The Wall Street Journal reports, “Weight-loss drugmakers are lobbying Congress to grant them access to a monster payday for their blockbuster treatments: Medicare coverage.” At last Thursday’s carrier conference, OPM pointed out a related advantage of the Medicare Part D EGWPs that the FEHBP will offer next year. Although the weight loss drugs may not be on the Medicare formulary, those drugs would be made available to FEHB annuitants via the Plan’s formulary, which can gap-fill the Medicare formulary.
CMS announced that the updated MMSE Section 111 GHP User Guide version 6.8 has been posted to the GHP User Guide page on CMS.gov. Refer to Chapter 1 for a summary of updates.”
Per Health Payer Intelligence, AHIP launched a marketing campaign targeting Pharma’s prescription drug pricing. “The payer organization stated that prescription drug pricing is out of control and explained health insurance’s role in reducing the impact.”
The Department of Health and Human Services proposed a rule to extend ACA marketplace, Basic Health Program, Medicaid, and CHIP coverages to 580,000 DACA recipients.
From the healthcare spending and plan design fronts
“About a year ago, Elevance Health launched a pilot program to offer digital concierge care to members who were recovering from COVID-19 infections.
“Since then, the insurer has expanded that initiative to offer concierge care management to members with a number of chronic conditions, including Crohn’s disease, cancer and diabetes. Anthony Nguyen, M.D., the chief clinical officer at Elevance, told Fierce Healthcare that the program was born from a desire to be “more engaging with our members.”
“The challenge for not only the programs that we have, the traditional ones, as well as others in the market, is that it’s not personalized,” Nguyen said. “It is not tailored to an ‘n’ of one.”
“Greater personalization was built into the foundation of the program, he said. For example, concierge care deploys a nurse matching tool that connects members with a clinician who is likely to connect and resonate well with them, improving the care journey.”
“Healthcare spending declined dramatically in 2020 thanks to the COVID-19 pandemic, but expenditures rebounded the following year, according to new data from the Health Care Cost Institute.
“The group released its annual look at cost and utilization trends last week, which found the average health spending for people with employer-sponsored coverage reached $6,457, up 15% from the 2020 average of $5,630. Spending declined by 4% in 2020 as utilization decreased, the researchers said.
“John Hargraves, director of data strategy at HCCI, told Fierce Healthcare that the 2020 data are an aberration in the long-term spending trends, which had grown steadily prior to the pandemic.
“It’s almost like 2020 is a missing data point in the long-term growth in the healthcare spending and use patterns that we’ve noted,” Hargraves said.”
From the telehealth and fraud waste and abuse fronts, the HHS Inspector General made available a “toolkit intended to assist public and private sector partners—such as Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units, and other Federal health care agencies—in analyzing their own telehealth claims data to assess program integrity risks in their programs.”
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.
“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.”
“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.
“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.”
“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.
“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.
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.
Govexec and the Federal Times report about yesterday’s release of OPM’s Postal Service Health Benefits Program interim final rule.
Fedweek offers interesting observations on the federal workforce demographics:
“For years, [federal agencies] focused on the “retirement wave”—or still more sweeping, the “retirement tsunami”—when the Baby Boom population hit retirement eligibility. That view continues today, with the constant repetition of statistics such as that 15 percent of the federal workforce is already eligible to retire, and that in five years 30 percent of current employees will be eligible.
“That wave never happened and there is no reason to believe it will.
“What has actually happened is that federal retirements have been a fairly steady flow at around 60,000 to 70,000 each year from agencies apart from the Postal Service (which accounts for about 40,000 more on average). That’s around 3 percent per year, so when it’s five years later, 15 percent or so already have retired and there’s still only 15 percent who are eligible.
“Since those first soundings about a retirement wave, the workforce actually has been increasing in age. The average is now 47—five years older than the overall U.S. workforce—with about 28.7 percent age 55 or above, up by a half-point just in the last six years. The percentage aged 60 and older—which more or less equates to retirement eligibility—rose from 9.4 to 14.5 percent over the last 15 years.”
This is the demographic challenge facing the FEHB Program which is ameliorated by the coordination of benefits with Medicare beginning at age 65. OPM improved the opportunities for coordination of benefits with Medicare by allowing carriers to integrate Medicare Part D prescription drug plans for 2024.
From the public health front —
Dana Farber Cancer Institute offers insights into which States have the highest cancer rates.
The Department of Human Services announced making progress in the “whole of government” response to long Covid.
STAT News tells us about the debate over universal infant screening for cytomegalovirus (CMV).
“[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.”[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, butnot for CMV. And testing for the infection in newborns isn’t widespread.
“Through my entire career, it’s been so clear that this field is really lacking in progress,” said Laura Gibson, an infectious diseases physician at UMass Memorial Health. “It’s just been frustrating to all of us in the field over decades.”
“That is starting to change, as state public health committees and legislatures begin to debate whether to mandate doing more robust screening for CMV. In 2019, Ontario became the first region in the world to test every baby for CMV. This year, Minnesota followed suit.”
“Obesity and diabetes in mothers have traditionally been considered risk factors for the child to also develop obesity. But a new study suggests that more narrow measures of health during pregnancy could help better assess that risk.
“Researchers grouped pregnant women based on specific metabolic traits and found that insulin resistance was associated with the highest risk, compared with other traits such as high cholesterol and triglycerides, according to a study published in JAMA Network Open on Tuesday.
“The risk linked to insulin resistance was even higher than that associated with prepregnancy obesity, defined as a body mass index over 30, and with diabetes diagnosed in gestation, the study said.”
From the Rx coverage front —
AHIP offers a new resource that “highlights how biosimilars offer an effective, lower-cost alternative to a brand name biologic product. In the last 10 years, for example, $36 billion of biosimilar medication spending was associated with $56 billion in savings. And savings from biosimilars are expected to exceed $180 billion over the next 5 years — a more than 4-fold increase from the last 5 years.”
STAT News reports on cancer drug shortages that have plagued our country for years.
From the telehealth front, mhealth intelligence informs us that “According to the FAIR Health Monthly Telehealth Regional tracker, telehealth use increased [7.3%] across the country in January, with rates rising at the national level and in all US Census regions.” My word, telehealth use increased in the winter?!?
Finally, in Medicare Advantage and Part D News, CMS lowered the boom on Medicare Advantage and Part D plans with a new final rule to “strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care.” This action follows a payment policy and risk adjustment rule compromise last week.
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.
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.”
From the end of the public health emergency front –
CMS issued a comprehensive fact sheet titled “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Notwithstanding the title, the fact sheet includes sections on how the end of the PHE impacts
Private Health Insurance
Vaccines: Most forms of private health insurance must continue to cover COVID-19 vaccines furnished by an in-network health care provider without cost sharing. People with private health insurance may need to pay part of the cost if an out-of-network provider vaccinates them.
Testing: After the expected end of the PHE on May 11, 2023, mandatory coverage for over-the- counter and laboratory-based COVID-19 PCR and antigen tests will end, though coverage will vary depending on the health plan. If private insurance chooses to cover these items or services, there may be cost sharing, prior authorization, or other forms of medical management may be required.
Treatments: The transition forward from the PHE will not change how treatments are covered, and in cases where cost sharing and deductibles apply now, they will continue to apply.
Private Health Insurance and Telehealth
As is currently the case during the PHE, coverage for telehealth and other remote care services will vary by private insurance plan after the end of the PHE. When covered, private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.
For additional information on your insurer’s approach to telehealth, contact your insurer’s customer service number located on the back of your insurance card.
Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.
Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.
The DEA created a 30 day public comment period for this proposed rule.
From the U.S. healthcare business front, STAT News tells us about this surprising twist
On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles. * * *
The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.
The FEHBlog’s guess is that drug manufacturers will be lined up at the bankruptcy courthouse door to place a bid on the company if allowed.
“Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said.
“Last summer, the Journal reported Seagen, a Washington-based company currently worth more than $30 billion, was considering selling to Merck & Co. for upwards of $40 billion. But as Bloomberg would later report, the deal stalled out because of disagreements over price. Since then, Seagen has brought on a new CEO, the longtime Novartis executive David Epstein, who played an integral role in ramping up the Swiss pharmaceutical giant’s cancer drug division.
“Should Pfizer acquire Seagen, it would gain access to a slate of experimental medicines as well as four marketed products that, together, generated $2 billion in revenue last year. Pfizer recorded $100 billion in product revenue in 2022, but estimates sales from its COVID-19 vaccine and Paxlovid therapy will fall significantly in the coming months. It also expects to lose around $17 billion in annual revenue between 2025 and 2030 due to the expiration of key patents.”
From the Rx coverage front —
The Wall Street Journal fills us in on the side effects of the new semaglutide weight loss drugs. For example, “Semaglutide spurs weight loss by stimulating the release of insulin and lowering blood sugar. It also delays stomach emptying, which causes people to feel full quickly and stay sated for longer stretches. When a patient comes off the drug, their normal appetite returns. * * * “People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism.”
The Journal also reports that “Amyloid Gains Converts in Debate Over Alzheimer’s Treatments; Dispute has far-reaching consequences, including whether Medicare will pay for new anti-amyloid drugs [e.g., Aduhelm and Leqembi].” Nevertheless, “Dr. [David] Knopman [,a Mayo Clinic neurologist,] said that Leqembi’s success is only a partial vindication of the amyloid hypothesis, which in the minds of many doctors promised to stop Alzheimer’s in its tracks or even reverse certain symptoms.”
From the mental health care front, David Leonhardt, the New York Times Morning columnist, “examines the raging debate about smartphones and teenage mental health.”
I called Lisa Damour last week and asked what advice she would give to parents. Damour is a psychologist who has written two best-selling books about girls and just published a new book, “The Emotional Lives of Teenagers.” She is no anti-technology zealot. She thinks social media can have benefits for teenagers, including connections with peers. But she also sees reason for concern.
Her first piece of advice is not to blame teenagers. They didn’t invent smartphones, and earlier generations would have used those phones in the same ways that today’s teens are.
Her second piece of advice might be summarized as: less. She believes teenagers should rarely have their phones in their bedrooms, especially not at night. A phone is too disruptive to sleep, and sleep is too important to mental health.
Parents can also introduce digital technology in stages, recognizing that a 13-year-old brain is different from a 17-year-old brain. For younger teens, Damour suggests a phone that can send and receive texts but does not have social media apps.
From the miscellany department –
Beckers Hospital Review provides details on the business model of One Medical, which became part of Amazon last week.
The company employs primary care providers across more than 125 clinics in 19 markets, according to its website. One Medical then partners with local hosptials and health systems to provide specialty care.
One Medical offers a subscription-based membership — for $199 a year (though Amazon is now offering a promotion for $144 annually) — that gives patients access to its digital health platform, with 24-7 access to virtual care and online appointment booking and prescription renewals. The company still bills those patients’ insurance for the visits.
Govexec reports “The federal employees appeals board is setting new precedents restricting when agencies can fire employees who were injured on the job, issuing new rulings on cases that languished for years while the agency was rendered partially incapacitated.”
The Wall Street Journal tells us “The White House said there is no consensus within the Biden administration over the origins of the Covid-19 virus, a day after the disclosure of an Energy Department assessment that the pandemic likely originated with a leak from a Chinese lab.”
In the 1980s and 1990s, the Washington Post had a television critic named John Carmody who would warn readers at the beginning of his column to “strap yourselves into your breakfast nook” when he had big news. So strap yourselves in, and here goes. (The photo to the right is a rough approximation of a breakfast nook, a concept which has fallen out of style evidently.
Over the next 18 to 24 months, according to the Wall Street Journal, Humana will withdraw from the employer health benefits market to focus on the government health programs market.
Humana, which currently offers many FEHB HMO plans, placed the FEHB Program in the “bye-bye” employer health benefits market even though the employer is the federal government. The FEHBlog, and Congress for that matter, prefer to view the FEHB Program as part of the employer market.
In short, Humana could have justified staying in FEHB but chose not to do so. The decision is worth pondering, particularly if you have a long-term perspective.
In other U.S. healthcare business news —
Healthcare Dive reports on earnings announcements from telehealth vendors Teladoc and Amwell.
“While 80% of respondents said they had used telemedicine, there were only two categories where a majority of people preferred telemedicine over in-person care: prescription refills and minor illnesses. More than 60% of people surveyed preferred in-person visits for mental health and chronic condition care, while more than 70% wanted an in-person annual wellness visit. The starkest divide was on physical therapy: 80% of people preferred in-person visits, while only 20% preferred telemedicine.”
Biopharma Dive reports on Moderna’s earnings announcement.
In other vaccine news, CNN tells us
“The independent vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Wednesday in favor of the two-dose Jynneos mpox vaccine for adults at risk of catching the disease during an outbreak.”
“If the CDC agrees with the committee’s recommendation, there will be a recommendation in place to give the vaccine to people who are at risk for mpox during future outbreaks.”
“Even as mpox cases continue to fall, the CDC is encouraging people who are at risk to get vaccinated.”
From the preventive services front —
The U.S. Preventive Services Task Force issued for public comment a draft research plan regarding preventive interventions for perinatal depression. The public comment deadline is March 22, 2023.
The Mercer consulting firm offers useful observations on how employers and health plans can optimize their investments in preventive care.
The FEHBlog recalls pointing out a Social Determinants of Health Atlas a few years ago. Check out the CDC’s list of health mapping tools that are now available.
From the Rx coverage front, Beckers Hospital Review tells us that the Centers for Medicare and Medicaid Services will not change its Medicare coverage policy on Aduhelm, an Alzheimer’s Disease treatment, based on the recent FDA approval of Leqembi.
CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker’s efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan.
“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said in a Feb. 22 statement. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”
If “any new evidence” becomes available or an amyloid-targeting Alzheimer’s drug receives traditional approval, CMS said it may reconsider its coverage decision.
As readers know, CMS’s Medicare coverage decision on these drugs effectively controls the market for these drugs.
From the miscellany department
Affordable Care Act FAQ 57 was issued yesterday. This FAQ concerns implementation guidance for the No Surprise Act’s anti-gag clause provision.
FedSmith identifies five milestones toward federal retirement.
Kaiser Family Foundation has created federal and state litigation trackers regarding reproductive rights.
From the U.S. healthcare business front, the Wall Street Journal reports
Amazon.com Inc. will be able to close its purchase of 1Life Healthcare Inc., the operator of the One Medical line of primary-care clinics, without a legal challenge by antitrust enforcers.
The Federal Trade Commission won’t sue in time to block the $3.9 billion deal, including debt, but will continue its investigation of the merger, an agency spokesman said. The decision clears a path for Amazon to substantially expand its healthcare offerings and operate physical medical clinics. Amazon has invested in the healthcare space for years, including with an online pharmacy and other health ventures.
“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”
Becker’s Hospital Review offers two articles on Mark Cuban’s Cost Plus Drug Co.
As news outlets, celebrities, swingers on Reddit and people on Twitter praise Cost Plus Drug for its low prices on hundreds of generics, some of its products are more expensive than options at local pharmacies, KHNreported using GoodRx data.
For example, one presentation of amoxicillin-clavulanate, an antibiotic currently in shortage, is $267.60 at Cost Plus Drug Co. and $109.44 at the average community pharmacy.
Mr. Cuban told the outlet that its analysis was not comprehensive because of the company’s pricing model, which is a 15 percent markup, $3 for labor per drug and $5 for shipping. Because the shipping cost is overall and not for each medication, Mr. Cuban said his pharmacy can still offer a cheaper sale.
In the other article, BHR informs us that the Cost Plus Drug Co., which already has business arrangements with three prescription drug managers, is contacting independent pharmacies for business.
Global vision and brain research non-profit BrightFocus Foundation celebrates the U.S. Food and Drug Administration’s (FDA) approval of Syfovre (pegcetacoplan injection), the first-ever treatment to slow the progression of vision loss from geographic atrophy, an advanced form of dry age-related macular degeneration and a leading cause of blindness.
“Today’s FDA approval of Syfovre provides hope to the more than five million people worldwide who are at risk of permanent vision loss from geographic atrophy,” said BrightFocus President and CEO Stacy Pagos Haller. “This first-of-its-kind treatment is a momentous step forward in vision research and will make a meaningful difference in the lives of millions of people.”
An estimated one million people in the U.S. have geographic atrophy, an advanced and severe form of age-related macular degeneration in which regions of cells in the retina waste away and die (atrophy). This progressive and irreversible disease can lead to permanent vision loss. Nearly 20 million adults in the U.S. have some form of age-related macular degeneration (AMD), almost double the previous estimate of 11 million people, according to a new report.
People living with geographic atrophy often experience emotional hardships including anxiety, feeling powerless, and frustration. Approximately one in three have recently withdrawn from their social lives because of their disease, and BrightFocus offers a free AMD community group and educational audio chats for affected individuals.
Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide.
The New York Times Morning column criticizes the public health system for undertreating people with opioid use disorder, obesity and mental health issues, among other problems.
Similarly, HHS’s Agency for Healthcare Research and Quality calls attention to the underuse of cardiac rehabilitation in our country.
From the Rx coverage front —
BioPharma Dive explains that while the last decade’s lapse of patents impacted blockbuster small-molecule drugs, this decade’s lapse impacts specialty drugs such as Humira and Keytruda. Time will tell whether patients will convert to biosimilar drugs as quickly as they converted to generic drugs when patents lapse.
STAT News reports on “A battle between Vertex and insurers [over copay assistance accumulators] is leaving cystic fibrosis patients with crushing drug costs. Copay assistance accumulators prevent co-pay assistance from accumulating toward the plan’s out-of-pocket payments maximum required by the Affordable Care Act.
The Institute for Clinical and Economic Research related a final evidence report on treatments for multiple sclerosis.
From the medical research front, STAT News reports
An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced.
The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.
In the results of a Phase 3 clinical trial presented Saturday, 22% of patients with acute myeloid leukemia who were administered Iomab-B to prepare their bone marrow for transplants had durable remissions lasting six months or more. None of the patients in the study who received conventional care prior to transplant achieved durable remissions.
Amazing.
From the miscellany / tidbits department
The U.S. Preventive Services Task Force proposes to renew the following Grade A recommendation:
The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid.
The public comment period on this renewal is open until March 20, 2023/
Eligible commercial members will gain access to a virtual care team that conducts an initial health screening, creates a personalized care plan, and then provides care services, according to a Feb. 7 news release.
The virtual care services will take place through Anthem’s app, Sydney Health. The app offers 24/7 medical text chat, preventive wellness visits, support services, including new prescriptions and refills, and in-network referrals.
Virtual primary care is now available to eligible individuals enrolled in Anthem’s fully insured plans and certain large group administrative services clients.
From the Omicron and siblings front, HealthDay tells us
Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows
The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it
Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1
From the public health front —
Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.
“A new study found that extreme temperatures may raise the risk of death from heart disease. * * * To protect your heart on hot days, stay hydrated, seek shade, and wear light clothes. On cold days, hydrate and avoid too much strenuous outdoor activity.”
From the healthcare quality front
Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.
From the Medicare front —
The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
“Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
“Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
“Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness.
In hospital pricing transparency news —
Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.
From the HR department
The Society for Human Resource Management tells us
“Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
“All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act?
HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”
From the tidbits department
Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”
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