Thursday Miscellany

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Fierce Healthcare tells us that “Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel [,the Advisory Committee on Immunization Practices] decided [today]. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA.”

Fedweek reports that “Federal employees, their unions and members of Congress continue to watch for details of federal agency ‘reentry’ and ‘post-reentry’ operational plans, with the deadline having passed on Monday (July 19) for agencies to submit those plans to OMB but with changes to telework and other workplace policies likely still weeks or months away.”

According to a press release,

Senators Patrick Leahy (D-Vt.) and Steve Daines (R-Mont.) on Tuesday [July 20] requested updates from both the Federal Trade Commission (FTC) and the Department of Justice (DOJ) on their recent efforts to combat anticompetitive conduct in the health insurance industry.  The two senators recently served as chief cosponsors of the bipartisan Competitive Health Insurance Reform Act (CHIRA), which protects consumers by repealing a long-outdated antitrust exemption for the health insurance industry.  Decades of consolidation by health insurance brokers has primed the industry for abuse, allowing insurers to exert market power in order to raise premiums, restrict competition, and deny consumers choice. 

Since the CHIRA’s passage in January of this year, neither the FTC nor the DOJ has announced major steps to exercise their expanded antitrust enforcement authority under the new law.  In their letter, the senators called on the agencies to provide information on any enforcement actions, guidelines, rulemaking, or other actions taken to extend antitrust enforcement to the health insurance industry since then.

Following up on Mondays’ ACA FAQ 47, HHS today announced “the launch of The HIV Challenge, a national competition to engage communities to reduce HIV-related stigma and increase prevention and treatment among racial and ethnic minority people. Through this challenge, HHS is seeking innovative and effective approaches to increase the use of pre-exposure prophylaxis medication (PrEP) and antiretroviral therapy (ART) among people who are at increased risk for HIV or are people with HIV. The HIV Challenge is open to the public, and HHS will award a total of $760,000 to 15 winners over three phases. Phase 1 submissions are open from July 26, 2021, through September 23, 2021.”

Kaiser Health News explains how the Centers for Medicare and Medicaid Services is reevaluating its wellness program for pre-diabetic Medicare beneficiaries.

Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).

Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.

Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.

STAT News reports that

Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.

Happify, founded in 2012, recently announced it had raised $73 million to bolster its efforts in digital therapeutics, a space that is rapidly growing as well-funded companies make the case to regulators, insurers, and clinicians that software can be used to treat disease.

The new product, called Ensemble, is designed to treat both major depressive disorder and generalized anxiety disorder. The software, accessible on both computers and smartphones, guides patients through 10 weeks of cognitive behavioral therapy, or CBT, and other related techniques aimed at changing behavior patterns and teaching coping skills.

The FEHBlog likes the company’s name.

The American Medical Association wants the Food and Drug Administration to loosen up on its opioid prescribing rules which conflict with patient care. Perhaps the FEHBlog is oversimplifying this issue, but haven’t we been down this road to perdition before?

In closing, Fierce Healthcare notes that

Large tech giants are jumping into a growing interoperability solutions market as new federal regulations spur the healthcare industry to open up and share medical records data.

Google Cloud rolled out a new tool called the healthcare data engine, currently in private preview, that helps healthcare and life sciences organizations harmonize data from multiple sources, including medical records, claims, clinical trials and research data.

It gives organizations a holistic view of patient longitudinal records, and enables advanced analytics and AI in a secure and compliant cloud environment, according to Google Cloud executives.

Midweek update

Photo by Piron Guillaume on Unsplash

Yesterday, “at her first meeting of the Chief Human Capital Officers (CHCO) Council, Office of Personnel Management (OPM) Director and Council Chair, Kiran Ahuja, announced that the CHCO Council’s functions will be restored to OPM, after the Council’s leadership and administration were bifurcated between OPM and General Services Administration (GSA) since 2019.”  Sic semper attempted GSA merger.

The North Carolina Attorney General announced “a historic $26 billion agreement that will help bring desperately needed relief to people across the country who are struggling with opioid addiction. The agreement includes Cardinal, McKesson, and AmerisourceBergen – the nation’s three major pharmaceutical distributors – and Johnson & Johnson, which manufactured and marketed opioids. The agreement also requires significant industry changes that will help prevent this type of crisis from ever happening again. The agreement would resolve investigations and litigation over the companies’ roles in creating and fueling the opioid epidemic. State negotiations were led by Attorneys General Josh Stein (NC) and Herbert Slatery (TN) and the attorneys general from California, Colorado, Connecticut, Delaware, Florida, Georgia, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, and Texas.”

Healthcare Dive informs us that “Anthem, the nation’s second largest insurer [and a Blue Cross licensee], saw robust membership growth during the second quarter, adding 1.9 million members, a 4.4% increase over the prior-year period. The growth was fueled entirely by government programs, largely Medicaid and Medicare, while commercial membership declined slightly.  The Indianapolis-based insurer raised its forecast for the full year as its performance in the second quarter outperformed expectations. Even though COVID-19 cases continue to rise due to the delta variant and non-COVID-19 care resumes, Anthem’s medical loss ratio of 86.8% came in below company and analyst expectations.”

Healthcare Dive further reports that “Americans’ medical debt may have reached $140 billion last year, significantly higher than past estimates and outweighing all other types of personal debt in the U.S., according to a new study published in JAMA. Researchers analyzed a tenth of all credit reports from rating agency TransUnion to find nearly one in five Americans had medical debt in collections in June last year — more than any other type. Debt was significantly more concentrated in states that had yet to expand Medicaid under the Affordable Care Act. The analysis reflects care provided prior to COVID-19, but early data shows the pandemic has likely only exacerbated the perennial issue of medical debt in the U.S.” The FEHBlog is surprised that one decade into the Affordable Care Act this issue has not diminished.

In another downbeat but important story, AHIP tells us that “price gouging on COVID-19 tests by certain providers continues to be a widespread problem, threatening patients’ ability to get the testing they need.”

The FEHBlog also ran across the following three interesting articles in Forbes:

  • “Most hospital executives will say it’s impossible to run a business on Medicare rates. The government health insurance program for seniors pays less for services than it costs to deliver them and private insurance has to make up the difference. But Eren Bali doesn’t buy the cost-shifting argument. The serial entrepreneur who grew up in rural southeast Turkey believes the issue isn’t the rates but an outdated system using old technology. “There’s so much waste because providers are so used to charging through the roof in this country, they’ve never thought about being efficient,” says Bali, 37, the CEO and cofounder of Carbon Health.” This article is a day brightener.
  • “UnitedHealth Group is rolling out an increasing number of partnerships to “address health equity challenges” across the U.S.” The article adds that “UnitedHealth’s effort comes as the company and rivals including Anthem, CVS Health’s Aetna health plan unit, Humana and others address social determinants of health as insurers intensify strategies to reduce costs and improve outcomes beyond covering traditional medical treatments.”
  • “The coronavirus pandemic forced many hospitals to confront an uncomfortable truth: they were sitting on troves of patient data but, despite tens of millions of dollars spent on electronic health records and IT infrastructure, couldn’t extract useful insights to help treat the virus ravaging the wards. This experience was the tipping point that pushed a group of 17 hospitals to come together, including three new members announced this week, to raise $95 million for a startup called Truveta.” The article adds that “The aim of the company is to enable hospitals to monetize patient data that has been de-identified in ways that may both improve existing treatments and develop new ones. With the addition of Texas-based Baylor Scott & White Health, Maryland-based MedStar Health and Texas Health Resources, the hospital-governed Truveta now says it represents organizations that provide 15% of patient care in the United States. The Seattle, Washington-based startup is helmed not by a veteran of the healthcare world, but by former Microsoft executive Terry Myerson, who’s better known for his work on Windows and Xbox.”

Midweek update

At the top of FEHB news today is the release of the Congressional Budget Office’s report on the Postal Service Health Benefit (“PSHB”) Program provisions of the Postal Reform bill.

CBO expects that PSHB premiums would be lower than those for FEHB plans because Medicare would cover most of the health care costs for Medicare-eligible enrollees in PSHB plans. CBO estimates that USPS spending on health insurance premiums for active workers and their dependents would decrease by roughly $2.5 billion over the 2021-2031 period; those amounts are recorded as off-budget. CBO also estimates that federal spending for health insurance premiums for USPS annuitants and their dependents would decrease by $2.5 billion over that same period; those amounts are recorded as on-budget. * * *

FEHB premiums would rise slightly after those enrollees moved to the PSHB program, CBO expects. Over time, as USPS workers and annuitants enroll in a PSHB plan rather than in an FEHB plan, CBO expects that FEHB premiums would decrease because non-USPS enrollees in FEHB would have lower expected health care costs, on average, than enrollees joining the PSHB program. The federal government’s share of payments for health insurance premiums for non-USPS annuitants is recorded as on-budget direct spending. CBO estimates that spending for such annuitants would decrease by $61 million over the 2021-2031 period.

CBO also explains that the PSHB savings results from a cost shift to Medicare. Because FEHB and PSHB premiums are calculated for a combined risk pool of plan members, the Medicare savings will redound to the benefit of the Postal Service and all of the PSHB members. The lower premiums will encourage enrollment in the PSHB.

If OPM simply allowed all FEHB plans to integrate their prescription drug benefits with Medicare Part D (known as Part D EGWPs), then FEHB plan members and federal and postal employers, all of whom pay Medicare taxes, will receive lower premiums, thereby avoiding the unnecessary balkanization of the FEHB. The decision is OPM’s to make as Congress in 2003 expressly permitted FEHB plans to adopt Part D EGWPs.

In related new, CalPERS Board of Administration, which manages the the California state employees health benefit program, “approved health plan premiums for calendar year 2022, at an overall premium increase of 4.86%.” This suggests that we are in store for a sizable FEHB premium increase for 2022.

As the FEHBlog mentioned yesterday, he has been attending the NCQA’s virtual Digital Quality Summit which has been focusing on health equity, a worthy goal. During last year’s virtual DQS, the FEHBlog came up with the idea of adding the Census Bureau’s racial and ethnic identifiers to the ICD-10 code set which would allow health care providers to readily share that important data with health plans. Today the FEHBlog pushed the idea forward with the patient centered track. Time will tell.

Similarly, Govexec informs us that “Top diversity officials at four major agencies said on Tuesday that obtaining and using better data will be crucial to advancing diversity, equity, inclusion and accessibility in the federal workforce.”

In sad news, the Washington Post reports that

Deaths from drug overdoses soared to more than 93,000 last year, a staggering record that reflects the coronavirus pandemic’s toll on efforts to quell the crisis and the continued spread of the synthetic opioid fentanyl in the illegal narcotic supply, the government reported Wednesday. The death toll jumped by more than 21,000, or nearly 30 percent, from 2019, according to provisional data released by the National Center for Health Statistics, eclipsing the record set that year.

The Post adds

There are some signs that the Biden administration and Congress are preparing to renew efforts to address what was the nation’s most serious public health crisis before the pandemic. President Biden on Tuesday nominated former West Virginia public health official Rahul Gupta to be his drug czar. Gupta has cited the shift from in-person care during the pandemic as one of the contributors to increased addiction-related public health problems.

In prescription drug news

  • The Drug Channels blog discusses 2020 PBM drug trend reports. Top line: “[D]rug spending continues to grow more slowly than every other part of the U.S. healthcare system. Spending growth at CVS and Express Scripts was somewhat higher in 2020 compared to the 2019 figures, due primarily to faster utilization growth.”
  • The Boston Globe reports that “At least half-a-dozen private health insurers in some of the nation’s largest states are balking at covering Biogen’s controversial drug for Alzheimer’s disease, saying it is an experimental and unproven treatment despite being approved by the federal government one month ago. Six affiliates of Blue Cross and Blue Shield in Florida, New York, Michigan, North Carolina, and Pennsylvania indicated in policies posted online they will not cover the Cambridge biotech’s drug, Aduhelm, because they consider it ‘investigational’ or ‘experimental’ or because “a clinical benefit has not been established.” Aduhelm, which is priced at $56,000 a year, is intended to slow cognitive decline in patients with early Alzheimer’s symptoms, regardless of their age. * * * James Chambers, an associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, said that insurers have occasionally opted not to cover expensive specialty medicines for rare diseases, but that he’s never seen firms refuse to pay for an approved drug that could be prescribed to millions of people. ‘This is unprecedented,’ said Chambers, who has spent seven years studying how private insurers decide which drugs to cover. ‘Maybe it’s not entirely surprising given the controversy surrounding the drug’s approval, but it’s not something I’ve seen before.’” The FEHBlog expects that this is a prudent shot across the manufacturer’s bow. The FEHBlog is amazed that Biogen has not yet backed off on the $56,000 price annually per patient. In a STAT News interview, the acting FDA Commissioner Janet Woodcock remarked “The accelerated approval was based on very solid grounds,” she said. “I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients.”
  • Bloomberg reports on a recent Senate hearing on drug prices. Topics included patent reform and pay for delay deals.

In other news

  • The federal government’s principal healthcare fraud and abuse report for the last federal fiscal year was released. “During Fiscal Year (FY) 2020, the Federal Government won or negotiated more than $1.8 billion in health care fraud judgments and settlements,2 in addition to other health care administrative impositions. Because of these efforts, as well as those of preceding years, almost $3.1 billion was returned to the Federal Government or paid to private persons in FY 2020. * * * In FY 2020, the Department of Justice (DOJ) opened 1,148 new criminal health care fraud investigations. Federal prosecutors filed criminal charges in 412 cases involving 679 defendants. A total of 440 defendants were convicted of health care fraud related crimes during the year. Also, in FY 2020, DOJ opened 1,079 new civil health care fraud investigations and had 1,498 civil health care fraud matters pending at the end of the fiscal year. Federal Bureau of Investigation (FBI) investigative efforts resulted in over 407 operational disruptions of criminal fraud organizations and the dismantlement of the criminal hierarchy of more than 101 health care fraud criminal enterprises.”
  • Becker’s Hospital Review tells us about the telehealth provisions of the CMS proposed 2022 Medicare Part B physician payment rule which would preserve the status quo through 2023.

Midweek Update

Photo by Manasvita S on Unsplash

From the COVID-19 front

  • The Wall Street Journal reports that “The highly transmissible Delta variant has become the dominant strain of the Covid-19 virus circulating in the U.S., according to federal data. It is spreading rapidly as communities loosen pandemic restrictions and officials struggle to reach unvaccinated people. The Delta variant, also known as B.1.617.2, made up 51.7% of Covid-19 infections in the two weeks ended July 3, according to genetic sequences from positive Covid-19 tests submitted to the U.S. Centers for Disease Control and Prevention.”
  • The Journal adds that “Covid-19 vaccines available in the U.S. protect against the Delta variant, but the virus is of great risk to people who aren’t vaccinated, according to public-health and infectious-disease experts. * * * Warm weather is helping to keep numbers of new cases down, and infections are likely to rise again in the fall, said Dr. Paul Sax, clinical director of the Division of Infectious Diseases at Brigham and Women’s Hospital in Boston. ‘Last summer we got a little bit overconfident,’ he said. ‘I don’t want us to make the same mistake again this time. We need to push as hard as we can to get as many people vaccinated as possible.’”
  • AHIP updates us on the progress made by its Vaccination Community Connectors program. “The COVID-19 pandemic has been a fundamental part of Americans’ lives for 15 months and counting. America cannot afford to lose any more time in achieving community immunity. Public-private partnerships have helped to support our communities through the crisis this far. By extending those partnerships through secure sharing of data about who has been immunized, we can better target every outreach and connection to put an end to the pandemic and get back to the moments we all miss. For more information, read our white paper with Blue Cross Blue Shield Association (BCBSA) and the Association for Community Affiliated Plans (ACAP).”
  • The FEHBlog noticed today that the OPM Inspector General has posted his semi-annual report to Congress for the period ended April 30, 2021, and OPM’s management response thereto. The Inspector General’s report includes an update of his earlier assessment of the pandemic’s impact on the FEHB Program. With all due respect, the FEHBlog finds the OIG’s assessment unnecessarily pessimistic but it’s for the readers to form their own opinions.

From the innovation front

  • Fierce Pharma reports that “Many pursuits have been put on hold during the coronavirus pandemic. But biopharmaceutical innovation isn’t one of them. In 2020, the FDA approved 53 new drugs, the second-most in a single year, after 2018’s bounty of 59. And the momentum has continued through the first half of 2021. With the FDA endorsing its 29th novel drug on June 30, the industry was slightly ahead of last year’s pace. * * * n terms of treatment areas, it is of little surprise that oncology accounts for 12 of this year’s approvals. That figure represents 44% of all new drug approvals this year, an even higher rate than in 2020 when 20 of 53 new drugs were in the oncology class. * * * The FDA’s roundups of 2021’s novel drug approvals can be found here and here.”
  • Employee Benefit News informs us that “Employers have a new tool in their arsenal to help employees reach a healthier weight and reduce their healthcare costs. DayTwo, a precision medicine company, has released new outcomes from its employer and health plan nutrition programs, to tackle high-risk and high-cost metabolic conditions, like obesity, Type 2 diabetes and pre-diabetes. The program provides users with a microbiome screening, which measures how the body digests food, in order to offer AI-powered nutritional plans tailored to their needs. After one year, employees who used the DayTwo program lost an average of 19 pounds and reduced their body mass index by 3.3 points, according to a release. The program is meant to reduce the reliance on medication and help employees with obesity and Type 2 diabetes lose weight naturally.”
  • mHealthIntelligence tells us that “While many healthcare providers are just now getting into the remote patient monitoring arena, Ochsner Health has scaled its platform to a national level, and is now monitoring more than 20,000 people in health plans across the country. And still, says Julie Henry chief operating officer for the New Orleans-based health system’s digital medicine department, ‘we’re learning lessons each and every day.’ That’s one of the guiding principles behind a connected health service that is seeing immense growth in the wake of the coronavirus pandemic, which has pushed many health systems to shift healthcare services from the hospital to the home. It’s a work in progress for everyone, from those deploying the technology to those paying for it. And there isn’t a hospital, clinic or practice out there that isn’t learning something new.”

In other healthcare news

  • The Federal Register announced today the last Thursday’s No Surprises Act interim final rule will be published in the July 13 issue. Publication triggers the sixty day public comment period which should end on Monday September 13 (as the 60 day period ends on Saturday September 11.)
  • Beckers Hospital Review reports that “Amazon Care, the e-commerce giant’s new healthcare venture, has approached several big health insurers in an effort to expand coverage of its services, Insider reported July 7.  The healthcare venture reportedly talked to Aetna, Premera Blue Cross and Blue Cross Blue Shield of Massachusetts, according to people familiar with the discussions.”

No Surprises Thursday

Photo by Josh Mills on Unsplash

The federal regulators, including the Office of Personnel Management, achieved their statutory deadline today for issuing the first round of No Surprises Act implementing rules. Here’s the regulators’ output, compliments of the Labor Department:

There is no doubt in the FEHBlog’s mind that the regulators did a fine job of making a silk purse out of sow’s ear / the poorly drafted statute. This rule will help carriers and providers meet the January 1, 2022, launch date. This law, if properly implemented, and signs are looking good now, will protect consumers from surprise medical bills, which was clearly Congress’s objective, but without creating an IT nightmare.

The regulators plan a second round of No Surprises Act rules for October 1, 2021. The second round will focus on the independent dispute resolution process.

From the COVID-19 front —

  • The New York Times reports that “The Johnson & Johnson coronavirus vaccine is effective against the highly contagious Delta variant, even eight months after inoculation, the company reported on Thursday — a finding that should reassure the 11 million Americans who have gotten the shot. The vaccine showed a small drop in potency against the variant, compared with its effectiveness against the original virus, the company said. But the vaccine was more effective against the Delta variant than the Beta variant, first identified in South Africa — the pattern also seen with mRNA vaccines.”
  • Medscape informs us that “The White House on Thursday announced it will send “strike teams” to 1000 counties where the COVID-19 Delta variant is spreading rapidly. The teams will be made up of health and logistics experts from several federal agencies and will conduct coronavirus testing, distribute medicines designed to fight the virus, and boost local and state efforts to increase vaccinations.”

In Thursday Miscellany —

  • GoodRx is tracking prescription drug manufacturer price changes which typically are made effecting January 1 and July 1.
  • The Centers for Medicare and Medicaid Services “is proposing actions that aim to close health equity gaps by providing Medicare patients battling End-Stage Renal Disease (ESRD) with greater access to care, through the ESRD Prospective Payment System (PPS) annual rulemaking. This proposed rule would update ESRD PPS payment rates, make changes to the ESRD Quality Incentive Program (QIP), and modify the ESRD Treatment Choices (ETC) Model.  The proposed changes to the ETC Model policies would aim to encourage dialysis providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model the agency’s first CMS Innovation Center model to directly address health equity.”
  • The Aetna Foundation and U.S. News and World Report released their 2021 healthiest U.S. communities rankings this week.

2021 Healthiest Communities- Top 10

*See the full rankings here

Top 10 Counties

  1. Los Alamos County, New Mexico
  2. Douglas County, Colorado
  3. Falls Church, Virginia
  4. Loudoun County, Virginia
  5. Broomfield County, Colorado
  6. San Miguel County, Colorado
  7. Pitkin County, Colorado
  8. Howard County, Maryland
  9. Morgan County, Utah
  10. Routt County, Colorado

2021 Key Measures

Top 5 Communities for Health Outcomes

  1. San Juan County, Washington
  2. Marin County, California
  3. Carver County, Minnesota
  4. Stevens County, Minnesota
  5. Hunterdon County, New Jersey

Top 5 Communities for Access to Health Care

  1. Olmsted County, Minnesota
  2. Montour County, Pennsylvania
  3. Suffolk County, Massachusetts
  4. Johnson County, Iowa
  5. Perry County, Kentucky

Top 5 Communities for Mental Health

  1. Honolulu County, Hawaii
  2. Pitkin County, Colorado
  3. Fairfax County, Virginia
  4. Santa Clara County, California
  5. San Mateo, California

Welcome Director Ahuja

OPM Headquarters a/k/a the Theodore Roosevelt Building

OPM’s new Director Kiran Ahuja was sworn in today. Here is a link to the OPM press release on the festivities.

Health Payer Intelligence informs us that “The Alliance of Community Health Plans (ACHP) has proposed a number of recommendations to improve the Federal Employees Health Benefits (FEHB) program’s plan comparison tool in order to boost quality and enrollment, according to a recent issue brief.” ACHP’s action is timely because OPM has been focusing attention on the plan comparison tool in consultation with interested carriers and presumably other stakeholders.

According to a Committee press release, “The House Appropriations Subcommittee on Financial Services and General Government today approved by voice vote its fiscal year 2022 bill. [This is the bill that funds OPM and the FEHB.] For fiscal year 2022, the draft bill includes $29.1 billion in funding, an increase of $4.8 billion over 2021.” 

Sen. Chuck Grassley (R Iowa) announced

Sen. Chuck Grassley (R-Iowa) today joined Senate Majority Whip Dick Durbin (D-Ill.) Sen. Angus King (I-Maine) to introduce the Drug-price Transparency for Competition (DTC) Act, a bill that would require price disclosures on advertisements for prescription drugs, in order to empower patients and reduce spending on medications. Last week, the Government Accountability Office (GAO) released a report – requested by Durbin and Grassley – which found direct-to-consumer (DTC) advertisements of prescription drugs contribute to an enormous amount of Medicare costs. Specifically, the DTC Act would require DTC advertisements for prescription drugs and biological products to include a disclosure of the list price, so that patients can make informed choices when inundated with drug commercials. 

Speaking of drug prices, let’s take a look at recent news on the new Alzheimer’s Disease drug, Aduhelm.

  • Yesterday, Biogen issued a bulleted defense of its pricing, which is $56,000 annually per patient. STAT News points out “For families and physicians grappling with the historic approval this month of the controversial Alzheimer’s drug Aduhelm, there’s no shortage of unanswered questions. But a critical one has largely been overlooked: Once patients start taking the medication, how will they know when it’s time to stop? “We don’t have any guidance on how long to give this medication to someone who doesn’t experience adverse events,” said William Mantyh, a behavioral neurologist at M Health Fairview University of Minnesota Medical Center. “With a drug like aducanumab where the upfront demonstrated efficacy is up in the air, it really makes it hard for a clinician to figure out when to stop the drug based on a patient’s clinical symptoms.”
  • Axios interviewed AHIP CEO Matt Eyles on Aduhelm pricing. In response to an Axios question on acceptable pricing, Mr. Eyles responded that “The best information we have is what [the Institute for Clinical and Economic Review] puts out.” ICER stated on June 7 that “At the ICER public meeting on aducanumab on July 15, 2021, we will tackle important questions [about Aduhem] with all stakeholders at the table. We will also address the question of fair pricing for a drug that now seems likely to become one of the top selling drugs in the history of the United States. ICER’s preliminary draft report calculated a fair annual price to lie between $2,500-$8,300. Even in our most optimistic cost-effectiveness scenario — which ignores the contradictions within the two pivotal trials and presumes that only the positive trial captures the true benefits of treatment — aducanumab’s health gains would support an annual price between $11,100-$23,100. The list price of $56,000 per year announced today by the drug maker far exceeds even this optimistic scenario. Our report notes that only a hypothetical drug that halts dementia entirely would merit this pricing level. The evidence on aducanumab suggests that, at best, the drug is not nearly this effective. Nonetheless, even at the lower range of the estimated number of eligible patients, at this price the drug maker would stand to receive well in excess of $50 billion per year even while waiting for evidence to confirm that patients receive actual benefits from treatment.
  • The Wall Street Journal reports that “Eli Lilly & Co. plans to submit its Alzheimer’s drug for market clearance under an expedited review this year, in a sign that regulators are encouraging development of treatments for the disease after a recent approval. Lilly said Thursday that the U.S. Food and Drug Administration had designated the company’s experimental Alzheimer’s drug, called donanemab, for the agency’s accelerated approval process. The FDA decision comes after the agency cleared Biogen Inc.’s Aduhelm, the first Alzheimer’s therapy to receive approval in nearly two decades but one that has drawn criticism from doctors and researchers skeptical the drug works. * * * Donanemab performed better in a trial than Biogen’s drug did in its trials, and health insurers and patients would probably prefer it over Aduhelm, J.P. Morgan analyst Chris Schott said in a note to investors.“Donanemab’s approval would be a major blow to Aduhelm’s commercial prospects,” Brian Skorney, a Robert W. Baird & Co. analyst, said in a research note. “We think it would make zero sense for FDA to approve Aduhelm, but not donanemab.” Ah, competition.

In other drug pricing news, Fierce Healthcare tells us that

Cigna is launching a new program that aims to incentivize eligible members to switch to biosimilar drugs.

Under the new Shared Savings Program, members will be offered a one-time $500 debit card for healthcare services or medications if they make the decision to switch to a biosimilar, according to an announcement provided first to Fierce Healthcare.

The program will be made available first to [approximately 7,000] eligible patients taking Remicade, a brand-name biologic that treats a number of inflammatory conditions such as Crohn’s disease and psoriasis. Remicade infusion costs can vary, but Cigna claims data suggest the average regimen costs $30,000 per year, with expenses growing depending on the site of administration.

Two biosimilars for the drug, Avsola and Inflectra, will be moved to the insurer’s preferred tier in July. Eligible customers and their providers will be notified by Cigna about their eligibility to participate in the Shared Savings Program in the coming weeks, the insurer said.

In COVID-19 news —

  • Fierce Biotech reports that “The FDA green-lit its first antibody test that doesn’t use blood samples to check for evidence of a COVID-19 infection and instead relies on simple, painless mouth swabs. Developed by Diabetomics, the rapid, lateral-flow diagnostic received an agency emergency authorization allowing it to be used at the point of care for adults and children. Designed to deliver a result within 15 minutes, the CovAb test also does not require any additional hardware or instruments. When administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels, the test demonstrated a false-negative rate of less than 3% and a false-positive rate of nearly 1%, according to the company.” 
  • The New York Times reports that the Baltimore Maryland factory that had been producing the single dose Johnson & Johnson COVID-19 vaccine remains shuttered which Congress investigates its owner Emergent Biosolutions.
  • The NIH Director’s blog informs us about new NIH research on how Immunity generated from COVID-19 vaccines differs from an Infection. “The good news so far is that, unlike the situation for the common cold, we have now developed multiple COVID-19 vaccines. The evidence continues to suggest that acquired immunity from vaccines still offers substantial protection against the new variants now circulating around the globe. The hope is that acquired immunity from the vaccines will indeed produce long-lasting protection against SARS-CoV-2 and bring an end to the pandemic. These new findings point encouragingly in that direction. They also serve as an important reminder to roll up your sleeve for the vaccine if you haven’t already done so, whether or not you’ve had COVID-19. Our best hope of winning this contest with the virus is to get as many people immunized now as possible. That will save lives, and reduce the likelihood of even more variants appearing that might evade protection from the current vaccines.” Amen to that.

In a bit of Thursday miscellany

  • Patient Engagement reports that “Optum is bringing healthcare right into Utah’s backyard, rolling out a new Optum Mobile Health Clinic to improve care access for individuals in Optum Care Network Utah. The mobile health clinic, a 45-foot-long vehicle with two private exam rooms, a waiting room, and an imaging lab, is set to address the leading care access barriers experienced by Utahns.” Well done.
  • A friend of the FEHBlog called his attention to the NIH report on an engaging study suggesting scientists may need to rethink which genes control aging.

New OPM Director plus Tuesday’s Tidbits

OPM Headquarters a/k/a the Theodore Roosevelt Building

The Senate narrowly confirmed Kiran Ahuja to be Office of Personnel Management Director this afternoon. Here’s the Senate play by play from the Senate Press Gallery website.

1:37 p.m. Cloture was invoked on the Ahuja nomination, 51-50. Vice President Harris broke the tie.

2:26 p.m. Senator Peters spoke in support of the Ahuja nomination.

2:30 p.m. The Senate began a vote on confirmation of Executive Calendar #107 Kiran Arjandas Ahuja to be Director of the Office of Personnel Management for a term of four years.

3:26 p.m. By a vote of 51-50, the Senate confirmed Executive Calendar #107 Kiran Arjandas Ahuja to be Director of the Office of Personnel Management for a term of 4 years. The Vice President cast the tie breaking vote. 

Here is a link to Ms. Ahuja’s Wikipedia page. Here are links to the Federal Times, Govexec and Federal News Network reports on this event. The FEHBlog wishes Ms. Ahuja good luck.

The Senate Health Education Labor and Pensions Committee held a hearing on COVID-19 vaccination efforts today. Here is a link to the Sen. Patty Murray’s (D Wash) statement on the hearing. Sen. Murray is the Committee chair.

In this regard, the Wall Street Journal reports that

The White House said the U.S. will fall short of President Biden’s goal for 70% of the adult population to receive at least one coronavirus vaccine dose by July 4.

Mr. Biden had set the goal in early May, with an aim for a return to normalcy to mark the Independence Day holiday. White House Covid-19 coordinator Jeffrey Zients said Tuesday the target had been met for those age 30 and over but not for the overall eligible population.

Mr. Zients said it would take a few extra weeks to reach the president’s target and cited a reluctance to get the vaccine among people between the ages of 18 and 26 as one of the challenges facing the country.

“The reality is many younger Americans have felt like Covid-19 is not something that impacts them and they have been less eager to get the shot,” Mr. Zients said.

On Thursday, June 24, at 10 am, the Financial Services and General Government Subcommittee of the House Appropriations Committee will markup the fiscal year 2022 appropriations bill that includes OPM and FEHB appropriations. Here’s a link to a Fedweek article on the markup.

STAT News offers a couple of sobering articles, one on antibiotic resistance and the other on health equity concerns

  • According to a new STAT Report an estimated 700,000 people die annually from antimicrobial resistance, a number that could rise to 10 million by 2050, according to a World Health Organization report issued in 2019. In the U.S. alone, there are more than 2.8 million antibiotic-resistant infections and 35,000 deaths from those infections each year, according to data from the Centers for Disease Control and Prevention. A number of issues have fueled resistance and stunted development of new antibiotics. And while there are various efforts underway to address those challenges, creating incentives to change the trajectory of antibiotic resistance takes commitment and imagination. There are several experiments under way that aim to spur development of new products while still ensuring profit. In the U.K. and Sweden, pilot programs are testing a pull incentive, which involves a subscription-style business model in which a government offers upfront payments to drug makers in exchange for unlimited access to their antibiotics. The idea is to enable drug companies to recover their costs and make an appropriate profit without having to sell large volumes of antibiotics. Last week, U.S. lawmakers re-introduced legislation to create a similar mechanism.
  • [Researchers have identified]232 counties in the mainland U.S. where men aged 49 and under are at unusually high risk of dying from colorectal cancer, according to a study published last year in the American Journal of Cancer Research. The researchers also found that compared with white men, Black men in these hot spots who have colorectal cancer are more likely to be diagnosed with advanced stages of the disease and less likely to survive it. * * * [S]ince the 1990s, even as colorectal cancer rates have declined for people 50 and older, they have more than doubled among American adults under 50, according to the National Cancer Institute. By 2030, predicts a study published in April, colorectal cancer will be the leading cause of cancer-related deaths in people aged 20 to 49. The reason behind the rise remains a mystery. “We don’t know where this is coming from,” said Charles R. Rogers, an assistant professor of public health at the University of Utah School of Medicine and lead author of the hot spots study. “Just like we don’t really know why Black people have the highest chance of getting and dying from it.” The article explains how researches like Professor Rogers are shedding light on the cause of this inequity by studying the hot spots, among other things.

In brighter Tuesday Tidbits

  • The Patient Centered Outcomes Research Institute funded by health plan premiums is seeking public comment on its national health priorities. The public comment period runs from June 28 through August 27.
  • Fierce Healthcare reports that “Five Blues plans are teaming up to invest in a new pharmacy solutions venture called Evio. Blue Cross Blue Shield of Massachusetts, Blue Cross Blue Shield of Michigan, Blue Shield of California, Highmark Health and Independence Blue Cross are backing Evio, according to an announcement released Tuesday. The new company aims to establish outcomes-based arrangements with drugmakers, especially for high-cost therapies. In addition, Evio aims to collect and provide real-world evidence for medications to ensure the right product is getting to the right patient.” Makes sense to the FEHBlog.
  • Fierce Healthcare also informs us that “Amazon Web Services wants to help incubate early-stage digital health companies that can collaborate with the tech giant’s healthcare customers and partners. Amazon’s cloud division launched a healthcare accelerator to boost startups’ growth in cloud technologies and enable early-stage companies to tap into AWS’ technical and commercial expertise. The program will focus on technologies such as remote patient monitoring, data analytics, patient engagement, voice technology and virtual care, according to a blog post from Sandy Carter, vice president of worldwide public sector partners and programs at AWS.”

Monday Roundup

Photo by Sven Read on Unsplash

The International Foundation of Employee Benefit Plans informs us that

The Department of Labor’s (DOL) Employee Benefits Security Administration along with the Office of Personnel Management, Internal Revenue Service, Department of the Treasury, Centers for Medicare & Medicaid Services, and Department of Health and Human Services (collectively, The Departments) issued an information collection related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage.​

In addition, the Departments and OPM are also seeking input about whether the requirements apply to Federal Employees Health Benefits carriers, including whether or not they are also health insurance issuers.

Here’s the FEHBlog’s input on that last point. Congress extended specific provisions of Division BB of the Consolidated Appropriations Act, 2021 to the FEHB Program when it created a new Section 8902(p) of the FEHB Act. Today’s notice concedes that Section 204 was not among those provisions in Section 8902(p). Regulations are intended to implement and interpret statutory law, and in the case of the FEHBP there is no statute to implement here. What’s more carriers already are obligated to report aggregated prescription benefit data to OPM. In other words, the regulatory field is occupied as far as the FEHB Program is concerned. The public comment deadline on this information collection notice is July 23, 2021.

The American Hospital Association gleefully reports

Nearly 100 bipartisan House members led by Reps. Thomas Suozzi, D-N.Y., and Brad Wenstrup, R-Ohio, urge the departments of Health and Human Services, Labor and the Treasury [in a June 17, 2021 letter] to ensure their rulemaking for the No Surprises Act reflects congressional intent for a balanced process to settle payment disputes between health plans and providers. The lawmakers also emphasized the need to provide sufficient time for public comments and evaluation through proposed notice and comment rulemaking. 

The FEHBlog wonders what caused Congress to fire this shot across the regulator’s bow. The statutory deadline for these rules is October 1, 2021, thereby creating an all too brief three month long implementation period for providers, payers, lawyers and arbitrators. This should be interesting.

To show that the FEHBlog is not entirely cranky as he writes this post, CVS Health announced today

Over the last year, Aetna, a CVS Health® company, has been implementing a comprehensive strategy to reduce suicide attempts 20 percent among Aetna members by the year 2025. With the right intervention and support, resources and management of suicidal thoughts, suicide is known to be preventable. In fact, 90 percent of people who die by suicide have a potentially treatable mental health condition.

This month, Aetna is launching its latest initiative — the development of a specialty provider network with a sole focus on suicide prevention in collaboration with Psych Hub, the world’s most comprehensive platform for mental health education. The joint effort will further arm Aetna practitioners with no-cost, evidence-based instruction, tools, and resources to identify and treat those at risk of suicide.

Well done and best of luck.

Also from the COVID-19 front Bloomberg informs us

After more than a year of obsessively tracking Covid-19 case numbers, epidemiologists are starting to shift focus to other measures as the next stage of the pandemic emerges.

With rich countries vaccinating growing proportions of their vulnerable populations, the link between infection numbers and deaths appears to be diminishing. Now, in some places the focus is on learning to live with the virus — and on the data that matter most to avoid fresh lockdowns.

“It’s possible we’ll get to a stage of only monitoring hospitalizations,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins University’s Coronavirus Resource Center, which has built one of the most comprehensive platforms to track the virus and its impact.

The Wall Street Journal provides an overview of the COVID-19 variant called Delta.

The latest data from The Centers for Disease Control and Prevention estimates the Delta variant makes up 9.9% of reported U.S. Covid-19 cases, while Alpha stands at 65.5%. * * *

Scientists are still studying the virus and their early conclusions aren’t definitive. But British scientists, who have probably done the most work on the variant, estimate it is from 40% to as much as 80% more infectious than the so-called Alpha variant, or B.1.1.7, which was first identified in England last year, is now prevalent in the U.S. and is itself more contagious than the version of the virus that emerged in China in 2019.

An analysis of more than 14,000 Delta cases by England’s public-health agency found a double dose of the shot developed by Pfizer Inc. and BioNTech SE reduces the risk of hospitalization after infection with Delta by 96%. Two doses of the vaccine developed by the University of Oxford and AstraZeneca reduce the risk by 92%, Public Health England said.

Very few of those hospitalized in the U.K. have been fully vaccinated, with the new cases mostly among younger people who aren’t yet vaccinated. There is no evidence that young adults and children are more at risk proportionately from this variant than other age groups, and the increased transmission mostly reflects the fact that they haven’t been immunized, scientists say.

In other news that caught the FEHBlog’s eye this Monday —

  • The FEHBlog enjoys following the healthcare efforts of business giants like Amazon, Apple, and Walmart. ZdNet reports on Microsoft’s new healthcare strategy.
  • Louisville KY television station WDRB tells us

Brentwood, Tenn.-based LifePoint Health [a large regional health system that owns over 80 hospitals] will acquire Louisville-based Kindred Healthcare LLC, a specialty hospital company, for undisclosed terms, according to a news release Monday. The deal is scheduled to close by the end of the year. The announcement comes weeks after Louisville-based Humana Inc. said it would absorb the remainder of the former Kindred’s home health and hospice business. In the news release, LifePoint said it plans to continue Kindred’s strategy of growing by establishing joint ventures and partnerships with hospitals. * * * LifePoint said it plans to invest $1.5 billion in its business following the deal.

At the time of wrapping up this post on Monday evening, the Senate had not yet taken up Kiran Ahuja’s nomination to be OPM Director. The FEHBlog will keep an eye on this matter. [Tuesday morning supplement — The Senate Press Gallery Calendar informs us that

The Senate on Tuesday morning at 11:45 am will hold two votes:

  1. Confirmation of the Fonzone nomination.
  2. Motion to invoke cloture on Kiran Ahuja to be Director of the Office of Personnel Management.

The Senate will recess following the cloture vote on the Ahuja nomination until 2:15 p.m. 

At 2:30 p.m. vote:

  1. Confirmation of the Ahuja nomination.

Thursday Miscellany

U.S. Supreme Court building, Wash. DC

At long last, the U.S. Supreme Court issued its opinion today in the third case reaching the Court on the issue of the constitutionality of the Affordable Care Act (“ACA”). In an opinion written by Justice Breyer and joined by the Chief Justice and four other Justices, the Court ruled in short as follows:

As originally enacted in 2010, the Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage. The Act also imposed a monetary penalty, scaled according to in- come, upon individuals who failed to do so. In 2017, Con- gress effectively nullified the penalty by setting its amount at $0. See Tax Cuts and Jobs Act of 2017, Pub. L. 115–97, §11081, 131 Stat. 2092 (codified in 26 U. S. C. §5000A(c)).

Texas and 17 other States brought this lawsuit against the United States and federal officials. They were later joined by two individuals (Neill Hurley and John Nantz). The plaintiffs claim that without the penalty the Act’s minimum essential coverage requirement is unconstitutional. Specifically, they say neither the Commerce Clause nor the  Tax Clause (nor any other enumerated power) grants Congress the power to enact it. See U. S. Const., Art. I, §8. They also argue that the minimum essential coverage re- quirement is not severable from the rest of the Act. Hence, they believe the Act as a whole is invalid. * * *

[W]e conclude that the plaintiffs in this suit failed to show a concrete, particularized injury fairly traceable to the defendants’ conduct in enforcing the specific statutory provision they attack as unconstitutional. They have failed to show that they have standing to attack as unconstitutional the Act’s minimum essential coverage provision. Therefore, we reverse the Fifth Circuit’s judgment in respect to standing, vacate the judgment, and remand the case with instructions to dismiss.

Justice Thomas filed a concurring opinion, and Justice Alito, joined by Justice Gorsuch, filed a dissenting opinion. The FEHBlog confidently can state that he predicted this favorable outcome for the ACA. It always has been clear to the FEHBlog that the Supreme Court took the case to kill the lawsuit, not the law.

The Senate will take up Kiran Ahuja’s nomination to be OPM Director when it resumes floor business on Monday June 21. If Ms. Ahuja’s nomination is not confirmed next week, the Senate will be away from our Nation’s capital for two weeks for the Independence Day holiday.

Reg Jones’ latest column in FedWeek concerns federal employee survivor benefits in the case of a post-retirement marriage.

In federal employment news, Federal News Network reports that President Joe Biden signed the Juneteenth National Independence Day Act this afternoon, establishing June 19 as a federal holiday. Most federal employees will have tomorrow, June 18 off for observance as June 19 falls on a Saturday this year, the Office of Personnel Management said. * * * Nearly every state already recognizes Juneteenth as a holiday, but it now becomes the first federal holiday created since Martin Luther King Jr. Day was established in 1983.”

In COVID-19 news and this should come as no surprise, Medscape informs us that “More than half of unvaccinated Americans would prefer to get a COVID-19 vaccination at their doctors’ office, according to the results of a new national survey. * * * The preference to be vaccinated in a medical office was three to five times higher among unvaccinated Americans than were other strategies such as vaccinations at retail pharmacies or drug stores, community health centers, public health clinics, drive-up clinics, and large public vaccination sites.” As of today, 65% of Americans over age 18, and 87% of Americans over age 65, have had at least one dose of a COVID-19 vaccination.

In a burst of closing miscellany —

  • Kaiser Health News tells us that ” The pandemic-caused recession and a federal requirement that states keep Medicaid beneficiaries enrolled until the national emergency ends swelled the pool of people in the program by more than 9 million over the past year, according to a report released Thursday. The latest figures show Medicaid enrollment grew from 71.3 million in February 2020, when the pandemic was beginning in the U.S., to 80.5 million in January, according to a KFF analysis of federal data.”
  • Health Payer Intelligence informs us that “Medicare Advantage plans may better address racial care disparities than fee-for-service Medicare, according to the second in a series of reports that ATI Advisory has prepared for Better Medicare Alliance (BMA) in 2021. “With over 26.5 million beneficiaries enrolled in Medicare Advantage today, this report shows that minority beneficiaries are a driving force behind these enrollment gains; turning to Medicare Advantage to meet their health and social needs. When policymakers stand up for Medicare Advantage, they stand up for these seniors, too,” Allyson Y. Schwartz, president and chief executive officer of the Better Medicare Alliance, said in the press release. Around half of all Black Medicare beneficiaries and 53 percent of Latinx Medicare beneficiaries are in a Medicare Advantage plan, the report found. In contrast, only 34 percent of White beneficiaries and 31 percent of those who identified as “Other” races were enrolled in a Medicare Advantage plan.”
  • STAT News reports that “ovarian cancer, which kills about 15,000 Americans every year, has historically been one of the thornier cancers to treat. Only in the last few years has a new class of potent drugs, called PARP inhibitors, started to change that. But even with these promising new treatments, too often, tenacious tumors come roaring back. So there’s a need for yet newer drugs that can overcome any resistance the cancer evolves. According to research published Thursday, scientists might have found one. And it’s not actually a new drug at all. In fact, it’s been sitting, retired, in a drug library for decades. “While evaluating mechanisms of PARP inhibitor resistance over the last few years we came across this drug, novobiocin, which curiously enough, is an antibiotic,” said Alan D’Andrea, director of the Susan F. Smith Center for Women’s Cancers at the Dana-Farber Cancer Institute and co-author of the new study.” Encouraging.
  • “The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.  ‘Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more,” said Theresa M. Michele, M.D., director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.’”

Midweek Update

Photo by Dane Deaner on Unsplash

The Senate took no action on Kiran Ahuja’s nomination to be OPM Director today as Senators Booker and Peters remain out of pocket due to family illnesses.

On the hospital front —

  • The Advisory Board informs us about U.S. News and World Reports most recent rankings of children’s hospitals.
  • Axios reports that “Some of the hospitals with the highest revenue in the country also have some of the highest prices, charging an average of 10 times more than the actual cost of the care they deliver, according to new research by Johns Hopkins University provided exclusively to Axios.”

On the mental healthcare front, we have two articles on start- up companies from Katie Jennings in Forbes. One concerns Burlingame, Calif.-based Lyra Health and the other concerns “Lifestance Health Group, one of the nation’s largest outpatient mental health providers.” Check them out.

On the prescription drug front —

  • Healthcare Dive reports that “Anthem, one of the biggest U.S. payers, has joined an initiative to create low-cost generic drugs for hospital and retail pharmacies. The initiative CivicaScript, a subsidiary of hospital-owned nonprofit drugmaker Civica Rx, plans to initially develop and manufacture six to 10 common but pricey generic medicines that don’t have enough market competition to drive down cost, officials said Wednesday. The first generics could be available as early as 2022.”
  • Fierce Pharma informs us that “Antibody treatments have shown little success in helping COVID-19 patients with  severe disease. But a large [UK] study of hospitalized patients reveals that Regeneron’s antibody cocktail can reduce the chance of death in patients who haven’t produced their own antibody responses to the disease.”
  • STAT News interviews the Alzheimer Association’s CEO about the newly approved drug Aduhelm.

In miscellaneous news

  • The Wall Street Journal reportsApple Inc. Chief Executive Tim Cook has said the company’s greatest contribution to mankind will be in health. So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction, according to people familiar with them and documents reviewed by The Wall Street Journal.”
  • Healthcare Dive tells us that “A University of Pennsylvania study that tracked Medicare claims for about 1.35 million beneficiaries who had joint replacement surgery found that hospitals participating in bundled payment programs spent less on the hip and knee joint procedures than hospitals receiving traditional fee-for-service payments. Spending, however, did not differ between hospitals that voluntarily joined bundling programs and those whose involvement was mandatory, according to the findings, which were published in a JAMA research letter. The results failed to validate assumptions that voluntary participants tend to achieve greater savings because they choose programs for the opportunity to reduce spending. The findings come as the head of the Center for Medicare and Medicaid Innovation, Elizabeth Fowler, suggested the agency would look to shift away from voluntary arrangements in favor of more mandatory models.”
  • Fierce Healthcare informs us that “The Centers for Disease Control and Prevention (CDC) released new interim guidance late Monday for healthcare providers treating patients with post-COVID conditions—an umbrella term the agency is using to capture a wide range of physical and mental health issues that sometimes persist four or more weeks after an individual’s COVID-19 infection. Sometimes referred to as “long COVID,” the conditions can present among COVID-19 patients regardless of whether they were symptomatic during their acute infection, the agency wrote in the guidance.”