From Capitol Hill, Fierce Healthcare points out four legislative items that providers should be tracking for the remainder of this year.
From the Omicron and siblings front, the Washington Post reports
Cold weather favors the coronavirus. But as summer gives way to fall, infectious-disease experts are guardedly optimistic that the spread of covid-19 this autumn and winter won’t be as brutal as in the previous two years of the pandemic.
Coronavirus scenarios from multiple research teams, shared in recent weeks with federal officials, foresee stable or declining hospitalizations in early fall.The scenarios show the possibility of a late-fall surge. A new variant remains the biggest wild card. But several factors — including the approval this week of reformulated boosters and the buildup of immunity against the latest strain of the virus — could suppress some of the cold-season spread, experts say.
In related news, the Wall Street Journal informs us
U.S. health authorities plan to recommend that people get Covid-19 boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.
The annual cadence would be similar to that of flu shots, White House officials said Tuesday, though elderly people and those with weakened immune systems may need more frequent inoculations.
A shift to annual Covid-19 boosters would be a departure from current practice and comes after many people in the U.S. have ignored calls to get a first or second booster, partly due to fatigue with repeat inoculations.
“Barring any new variant curveball,” said White House coronavirus coordinator Ashish Jha, “for a large majority of Americans, we are moving to a point where a single annual Covid shot should provide a high degree of protection all year.”
A very sensible approach, indeed!
From the healthcare business front, Healthcare Dive tells us
Amazon and One Medical said Friday that antitrust regulators want more information about the online retailer’s proposed $3.9 billion acquisition of the primary care group.
The Federal Trade Commission sent a second request for information on Friday, One Medical said in a filing with the U.S. Securities and Exchange Commission.
A second request from the FTC means the two cannot move forward with the deal “until the companies have substantially complied with the additional investigatory request,” according to the FTC.
Amazon and One Medical will “promptly respond” to the second request, the primary care group said in the SEC filing.
Drug Channels surveys the upcoming Humira price war as biosimilar competitors take the field.
CMS posted new information about available group health plan defenses to CMS contractor assertions that the GHP has failed to properly coordinate its benefits with Medicare.
Beckers Payer Issues offers expert opinions on the impact of the transparency in coverage rule on consumerism now that the three machine-readable files of health plan pricing data have been posted for two months. For example, “Neil Mayle is the founder and president of Visible Charges, a Cambridge, Mass.-based company that provides clients with curated datasets of both payer- and provider-negotiated service prices. * * * ‘I think we’ve gone from nothing to a lot,’ Mr. Mayle said. ‘We haven’t gone to perfect.'” Of course, it was only the first of three stages in transparency in coverage rule disclosures.
The FEHBlog noticed today these CMS and DOL fact sheets on the No Surprises Act which are worth a gander.
The Senate returns to Capitol Hill for committee business and floor voting tomorrow. The Wall Street Journal adds “Between now and Election Day, senators are scheduled to be back in Washington for four weeks, then gone a week, and then back for two weeks in October.” The House of Representatives will be engaged in committee business but not floor voting this week. The House resumes floor voting next week.
The White House is asking Congress for $47.1 billion in emergency funding for Covid-19 and monkeypox and to back Ukraine in its war with Russia, as well as spending for natural disasters, according to administration officials.
Congress must vote on a spending bill by the end of September to avoid a partial government shutdown. Lawmakers are expected to use a stopgap funding measure that will maintain funding levels for the short term.
The White House is asking Congress to add the emergency funding on top of that, with about $22.4 billion for Covid-19 vaccines, testing programs, clinical trials and research; $4.5 billion to bolster efforts to fight monkeypox; and $6.5 billion to help areas of the country prepare for and recover from natural disasters. * * *
The emergency funds wouldn’t be paid for with new or shifted revenue, and would be new money that hasn’t been previously appropriated.
[As of last Friday, September 2] Senate Republican leadership didn’t immediately respond to a request for comment about the White House’s request for emergency funding. Spending bills require 60 votes, and in the 50-50 Senate at least 10 Republicans would need to back any bill that contained the administration’s request.
[President] Biden intends to nominate Richard Revesz, the AnBryce Professor of Law and Dean Emeritus at the New York University School of Law, to be administrator of the Office of Information and Regulatory Affairs, which is housed within the White House Office of Management and Budget. Biden has not had a permanent OIRA head since taking office.
From the U.S. healthcare business front, the Wall Street Journal reports this afternoon that CVS Health has struck a deal to purchase Signify Health:
The drugstore giant’s deal to acquire home-healthcare company Signify Health Inc., announced Monday, will add 10,000 contracted doctors and clinicians and give CVS a hand in coordinating medical care for millions of Americans.
CVS, the nation’s biggest healthcare company by revenue, said that it agreed to acquire Signify for $30.50 per share in an all-cash deal, confirming earlier Wall Street Journal reports. CVS said it expects the deal, finalized over the weekend after a sales process that drew interest from companies from Amazon.com Inc. to UnitedHealth Group Inc., to close in the first half of 2023.
CVS for years has worked to transform itself from a pharmacy chain to an integrated provider of medical services, with the biggest step being its 2018 acquisition of insurer Aetna. Initially, CVS envisioned a model centered on pharmacists, in-store clinics and a giant insurance business.
But Karen Lynch, who took over as CVS CEO last year, determined that the company needs doctors on its payroll to fulfill those ambitions. She also set out to expand CVS’s presence in home healthcare, demand for which has been rising as the U.S. population has aged.
Signify’s model is based on an analytics-and-technology platform, used by doctors that go into homes equipped with connected iPads, that allows the clinicians to assess patient needs and connect them with follow-up services.
The clinicians “operate much like Uber drivers,” said Kyle Armbrester, Signify Health chief executive. “We’re in a gig economy and this is a flexible model.”
The deal is the latest for a home-health company. Rival Walgreens Boots Alliance Inc. last week finalized a deal to purchase a majority stake in CareCentrix, Inc., another home-healthcare platform.
This spring, UnitedHealth agreed to buy LHC Group Inc., one of the country’s largest home-health firms, for about $5.4 billion. Last year, Humana Inc. agreed to take full control of home-health provider Kindred at Home. Both LHC and Kindred provide continuous home-healthcare services.
Signify has grown to serving more than 2.5 million homes from around 300,000 five years ago, said Mr. Armbrester, who is set to remain CEO of Signify Health after the acquisition.
From the public health front, NPR Shots discusses the new Covid boosters and Precision Vaccinations discusses flu shots. The FEHBlog checked chain pharmacies in his locality in Dripping Springs, TX. Flu shots are already available, and the new Covid boosters will be available mid-week.
Congress’s State / District work break ends next Monday Labor Day.
From the Omicron and siblings front, Federal News Network tells us that last Friday the U.S. Court of Appeals for the Eleventh Circuit, which is based in Atlanta, issued a ruling on the federal government’s appeal of a district court preliminary injunction of the Biden Administration’s Covid vaccination mandate on federal government contractors.
The three-judge panel’s majority found that a narrower injunction to block the mandate would have been warranted, and that once the case is fully litigated, the plaintiffs are at least “reasonably” likely to win their claim that the president can’t use his authority under procurement law to mandate vaccines for contractors.
But the court found Georgia District Court Judge Stan Baker went too far by applying the injunction nationwide during the case’s earliest stages last December. Instead, the court ruled, the injunction can only apply to the handful of parties who actually sued. * * *
In this case, that means the government is barred from enforcing the mandate against members of the Associated Builders and Contractors (ABC), and state agencies from seven states that were part of the same suit: Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. * * *
The administration completely suspended enforcement of the contractor mandate right after Judge Baker’s decision last December, and hasn’t yet said how it will respond to the new ruling partially lifting his injunction. A spokesman for the Office of Management and Budget did not immediately respond to an inquiry Friday evening.
From the healthcare cost front, Fierce Healthcare informs us
Healthcare price increases during the past year pale in comparison to those seen across the rest of the economy, suggesting that the healthcare sector has so far been spared from the full impact of 2022’s rapid inflation.
Healthcare’s upward price movement has so far been led by hospitals and nursing homes as opposed to other medical care spend, per an analysis of Bureau of Labor Statistics data released Wednesday.
Policy analysts affiliated with the Kaiser Family Foundation and the Peterson Center on Healthcare wrote that those quicker increases are likely a reflection of staff shortages and rising average wages and are likely to continue “unless hospitals can find ways to operate with fewer staff.”
With health prices often set in advance by the Centers for Medicare & Medicaid Services or private insurance contracting, however, the analysts wrote that “the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.”
In post-Dobb’s news, the Department of Health and Human Services brings us up to date on the steps that the Biden Administration has taken to protect access to abortion services. Most recently,
Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. The letter also underscored that current or proposed abortion restriction laws do not negate providers’ responsibilities to comply with federal laws protecting access to emergency health care. Also today, HHS issued a report and plan of action in response to the Dobbs v. Jackson Women’s Health Organization Supreme Court decision.
From the mental healthcare front, NPR brings us inside the operations of 988 call centers in Pennsylvania.
The 2020 law enacting the 988 number also allows states to pass legislation to add a small fee to cell phone bills as a permanent source of funds for 988 and associated mental health services. So far, only four states have done so, and only two more have proposed legislation.
Pennsylvania is not one of those states, and doesn’t have any other funding plan implemented. That worries Kevin Boozel, who heads the County Commissioners Association of Pennsylvania.
“This is life or death,” Boozel says. “And you can’t halfway do it.”
He pointed out that Pennsylvania has decided to hold back on publicizing the new 988 number until next year. The fear is that too many calls could flood the system, and counties need more time to set up funding, hire workers and build capacity for things like those mobile crisis teams.
Challenges aside, In Centre County, Herr McCann emphasizes that calling the hotline works. In most cases, just talking with someone is enough to defuse a crisis.
“When they have someone who is empathetic and who listens, that connection helps them,” she said. That lets people know that “it isn’t hopeless. There is hope out there. There is help out there.”
From the health benefit plan design front, Fierce Healthcare reports
Bicycle Health, a virtual provider for opioid use disorder treatment, has announced it is now part of Cigna Evernorth’s behavioral health network.
The startup’s services will now be available to all Evernorth and Cigna health plan customers in the 24 states where Bicycle Health operates. The potential reach is millions of patients, the company told Fierce Healthcare without disclosing additional details.
More than 200 post offices and other U.S. Postal Service facilities are set to shed some of their operations as soon as this year as the mailing agency seeks to consolidate those functions at larger buildings, according to documents shared by management.
The changes will mean letter carriers no longer go to their local facility to pick up mail for their route, instead traveling farther distances after starting at a consolidated location. The impacted post offices will still conduct their retail operations, but many of the back-end functions will be stripped away and relocated. They are connected to an initial 10 buildings that USPS previously announced it was standing up in previously closed facilities, as well as an additional 11 centers.
Most post offices around the country operate as delivery units, meaning mail carriers go to them to pick up mail and packages for their routes before bringing them to homes and businesses. Postmaster General Louis DeJoy has repeatedly decried this model, saying it is inefficient and can lead to as many as dozens of such units in one metropolitan area. Instead, he is looking to open “sorting and delivery centers” around the country, as well as larger mega-centers, that can take on more work in less space. Letter carriers will have to travel farther to take mail to its final destination, but DeJoy said it will save costs on the contracted trucks that USPS hires to bring mail between various facilities.
The impactedsites are located in Georgia, New York, Texas, Florida, Michigan, Pennsylvania, Ohio, Kansas, Maryland, Massachusetts, West Virginia, Kentucky, Washington, North Carolina, Indiana and Arkansas. The initial consolidations are expected to begin as soon as next month.
Thanks to Aaron Burden for sharing their work on Unsplash.
Congress is on a State / District work break again this week.
The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.
Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.
Here’s a link to a Fierce Healthcare article on the new rules.
The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.
But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.
As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S.
This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.
The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce.
The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.
Fingers crossed.
On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.
NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes
Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.
A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.
The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox.
The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.
From the Rx coverage front, BioPharma Dive reports
The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.
The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.
Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.
Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.
Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.
Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.
From the U.S. healthcare business front, the Wall Street Journal reports
Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.
Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.
CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.
There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.
Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization. The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”
From Capitol Hill, Federal News Network identifies five federal workforce items on Congress’s to-do list.
From the omicron and siblings front, the Wall Street Journal reports
The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come. * * *
Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months, an HHS spokesman said. * * *
Switching vaccine purchasing to the commercial market would mean that each insurer and pharmacy benefit manager would be negotiating with drug manufacturers and prices would likely be higher than what the federal government has paid, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. Insurers would have to start paying for the vaccines, he said, likely raising premiums.
More than 2 years after patients started reporting long-lasting symptoms after acute SARS-CoV-2 infection, the U.S. announced its national long COVID plan.
The National Research Action Plan on Long COVID aims to improve prevention, diagnosis, and treatment for long COVID, which currently affects up to 23 million people in the U.S., about 1 million of whom may be out of the workforce at any given time because of the condition, according to Admiral Rachel Levine, MD, HHS assistant secretary for health. * * *
Long COVID advocates expressed mixed opinions. Hannah Davis, co-founder of the Patient-Led Research Collaborative, noted the fact that “there’s going to be an [Office of Long COVID Research and Practice] is pretty amazing.”
But Davis voiced concerns about the scarcity of prevention efforts addressed by the plan. “I think there’s still a feeling like we can get through this without minimizing cases, but we really need to be focused on prevention as well,” she said.
Diana Berrent, founder of Survivor Corps, told MedPage Today that the administration “nailed the institutional challenge of long COVID” but also thought the plan was insufficient.
“Millions of Americans, young and old, are suffering the aftermath of COVID and need immediate relief from their pain,” Berrent said. “An established office in HHS is a welcome step but nothing short of actual treatments and therapeutics will do the trick.”
From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of monkeypox cases, and MedPage Today reports
The Biden administration is making an additional 1.8 million doses of the Jynneos monkeypox vaccine available beginning Monday, and will be targeting certain large events — such as gay pride marches that attract many LGBTQIA participants — as sites for monkeypox vaccination and outreach, administration officials said Thursday.
From the healthcare costs front, Healthcare Dive reports
U.S. employers will pay 6.5% more on average for employee healthcare coverage in 2023 compared to this year, according to an Aon report out Thursday.
The latest predicted rise, while a jump from the 3.7% growth in employer costs between 2021 and 2022, is still far below the 9.1% Consumer Price Index, a figure reflecting inflation.
Inflation typically hits healthcare costs later than other goods and services due to the multi-year nature of contracts between providers and insurers, but impacts will become more prevalent over the year, according to the report.
Speaking of higher costs, Fierce Healthcare discusses Moody’s report on how an economic downturn would impact health plans.
From the No Surprises Act front, the American Hospital Association informs us “The Centers for Medicare & Medicaid Services has launched a new webpage with resources and guidance related to the dispute resolution process under the No Surprises Act, including guidance for disputing parties and a walkthrough of the federal portal. CMS also has added functionality to the portal for initiating disputes, including a button to upload supporting documents at initiation.”
From the miscellany department —
Fierce Healthcare discusses J.D. Powers’ annual study of Medicare Advantage plans. “[T]he analysts found members’ general satisfaction is up from 2021 and is higher than satisfaction reported by people in employer-sponsored plans. However, while members said they’re happy with access to preventive and routine care, coverage of mental health and substance abuse treatment is lacking.”
STAT News calls our attention to “a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.” According to the article, “When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.”
The FEHBlog is back inside the Capital Beltway this week so let’s kick it off with a link to the President’s remarks at his signing of the budget reconciliation act (H.R. 5376) into law.
Because the new law’s drug pricing changes will impact the FEHB Program most, here is a link to STAT New’s article unpacking those provisions.
From the omicron and siblings front, Federal News Network reports that the Safer Federal Workforce Task Force is following the CDC’s lead by easing restrictions to stop the Covid spread.
MedPage Today offers a fascinating article in which a Johns Hopkins epidemiologist assesses the current case of polio paralysis in New York through a historical lens.
Polio is a fecal-oral pathogen and the Sabin vaccine, as an oral vaccine, more naturally mimicked the natural route of infection and therefore triggers different and more potent immune responses than the injectable Salk vaccine. Also, because it is a “live” vaccine, the vaccine virus is shed and can passively immunize close contacts of vaccinated individuals. For these reasons, the Sabin vaccine eventually came to be a more dominant and preferred vaccine than the [original, injected] Salk version.
However, as polio receded as a public health threat, rare complications elicited by the Sabin vaccine became intolerable in many Western countries. The “live” nature of Sabin’s vaccine, in rare instances, could lead to vaccine-associated paralytic polio. In even rarer circumstances, the virus could mutate or recombine with other viruses to become a circulating vaccine-derived poliovirus (cVDPV) that could be capable of infecting others, and in some cases, causing paralysis. This is why 2 decades ago — with polio no longer an issue domestically — the U.S. switched to an all-Salk injectable polio vaccine regimen for children, away from a combination that used the Sabin oral polio vaccine (OPV) and the injectable polio vaccine. But many countries, especially those in which wild polio still circulates, still use OPV. * * *
In response, [U.S.] healthcare professionals and policymakers need to encourage widespread immunization in areas in which cVDPVs have been found. It is not surprising that this problem has been detected in the same locales in which a very large measles outbreak recently occurred. I suspect other areas likely have cVDPVs circulating as well, and broader wastewater surveillance coupled with targeted catch up immunization will be critical. I can’t stress this point enough: high vaccination rates are required for resiliency.
In related virus news, the Centers for Disease Control released a report titled “Hepatitis C Treatment Among Insured Adults — the United States, 2019–2020.”
What is already known about this topic?
Direct-acting antiviral (DAA) treatment is recommended for nearly all persons with hepatitis C and cures ≥95% of cases. Treatment saves lives, prevents transmission, and is cost saving.
What is added by this report?
Treatment rates are low overall and vary by age and insurance payor. DAA treatment is lowest among young adults aged 18–29 years and Medicaid recipients, and within Medicaid, among persons reporting Black or other race and persons in states with treatment restrictions.
What are the implications for public health practice?
Timely initiation of DAA treatment, regardless of insurance type, is critical to reducing viral hepatitis–related mortality, disparities, and transmission.
Also of note,
Across insurance types, ≥75% of persons treated initiated treatment within 180 days after diagnosis. The smaller percentage of persons treated within 180 days after diagnosis might indicate lack of access to a hepatitis C treatment provider, insurance denial, or loss to follow-up. Treatment coverage can be increased by providing integrated care, patient navigation, and care coordination (15). The introduction of simplified hepatitis C treatment algorithms reducing the number of laboratory tests and in-person visits can facilitate patient-centered treatment (20).
From the U.S. Healthcare business front
The Food and Drug Administration issued “a final rule to improve access to hearing aids which may, in turn, lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without needing a medical exam, prescription or a fitting adjustment by an audiologist.” The rule will take effect in 60 days / mid-October.
STAT News reports Merck has cut a deal to enter the mRNA market.
On Tuesday, the company announced a deal to develop mRNA-based vaccines and therapies with Orna Therapeutics, a Cambridge-based startup that launchedduring the pandemic with a slightly different take on mRNA technology. Merck will pay Orna a $150 million upfront fee, invest $100 million in a new funding round for the company, and offer $3.5 billion in longer-term milestones.
The American Hospital Association tells us.
Hospital patients are sicker and more medically complex than they were before the COVID-19 pandemic, driving up hospital costs for labor, drugs and supplies, according to a new AHA report.
“Combined with rapidly rising economy-wide inflation and reimbursement shortfalls, these mounting costs are threatening the financial stability of hospitals around the country,” the report notes.
Hospital patient acuity as measured by average length of stay (ALOS) rose almost 10% between 2019 and 2021, including a 6% increase for non-COVID-19 Medicare patients as the pandemic contributed to delayed and avoided care, the report notes. For example, ALOS rose 89% for patients with rheumatoid arthritis and 65% for patients with neuroblastoma and adrenal cancer. In 2022, patient acuity as reflected in the case mix index rose 11.1% for mastectomy patients, 15% for appendectomy patients and 7% for hysterectomy patients.
These increases have occurred at a time of significant financial challenges for hospitals and health systems, which have still not received support to address the delta and omicron surges that have comprised the majority of all COVID-19 admissions. As a result, AHA is asking Congress to halt its Medicare payment cuts to hospitals and other providers; extend or make permanent certain waivers that improve efficiency and access to care; extend expiring health insurance subsidies for millions of patients; and hold commercial insurers accountable for improper and burdensome business practices.
From the federal policy front, Fierce Health tells us about four healthcare policy changes beyond government negotiation of a subset of Medicare-covered drugs and extension of ACA subsidies found in the budget reconciliation bill that Congress approved last week. The President is scheduled to sign the bill into law tomorrow.
Here are four other health policy changes to look for in the bill:
First, expands eligibility for the full amount of low-income Part D subsidies from 135% of the federal poverty line to 150% of the FPL.
Gets rid of the cost-sharing for adult vaccines for Medicare Part D. The FEHBlog has personal experience with this one. In 2020 he received the new Shingrix vaccine under Medicare Part D. The vaccine was eligible for no cost sharing when administered in-network under the Affordable Care Act. However, under Part D, the FEHBlog was charged $200 for each of the two doses. This big bowl of wrong will be remedied in 2023.
Delays the controversial Part D rebate rule, again. “The Trump-era rule would eliminate the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.”
Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. “The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.”
From the Omicron and siblings front, BioPharma Dive informs us
British drug regulators on Monday approved a two-pronged vaccine from Moderna that’s designed to fight both the original version of the coronavirus and the omicron variant.
The decision makes the U.K. the first country to clear a COVID-19 booster that’s been specifically tailored to a newer form of the virus. While the original shots, like Moderna’s Spikevax, remain strongly effective at preventing hospitalization and death, they’ve had a harder time warding off infections from omicron and its subvariants. * * *
Speaking to a [U.S.] advisory committee in June, executives from Moderna and Pfizer said dual-acting boosters with a BA.4 or BA.5 could be available in large volumes in October and November, although they would first need to undergo regulatory review before they could be administered.
Separately, Novavax on Monday asked the FDA to authorize its COVID-19 vaccine as a booster shot in people 18 and older. The shot is only available as a primary series to those who haven’t yet been vaccinated.
The Centers for Disease Control released updated guidance on what to do if exposed to Covid.
The Wall Street Journal reports on assessing Covid-19 risks after easing CDC guidelines, which began last week. The headline notes, “More decision-making is shifting to individuals, and here is what doctors recommend.”
From the monkeypox front, the Journal discusses “What to Know About Symptoms, Vaccines and How It Spreads,” and Beckers Hospital Review offers five monkeypox updates, including a complete explanation of how the World Health Organization is going about changing the disease’s name.
From the mental healthcare front, about ten years ago, the FEHB Program under OPM’s leadership was the first large employer-sponsored program to cover a form of autism therapy called “applied behavior analysis” (ABA). A STAT News investigation discloses
ABA has long been viewed as the gold standard for kids with autism, so much so that every state mandates insurance coverage. For some families, it is the only option that insurance will cover at all.
But like other pockets of the health care industry, this one has been transformed over the past decade by a flood of investments from private equity firms, drawn by the promise of insurance reimbursement and the rising rate of autism in children across the U.S., now estimated at 1 in 44 kids.
Families and clinicians who once believed fully in the promise of ABA say the financial investors’ fixation on profit has degraded the quality of services kids receive, turning it into the equivalent of fast food therapy. They’ve grown disillusioned with the industry, they told STAT.
The HHS Inspector General is auditing Medicaid claims for ABA. The final audit report is expected later this year.
From the Rx coverage front, the Drug Channel blog discloses
Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type.
The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion—an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart. Hospitals accounted for 87% of these skyrocketing 340B purchases.
What’s more, the difference between list prices and discounted 340B purchases also grew, to $49.7 billion (+$7.0 billion). This figure approximates the money collected by 340B covered entities.
340B advocates have been screaming that “drug companies are cutting 340B,” but the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.
From the U.S. healthcare business front, Beckers Payer Issues provides an interview with “Kyu Rhee, MD, a senior vice president at CVS Health and chief medical officer at Aetna. He sat down with Becker’s to discuss ongoing trends across the healthcare industry and how he is working to create a “values-based” care system through opportunities offered by a global pandemic.”
Congress is on a State / District work break until after Labor Day.
The Change Healthcare antitrust trial is ongoing. The judge Hon. Carl J. Nichols will be deciding the case without a jury. He was heard evidence for ten days already. The case is U.S. v UnitedHealth Group et al., 22-cv-481, U.S. District Court for the District of Columbia.
From the Omicron and siblings front, Bloomberg Prognosis informs us
Scientists fear that the omicron shots coming this fall won’t be all that much better at keeping people from getting Covid than the shots we already have. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all, writes Bloomberg’s Madison Muller, Riley Griffin and Fiona Rutherford.
“Even with the highly flexible platform of mRNA, which is more flexible than virtually anything we’ve had before, it’s going to be very difficult to keep up with the pace of newly evolving variants,” Anthony Fauci, President Joe Biden’s chief medical adviser told Bloomberg. “Which gets us to the question: What about a pan-coronavirus vaccine?”
Aim high.
From the monkeypox front, the World Health Organization has renamed the disease that is quite bland.
Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades.
A clade means “a group of organisms believed to have evolved from a common ancestor, according to the principles of cladistics, e.g., “the great ape and human clade.” How will WHO distinguish between the monkeypox clade and the chickenpox clade? Time will tell.
From the U.S. healthcare business front, Fierce Healthcare tells us
Humana will acquire a Wisconsin managed care plan in a bid to bulk up its Medicaid services, the insurer announced Friday.
Inclusa, Inc. offers long-term care coverage as well as supporting 16,600 older adults and adults with disabilities in Wisconsin’s Family Care program. The managed care organization has worked with local providers and community resources for more than 20 years to connect members with necessary support and services.
Inclusa partners with more than 6,000 service providers across about 40 service categories, as well as contracts with the state to provide family care services in 68 of Wisconsin’s 72 counties, according to the announcement.
The Wall Street Journal offers two expert interviews on mental health issues:
Speaking of eating, Forbes offers the five best diets for people with diabetes in 2022.
NPR reports on initial experience with the 988 lifelines.
The 988 hotline is the nation’s most comprehensive mental health crisis service and can provide crucial help to those in emotional distress. If you’re thinking about suicide but not taking steps to act on it, 988 is unlikely to call law enforcement without your consent. Instead, 988 counselors can provide resources, referrals and a kind ear. However, if you’re at imminent risk and could act on a plan to kill yourself, police may be called, and you could be taken to a hospital involuntarily.
Sonyia Richardson, a licensed clinical social worker who owns a counseling agency that serves mostly Black and brown clients in Charlotte, N.C., said she didn’t immediately tell her clients about 988 when it launched. Even though she’s a member of her state’s 988 planning committee, she said she needed time to develop trust in the service herself. When she learned at a recent committee meeting that fewer than 5% of 988 calls in North Carolina led to a law enforcement response, she felt reassured.
Based on the Centers for Disease Control Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog latest weekly chart of new Covid cases:
Note: the massive surge on the left is the original Omicron surge, but the label didn’t carry over from the spreadsheet to the FEHBlog.
The CDC’s weekly review of its Covid statistics tells us
As of August 10, 2022, the current 7-day moving average of daily new cases (103,614) decreased 13.8% compared with the previous 7-day moving average (120,151). * * *
CDC Nowcast projections* for the week ending August 13, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 88.8% (95% PI 87.5-90.0%). The national proportion of BA.4 is projected to be 5.3% (95% PI 4.9-5.7%), BA.4.6 is projected to be 5.1% (95% PI 4.1-6.4%), and BA.2.12.1 is projected to be 0.8% (95% PI 0.7-0.9%).
Here’s the CDC’s Daily Trends in Number of New COVID-19 Hospital Admission chart from its weekly review.
The CDC’s weekly review adds, “The current 7-day daily average for August 3–9, 2022, was 6,003. This is a 2.6% decrease from the prior 7-day average (6,163) from July 27–August 2, 2022.”
Here’s the FEHBlog latest daily chart of new Covid deaths for 2022:
Unfortunately, both labels fell off this chart. The missing label under the horizontal axis 3 -5 reads Omicron, and the missing label over weeks 14 – 17 reads Omicron’s siblings. The CDC’s weekly review adds, “The current 7-day moving average of new deaths (400) has decreased 6.7% compared with the previous 7-day moving average (429).”
New cases, new admissions and new deaths have plateaued and are trending down.
Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the first week of the Covid vaccination era in December 2020 to this week.
Administered vaccines jumped back up to over 2 million this week. The CDC’s weekly review adds.
Overall, about 262.0 million people, or 78.9% of the total U.S. population, have received at least one dose of vaccine. About 223.5 million people, or 67.3% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 107.9 million people have received a booster dose,** but 50.0% of the total booster-eligible population has not yet received a booster dose.
COVID-19 mRNA vaccines have been safe for pregnant women, according to observational data from a large Canadian study.
In fact, the pregnant women reported fewer serious health events than non-pregnant women in the 7 days following vaccination and a similar number of events as a control group of unvaccinated pregnant respondents, as researchers led by Manish Sadarangani, DPhil, of the BC Children’s Hospital Research Institute in Vancouver, reported in The Lancet Infectious Diseases.
The Wall Street Journal reflects on yesterday’s CDC easing Covid restrictions intended to shut down the disease, a state which will not happen anytime soon.
Federal health officials’ move this week to relax pandemic precautions gave business leaders the momentum many have been looking for to return to pre-Covid behaviors.
The new guidelines, issued Thursday by the Centers for Disease Control and Prevention, generally bring the federal guidance in line with policies that had already shifted at companies, schools and public transportation, among other settings. The agency said it no longer recommends that people quarantine after being exposed to the virus, as long as they don’t feel sick, get tested after five days and wear a high-quality mask around others for 10 days.
Many executives and city leaders who had been struggling to break pandemic work-from-home habits see this as a boost to their halting efforts to bring people back into the workplace. They say that previous CDC recommendations made it difficult to enforce their policies, since one exposure could send an entire team home.
It’s worth noting that the CDC issued the revised guidance even though its Spring 2022 innovation based on community levels of the Covid is blinking red.
Overall, 51 out of 52 jurisdictions* had high- or medium-level counties this week. Nevada is the only jurisdiction to have all counties at low Community Levels.
The American Hospital Association calls our attention to another aspect of the Administration’s revised guidance:
The Food and Drug Administration yesterday advised people who get a negative result from an at-home COVID-19 antigen test to test themselves again after 48 hours to reduce the risk of missing an infection and spreading the virus to others.
“Today’s recommendations are based on the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result,” the agency said
Govexec brings us up to date on the ongoing litigation against the federal government’s Covid vaccination mandate
Remember the vaccine mandate for federal contractors that President Biden issued last September?
Ambika Biggs, a partner at the law firm Hirschler who specializes in government contracting, told Government Executive earlier this week the matter is likely to be appealed to the Supreme Court, especially if there is a circuit split on decisions.
These cases really “come down to the interpretation of the Federal Property and Administrative Services Act, which is just called the Procurement Act” and “whether President Biden had authority under that act to issue the executive order that put the federal contractor mandate in place,” said Biggs. The main argument she’s seen in the pleadings is that “there wasn’t a close enough nexus between wanting an economical and efficient system for procurement and the actual vaccine mandate,” and the mandate was more about public health, which is usually under states’ jurisdiction.
The FEHBlog does not expect this issue to get to the Supreme Court.
From the monkeypox front, Beckers Payer Issues recounts seven payer reactions to the announcement of a public health emergency.
From Capitol Hill, the American Hospital Administration reports
The House today voted 220-207 [along party lines] to pass the Senate’s [budget reconciliation bill] (H.R. 5376), sending it to President Biden for his signature. Passed by the Senate Sunday, the roughly $700 billion social spending package would extend for three years the American Rescue Plan Act’s expanded subsidies for coverage purchased through the Health Insurance Marketplaces; allow Medicare to negotiate prices for insulin and certain other drugs; implement tax changes and spending subsidies to address climate change; and reduce the deficit, among other provisions.
The International Foundation of Employee Benefit Plans offers six aspects of the legislation that are relevant to employers and health plan sponsors.
While the prescription drug provisions of the law are tied only to Medicare Parts B and D, employers and plan sponsors that provide retiree health care benefits, especially through employer group waiver plans (EGWPs), will want to be familiar with this legislation and its impact. They may wish to discuss changes with their advisors to see how their plans may be affected.
That’s good advice.
From the U.S. healthcare costs front, the benefits consulting firm Mercer announced
While significantly higher than the increase of 4.4% projected for 2022, the 2023 increase lags overall inflation, which is currently running at about 9% (see Figure 1). According to Sunit Patel, Mercer’s Chief Actuary for Health and Benefits, “Because health plans typically have multi-year contracts with health care providers, we haven’t felt the full effect of price inflation in health plan cost increases yet. Rather it will be phased in over the next few years as contracts come up for renewal and providers negotiate higher reimbursement levels. Employers have a small window to get out in front of sharper increases coming in 2024 from the cumulative effect of current inflationary pressures.”
From the U.S. healthcare business front, Becker’s Payer Issues reports
Humana has completed the sale of a 60 percent stake in its subsidiary Kindred at Home’s hospice and personal care business to the private equity firm Clayton, Dubilier & Rice. The divisions have been restructured into a standalone company, according to an Aug. 11 Humana news release. The $2.8 billion deal was first announced in April. “Humana will continue to support the long-term success of these operations through our minority ownership and ongoing strategic partnership,” CFO Susan Diamond said in the news release.
Health Care Service Corp. has signed an agreement to purchase Trustmark Health Benefits from employee benefits firm Trustmark for an undisclosed amount. HCSC, the parent company of BCBS Illinois, Montana, New Mexico, Oklahoma and Texas, said in an Aug. 11 news release the acquisition would allow the company to serve more members that desire more customizable health benefits. Trustmark Health Benefits provides voluntary benefits, fitness management products and small group plan administration. The Lake Forest, Ill.-based company said no changes to benefits for existing members will occur when the deal is expected to close later this year.
UnitedHealthcare is rebranding one of its fastest-growing health plan designs. Surest plans, first launched in 2016 as Bind, are available nationwide for self-funded employers and in 11 states for fully insured plans. UHC said it plans to make Surest available as an option for fully insured customers in five more states by the end of the year. Surest plans have the fastest growth rate among its employer-sponsored plan designs, the insurance giant said Thursday.
From the Capitol Hill front, Health Affairs Forefront offers articles from
Prof. Katie Keith on the Affordable Care Act provisions in the budget reconciliation bill (H.R. 5376) that the House of Representatives will take up on Friday, and
Prof. Rachel Sachs on the Democrats’ drug pricing proposal in that bill.
The FEHBlog found information in Prof. Sachs’ article about the proposed $35 cap on insulin copayments.
[T]he IRA was drafted to include a $35 out-of-pocket cap on insulin not only for Medicare beneficiaries, but also for privately insured patients. The parliamentarian ruled that the application of this out-of-pocket cap to privately insured patients did not comply with the reconciliation rules. Rather than unilaterally remove this provision (as the Democrats did with the inflationary rebate provision), Democrats chose to advance the bill with the provision included. Republican Senators then chose to challenge its inclusion, and 43 Republicans voted to strip the $35 out-of-pocket cap for privately insured patients from the bill, enough to result in its removal. (Although seven Republicans voted with all 50 Democrats to keep the cap, the provision needed 60 votes to remain in the bill.)
The Hill adds “Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on [non-Medicare] patients’ insulin costs back up for a vote this fall after Republicans blocked it over the weekend.”
Roll Call discusses the cost shifting between Medicare and other insurance programs, including the FEHBP, once the law is enacted and takes effect. Medicare does not negotiate prices with providers; it sets them.
President Biden announced on Wednesday his intent to appoint a prominentsurgeon and professor who has been at the vanguard of advances in cancer treatment to lead the federal government’s main agency for cancer research and training.
The president will appoint Dr. Monica Bertagnolli to be director of the National Cancer Institute, part of the National Institutes of Health, which has about 4,300 employees and had a $6.35 billion budget in fiscal 2021. She is currently the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute, a top cancer hospital. Bertagnolli will be the first woman to hold this position.
“Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology, advancing, in particular, current understanding of the gene that promotes gastrointestinal cancer development,” said an announcement from the White House. “As a physician-scientist, she led gastrointestinal science initiatives from 1994 to 2011 within the [National Cancer Institute]-funded Cancer Cooperative Groups.” She also served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center from 2007 to 2018.
Good luck, Dr. Bertagnolli.
From the omicron and siblings front, Forbes reports
Pfizer and BioNTech have completed clinical trials for vaccines that include specific protection against the original omicron variant. Now the two companies have begun testing for vaccines specific to the BA.4 and BA.5 Omicron subvariants, which are the fastest spreading variants of Covid-19 in the United States. Manufacturing for the new vaccines has already begun, and could be rolled out as early as October pending regulatory approvals. That’s good news as we approach the fall and winter, which have been the times of year where Covid spread is at its highest. Competitor Moderna has also begun testing an omicron-specific booster, but the FDA has not yet authorized any Omicron-specific vaccines.
Researchers have identified monkey antibodies that are effective against numerous Covid variants and other coronaviruses, a discovery that could help scientists develop better vaccines and prepare for future pandemics as pharma firms race to update their shots.
If the monkey antibodies research is successful, then the WHO definitely should change monkeypox’s name.
From the medical research front, STAT News tells us
With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month.
By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.
The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — though not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.
Fingers crossed for a successful outcome.
From the U.S. healthcare business front, Fierce Healthcare reports
Amazon Care, which currently offers virtual health visits, in-person primary care visits at patients’ homes or offices and prescription delivery, is adding behavioral health care to its slate of services.
Amazon’s health service business plans to team up with teletherapy startup Ginger as an optional add-on to Amazon Care. Through the partnership, Amazon Care users will be connected to Ginger’s on-demand mental health services including behavioral health coaches, licensed therapists and psychiatrists, according to a live website about the service. * * *
The new service hasn’t launched yet, according to people familiar with the matter, Business Insider reported.
As an aside, Smart Brief discusses telemedicine in pediatrics.
Fierce Health also tells us
A company with a long history of providing medical supplies for chronic conditions is expanding its business into monitoring and coaching services for diabetes patients.
CCS, which now includes CCS Medical and CCS Health, aims to provide a more integrated experience for chronic care management, Tony Vahedian, CEO of CCS, said in an interview. * * *
“We believe we’re in the appropriate position to really take that fragmented experience and make it an integrated, seamless experience because not only can we deliver the products at the time, but we also can coach them and provide that clinical care,” the CEO noted. CCS can combine its home-delivered medical supplies business with accredited clinicians supported by proprietary data and technology to simplify the patient experience, he added.
The company supports more than 200,000 patients living with chronic conditions in the U.S. and delivers more than 1.2 million shipments of medical supplies to patients in their own homes.
From the nudging front, Health Payer Intelligence shares another survey illustrating that participants in employer-sponsored health plans need more help with health plan literacy.
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