Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–Congress, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Today was the belated second day of the OPM AHIP FEHB carrier conference. We learned this afternoon:

  • OPM has requested contractor proposals for its Postal Service Health Benefits Program (PSHBP) enrollment system.
  • OPM has created a new Carrier Connect system to receive PSHBP applications and benefit and rate proposals from carriers.
  • The new system will be available to receive PSHBP applications beginning June 26, 2023, and ending August 31, 2023, for the inaugural PSHBP year 2025.
  • OPM will release decisions on those applications in November 2023.
  • All cross-over enrollments to the PSHBP will become effective on January 1, 2025.

OPM also discussed its well-received initiative to allow FEHB carriers to offer integrated Medicare Part D prescription drug plans for 2024. These Part D EGWPs will be features of all PSHB plans beginning in 2025.

From Capitol Hill, Politico reports

  • “President Joe Biden immediately rejected Kevin McCarthy‘s opening debt-limit proposal, but it prompted movement elsewhere: A growing number of House Democrats want party leaders to restart negotiations.
  • “The party is still firmly behind Biden and Senate Majority Leader Chuck Schumer, who declared the speaker’s pitch dead on arrival in the upper chamber, in the position that Congress should raise the debt ceiling without any conditions. But a growing contingent of Democrats are acknowledging that Biden’s blanket refusal to engage with McCarthy may need to change — especially if House Republicans manage to pass their bill as planned next week.”

A Senate Finance Committee press release informs us, “Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a bipartisan framework that the Committee will use to pursue legislative solutions to modernize and enhance federal prescription drug programs, with the goal of reducing drug costs for patients and taxpayers.”

STAT News adds, “A legislative package of mostly drug pricing policies is coming together in the Senate, and these policies were not expected to be part of it, four drug lobbyists said. It seems to be an effort by Finance Chair Ron Wyden (D-Ore.) to play catch-up, in an effort to be included in the package that Senate Majority Leader Chuck Schumer is pulling together.”

Also from Washington DC —

  • STAT News tells us
    • “President Biden will nominate oncologist Monica Bertagnolli, director of the National Cancer Institute, to lead the National Institutes of Health, three people familiar with the White House’s plans told STAT.
    • “Bertagnolli last fall became the first woman to direct NCI, the largest of the NIH’s 27 departments, amid the president’s efforts to relaunch the Cancer Moonshot with the goal of halving cancer deaths and vastly curbing new cases.”
  • The U.S. Preventive Services Task Force is making progress in reevaluating the incomplete grade given to screening for partner violence or abuse of older and vulnerable adults.
  • Health Leaders Media points out
    • “CMS recently released the fiscal year 2024 inpatient prospective payment system proposed rule, and with it came the annual proposed ICD-10-CM diagnosis code changes which include new codes to enhance the tracking and progression of Parkinson’s disease and more reimbursement for certain social determinates of health (SDOH).
    • “The proposed rule includes 395 additions, 12 revisions, and 25 deletions to the ICD-10-CM diagnosis code set. If finalized, these changes will take effect October 1.
    • “Of the 395 new ICD-10-CM codes, 123 of them are external cause codes to capture accidents and injuries. CMS also proposes 36 new codes for osteoporosis with current pathological pelvic fracture.”

In studies news

  • Health Affairs informs us
    • “Hospitals must disclose their cash prices, commercial negotiated rates, and chargemaster prices for seventy common, shoppable services under the hospital price transparency rule. Examining prices reported by 2,379 hospitals as of September 9, 2022, we found that a given hospital’s cash prices and commercial negotiated rates both tended to reflect a predetermined and consistent percentage discount from its chargemaster prices. On average, cash prices and commercial negotiated rates were 64 percent and 58 percent of the corresponding chargemaster prices for the same procedures at the same hospital and in the same service setting, respectively. Cash prices were lower than the median commercial negotiated rates in 47 percent of instances, and most likely so at hospitals with government or nonprofit ownership, located outside of metropolitan areas, or located in counties with relatively high uninsurance rates or low median household incomes. Hospitals with stronger market power were most likely to offer cash prices below their median negotiated rates, whereas hospitals in areas where insurers had stronger market power were less likely to do so.”
  • The All of Us Program offers its research roundup.

From the U.S. healthcare business front, Fierce Healthcare reports

  • “Express Scripts is rolling out new programs that aim to better support independent pharmacies in rural areas.
  • “The pharmacy benefit management giant said Thursday that the IndependentRx Initiative is designed to build on a slew of recently announced updates to its model that put a focus on greater transparency. The PBM said it will boost reimbursement to independent pharmacies that are the only location within 10 or more miles of an Express Scripts customer.
  • “This includes growing incentive-based programs that pay for performance, such as when a pharmacy dispenses 90-day prescriptions to improve medication adherence.
  • “The PBM added that these pharmacies will have greater opportunities to participate in its retail pharmacy network.”

From the telehealth front, mhealth Intelligence observes

  • “Published in the American Journal of Drug and Alcohol Abuse, new data shows that patient retention rates following the implementation of telehealth for opioid use disorder (OUD) treatment were higher than those for in-person care.
  • “According to the Centers for Disease Control and Prevention (CDC), about 2.7 million people in the US have OUD, and overdoses appeared to have increased during the COVID-19 pandemic.
  • “However, the pandemic allowed physicians to explore new methods of providing care, including telehealth. To assess the efficacy of treating OUD through telehealth, a digital provider of medication-assisted treatment (MAT), Ophelia Health, conducted a study that assessed patient 180-day and 365-day retention rates.”

From the miscellany front

  • The Wall Street Journal offers its occasional Future of Healthcare series.
  • Kaiser Family Foundation provides a resource to answer “Key Questions About Implementation of the Medicare Drug Price Negotiation Program.”
  • Here’s a final HIMSS report from the last day of the conference.

Midweek Update

David Ermer–Congress, Electronic health records, HSA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC —

Roll Call brings us up to date on the debt ceiling issue. “House Republicans unveiled legislation Wednesday to pair their favored spending cuts and energy and regulatory policies with a debt limit increase lasting through early next year.” “Measure viewed as a ‘conversation starter’ with government cash crunch seen as early as June.”

The Wall Street Journal informs us that the U.S. Supreme Court extended its stay of an injunction restricting sales of an abortion pill from midnight tonight to midnight Friday.

  • “The justices have three primary options. They could grant the emergency requests and leave mifepristone on the market indefinitely during litigation, which could preserve the status quo for many months. They could leave the pill in place temporarily and agree to review the case in full, even though lower courts aren’t done reviewing it. Or they could deny the emergency appeals outright.” 

As anticipated, Health Affairs Forefront has posted here and here helpful articles explaining the final 2024 Notice of Benefit and Payment Parameters released earlier this week.

From the U.S. healthcare business front —

  • Beckers Payer Issues tells us,
    • Elevance Health posted double-digit revenue growth and beat investor expectations in the first quarter of 2023, according to the company’s earnings report published April 19.
    • “Elevance Health is off to a strong start in 2023, driven by our continued focus on whole health and advancing health beyond healthcare,” President and CEO Gail Boudreaux said.
  • Beckers Hospital Review adds,
    • Mark Cuban is creating an independent pharmacy network to “serve patients more widely” after pitching the idea to local pharmacy owners in February. 
    • Mark Cuban Cost Plus Drug Co. has operated as a mail-order, online pharmacy since January 2022, but with its latest endeavor, the business is looking to expand access to its portfolio of more than 1,000 prescription drugs.
    • The collaboration between independent pharmacies and Cost Plus Drugs includes a “Team Cuban Card,” which acts like an insurance card at pharmacy checkouts. 
    • Independent pharmacists interested in partnering with Cost Plus Drugs were asked to complete an interest form with the company detailing the type of pharmacy they run and how patients access the services offered. So far, Cost Plus Drugs has 36 affiliate locations, with five in Florida, seven in Indiana, six in New Jersey and 18 in Texas. The company said it will add new sites every month.
    • This is part of a larger movement to prevent more local pharmacy closures, Mr. Cuban told Becker’s. 
  • STAT News reports
    • Because Johnson & Johnson is the largest healthcare company in the world, its financial fortunes tend to be a bellwether for the industry at large. And parsing J&J’s positive results from the last quarter, released yesterday, analysts see hope that the pharmaceutical business is in good shape despite a difficult macroeconomic environment.

From the HIMSS conference —

  • Med City News shares a conference presentation by “Glen Tullman — CEO of care navigation company Transcarent, as well as former CEO of Allscripts and Livongo. Mr. Tullman discussed what he thinks the future of healthcare will look like during the HIMSS conference in Chicago. He laid out five predictions, including an increased focus on consumer expectations and more investment in AI.”
  • Fierce Healthcare points out
    • Companies like Best Buy and VillageMD are disrupting the traditional healthcare industry by bringing a more consumer-centric approach to providing medical services.
    • During a keynote address Wednesday morning at HIMSS23, executives at these so-called “disrupters” shared their vision for the future of care delivery.
  • You will find HIMSS links to its sessions here and here.

From the Rx and medical test coverage front —

  • The Institute for Clinical and Economic Research issued a white paper
    • Evaluating Best Practices and Potential Reforms for White Bagging, Brown Bagging, and Site of Service Policies that Seek to Address High Markup in Drug Prices
      • — White bagging, brown bagging, and site of service policies developed by payers can reduce significant markup costs for clinician-administered drugs but have sparked concerns and legislative action related to their impact on patients and providers —
      • — White paper evaluating best practices and potential policy reforms was informed by input from a diverse set of hospitals, provider groups, and payers.
  • Medscape delves into the debate over the optimal time period for using weight loss drugs.
  • The Wall Street Journal examines new blood tests that offer early detection of cancers and Alzheimer’s Disease.
    • “Questions include who should be getting them, and what patients should do about positive results.”

From the miscellany front —

  • Fierce Healthcare informs us, as the FEHBlog expected,
    • The federal No Surprises Act “appears” to be effectively protecting patients from the most frequent sources of unexpected medical bills, though several coverage gaps such as those relating to ground ambulance services are still leaving some patients with hefty bills, according to a new qualitative report.
    • To get a read on the consumer protection legislation after a full year of implementation, researchers from the Urban Institute and Georgetown University’s Center on Health Insurance Reforms, with backing from the Robert Wood Johnson Foundation, interviewed 32 regulators and stakeholders representing consumers, payers, hospitals, billing companies and other relevant industry subsectors.
    • These informants “largely agreed that consumers are being well protected from surprise balance bills covered under the law,” researchers wrote in the report.
  • Health Payer Intelligence notes
    • Many consumers would be interested in a type of account that was like a health savings account (HSA) in its construction but able to be attached to plans other than high deductible health plans (HDHPs), a survey from Employee Benefit Research Institute (EBRI) stated.
    • “We decided to test enrollee interest in a new type of health account similar to an HSA. Like an HSA, the new health account could be funded by both workers and employers, could be invested in the stock market, and would be portable from job to job. Earnings would grow tax free, and contributions would be capped,” the EBRI researchers explained.
    • “Unlike an HSA, this new health account would not have to be paired with a high-deductible health plan; it could be paired with any health plan.”
  • “AHIP released the latest version of its comprehensive, biennial report, Health Coverage: State-to-State 2023, which analyzes health coverage and health insurance provider industry employment for all 50 states and the District of Columbia.”

Weekend Update

David Ermer–Congress, End of the PHE, NE, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

The Senate and the House of Representatives return to Washington, DC for Committee business and floor voting tomorrow.

On Thursday, April 20, OPM will hold the postponed second day of the OPM AHIP FEHB Carrier Conference. Of course, the FEHBlog will be in attendance.

Federal News Network tells us

  • “Just 19 of the 74 agencies in the 2022 Best Places to Work in the Federal Government rankings either held steady or improved their employee engagement score.
  • “But among many declining trends in the Partnership for Public Service’s results, some agencies still managed to shine.
  • “When we look at these averages, I think it’s so much more powerful when we pull apart and look at the variation across government and within agencies,” said Max Stier, the Partnership’s president and CEO, at a Best Places to Work ceremony Wednesday.”

From the regulatory front, the Department of Health and Human Services announced its plan to continue PREP Act liability protections related to Covid testing, preventive services and treatments well beyond May 11.

From the U.S. healthcare business front

  • Beckers Payer Issues lists 100 things to know about the Blue Cross Blue Shield system.
  • The Wall Street Journal reports “Merck & Co. said it agreed to acquire Prometheus Biosciences Inc. for $10.8 billion, a push into the lucrative market for immune-disease treatments.”
  • Healthcare Dive discusses the financial condition of non-profit hospitals.

From the medical research front, The Wall Street Journal informs us

  • “Moderna Inc. and Merck & Co.’s cancer vaccine helped prevent relapse for melanoma patients, results from a midstage trial showed, demonstrating progress in the pursuit of shots to ward off cancer by jump-starting the immune system. 
  • “About 79% of high-risk melanoma patients who got the personalized vaccine and Merck’s immunotherapy Keytruda were alive and cancer-free at 18 months, compared with about 62% of patients who received immunotherapy alone, researchers said Sunday. The 157-person trial offers some of the strongest evidence yet that such vaccines could benefit cancer patients. 
  • “I am fairly encouraged that this will open up a whole new set of trials,” said Jeffrey Weber, the senior investigator on the trial and deputy director of the Perlmutter Cancer Center at NYU Langone Health.”

From the artificial intelligence front, NPR discusses efforts to use AI to improve a volunteer driven app for the visually impaired called Be My Eyes.

  • “Hans Jørgen Wiberg, a Danish furniture craftsman, created the app after he got tired of calling his friends and family to ask for help identifying things. (Wiberg is visually impaired.) He spent a couple years developing it, and the app launched in 2015. 
  • “But eight years later, there’s a twist. As artificial intelligence, or AI, becomes more accessible, app creators are experimenting with an AI version using tech as well as human volunteers. Be My Eyes CEO Mike Buckley says the argument for AI is that it can do things people cannot. 
  • “What if the AI ingested every service manual of every consumer product ever?,” says Buckley. “And so you could tap into the AI and say, ‘How do I hook up my Sony stereo?'” Furthermore, Buckley says, “we took a picture of our refrigerator and it not only told us what all the ingredients were but it told us what we could make for dinner.”

Nifty.

Fortune Well identifies “The five best supplements for healthy aging, according to a longevity expert.” The article notes “If you’ve ever walked down the supplement aisle in a pharmacy, you’ve seen the overwhelming abundance of options available for your medicine cabinet. According to the 2022 Council on Responsible Nutrition Consumer Survey on Dietary Supplements, 75% of Americans use dietary supplements, most on a regular basis.” By the way, the five best are

  • Calcium for bone strength
  • Vitamin D for immunity and bone strength
  • Probiotics for gut health
  • Magnesium for mood, and
  • Multivitamins to cover the bases.

Midweek update

David Ermer–Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Rx coverage–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From our Nation’s capital —

  • STAT News reports
    • “Senators are slightly delaying their latest legislative push on health care, but as they do, a clearer picture is emerging about what’s in — and out — of the mix.
    • “The Senate health committee was expected to mark up legislation related to generic drugs, pharmacy benefit managers, and some leftovers from the Food and Drug Administration’s user fee agreements next week, but leaders are planning to reschedule the meeting, several sources told STAT.
    • “But 17 health care industry lobbyists and Senate staffers said Democratic leadership is targeting relatively low-hanging fruit that is bipartisan, and already has established history in legislation [i.e., a $35 copay on insulin in the commercial market]”.
  • Beckers Payer Issues tells us that “the Justice Department has decided to seek a stay pending appeal of a Texas federal judge’s ruling that struck down an ACA provision requiring insurance companies to provide coverage for preventive services, CNN reported April 11.”
  • The Department of Health and Human Services proposed a HIPAA privacy rule change “to strengthen its protections by prohibiting the use or disclosure of protected health information (PHI) to investigate, or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care.” The public comment period will end sixty days after April 17, 2023, the day on which the proposed rule will be published in the Federal Register.

From the public health front —

  • MedPage Today informs us
    • Fentanyl adulterated with xylazine is an “emerging drug threat” in the U.S. and requires immediate action, the Biden administration warned.
    • “This is the first time in a nation’s history that a substance is being designated as an emerging threat by any administration,” said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), during a phone call with reporters late Tuesday afternoon. “And it couldn’t come at a more critical time.”
  • ABC News reports
    • The number of sexually transmitted infections (STIs) in the United States shows “no signs of slowing,” new federal data shows.
    • A total of 2.53 million cases of chlamydia, gonorrhea and syphilis were recorded in 2021, according to a new report published Tuesday from the Centers for Disease Control and Prevention.
    • That’s a 5.8% increase from the 2.39 million cases reported in 2020 and a 7% increase from five years ago when 2.37 million STIs were recorded in 2017.
    • “I’d like people to understand that this data actually impacts them whether they think it does or not and it’s because STIs happen to everyone, regardless of socioeconomic, religious, political lifestyle,” Dr. Kameelah Phillips, an OBGYN in New York City, told ABC News. “I’d like them to really understand that routine testing at their health care office is super important … gonorrhea doesn’t care who you are.”
    • While certain STIs did not reach pre-pandemic levels, others — such as syphilis — are recording the highest numbers seen in more than 70 years.

From the mental healthcare front —

  • Benefits Pro highlights a survey finding that
    • 21% of workers at ‘high mental health risk’ and unaware of available [employer sponsored] counseling.
    • Employees often do not know the range of resources available to them in their benefits packages and are often unaware of counseling included in the company’s employee assistance program, according to a TELUS survey.

Federal agencies and the Postal Service sponsor EAPs, but the FEHBlog is unaware of OPM creating a connection between those programs and the FEHBP.

From the Rx coverage front —

  • Drug Channels offers a report on specialty pharmacies which informs us that “Drug Channels Institute (DCI) estimates that in 2022, retail, mail, long-term care, and specialty pharmacies dispensed about $216 billion in specialty pharmaceuticals prescriptions. That’s an increase of 12% from the 2021 figure.”  
  • The Institute for Clinical and Economic Research released
    • a Protocol outlining how we will conduct our third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies, and
    • a Draft Evidence Report assessing the comparative clinical effectiveness and value of exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics) and lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) for sickle cell disease.  The draft report represents the midpoint in ICER’s eight month long review process.

From the medical research developments front

  • STAT News reports, “A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments.” It’s a heartening medical research story about Mr. Fox’s productive efforts.
  • Medscape reports
    • Phototherapy is a safe, effective, noninvasive, and inexpensive way of boosting cognition for patients with dementia, new research suggests. It may be “one of the most promising interventions for improving core symptoms” of the disease.
    • A new meta-analysis shows that patients with dementia who received phototherapy experienced significant cognitive improvement compared to those who received usual treatment. However, there were no differences between study groups in terms of improved depression, agitation, or sleep problems.

Weekend update

David Ermer–Congress, FDA, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Eric Heininger on Unsplash

Congress remains on a District / State work break which concludes next Monday following the Easter and Passover holidays.

OPM has rescheduled the second day of the 2023 OPM AHIIP carrier conference for April 20, 2023 from 11 am to 4:15 pm ET.

From the public health front —

  • NPR Shots discusses the simple intervention that may keep Black moms healthier — daily home-administered blood pressure readings.
    • Blood pressure is just one way to measure a person’s health, but during pregnancy and soon after, it’s a critical metric. Unchecked, high blood pressure can contribute to serious complications for the pregnant woman and baby, and increase the risk of death.
  • Politico tells about new efforts underway to solve the crisis in mental health problems among children and adolescents that accompanied the Covid pandemic.
    • Sen. Bob Casey (D-Pa.) plans to introduce three bills aimed at improving mental health care for kids, one of his aides told POLITICO. One bill, set to be reintroduced soon, would create grants for children’s mental health services and make them more accessible. Another would help gather more accurate national data on mental health and children, and the third would focus on the mental health of kids in foster care.
    • And children’s health providers tell government leaders it’s now critical that the federal government step up support for an overburdened system, arguing for increased funding for graduate medical education programs and boosted government reimbursement rates for mental health services.

From the Rx coverage front —

  • USA Today discusses challenges related to using the new generation of weight loss drugs. “Drugmakers are working hard to convince Americans they need their next-generation weight loss medications. But many come with side effects – and the fact we don’t really know what happens long-term.”
  • The Wall Street Journal offers an essay about potential uses for inhalable therapies beyond asthma.
    • “We’re pushing the boundaries of delivery,” said Philip Santangelo, a professor of biomedical engineering at Emory University. 
    • Respiratory diseases that spread through the air are a key target. Dr. Santangelo and colleagues are developing inhalable drugs that use an RNA-editing tool known as CRISPR-Cas13 and messenger RNA to kill viruses such as Covid-19, influenza and respiratory syncytial virus or RSV. Using nebulizers that dispense medicine as mist via a mask, they have tested the delivery of some of the medicines on rhesus monkeys, cows, horses and pigs. The tests in pigs showed that getting the drugs to the lungs reduces the severity and spread of infections, Dr. Santangelo said. 

From the medical research front —

  • Forbes reports, “Researchers have uncovered an unusual way some cancer cells make nutrients they need to grow, a discovery that could hold the key to starving one of America’s deadliest cancers [pancreatic] with a drug we already possess and raising hopes for a powerful new treatment against a disease that is often caught late and has one of the lowest survival rates of any cancer.”
  • Fortune Well discusses new developments in cancer testing via blood studies.

Friday Factoids

David Ermer–ACA, CDC, CMS, Congress, COVID-19, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.

The CDC’s Covid data tracker and weekly review support ending the emergencies.

Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:

During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:

  • Special enrollment rights under HIPAA
  • COBRA elections, payments and notifications
  • Benefit claims, appeals and external reviews

Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.

This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.

Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.

Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:

Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.

CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,

The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed. 

The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.

CMS also offered a fact sheet on the final actions.

From the SDOH front, Health Payer Intelligence informs us

OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.

OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.

The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.

OMB will release changes to Directive No. 15 in 2024.

Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.

From the miscellany department —

  • EBRI posted Fast Facts on “High-Cost Health Care Claimants: Health Care Spending and Chronic Condition Prevalence Among Top Spenders.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19 vaccine, FDA, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The Senate Finance Committee held a hearing today on “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” Fierce Healthcare reports

Sen. Ron Johnson, R-Wisconsin, said during the hearing that “this whole area is ripe for gamesmanship.” He then asked Matthew Gibbs, PharmD and Capital Rx President, what Capital Rx’s model would bring to the table that sets it apart from other players like Amazon or Mark Cuban Cost Plus Drug that are aiming to shake up the traditional PBM space.

Gibbs emphasized Capital Rx’s focus on transparency, something that sets it apart in the broader market.

“Using a price index like NADAC, which is published by CMS, they actually do the survey of the pharmacies, and getting it more robust so that it’s not voluntary—today it’s a voluntary survey—and getting responses to that will lead us to the actual drug costs,” Gibbs said. “And then you can have your nuances of Costco, Mark Cuban. And the person can actually go in and look and actually be informed about the real prices once and for all. The only way is to level set.”

“We have the tools already,” he said. “We just need to employ them.”

Meanwhile, the National Council of State Legislatures discusses the wide variety of state laws being imposed on PBMs, which only complicates matters.

In Affordable Care Act New, MedPage Today reports, “A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters.” The FEHBlog won’t delve into this case now because he expects the U.S. Court of Appeals for the Fifth Circuit to promptly stay this decision.

From the Omicron and siblings front, WebMD tells us

The CDC has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website now explains.

16.4% of people in the U.S. have gotten the latest booster that was released in September, CDC data shows.

MedPage Today opines on a World Health Organization “Booster Update: Here’s What They Got Right and Wrong.”

In FDA / drug development news —

  • Beckers Hospital Review reports
    • On May 9 and May 10, an FDA advisory panel will discuss whether to recommend the agency approve what could be the first over-the-counter birth control pill. 
    • The pill, a 0.075-milligram norgestrel tablet [manufactured by French drugmaker Laboratoire HRA Pharma], “is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
  • BioPharma Dive informs us
    • “Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.
    • “The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.
    • “J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.”

From the U.S. healthcare business front —

Healthcare Dive relates

  • Walgreens’ growing U.S. healthcare segment is continuing to bolster the retail health chain’s financial performance. The business, which includes value-based provider VillageMD, recorded $1.6 billion in sales in the second quarter, an increase of $1.1 billion from last year.
  • VillageMD sales were up 30%, including a boost from its recent acquisition of medical group Summit Health. Specialty pharmacy Shields Health Solutions grew sales 41%, while at-home care provider CareCentrix’s sales were up 25%.
  • Thanks in part to a jump in revenue in its healthcare segment, Walgreens’ results beat Wall Street expectations even as profit declined more than 20% amid lower COVID-19 vaccine volumes and test sales, higher salary costs, opioid litigation charges and costs associated with its $3.5 billion investment in its Summit acquisition.

and

  • Oak Street Health disclosed on Thursday that the antitrust waiting period for its planned sale to CVS Health has expired.
  • CVS and Oak Street filed the required notification forms under the Hart-Scott-Rodino Act with the Department of Justice and Federal Trade Commission on Feb. 24. The waiting period under the HSR Act ended Monday, according to a new proxy filing from Oak Street.
  • The disclosure means the $10.6 billion deal has cleared one regulatory hurdle — companies can’t consummate mergers until the HSR waiting period expires — but regulators could still challenge the acquisition on antitrust grounds in the future.

From the healthcare studies front —

  • Bloomberg tells us the story behind a breast cancer scare. Last week, I noticed a breast cancer study report that struck the FEHBlog as overblown, and it turns out that this report is the breast cancer scare that Bloomberg discusses.
  • NBC News reports
    • “Losing weight — even if some pounds are gained back — may help your heart over the long term, according to a study published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.
    • “The findings may be welcome news to those who have found it difficult to keep weight off and feared the risks thought to be associated with gaining weight back.
    • “In the new study, researchers analyzed data from 124 clinical trials with a total of more than 50,000 participants. They found that risk factors for heart disease and Type 2 diabetes decreased for people who lost weight through intensive behavioral programs. The diminished risk persisted for years after they were done with the programs, even if some, but not all, of the weight came back.”
    • “The whole time your weight is less than it would otherwise have been, your risk factors for heart disease are lower than they would have been,” co-author Susan Jebb, a professor of diet and population health at the University of Oxford in the United Kingdom, said in an email.
  • The Centers for Disease Control announced 
    • The expanded availability of opioid use disorder-related telehealth services and medications during the COVID-19 pandemic was associated with a lowered likelihood of fatal drug overdose among Medicare beneficiaries, according to a new study.
    • “The results of this study add to the growing research documenting the benefits of expanding the use of telehealth services for people with opioid use disorder, as well as the need to improve retention and access to medication treatment for opioid use disorder,” said lead author Christopher M. Jones, PharmD, DrPH, Director of the National Center for Injury Prevention and Control, CDC. “The findings from this collaborative study also highlight the importance of working across agencies to identify successful strategies to address and get ahead of the constantly evolving overdose crisis.”

From the healthcare quality front, Beckers Hospital Review relates

CVS and Optum have struggled to integrate behavioral health into their payer-provider models, Behavioral Health Business reported.

For Optum, the challenges lie in integrating all the different IT systems from the providers the company has bought, Trip Hofer, the CEO of Optum Behavioral Health Solutions, said at the news outlet’s VALUE conference. For example, Optum in 2022 acquired Kelsey Seybold Clinic, a medical group in Houston with 500 healthcare professionals.

“Kelsey Seybold says, ‘Trip, here’s my issue. I have access problems for depression, stress and anxiety for adults.’ And I’m like, ‘Well, we have a ton of solutions for you,'” Mr. Hofer said, according to the March 27 story. “Six months later, we still can’t get it implemented because it’s like, ‘Well, how do I get data back to them?'”

Deborah Fernandez-Turner, DO, deputy chief psychiatric officer of CVS payer subsidiary Aetna, said at the conference that it’s time-consuming and complex to build behavioral health into payer-provider companies.

CVS, for instance, has started bringing mental health providers and virtual behavioral health access into its MinuteClinics, according to the story.

Keep on truckin’

The FEHBlog had planned to discuss the OPM-AHIP carrier conference in this post. However, the second day of the conference was postponed today due to a power outage affecting the webinar operations. The second day will be rescheduled, and the FEHBlog will bring readers up to date then.

Monday Roundup

David Ermer–Congress, Government Contracting, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Politico points out that

The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.

The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].

In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”

This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.

CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.

The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.

From the Rx coverage front —

STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing

What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.

Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.

As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *

Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.

Beckers Hospital Review informs us

Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay. 

The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens. 

The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.

From the substance use disorder front, STAT News reports

Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.

The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”

The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.

While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.

From the U.S. healthcare business front —

  • Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
  • Healthcare Dive tells us
    • “CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
    • “CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
    • “That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
  • Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
    • “Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
    • “The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
    • “Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
    • “Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”

Weekend update

David Ermer–Congress, Federal employment benefits, OPM, U.S. Healthcare–
The Bluebonnet — Texas state flower

The House of Representatives and the Senate are in session this week for Committee business and floor voting. Both bodies are on a State/district work break for the first two weeks of April.

Last Friday, OPM released to FEHB carriers its technical guidance supporting its call letter for 2024 benefit and rate proposals.

Federal News Network offers a long look at OPM’s process to implement the Postal Service Health Benefits Program.

OPM and AHIP will hold their annual conference for FEHB carriers on Wednesday and Thursday this week. The agenda can be found here. The 2024 call letter and PSHBP implementation are agenda topics.

From the healthcare front —

NPR Shots discusses

Fortune Well highlights the value of common mental health care drugs.

STAT News reports

Millions of diabetes cases may be missed under the current U.S. screening guidelines, especially among Asian Americans, according to a new study. A better way to test for the condition would be to leave body weight out of it, the researchers suggest.

Current guidelines from the U.S. Preventive Services Task Force recommend screening adults ages 35-70 who are considered overweight or obese (having a body mass index over 25).

However, racial and ethnic minority groups, especially Asian people, tend to develop diabetes at lower BMIs, so to identify more people with the condition across groups, all adults ages 35-70 regardless of their weight should be screened, researchers said in a study Friday in the American Journal of Preventive Medicine.

NPR Shots also invites us to meet the amazing “glass-half-full girl” whose brain was rewired as an infant after losing the left hemisphere.

In most people, speech and language live in the brain’s left hemisphere. Mora Leeb is not most people.

When she was 9 months old, surgeons removed the left side of her brain. Yet at 15, Mora plays soccer, tells jokes, gets her nails done, and, in many ways, lives the life of a typical teenager.

“I can be described as a glass-half-full girl,” she says, pronouncing each word carefully and without inflection. Her slow, cadence-free speech is one sign of a brain that has had to reorganize its language circuits.

Yet to a remarkable degree, Mora’s right hemisphere has taken on jobs usually done on the left side. It’s an extreme version of brain plasticity, the process that allows a brain to modify its connections to adapt to new circumstances.

Because it’s Sunday, here are two opinion pieces

  • The New York Times shares expert opinions on preparedness for the next pandemic.
  • Three professors of surgery at the University of California Medical Center defend the current United Network for Organ Sharing (UNOS).
    • As a private, nonprofit organization under contract with the federal government to manage the national organ transplant system, UNOS spearheads the complex, multidisciplinary organ procurement, matching, and delivery processes. With its contract up for renewal this spring, UNOS has come under heavy scrutiny, including in a recent guest column published in the New York Times, in which UNOS and other system organizations’ performances were blamed for the death of a kidney transplant candidate. This is just one example in a series of accusations made across news media, social media, and even in Congress.
    • Painting with such a broad and biased stroke creates an unfair representation of our highly nuanced organ transplant system and the people who run it. As transplant surgeons with a long history of involvement with the system — including one of us (Roberts) serving as a past Board President of UNOS/Organ Procurement and Transplantation Network (OPTN) — we have intimate knowledge of both its successes and its shortcomings. While UNOS has room to improve operationally — and is working to do so — we clearly see the organization’s life-changing results in our operating rooms and offices. More work lies ahead, however, such as addressing the fact that a rising number of organs are recovered but not transplanted.

Thursday Miscellany

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

From Washington DC —

Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.

FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.

From Capital Hill –

Fierce Healthcare informs us

A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry. 

The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices. 

Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by

  • Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.  
  • Modernizing maternal health care through telehealth to support women of color and women living in rural America. 
  • Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.

STAT News relates

The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.

Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.

At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.

CMS expects to revisit this Medicare decision publicly this summer.

Beckers Hospital Reviews highlights

For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs. 

The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock. 

The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.

In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.

“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing. 

The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted  a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”

Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.

From the miscellany department —

  • Medscape reports
    • “Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
    • “In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
  • Per Beckers Hospital Review
    • 42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago. 
    • Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings. 
    • The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
  • Medscape notes
    • For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
    • The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
    • The study was published by JAMA Network Open on March 22.
    • “These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)