Friday Stats and More

Rx coverage

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the Centers for Disease Control’s weekly interpretative summary of its Covid statistics:

New Cases — “As of January 4, 2023, the current 7-day average of weekly new cases (67,243) increased 16.2% compared with the previous 7-day average (57,847). A total of 101,094,670 COVID-19 cases have been reported in the United States as of January 4, 2023. * * *

The most prevalent Omicron lineages this week are BQ.1.1, projected to be 34.4% (95% PI 26.7-
43%); XBB.1.5, projected to be 27.6% (95% PI 14.0-46.5); and BQ.1, projected to be 21.4% (95% PI 16.1-27.7%). XBB, BA.5, BN.1, BF.7, and BA.2.75 are all projected to be between 1% and 5% of circulating viruses.”

New Hospitalizations — “The current 7-day daily average for December 28, 2022–January 3, 2023, was 6,519. This is a 16.1% increase from the prior 7-day average (5,613) from December 21–27, 2022.”

New Deaths — “The current 7-day average of new deaths (390) increased 8.3% compared with the previous 7-day average (360). As of January 4, 2023, a total of 1,091,184 COVID-19 deaths have been reported in the United States.”

Vaccinations — “As of January 4, 2023, 665.1 million vaccine doses have been administered in the United States. Overall, about 229.3 million people, or 69.1% of the total U.S. population, have completed a primary series. More than 48.2 million people, or 15.4% of the U.S. population ages five years and older, have received an updated (bivalent) booster dose.”

Politico observes

Though Covid hospitalizations appear to be on the rise nationwide, experts don’t project this Omicron subvariant alone to cause a spike — forecasts from early data suggest they’ll remain fairly steady, Céline Gounder, an infectious disease specialist and senior fellow at the Kaiser Family Foundation, said. * * *

The prediction matches the data from Singapore, where a related subvariant recently became dominant but didn’t result in a spike in hospitalizations and deaths — though that country’s vaccination rate is higher than that of the U.S.

But some individuals — particularly people who are older or pregnant or have weakened immune systems — are at heightened risk from the virus, regardless of larger population trends.

“I’m a bit concerned with it just because it’s coupled with the extremely low booster rates of those over 65,” Katelyn Jetelina, epidemiologist and professor at the University of Texas Health Science Center, said. “Our most vulnerable aren’t as protected.”

The FEHBlog was encouraged to read this American Hospital Association post about a National Institutes for Health / HHS trial:

The Department of Health and Human Services will launch this month a COVID-19 Home Test to Treat telehealth pilot program in Berks County, Pa. Program organizers will work this year with public health departments to expand the program to 100,000 people in vulnerable communities. Telehealth services provider eMed will implement the program, and UMass Chan Medical School will analyze the impact on participating communities.

“At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, which will launch the program with HHS’ Administration for Strategic Preparedness and Response.

NPR adds

“What is clearer now, compared to even a year ago, is that we can really blunt the worst of [Omicron] by doing the things that we know work,” Dr. Ashish Jha, the White House coronavirus response coordinator, told NPR in an interview.

That includes getting vaccinated and boosted, especially if you’re older. Most deaths from COVID-19 are occurring in people age 65 or older.

Other precautions include avoiding crowded, poorly ventilated parties, restaurants, bars and other places; testing before gathering; and, yes, putting that mask back on in risky situations. And if you do get sick, check with your doctor about getting treatment quickly.

“It is a time not to let your guard down,” warns Dr. Tina Tan, an infectious disease specialist at Northwestern University.

The good news is the worst appears to be over from the RSV surge that has been making life miserable for many children and their parents. RSV cases have been falling steadily since the end of November, according to the Centers for Disease Control and Prevention.

At the same time, the flu — which also came roaring back this fall after mostly disappearing for the previous two years — looks like it’s finally receding in most places, according to the latest data out Friday from the CDC.

From Capitol Hill, Roll Call reports that Rep. Kevin McCarthy (R CA) has been elected House of Representatives speaker. The 118th Congress, therefore, is in session.

From the Rx coverage front —

STAT News reports

The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease.

The [intravenously administered] drug, called Leqembi [scientific name lecanemab], was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.

Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Unless Medicare changes the way it pays for drugs like Leqembi, Eisai expects a relatively slow rollout. * * *

Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The FDA-approved label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% currently living with an Alzheimer’s diagnosis.

The label also mandates that patients undergo three additional brain scans during the first 14 weeks of treatment as a precautionary step to monitor for potentially serious brain swelling or bleeding episodes. * * *

Technically, the FDA granted accelerated approval to Leqembi, a faster path to the market based on preliminary evidence that the drug eliminates toxic amyloid. It’s the same controversial, regulatory shortcut that the FDA used to approve Aduhelm. But unlike Biogen, Eisai within days is expected to submit the cognition data from its positive, confirmatory study to the FDA, which will then consider the drug for full, or final, approval.

BioPharma Dive tells us, “The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.” This keeps the drug on track to be on the market when the Humira patents are lifted on July 1, 2023.

According to a press release issued on January 5, 2023:

Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.

Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people. * * *

Synergie Medication Collective will go to market in January of 2023.

STAT News reports

For only the second time since launching nearly two years ago, the AMR Action Fund has announced an investment in a fledgling biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance.

In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The drug, which is about to enter Phase 2 testing, is targeting hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections that originate from pneumonia.

From the health plan design front, EBRI released a study on cost-sharing trends for medical services from 2013-2020.

From the healthcare business front —

Beckers Hospital Review informs us.

VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-CityMD Jan. 3, adding more than 2,800 providers to its ranks. 

News of the deal’s completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.

VillageMD, established in 2013, operates standalone Village Medical practices, full-size Village Medical practices alongside Walgreens pharmacies, and primary care in the home and virtually. 

The combination of Summit Health-CityMD and VillageMD creates one of the largest independent provider groups in the country, according to the companies’ news release. With the buy, VillageMD more than doubles its locations from more than 250 to more than 680 in 26 markets and grows its ranks by more than 2,800 providers. VillageMD declined to share the precise number of providers it now employs, but did say it employs more than 20,000 people. 

The addition also strengthens VillageMD’s footprint in five states. Summit Health and CityMD have locations in New York, New Jersey, Connecticut, Pennsylvania and Central Oregon. 

Fierce Healthcare discusses the Federal Trade Commission’s proposed rule banning post-employment non-compete clauses in employment agreements on healthcare.

Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday [January 5] will affect almost all industries, experts say.

Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.

The public has 60 days to submit comments before the FTC can make it final.

“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.

Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation “blatantly unlawful.” * * *

Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can’t work for another company for two years after you leave.”

In closing, FedSmith updates us on federal retirement statistics for those interested.

Midweek Update

David Ermer–AHRQ, COVID treatment, COVID-19, HSA, Mental health care, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Wall Street Journal reports

Kevin McCarthy and his allies launched a new round of talks late Wednesday with a small but stubborn band of conservative holdouts who have blocked his bid for House speaker, as Republicans sought a path forward following a second day of votes without a winner.

Mr. McCarthy didn’t reach the majority in of three votes on Wednesday, deepening doubts about whether he would ever be able to bring enough Republicans to his side and fueling talk of alternatives.

Twenty GOP lawmakers remained opposed, along with all Democrats, blocking the California Republican from getting the necessary majority of the full House. After the sixth vote, the House adjourned and reconvened at 8 p.m. [at which point the House voted 216 to 214 to call it a day and convene at noon on Thursday.]

A flurry of meetings were taking place by early evening with Republicans shuttling between offices. In one major concession, a McCarthy-aligned super PAC, the Congressional Leadership Fund, agreed to stop picking candidates in primaries where the seat is expected to stay in Republican hands.

From the Omicron and siblings front, we have a man bites dog story.

First Nature informs us that “COVID drug Paxlovid was hailed as a game-changer. What happened?
Insufficient investment and fears about rebound and side effects are driving dowthe n use of a lifesaving antiviral.” The FEHBlog, who has had four Covid vaccinations, points his finger at the government for promoting vaccinations, which, while helpful for older and immunocompromised folks don’t prevent the illness yet, over Paxlovid, a treatment for virtually everyone.

Here’s the twist. CNBC reports

A new antiviral pill for Covid was found to be as effective as Paxlovid at curbing mild to moderate illness among people at high risk of severe disease in a Phase 3 trial in China.

The results, published Wednesday in The New England Journal of Medicine, suggest that the treatment had fewer side effects than Paxlovid, the go-to antiviral for high-risk patients. Around 67% of people who took the experimental pill, called VV116, reported side effects, compared to to 77% who took Paxlovid.

The new pill was also less likely than Paxlovid to cause unexpected side effects due to reactions with other medications, such as those for insomnia, seizures or high blood pressure.

“You have a medication that looks to be just as good as Paxlovid, but less cumbersome,” said Dr. Panagis Galiatsatos, an assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

VV116 is similar to the antiviral remdesivir, which the Food and Drug Administration has approved as an IV infusion. But the team behind the new drug — pharma companies Junshi Biosciences and Vigonvita Life Science — tweaked the formula so that the body can absorb it in pill form, said Dr. Peter Gulick, an associate professor of medicine at Michigan State University. Gilead Sciences, which developed remdesivir, is testing a similar oral version of its drug.

From the Rx coverage front —

  • STAT News reports “Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday.” P.S. FEHB plans can only cover abortion drugs when abortion is necessary to save the life of the pregnant woman, or if the pregnancy arises from incest or rape.
  • The Drug Channels blog tells us

For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.

The factors behind declining drug prices will remain in the coming years—and become even stronger due to forthcoming changes in Medicare and Medicaid. Employers, health plans, and PBMs will determine whether patients will share in this ongoing deflation.

Read on for details and make up your own mind. And please pass the news along to the drug pricing flat earthers (#DPFE) who refuse to accept that brand-name drug prices are falling—or that prescription drug spending is a small and stable portion of overall U.S. healthcare expenditures.

  • Health Payer Intelligence tells us

Insulin costs vary based on insurance coverage type and coverage types that lead to high healthcare spending can force patients to ration their insulin supplies, a report from the US Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) uncovered.

Healthcare spending for individuals who have diabetes—including diabetes treatment, comorbidities, preventive care, and more—amounted to approximately $446 billion total in 2019. Drug costs, including spending on insulin, were responsible for nearly a third of that amount (32 percent).

Insulin users, who tend to be in a more severe stage of the disease, contributed 46 percent of the healthcare spending total among patients with diabetes. Average healthcare spending across the population of insulin users is 4.3 times higher than for non-institutionalized Americans. * * *

Medicare beneficiaries had the highest total out-of-pocket healthcare spending for the drug when compared to privately insured and uninsured individuals’ costs. Medicaid out-of-pocket healthcare spending on insulin was low and hard to estimate.

Most insulin users have either Medicare coverage (52 percent) or private insurance (33 percent). The remainder was covered by Medicaid or reported being uninsured.

It’s worth adding that Medicare covers insulin under Medicare Part B, not Part D.

From the U.S healthcare front —

  • The American Hospital Association relates “U.S. hospitals and health systems continued to experience negative operating margins through November 2022, Kaufman Hall reported today. Median operating margins were down 44% so far this year compared with 2021, as high labor and other costs continued to outpace revenues, according to data from over 900 hospitals.”
  • BioPharma Dive reports “Moderna said Wednesday it will pay $85 million to buy OriCiro Genomics, describing the company’s tools as “best in class” for the synthesis of plasmid DNA.”

From the telehealth front

  • The Agency for Healthcare Quality and Research released a report on the use of telehealth during the Covid era.
  • The Society for Human Resource Management reminds us “Employers [sponsoring health plans including FEHB plans] will have the option to provide pre-deductible coverage of telehealth services for people with high-deductible health plans for another two years [through December 31, 2024].

From the No Surprises Act front, Health Dive digs into the recent CMS report on first-year experience with the NSA’s arbitration process.

The report from regulators provides insight on how the arbitration system is faring so far. It helps paint a picture of how frequently the portal is being used and the types of services payers and providers found themselves fighting over. It also shows what providers have initiated the most disputes.

The vast majority of disputes originated from emergency room visits.

About 81% of disputes (excluding air ambulance services) started in the emergency room.

The entities that initiated the most [arbitrations] were mainly physician staffing and revenue cycle management firms, including TeamHealth and Envision Healthcare, private equity backed practices that staff emergency rooms around the country. As a business strategy, the two work out of network, which can lead to surprise billing if the hospital remains in network, according to a prior study from Yale researchers.

The 10 groups that submitted the most disputes accounted for 75% of all the disputes involving out-of-network emergency services and non-emergency items.

From the public health front, “the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of its annual National Survey on Drug Use and Health (NSDUH), which shows how people living in America reported about their experience with mental health conditions, substance use, and pursuit of treatment in 2021. The 2021 NSDUH national report includes selected estimates by race, ethnicity, and age group. It is the most comprehensive report on substance use and mental health indicators that SAMHSA has released to date.” This HHS announcement summarizes the survey’s findings.

From the OPM front, Federal News Network reports on OPM’s plans to refresh its website, which in the FEHBlog’s opinion can’t come soon enough. “Aside from overhauling its main website, OPM is also planning to make more updates to its retirement services. It’s the area of the agency that encompasses the most legacy — or outdated — technology in all of OPM, [an OPM spokesperson] said. Bravo.

The 118th Congress Convenes

David Ermer–CMS, Congress, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From our Nation’s Capital, Roll Call informs us

A bloc of [twenty] Republican opponents Tuesday kept Kevin McCarthy from becoming speaker on three ballots, and the House adjourned to come back on Wednesday and try again to pick a leader.

McCarthy, R-Calif., had told his colleagues as the day began he would not back down, and his supporters said there would be repeated votes. After three votes, the last of which saw McCarthy lose one of his earlier supporters, a motion from McCarthy ally Tom Cole of Oklahoma to adjourn until noon Wednesday was adopted by voice vote.

Roll Call adds

The history-making chaos in the House drew most of the attention Tuesday, but longtime senators were making history of their own.

Sen. Patty Murray, D-Wash., was elected as the first woman to serve in the constitutional office of president pro tempore, while Senate Minority Leader Mitch McConnell eclipsed Montana Democratic Sen. Mike Mansfield’s record for length of service as a party floor leader. * * *

And not to be outdone, [Sen. Chuck] Schumer had some history of his own, becoming the longest serving senator from the state of New York.

STAT News reports

The nation’s health agencies already have a long to-do list for 2023.

Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. Biden administration appointees are racing to fix pandemic-exposed cracks in the systems for mental health care, addiction treatment, and health coverage, even as millions of people are likely to be kicked out of Medicaid, the federal program serving low-income people with few resources. There’s still no one leading the National Institutes of Health.

And while Congress delivered many of the president’s requests in the end-of-year spending package last month, it also dropped several provisions that would have given federal health regulators more authority. 

From the New Years predictions front, STAT News informs us

For almost three years, hospitals and health insurers have been riding the waves of the Covid-19 pandemic. Even though they can better predict what lies ahead in 2023, there remain several big unknowns. STAT’s business reporters will be paying attention to three trends in particular: the end of the public health emergency, how hospital price hikes will affect people’s paychecks, and Medicare Advantage’s explosive growth.

From the pricing transparency front, Kaiser Health News reminds us that

As of Jan. 1, health insurers and employers that offer health plans [including FEHB plans] must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs. * * *

So how will it work?

Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like “repair of knee joint,” or “MRI of abdomen.” They can also enter a hospital’s or physician’s name or the dosage amount of a drug for which they are seeking price information.

Not all drugs or services will be available in the first year of the tools’ rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.

Once the information is entered, the calculators are supposed to produce real-time estimates of a patient’s out-of-pocket cost.

Starting in 2024, the requirement on insurers expands to include all drugs and services.

This requirement was created by the 2020 Transparency in Coverage Rule issued under the 21st Century Cures Act and the 2021 No Surprises Act.

On a related note, Health Leaders Media tells us

According to the recent report by the OIG investigating instances of incorrect co-surgery and assistant-at-surgery modifier usage, 69 of 100 sampled procedural services did not meet federal requirements.

An additional review of 127 corresponding services found that 49% were noncompliant with federal requirements, as well.

The OIG reviewed a randomly selected sample of 100 services rendered by Part B providers between 2017 and 2019 with certain CPT procedural codes and a Medicare Physician Fee Schedule (MPFS) co-surgery indicator of 1 or 2. The reviewed procedures included spinal fusions, knee replacements, and endovascular repairs, among others.

That’s a big bowl of wrong.

From the pricing reforms front, Fierce Healthcare relates

Physician group practices participating in the Bundled Payments for Care Improvement (BPCI) Initiative garnered cost savings for the top five conditions that require medical intervention but did not save money for the top five surgical procedures.

On the other hand, hospitals participating in the BPCI initiative saved money for both categories, according to a study in JAMA Health Forum.  

Researchers at the University of Pennsylvania said their findings underscore the “suitability of hospitals to bundled payment models, specifically highlighting their relative advantage over group practices in achieving cost and potential quality outcomes for medical conditions.”

From the Rx coverage front —

  • Biopharma Dive offers us a look back at the FDA’s drug approvals in 2022 — “The agency’s main review office cleared 37 new medicines last year, its lowest total since 2016 and well below 2021’s mark of 50.” — and a look forward at ten clinical trials to watch in the first half of 2023 — “Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.”
  • STAT News has questions stemming from the recent Congressional investigative report on the Aduhelm fiasco.
  • The New York Times reports “For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication. * * * Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said: “We are going to review the F.D.A.’s decision.”
  • The Wall Street Journal adds “Most abortions in the U.S. happen via the pill, according to the Guttmacher Institute. Several organizations that mail abortion pills, sometimes to women in states with abortion bans, have seen shipments increase since the Supreme Court’s latest abortion decision. * * * Also on Tuesday, the Justice Department issued an opinion saying that abortion pills can be sent through the U.S. mail, as long as the sender doesn’t intend them to be used unlawfully. The U.S. Postal Service and the Department of Health and Human Services had asked the Justice Department to clarify an 1873 law, which had been invoked by Mississippi’s attorney general in a lawsuit last year, that prohibits mailing items that can be used to produce abortions.”

From the mental healthcare front, the American Hospital Association places a spotlight on children and adolescent care.

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage–
Photo by Sincerely Media on Unsplash

The CDC’s Covid Data Tracker for the week ended December 29, 2022, informs us:

  • New Covid cases totaled 402,525, down 84,000 cases from the previous week.
  • The daily average of new Covid hospital admissions was 5,,668 up 3.7% from the previous week.
  • New Covid deaths totaled 2,530, down 400 deaths from the previous week.
  • 17.3% of the U.S. population aged 18 and older and 37.5% of the U.S. population aged 65 and older have received the bivalent booster.

The CDC’s weekly Fluview tells us

  • Seasonal influenza activity remains high but continues to decline in most areas.
  • Of influenza A viruses detected and subtyped during week 51, 83% were influenza A(H3N2) and 17% were influenza A(H1N1).
  • Fourteen influenza-associated pediatric deaths were reported this week, for a total of 61 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 20 million illnesses, 210,000 hospitalizations, and 13,000 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system was more than 4 times higher than the highest cumulative in-season hospitalization rate observed for week 51 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system decreased nationally from the week prior for the third week in a row.

From the No Surprises Act front, STAT News reports

Health care providers are swamping the government with billing disputes under the new law that bans surprise medical bills. So far, just 4% have ended in payment. 

That’s according to the Biden administration’s progress report on the No Surprises Act’s so-called independent dispute resolution (IDR) process, in which mediators help out-of-network providers and insurers decide appropriate payment amounts for services. So far, the government is fielding a much higher volume of requests than expected, mostly related to emergency services. Health care providers, air ambulance providers, and companies working for them submitted about 90,000 out-of-network payment disputes between April 15 and Sept. 30, far more than the roughly 17,000 anticipated in a full year. 

Also exceeding expectations is the complexity of the cases and the time it’s taking to reach resolutions, which has led to a severe backlog of disputes awaiting resolution. Of the roughly 23,000 cases closed so far, mediators made payment determinations in about 3,600 — 4% of the 90,000 submissions.

In the FEHBlog’s opinion, providers and payers should focus on resolving cases at the initial open negotiation phase. Last week, the NSA regulators announced that the administration cost for one arbitration would increase from $50 to $350 per party, which should encourage payers and providers to reach the FEHBlog’s conclusion.

From the public health front, the Hill relates according to a new CDC report

  • About 526,000 young Americans could have both Type 1 and Type 2 diabetes by 2060, up from 213,000 in 2017 
  • The expected surge is alarming health officials, who say the increase will disproportionately affect minority populations.
  • A potential factor behind the trend could be an increase in childhood obesity.

These statistics place in context this STAT News story titled “Wegovy [Novo Nordisk’s latest obesity drug] may help teens with obesity lose weight but isn’t a magic bullet.”

“I’m concerned that doctors are going to rush to judgment and employ a medication that is very expensive and has its own side effects without giving proper consideration of what the actual cause of the problem is,” said Robert Lustig, professor emeritus of pediatrics at the University of California, San Francisco. Wegovy costs more than $1,300 per month and can cause nausea, vomiting, and rare cases of pancreatitis.

Lustig said each teen’s obesity is caused by different genetic, environmental, and behavioral factors and requires tailored treatment. He worries that widespread use of Wegovy could lead physicians to overlook the root causes of an individual’s condition.

“Treating the downstream symptoms of the problem is only putting a Band-Aid on the problem, it’s not fixing the problem,” Lustig said. “I’m worried that Wegovy is a Band-Aid.”

Since Wegovy, Saxenda, and other drugs are meant to be taken over the long term to maintain weight loss — potentially the rest of an individual’s life — teenagers would be on the medication for an especially long time, and there isn’t yet information on the effects of the drug over that time span, Lustig added.

The FEHBlog did not realize that these are long-term drugs.

In other Rx coverage news, the Food and Drug Administration on Wednesday

approved Briumvi (ublituximab-xiiy) injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Researchers demonstrated Briumvi’s efficacy in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate (ARR) over the treatment period. In both studies, Briumvi significantly lowered the ARR compared to teriflunomide. The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.

From the miscellany department

  • Govexec reports on the Postmaster General’s plans for next year.
  • Milliman suggests “how to understand and impact health plan administrative expenses.”
  • The New York Times Morning column provides good year-end news: After spiking in 2020 and 2021, murders in large U.S. cities had decreased more than 5% this year and gun deaths, injuries, and mass shootings are also down this year. The Times attributes the drop to Covid’s transition to endemic status.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, FDA, Rx coverage, Uncategorized–
Photo by Josh Mills on Unsplash

The Washington Examiner reports that “President Joe Biden signed the nearly $2 trillion omnibus spending bill into law Thursday night while vacationing in St. Croix.”

The New York Times relates,

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.

The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documentsshowed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.

STAT News seconds the Times report:

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

STAT News also presents eight key takeaway‘s from the Congressional report on Aduhelm’s approval and reports

Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year. 

Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy. 

“The results from this long-awaited study are great news for hemophilia B patients that soon may have access to a second durable treatment option,” Luk Vandenberghe, a gene therapy expert at Harvard, said in a text message, after reviewing the results. 

Looking toward next year, STAT News discusses “three things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs.”

Consider the already-astronomical cost of chronic disease care in the United States: trillions of dollars devoted to diabetes, heart disease, kidney disease, cancer and other conditions, and still so many people unable to access necessary care and treatments. Consider the strain of Covid on the health care system, the decimation of public health staffing, and the scarcity of health care workers — and how all these costs make their way to patients. What bold moves can be made in 2023 to help reduce the cost of care? We’ll see.

Also, from the healthcare cost front, Beckers Hospital Review looks into “Questions about hospitals’ culture, leadership, survival and opportunity come with a trillion-dollar price tag given the importance of hospitals and health systems in the $4.3 trillion U.S. healthcare industry.” 

From the public health front, the Wall Street Journal reports

A measles outbreak among mostly unvaccinated children in Ohio that local health officials feared could take months to control has slowed in the past week, giving hope that what was expected to be a lengthy battle could be cut short.

The total number of cases since the outbreak began in November reached 82 on Thursday, but new cases have fallen off significantly in the last seven days or so, said Mysheika Roberts, Health Commissioner for the city of Columbus.

“It could be much worse,” Dr. Roberts said Thursday. “I’m hoping due to our outreach in the community, and the community’s willingness to roll up their sleeves and get vaccinated, that we might be starting to see the end of this. But obviously, it’ll take several weeks and days before we’ll know if this is actually over.”

From the Rx coverage front, Medscape tells us

Merck & Co Inc’s COVID antiviral molnupiravir speeds up recovery but does not reduce the hospitalisation or death rate in higher-risk vaccinated adults, detailed data from a large study showed on Thursday. * * *

When Merck originally tested molnupiravir, it was found 30% effective in reducing hospitalisations, but that was in unvaccinated patients.

In the latest study, led by University of Oxford researchers, nearly all of the more than 25,000 patients in the study had received at least three vaccine doses.

These results demonstrate that vaccine protection is so strong that there is no obvious benefit from the drug in terms of further reducing hospitalisation and deaths, said study co-author Jonathan Van-Tam from the University of Nottingham.

The drug was, however, effective in reducing viral load and can help hasten patient recovery by roughly four days, researchers estimated based on study data. 

In interesting social news,

About 2.6 million couples are saying “I do” this year [2022] — roughly 600,000 more than in prepandemic years, according to The Knot, a company that offers wedding-planning tools, a vendor marketplace and a gift-registry platform. 

The wedding boom is the byproduct of two years of the pandemic, when many ceremonies were postponed or pared down, says Lauren Kay, executive editor of The Knot. And ceremonies this year have a whole new vibe. Now, “people feel empowered to personalize, push the envelope—rules are out the window,” Mrs. Kay says. * * *

This year, “weddings are back, and people are excited to celebrate,” Mrs. Kay says. In 2023, weddings in the U.S. will likely return to prepandemic levels at 2.1 million, according to internal research from The Knot.

  • The Washington Post looks into “Why do people like being tipsy? Here’s how alcohol affects the brain. The buzz produced by alcohol comes from a cocktail of pharmacology and social ingredients, research shows.” The article also discusses how to enjoy alcoholic beverages responsibly.

Finally, the Department of Health and Human Services announced

a Notice of Proposed Rulemaking (NPRM), entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination. * * *

Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register.

The NPRM may be viewed here: https://www.hhs.gov/sites/default/files/conscience-rule-nprm.pdf – PDF

Boxing Day Update

David Ermer–Congress, FDA, OPM, Rx coverage–

Congress is on a State / District work break until January 3, 2023, when the 118th Congress convenes.

Govexec informs us

President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.

As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *

The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.

From the public health front —

  • The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
  • McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”

From the Rx coverage front —

  • The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.

A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.  * * *

Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.

Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *

Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, FDA, HSA, NIH, OPM, Rx coverage–

From Capitol Hill, the American Hospital Association tells us

The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.

The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.

The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.

The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”

In other 2023 Consolidated Appropriations Act or omnibus news

  • The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
  • Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
  • Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
  • The Wall Street Journal reviews the other omnibus provisions affecting businesses.

From the public health front —

Beckers Hospital Review informs us

While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times. 

COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.

“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”

Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.

Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.

“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS

The American Hospital Association tells us

The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.

“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”

STAT News reports

[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.

HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”

From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as

the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).

QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.

Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.

From the Rx coverage and medical research fronts –

MPR reports

The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ICER released evidence reports on Alzheimer’s Disease treatments (draft) and hemophilia A and B (final) STAT News explains

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.

Regarding hemophilia therapies, ICER observes

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).  

Key recommendations stemming from the roundtable discussion include:

  • The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
  • Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
  • At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

NIH announced

Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD). 

Amazing.

From the miscellany department, the Wall Street Journal and MedPage Today explore the new AI text tool known as ChatGPT. From the Journal article

If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.

Happy Winter Solstice

David Ermer–Congress, COVID vaccine mandate, COVID-19, FDA, No Surprises Act, OPM, Rx coverage–

Winter is not only coming; winter is here.

From Capitol Hill, the Wall Street Journal reports

Senators were bracing for a late night in the Capitol, as the timing of votes on the $1.65 trillion omnibus spending bill and possible amendments remained uncertain and the Friday night deadline to avoid a government shutdown crept closer. 

The Senate could start voting on amendments later Wednesday, teeing up a late night or early morning of voting, even as they also attend an address to Congress in the evening by Ukrainian President Volodymyr Zelensky. Adding to the pressure, senators are looking to get out of town ahead of winter storms expected in coming days.

“We’re still working on an agreement to vote on amendments and pass the omnibus tonight,” Senate Majority Leader Chuck Schumer (D., N.Y.) said Wednesday night. “We aren’t there yet, we’re making progress.” Once the Senate passes the measure, it would move to the House, which is expected to approve it quickly.

Politico Pulse, STAT News, and the Washington Post offer follow-up stories on the healthcare provisions in the omnibus. Of note, the Washington Post confirms

Congress again rebuffed the White House’s request for new dollars to combat the coronavirus. Last month, Biden administration officials urged lawmakers to approve about $9.25 billion in emergency funds to help ensure access to vaccines and treatments while supporting new research into long covid.

The battle over more funds has been ongoing since the spring, and Republicans have refused to budge, with one Senate GOP aide telling The Health 202 that they want further explanations on how the federal government has spent billions previously allocated for its pandemic response. 

Politico Pulse adds

A long list of measures aimed at tackling the ongoing opioid crisis is in the bill, including $1,575,000,000 in state grants to go toward substance abuse prevention and treatment. It also incorporates significant provisions of the Mainstreaming Addiction Treatment Act, including the elimination of a DEA requirement that clinicians get an extra certification to prescribe buprenorphine, and the NOPAIN Act, which improves access to FDA-approved non-opioid therapies for outpatient surgical procedures.

STAT News explains how the omnibus breathes new life into Medicare’s hospital-at-home program.

What’s more, this week the Senate confirmed the nominations of Rob Schriver to be OPM Deputy Director and Richard Revesz to be director of OMB’s Office of Information and Regulatory Affairs.

From the judicial front –

  • The Society for Human Resource Management tells us, “The 5th U.S. Circuit Court of Appeals recently ruled that the federal government cannot enforce a COVID-19 vaccine mandate on federal contractors. The court’s Dec. 19 decision found that the Biden administration overstepped its authority with the vaccine mandate.”
  • Healthcare Dive discusses the latest hearing before Judge Kernodle in the second Texas Medical Association challenge to the No Surprises Act independent dispute resolution rule. The FEHBlog finds this to be a premature lawsuit at best.

From the public health front

The nose knows why some people still can’t smell long after recovering from Covid-19.

A haywire immune response in the olfactory system was found to explain why some people still can’t smell long after symptoms of the disease have abated, according to a small, peer-reviewed study published Wednesday in the journal Science Translational Medicine. In some cases, the immune or inflammatory response was detected in patients with smell loss up to 16 months after recovery from Covid-19.

Compared with people who can smell normally, patients with long-term smell loss had fewer olfactory sensory neurons, cells in the nose responsible for detecting smells and sending that information to the brain. Patients with lingering loss of smell had an average of 75% fewer of the neurons compared with healthy people, said Brad Goldstein, a study co-author and sinus surgeon at Duke University.

“We think the reduction of sensory neurons is almost definitely related to the inflammation,” Dr. Goldstein said.

  • HHS announced “making an additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu.”
  • Beckers Hospital Review discusses how five payers are addressing maternal health.
  • A JAMA article examines whether “the new CDC Opioid Prescribing Guidelines will help correct the course in pain care.”

From the drug development and distribution front

The Institute for Clinical and Economic Research “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for multiple sclerosis (MS):

Monoclonal Antibodies

  • natalizumab (Tysabri®, Biogen)
  • ofatumumab (Kesimpta®, Novartis)
  • ocrelizumab (Ocrevus®, Genentech)
  • rituximab (Rituxan®, Genentech, and biosimilars)
  • ublituximab (TG Therapeutics)

Oral Therapies

  • dimethyl fumarate (Tecfidera®, Biogen, and generics)
  • diroximel fumarate (Vumerity®, Biogen)
  • monomethyl fumarate (Bafiertam®, Banner Life Sciences)
  • fingolimod (Gilenya®, Novartis)
  • ozanimod (Zeposia®, Bristol Myers Squibb)
  • ponesimod (Ponvory®, Janssen)
  • siponimod (Mayzent®, Novartis)
  • teriflunomide (Aubagio®, Sanofi)

Science reports,

As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science’s request believe her death was likely caused by the antibody, lecanemab.

“The brain swelling and the microhemorrhages … could be a serious side effect of the study medication,” and should be evaluated by trial investigators, says Ellis van Etten, a neuroscientist and neurologist at Leiden University.

Biopharma Dive informs us

  • Pfizer has started dosing patients in a Phase 2 study of its entry into a closely watched class of drugs for treating diabetes and obesity.
  • The dosing of the first patient with the drug, dubbed PF-07081532, triggered a $10 million payment to partner Sosei Heptares, the Japanese drugmaker said Wednesday. Pfizer scientists working with Sosei’s technology discovered the medicine, and Pfizer is responsible for developing it.
  • Pfizer aims to bring a once-daily oral treatment into a class of medicines known as GLP-1 agonists, which stimulate the body to produce insulin by acting on natural body hormones known as glucagon-like peptides. Most of the approved GLP-1 agonists must be injected.

Monday Roundup

David Ermer–Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, STAT News reports

Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics.

Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.

The bill’s text is not yet finalized, and the deal is still subject to changes.

Details may be found in the article.

Following up on last Friday’s post on emergency medical care, MedPage Today counters

The New York Times reported last week that a newly released federal government study believes that up to 250,000 people die in the U.S. annually due to misdiagnoses made in emergency rooms.

However, in a large document obtained by Inside Medicine that is not yet public, one expert contributing to an internal review of the report prior to its publication found a “fatal flaw” in the methodology behind some of the most crucial and eye-catching findings. Other major concerns were brought up by other reviewers and technical experts, which the study authors did not fully address prior to the release of the report. The technical expert concerned about the “fatal flaw” wrote that results were, “Headline grabbing, yes, but this is at best gravely misleading, given the concerns….”

Emergency medicine organizations have already pointed out major problems in the report. One thing not yet pointed out is that the magnitude of the findings fail every whiff test imaginable. If the findings of the report were somehow to be true, that would mean that 8.6% of all deaths in the U.S. — that is, 250,000 out of 2.9 million deaths (2019, the last pre-pandemic year) — are caused by mistakes and misses in ERs. That’s preposterous, on its face. * * *

This report seems unfamiliar with the idea that what we seek in medicine is net benefit. This report counts only the misses, but none of the saves ERs routinely make by following evidence-based medicine developed by emergency physicians, cardiologists, neurologists, and other experts working together. This report seems to think that abiding by the principle of balancing risks and harms is somehow synonymous with medical error. * * *

Here is the internal review and here is the link to the federal government’s report

In medical billing news, MedCity News informs us

Nearly 40% of Americans struggle to understand their medical bills, a recent survey showed. But the respondents also shared a few ways providers and insurers could step in to make bills less confusing.

The survey was released Friday by AKASA, an AI developer for healthcare operations. It was conducted online in March by YouGov and included responses from 2,026 U.S. adults. * * *

How can providers and insurers help? Survey respondents shared several ways:

  • About 27% said it would be beneficial to receive a call from the physician’s office or hospital staff before the medical procedure, explaining terms of payments and the payment plans available. 
  • Another 12% said they’d like an online calculator that can show cost ranges for procedures.
  • About 11% said it would be helpful to receive an email from their insurer that walks through the bill after they receive care.
  • About 9% said they’d like the payer to call and walk them through the bill.
  • Another 9% said they want access to live online customer service through their health plan’s website.
  • Additionally, 8% want a call from the physician’s office or hospital staff that explains the bill after receiving services.  

From the Rx coverage front, STAT News discusses current prescription drug shortages.

The Wall Street Journal adds

Medicines to lower fevers, clear congestion and ease aches and pains are in high demand this winter as the U.S. is experiencing a surge in pediatric cases of RSV, influenza and Covid-19. Parents and caregivers are struggling to find over-the-counter fever reducers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil) as well as amoxicillin, an antibiotic prescribed to treat common childhood ailments such as ear or upper respiratory infections. Both CVS Health Corp. and Walgreens Boots Alliance Inc. announced they have imposed purchase limits on children’s cold and flu medicines. * * *

Manufacturers are producing at full capacity [in contrast to the baby formula shortage] and directing inventory to where it is most needed, the Consumer Healthcare Products Association, which represents producers of over-the-counter medications. “However, we understand it might be frustrating for parents to quickly locate these products from their usual pharmacy or retailer due to intermittent out-of-stocks,” the group said. A spokeswoman for Johnson & Johnson, whose brands include pain relievers Tylenol and Motrin, said that while some products might be less readily available, the company isn’t experiencing widespread shortages of children’s Tylenol or Motrin.

From the mental health care front —

  • The Department of Health and Human Services announced “the annual release of the Department’s National Plan to Address Alzheimer’s Disease: 2022 Update – PDF. Through the National Plan, HHS and its federal partners work to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors.”
  • HR Dive explains how employers can help resolve the “unspoken crisis” in men’s mental health.

From the fraud, waste, and abuse front, Fierce Healthcare reports

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury [on November 14] convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars.

The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests, according to the Department of Justice (DOJ). * * *

The convicted individual—Minal Patel, 44, of Atlanta, the owner of LabSolutions LLC—personally pocketed $27 million of the $187 million that the scheme raked in from Medicare from July 2016 through August 2019.

Patient brokers, call centers and telemedicine companies also allegedly cashed in, as Patel paid them kickbacks and bribes after the Medicare beneficiaries agreed to take the tests, DOJ said. The patient brokers allegedly obtained signed doctors’ orders recommending the tests from telemedicine companies. Patel made the patient brokers sign contracts that misleadingly stated that the brokers were performing legitimate advertising services for LabSolutions.

At last week’s ABA Health Law Section Washington Health Law Summit, the FEHBlog learned about a recent federal anti-health care fraud law called the Eliminating Kickbacks in Recovery Act (“EKRA”). The law is directed at patient brokers, laboratories etc. in situations involving, for example, opioid misuse or this one. EKRA criminalizes fraud against private sector health plans as well as the federal treasury. Here’s a law firm’s article about EKRA if you are interested.

From the U.S. healthcare business front, Fierce Healthcare informs us

Two South [New] Jersey hospitals have signed a letter of intent to merge into a system of more than 10,000 employees and over $2.2 billion in annual revenues.

Camden, New Jersey-based Cooper University Health Care and Cape May Court House, New Jersey-based Cape Regional Health System said in a Wednesday announcement they’ll be working toward a definitive merger agreement in March and then regulatory approvals that “could take until the first quarter of 2024.”

Should the agreement come to pass, the joined system would comprise 900 licensed beds across the organizations’ two flagship hospitals, six urgent care centers and over 130 ambulatory locations across eight counties.

From the federal employment front, Federal News Network relates

Leaders in the Biden administration called for “major reforms” to the federal pay system, building on a not-so-new conversation around issues with the compensation system for much of the federal workforce.

The current structure for determining pay for the 1.5 million federal employees on the General Schedule is inherently flawed, the President’s Pay Agent said in its annual report to the president.

“As has been noted in earlier pay agent reports and discussed in other venues, we believe there is a need to consider major legislative reforms of the white-collar federal pay system, which continues to utilize a process requiring a single percentage adjustment in the pay of all white-collar civilian federal employees in each locality pay area without regard to the differing labor markets for major occupational groups,” the pay agent said in the Dec. 19 report. “The current pay comparison methodology used in the locality pay program ignores the fact that non-federal pay in a local labor market may be very different between different occupational groups. As currently applied, locality payments in a local labor market may leave some mission-critical occupations significantly underpaid while overpaying others.”

The pay agent, composed of Office of Personnel Management Director Kiran Ahuja, Labor Secretary Marty Walsh and Office of Management and Budget Director Shalanda Young, issued its annual report ahead of the planned 4.6% pay raisefor the federal workforce in 2023.

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

The Journal adds,

House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

STAT News tells us

Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

Investment News provides advice on income adjusted Medicare premium issues.

Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

In other health benefits news, Insurance News Net informs us

The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

 For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

 Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

From the Rx development and coverage front, we have three reports from STAT News —

  • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
  • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
  • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

From the public health front —

An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

  • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
  • Health Payer Intelligence tells us

Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

  • Increased drug deaths
  • Increased non-medical drug use
  • Increased premature death