This afternoon, OPM’s Postal Service Health Benefits Program Interim Final Rule was timely posted on the Federal Register’s website. The FEHBlog estimates that deadline for public comment on the rule is Monday June 5, 2023.
From the Omicron and siblings front, Becker’s Hospital Review tells us
“The FDA is planning to make another COVID-19 booster that targets omicron available for high-risk individuals, The Washington Post reported April 3.
“Under the authorization, people 65 and older and those with weakened immune systems would be eligible to receive a booster dose four months after their last bivalent shot.
“The policy will be “permissive,” meaning the agency will allow people to get another booster but will not definitively recommend it, sources familiar with the matter told the Post.
“The FDA is expected to announce the plan within several weeks, and the CDC is expected to quickly endorse it, sources said. “
From the anomalies front, Fierce Healthcare informs us
“Cash prices for certain hospital services were lower than the average insurance rate in nearly half of the facilities examined in a new study, which could influence rate negotiations between payers and providers.
“The study was published Monday in the journal Health Affairs and makes use of cash price data hospitals are required to disclose for 70 shoppable services. The findings suggest that some self-insured employers pay prices higher than the cash price, which could influence future negotiations with insurers or direct talks with providers.
“Researchers looked at the cash prices, commercial negotiated rates and chargemaster prices disclosed by 2,379 hospitals as of Sept. 9, 2022, per a federal rule that went into effect in 2021.
“The average and the median cash price made up 64% and 65% of the chargemaster rate.
“About 12% of the cash prices were set the same as chargemaster rates, and other cash prices were predominantly priced in increments of 5% off the chargemaster rates (64% of the time),” the study said.
“The study found that the cash prices were lower than the median commercial rates in 47% of cases, most often 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.
“Researchers also discovered that evaluation and management services were the most likely to have a lower cash price with 55% compared with medicine and surgery at 48%.”
From the Medicare Advantage front, Healthcare Finance confirms
“Health insurers and stakeholders have expressed support for the Centers for Medicare and Medicaid Services’ plan to phase in changes to the risk adjustment model over three years, in the 2024 Medicare Advantage Program and Part D Payment Policies released Friday.
“The model changes will begin in 2024, with the full brunt of phased-in risk adjustment to take effect in 2026, according to Susan Dentzer, president and CEO of America’s Physician Groups.
“We’re satisfied with this,” said Ms. Dentzer. “They mostly listened.”
“Insurers also voiced their support for the payment increase in the 2024 Medicare Advantage and Part D Rate Announcement.
“CMS anticipates a payment increase for Medicare Advantage plans of 3.32% from 2023 to 2024 as a result of various changes, including in risk adjustment.
“This compares to the 1.03% increase in revenue proposed in the 2024 Advance Notice released in February.”
“We appreciate that CMS recognized the serious concerns with several proposed policies in the Advance Rate Notice that would affect MA enrollees in 2024, including by phasing in changes over a period of three years,” said Matt Eyles, president and CEO of AHIP.
From the Omicron and siblings front, Kaiser Family News reports
More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so. The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus.
* * *
Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.
* * *
Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.
In other public health news
“The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
“The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
“The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.
In FDA and drug development news
BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
“The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.
The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months.
No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.
The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into themost valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.
OMB’s Office of Information and Regulatory Affairs concluded on March 29 its work on OPM’s Postal Service Health Benefits Program interim final implementation rule. The rule will be published in the Federal Register this week.
On Friday, the Justice Department noticed an appeal to the U.S. Court of Appeals for the Fifth Circuit from the Northern District of Texas’s ruling on the role of USPSTF in the ACA preventive services mandate provision. The motion to stay is stepping up the plate.
From the Omicron and siblings front, Fortune Well discusses a new Omicron variant.
XBB.1.16, dubbed “Arcturus” by variant trackers, is very similar to U.S. dominant “Kraken” XBB.1.5—the most transmissible COVID variant yet, Maria Van Kerkhove, COVID-19 technical lead for the WHO, said earlier this week at a news conference.
But additional mutations in the virus’s spike protein, which attaches to and infects human cells, has the potential to make the variant more infectious and even cause more severe disease. For this reason, and due to rising cases in the East, XBB.1.16 is considered “one to watch,” Van Kerkhove says.
It’s a warning we’ve heard before about other Omicron spawn—XBB.1.5 in particular. The variant, which rose to prominence late last year and early this year, elicited warnings that it could cause more severe disease, based on new mutations it had developed.
It was a fate that didn’t play out—though the variant certainly took the lead when it came to transmissibility. XBB.1.5 accounted for just under half of all globally sequenced cases in early March, according to the WHO.
Only time will tell when it comes to what, if any, differences in severity XB.1.16 will display. Mutations that seem concerning in theory aren’t always concerning in real life because of the highly complex nature of population immunity.
The FEHBlog does plan to lose sleep over XB1.16.
In other public health news, the American Medical Association identifies six things that doctors wish their patient knew about better nutrition.
From the end of the public health emergency front, Healthcare Dive is following the unwinding of the great Medicaid expansion that occurred during the pandemic.
In the U.S. healthcare business news, Healthcare Dive tells us
Uber Health is foraying deeper into healthcare with a new feature that allows providers to order prescriptions to be dropped off at patients homes same-day.
The same-day prescription delivery is meant to help patients adhere to a medication schedule, Uber said Thursday. The service is made possible through an integration of Uber Health’s dashboard with ScriptDrop, a tech platform connecting patients and pharmacies with couriers nationwide.
The company also said it expects to soon launch delivery of healthy food and over-the-counter medicine for patients, including Medicare Advantage and Medicaid beneficiaries.
In OPM news, the agency per Govexec “on Friday published new guidance tasking agencies with updating their policies to ensure that they afford a “non-discriminatory and inclusive” work environment to all employees, particularly transgender and other gender non-conforming workers.”
From the cybersecurity policy front, the Cybersecurity and Infrastructure Security Agency (CISA) reflects on its activities over the year since “the President signed the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA) into law—an act that is critical to improving America’s cybersecurity.” Here is CISA’s overview of that law which will be implemented by rulemaking. The proposed rule is expected soon.
The FEHBlog has been tracking two Federal Acquisition Regulation cybersecurity rulemakings:
It turns out that on March 15, 2023, OMB’s Office of Information and Regulatory Affairs bounced those rules back to the FAR Council, which has gone back to the drawing board.
From the cyber vulnerabilities front –
CISA added ten new known exploited vulnerabilities to its catalog. Bleeping Computer provides background on this action.
CISA issued the following warning, for which Cybersecurity Dive provides background.
CISA is aware of open-source reports describing a supply chain attack against 3CX software and their customers. According to the reports, 3CXDesktopApp — a voice and video conferencing app — was trojanized, potentially leading to multi-staged attacks against users employing the vulnerable app.
CISA urges users and organizations to review the following reports for more information, and hunt for the listed indicators of compromise (IOCs) for potential malicious activity:
Venture Beat identifies eight ChatGPT cybersecurity vulnerabilities for this year.
Bleeping Computer warns about an actively exploited bug affecting a WordPress page plug-in called Elementor Pro.
From the ransomware front, which is missing The Week in Ransomware (spring break?) Bleeping Computer, tells us,
Fake extortionists are piggybacking on data breaches and ransomware incidents, threatening U.S. companies with publishing or selling allegedly stolen data unless they get paid.
Sometimes the actors add the menace of a distributed denial-of-service (DDoS) attack if the message recipient does not comply with the instructions in the message. * * *
The attackers behind this activity use the name Midnight and started targeting companies in the U.S. since at least March 16.
Thanks to a joint effort by the HHS Office of Inspector General (OIG) and the Federal Bureau of Investigation (FBI), a cybercriminal marketplace known as BreachForums was forced offline, the Department of Justice (DOJ) announced.
In addition, BreachForums founder Conor Brian Fitzpatrick, 20, of Peekskill, New York, was arrested in mid-March and made his first appearance in court on March 24. Fitzpatrick allegedly created and administered a major hacking forum that allowed its 340,000 members to buy, sell, and trade stolen data since March 2022.
The platform offered its users bank account information, hacking tools, Social Security numbers, breached databases, and account login information, along with other personally identifiable information (PII).
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.
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.
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.”
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.
“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.”
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.
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.
“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.
This afternoon, the Affordable Care Act regulators issued FAQ 58 guiding health plans, including FEHB plans, on handling the end of the Covid public health emergency (PHE), which will happen on May 11.
Coverage of Covid diagnostic tests after May 11 (Bold items are the government’s, and italicized items are the FEHBlogs:
Section 6001 of the [Families First Coronavirus Relief Act] FFCRA requires plans and issuers to cover COVID-19 diagnostic tests that meet statutory requirements and certain associated items and services without imposing any cost-sharing requirements, prior authorization, or other medical management requirements. However, that requirement is applicable only to diagnostic tests and associated items and services furnished during any portion of the PHE beginning on or after March 18, 2020. Therefore, a plan or issuer is not required under section 6001 of the FFCRA to cover COVID-19 diagnostic tests and associated items or services furnished after the PHE ends.
Any plan or issuer that provides coverage for COVID-19 diagnostic testing furnished after the PHE ends, including over-the-counter (OTC) COVID-19 diagnostic tests purchased after the PHE ends, is not prohibited from imposing cost-sharing requirements, prior authorization, or other medical management requirements for those items and services under section 6001 of the FFCRA. However, plans and issuers are encouraged to continue to provide this coverage, without imposing cost sharing or medical management requirements, after the PHE ends
The Departments do not explain the closing sentence.
Coverage of approved Covid vaccines post-PHE
On May 12, approved Covid vaccines will be subject to the Affordable Care Act’s preventive services mandate. Consequently, they remain fully covered with no cost sharing when delivered in-network. Out-of-network coverage depends on the plan brochure (FEHB) or SPD (ERISA) language.
HSA, HRA, and FSA reimbursement of Covid testing and treatment is unaffected by the end of the PHC
Notice to members
The Departments encourage plans and issuers to notify participants, beneficiaries, and enrollees of key information regarding coverage of COVID-19 diagnosis and treatment, including testing. This includes the date when the plan or issuer will stop coverage if the plan or issuer chooses to no longer cover COVID-19 diagnostic tests or when the plan or issuer will begin to impose cost-sharing requirements, prior authorization, or other medical management requirements on COVID-19 tests, to the extent applicable under the plan or coverage. The Departments also encourage plans and issuers to continue covering benefits for COVID-19 diagnosis and treatment and for telehealth and remote care services after the end of the PHE.
The Departments then provide specific guidance to ERISA plans concerning notice, COBRA, etc. Nevertheless, the FEHBlog suggests that FEHB plans treat this as a requirement in the absence of OPM guidance.
In other top news of relevance to the FEHBP:
The Food and Drug Administration gave Narcan nasal spray over-the-counter status. Narcan’s manufacturer expects that OTC Narcan, which can save the lives of people struck down by an opioid overdose, will appear on pharmacy shelves in September, according to the Wall Street Journal.
Beckers Hospital News tells us,
“UnitedHealthcare, Aetna and Cigna are moving to trim their prior authorization programs, which providers have criticized as burdensome, The Wall Street Journal reported March 29.
“Starting in the third quarter of 2023, UnitedHealthcare will remove several procedures and medical devices from its list of services requiring prior authorization, according to the report. It also said it would eliminate many prior authorization requirements for gold-card doctors and hospitals beginning next year.
“We’re not deaf to the complaints out there,” Philip Kaufman, UnitedHealthcare’s chief growth officer, told the Journal. “We’ve taken a hard look at ourselves and this process.”
“The payer processes about 13 million prior authorization requests a year out of about 600 million claims, according to the report. Officials said the changes are projected to reduce the number of prior authorization to about 10 million per year.
“Cigna said it has been removing prior authorization requirements for about 500 services and devices since 2020, according to the report. Aetna said it is working to automate and simplify the prior authorization process.
“American Medical Association President Jack Resneck Jr., MD, told the Journal he is cautiously optimistic about UnitedHealthcare’s changes but wants to see the details to be sure they will bring meaningful improvements.”
FedWeek points out the OPM Inspector General issued an evaluation report on telehealth utilization during the pandemic earlier this month.
“In a sampling of telehealth claims, auditors found more than 2,000 related to services that “could not be performed via telehealth”—including for laser surgery, anesthesia, injections and colonoscopies—and billing for procedures incompatible with the provider’s specialty.
“However, OPM management disagreed with the IG’s recommendations in those areas, for example pointing out that telehealth is a well-established concept.
“The IG in turn disagreed, saying that “While telehealth is not a new offering in the FEHB, the variety of services offered and the technologies utilized have increased. When combined with the overall increase in telehealth utilization, we believe increased scrutiny and increased protections are both warranted moving forward.”
In U.S.healthcare business news, Healthcare Dive informs us
CVS closed its $8 billion acquisition of Signify on Wednesday. In a statement, CVS CEO Karen Lynch said the transaction will advance the company’s value-based care strategy by enhancing its presence in the home.
CVS and Signify will work on care delivery and engagement particularly for Medicare Advantage customers, according to a release on the deal’s close.
In conference news, Fierce Healthcare continues to report from the ViVE 2023 healthcare tech conference here and here. The FEHBlog will summarize his thoughts on the OPM carrier conference in Thursday’s post.
In FEHB news, Federal News Network interviews Kevin Moss, editor of Consumers’ Checkbook Guide to Health Plans for Federal Employees, about OPM’s approving the use of Medicare Part D EGWPs in FEHB plans for 2024. Mr. Moss shares the FEHBlog’s excitement about this cost-saving development. Two nifty features of Medicare Part D EGWPs in contrast to Medicare Advantage Prescription Drug plans are that Medicare Part A only annuitants can enroll in them and the Plan’s prescription drug benefits can gap fill them. However, Mr. Moss indicates for 2024 and beyond, the gaps in Part D coverage are fewer. In addition, the OPM AHIP carrier conference, which begins tomorrow, will feature a session on Medicare Part EGWPs.
The carrier conference also provides a session on Social Determinants of Health. In addition, the Agency for Healthcare Quality and Research reminded us today about the availability of its October 2022 National Healthcare Quality and Disparities Report.
“Good news and bad news on the long COVID front: Certain groups of people – like women, smokers, and those who had severe COVID-19 infections – are at a higher risk of long COVID, a review of more than 800,000 patients has found.
“That’s the bad news. Yet, researchers also found that patients who had at least two doses of the COVID vaccine had a significantly lower risk of getting long COVID down the line.”
The NIH Directors Blog discusses using a whole-person approach to lifting the burden of chronic pain from service members and veterans. This approach is currently in use at VA facilities.
Healio tells us about a retrospective atrial fibrillation (AF) diagnosis study.
“In a retrospective study, Turakhia and colleagues analyzed patient information from five U.S. medical claims data sets from 2012 to 2017. Researchers estimated undiagnosed AF based on the observed incidence of ischemic stroke, systemic embolism and AF incidence after a stroke or systemic embolism.
“The estimated U.S. prevalence of AF (diagnosed and undiagnosed) in the third quarter of 2015 was 5,628,000 cases, of which 11% were undiagnosed.
“The assumed 2‐year undiagnosed AF prevalence was 23% of the total prevalent patients with AF. Compared with diagnosed patients, those who remained undiagnosed tended to be women, to be older, to have more comorbidities and to have higher CHA2DS2‐VASc scores.”
“Together with the known burden of AF, this expanding unmet need underscores the critical importance of early detection. Our data can support both disease surveillance and future research and policy initiatives aimed at addressing this diagnostic gap.”
From the U.S. healthcare business front —
The American Hospital Association reports
“Hospital operating margins dipped again in February to -1.1% and continue to remain negative, though with less month-to-month variation, according to the latest report on hospital finances from Kaufman Hall. Costs of goods and services are now increasing faster than labor, with both labor and non-labor expenses per adjusted discharge 21% higher than in February 2020.
“Due to external economic factors, relatively flat margins are likely to continue in the near term,” the report states.”
“The tech-forward insurer Oscar Health has tapped former Aetna CEO Mark Bertolini to be its new chief executive, a move to jump-start the business as it seeks to win new customers and become profitable.
“Bertolini, 66, is a progressive thinker in the use of technology to deliver health services and has already been advising Oscar for the past 18 months. His appointment gives him an opportunity to put a stamp on the future of digital services and analytics in the industry he has served for four decades.
“I’m returning to the health care industry because I believe there is still work to be done,” Bertolini said during a conference call to announce his appointment on Tuesday. He said Oscar presents a unique opportunity to challenge the status quo in the industry and accelerate the shift toward a more “consumer-oriented” business model.”
Fierce Healthcare is covering the 2023 ViVE conference currently being held in Nashville, TN, here and here. “Focused on digital health innovation, the conference, sponsored by HLTH and the College of Healthcare Information Management Executives (CHIME), had 5,000 attendees in 2022,” its inaugural year, and 7,500 attendees this year.
“On Monday morning, a heavily armed attacker entered a Christian school in Nashville and fatally shot three 9-year-old children and three adults.
In a joint statement from conference co-organizers CHIME and HLTH, the organizations said they have committed to a combined $50,000 donation “on behalf of ViVE for the victims and their families of today’s tragic Covenant School shooting.”
STAT News offers a special report on the wisdom of using artificial intelligence to replace medical transcription.
In a noteworthy legal development, the American Hospital Association informs us
The AHA and AHIP today filed a [joint] friend-of-the-court brief in a False Claims Act case before the U.S. Supreme Court, arguing that the federal government’s erroneous construction and expansion of the FCA threatens the legitimate business activities of every government contractor, hospital, health care provider, health insurance provider and grant recipient in the nation.
In a separate statement, the organizations said, “While AHA and AHIP may not always share the same opinion on matters of litigation and policy, we agree that the current regulatory landscape and construction of the False Claims Act (FCA) creates an untenable situation for health care providers and health insurance providers. “If the government’s argument is accepted, our members will be forced to spend more on litigation and less on patient care.”
“We urge the Supreme Court to adopt an interpretation of the FCA that does not undermine the ability of our members to ensure that Americans have access to high-quality, affordable health care.”
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.
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.”
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.
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.
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