March 23–29, 2022, was 1,564. This is a 15.8% decrease from the prior 7-day average (1,858) from March 16–22, 2022. * * *

The current 7-day moving average of new [Covid] deaths (627) has decreased 14.4% compared with the previous 7-day moving average (732).

Here’s a link to the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the beginning of the Covid vaccination era until last Wednesday.

The CDC’s weekly review notes

As of March 30, 2022, the 7-day average number of adhttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlministered vaccine doses reported (by date of CDC report) to CDC per day was 214,405, a 17.8% increase from the previous week.

CDC’s COVID Data Tracker displays vaccination trends by age group, race/ethnicity, and urban/rural status. To see trends by age group and race/ethnicity, visit the Vaccination Demographic Trends tab. To see trends by urban/rural status, visit the COVID-19 Vaccination Equity tab.

The American Medical Association offers guidance to physicians concerning the FDA’s emergency authorization of a second Covid booster for Americans aged 50 and older.

HR Dive discusses what employers should take away from the Biden Administration’s updated approach to Omicron.

Here’s a link to the CDC’s weekly flu surveillance report or Fluview.

From the “and more” department —

  • HR Dive discusses what employers can do to help employees with adolescent children suffering from behavioral health issues. For example, because a shortage of child psychiatrists exists,

Telemental health programs offer convenient access (often at lower cost than in-person care) for many services—and some, like Brightline, are designed specifically for families of children with mental health needs. However, recent studies have shown that telehealth offerings are not being utilized as much for children as they are for adults, for rural populations as they are for urban ones, or for low-income communities as they are for wealthier ones. Clearly, there is an opportunity for employers to make vulnerable populations aware of the telemental health services available to them. 

  • BioPharma Dive identifies “Five FDA decisions to watch in the second quarter. Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.”

Midweek update

David Ermer–COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the OPM front —

Here is a link to OPM’s 2023 Congressional Budget Justification for Fiscal Year 2023, which confirms on page 36

Beginning in plan year 2023, this proposal would require all plans and issuers, including FEHB carriers, to cover three primary care visits and three behavioral health visits each year without charging a copayment, coinsurance, or deductible-related fee. For High Deductible Health Plans, these services would be considered pre-deductible for meeting Health Savings Account requirements. This proposal would increase FEHB premiums by approximately 0.8 percent.

In the FEHBlog’s opinion, OPM should condition these “free” visits on requiring the plan member to identify and use an in-network primary care provider or in-network primary behavioral care provider. Members who develop relationships with their healthcare providers in this manner are more likely to undergo preventive care and otherwise follow medical advice. That’s common sense. It’s worth adding that the Affordable Care Act typically limits reduced cost-sharing to claims involving in-network care.

Meanwhile, Meritalk discusses OPM’s perspective on the President’s proposed budget, and Federal News Network explains why diversity goals are crucial to the success of OPM’s FY 2022 to FY 2026 strategic plan.

FedSmith.com discusses the impact of retirement on federal employee benefits.

From the Omicron (and siblings) front, the Wall Street Journal reports

President Biden on Wednesday said the nation was in a new phase of the Covid-19 pandemic as he marked the launch of a new federal website where Americans can identify virus risks in their areas and recommendations for mitigating the threat.

The website, COVID.gov, aims to be a one-stop shop to help people get information on measures that could help protect them from the virus, such as local guidance for mask wearing and where to find free masks, vaccines and clinics that offer tests and oral antiviral treatments, Mr. Biden said.

“We’re now in a new moment in this pandemic,” Mr. Biden said. “It does not mean that Covid-19 is over. It means that Covid-19 no longer controls our lives.”

The FEHBlog is pleased to see that the new site includes a link that allows you to find a test to treat program near you.

From the Rx coverage front, BioPharma Dive informs us

By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine for ALS until researchers generate more evidence that it works.

Composed of neuroscience and drug development experts, the 10-person advisory committee on Wednesday voted 6 to 4 against the medicine, named AMX0035 and developed by the Cambridge, Massachusetts-based biotechnology company Amylyx Pharmaceuticals. In a study of about 140 volunteers, AMX0035 appeared to show modest benefits on survival and day-to-day function for patients with rapidly progressing ALS, better known to some as amyotrophic lateral sclerosis or Lou Gehrig’s disease. * * *

The FDA isn’t required to follow its advisers’ recommendations. But it usually does, making approval of AMX0035 now more of a long shot. A final decision is expected by late June.

In other news —

RAC Monitor notes that the Consolidated Appropriations Act 2022 continues to prohibit federal funding for the national patient identifier otherwise required by HIPAA. That’s unfortunate for the country.

Healthcare Economist discusses its views on high deductible plans that are a prerequisite to funding health savings accounts.

Monday Roundup

David Ermer–CDC, CMS, COVID treatment, COVID-19, OPM, Rx coverage–
Photo by Sven Read on Unsplash

The President released his Administration’s fiscal year 2023 proposed budget today. Here are links to OMB’s budget website and a Roll Call overview of the proposal.

Here is OPM’s budget wishlist (Budget at 130):

  • Amend administration of tribal FEHB enrollment system
  • Expand family member eligibility under FEDVIP (presumably increasing the age limit for eligible children from 22 to 26)
  • Expand FEDVIP to tribal employees
  • Expand FEHB to tribal colleges and universities.

OPM also released the agency’s FY 2022 to FY 2026 strategic plan today. Here is a link to OPM’s lookbook on that plan. The lookbook (p. 9) identifies one current agency priority goal related to the FEHBP (out of six in total)

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make more informed health insurance plan selection. By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art FEHBP Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

In other government reports, the Centers for Medicare and Medicaid Services issued

the 2021-2030 National Health Expenditure (NHE) report, prepared by the CMS Office of the Actuary, that presents health spending and enrollment projections for the coming decade. The report notably shows that despite the increased demand for patient care in 2021, the growth in national health spending is estimated to have slowed to 4.2%, from 9.7% in 2020, as supplemental funding for public health activity and other federal programs, specifically those associated with the COVID-19 pandemic, declined significantly.

From the Omicron and siblings front —

  • The Centers for Disease Control posted a new “Quarantine and Isolation Calculator — A tool to help determine how long you need to isolate, quarantine, or take other steps to prevent spreading COVID-19.”
  • The Institute for Clinicial and Economic Review issued an evidence report on four Covid outpatient treatments, including the Pfizer and Merck Covid pills.

This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest England CEPAC) on April 12, 2022. The Midwest England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
Register here to watch the live webcast of the virtual meeting.

ICER’s evidence ratings for the treatments reviewed include:

Sotrovimab delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

[Merck’s] Molnupiravir is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

[Pfizer’s] Paxlovid delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

Fluvoxamine is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

From the health equity front, Health Leaders Media reports

Despite willingness to address social drivers of health, two-thirds of physicians report inadequate time or ability to act, according to a new survey report.

KEY TAKEAWAYS

Nearly all physicians reported that at least one social driver of health affected the health outcomes of all or some their patients.

Financial instability (34% of patients) and transportation problems (24% of patients) were the top two social drivers of health experienced by physicians’ patients.

A solid majority of physicians (80%) reported that addressing social drivers of health is essential to improve health outcomes and decrease healthcare costs.

From the Rx coverage front, the FEHBlog noticed today that GoodRx has added a telehealth option to its website.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The House of Representatives and the Senate will be in session for Committee business and floor voting on Capitol Hill this week.

The President will send his fiscal year 2023 federal budget to Capitol Hill tomorrow. The Wall Street Journal offers an explanatory article about this process.

From the federal employment front, Federal News Network discusses the progress of recalling federal employees to their offices.

Also, the FEHBlog noticed that the Federal Times offers a 2022 Federal Benefits Guide — “Answers to commonly asked questions from federal employees, helpful resources, and more.”

From the vaccines front —

  • Precision Vaccines informs us “After decades of false starts, new research indicates four Respiratory Syncytial Virus (RSV) vaccine candidates are nearing the completion of late-stage trials. According to the U.S. CDC, RSV vaccines could drastically reduce hospital and intensive-care admissions for young children and seniors.” Fingers crossed.

[T]here is now a growing body of research that’s offering at least some reassurance for those who do end up getting infected — being fully vaccinated seems to substantially cut the risk of later developing the persistent symptoms that characterize long COVID.

While many of the findings are still preliminary, the handful of studies that have emerged in the past half year are telling a relatively consistent story.

“It may not eradicate the symptoms of long COVID, but the protective effect seems to be very strong,” says epidemiology professor Michael Edelstein, of Bar-Ilan University in Israel, who’s studying long COVID.

From the mental healthcare front —

  • The Wall Street Journal reports “Telemedicine startups make it easier to get ADHD Drugs. That made some [startup] workers anxious. Digital companies such as Cerebral and Done seized on looser pandemic rules for prescribing ADHD drugs like Adderall. Some workers said they felt pressure to provide the medications.”
  • Health Payer Intelligence points out

Employee mental healthcare spending rose, and employer mental healthcare spending fell after employers transitioned their workers from preferred provider organizations to high deductible health plans, a study from the Employee Benefit Research Institute (EBRI) found.

The researchers focused on individuals who had been diagnosed with one of three specific mental health conditions to assess the impact of transitioning from a preferred provider organization to a high-deductible health plan: anxiety, attention deficit hyperactive disorder (ADHD), and major depressive disorder (depression).

The study received funding from a handful of organizations, including the Blue Cross Blue Shield Association, the Independent Colleges and Universities Benefits Association (ICUBA), Pfizer, and PhRMA.

[T]he researchers indicated that high deductible health plans could be improved if employers apply value-based care to their high deductible health plan benefit design.

“Smarter deductibles accommodating services preventing the exacerbation of chronic conditions might be a natural evolution of health plans,” the study concluded. “Interventions that improve patient-centered outcomes while maintaining affordability may be found in the form of a clinically nuanced health plan that better meets workers’ clinical and financial needs.”

Because it remains National Kidney Month, the FEHBlog wishes to draw attention to this Fierce Healthcare article about how CVS Health offers personalized kidney care for health plan members.

CVS Kidney Care aims to provide an end-to-end experience to manage kidney care in the long term before it reaches chronic kidney disease or end-stage renal disease. It takes a home-first approach to its care model and is currently co-developing a hemodialysis device that is built specifically with home care in mind.

The device is co-developed by Deka Research & Development and is currently in clinical trials. [CVS Kidney Care President Lisa] Rometty said CVS expects to complete the trial by the end of this year, with anticipated approval and launch sometime in 2023.

CVS chose to get involved in developing the tool, she said, because the company saw an unmet need in the market for a device that’s built from the ground up for in-home dialysis rather than adapted to it. Existing tools are not designed to be easy for a senior patient to understand, for example, Rometty said.

“We did it because we really felt strongly at the time that there wasn’t at the time a device that would meet the unique experience and ease of use and also the safety and clinical aspects,” Rometty said.