Tuesday’s Tidbits

Congress

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Happy National Employee Benefits Day, an occasion created by the International Foundation of Employee Benefit Plans.

From the Capitol Hill front, Roll Call reports

The week is still young. But prospects for getting a bipartisan supplemental aid package for pandemic response efforts to President Joe Biden’s desk before a two-week recess seem increasingly remote.

Without a deal on amendments Republicans want to offer, the Senate on Tuesday rejected a procedural motion needed to begin debate on the bill, which would provide $10 billion for the Department of Health and Human Services to buy more therapeutics, vaccines and testing supplies and prepare for future virus variants.

Utah Sen. Mitt Romney, the lead GOP negotiator, said the underlying bill will have enough bipartisan support to pass if leaders can agree on an amendment process, but it’s an open question whether it will get done before the recess.

From the Omicron and siblings front, the Wall Street Journal reports

The Omicron BA.2 variant is increasing its share of U.S. cases and putting particular pressure on parts of the Northeast, where wastewater readings and Covid-19 cases have ticked upward again from low levels.

Recorded Covid-19 cases remain low nationally and hospitals are treating the smallest number of Covid-19 patients after any surge. Places where cases are rising, including New York, are reporting relatively small increases from recent troughs. The mixed signals are prompting officials to warn that BA.2 will likely lead to more viral transmission, but also hope among public-health experts that warming weather and built-up immunity in the population are muting the variant’s impact.

“There are certainly some big factors that are in our favor right now compared to the situation back in November and December,” said Bruce Y. Lee, professor of health policy and management at the City University of New York School of Public Health.

From the White House, the Administration announced

  • A “whole of government” effort to prevent, detect, and treat long Covid. Long Covid is a topic at the OPM AHIP FEHB carrier conference to be held virtually on April 27 and 28, 2022.
  • A regulatory fix to the so-called family glitch in the Affordable Care Act. The family glitch that this fix addresses stems from the fact that the ACA does not require employers to make contributions to family member coverage. “Should today’s proposed rule be finalized, family members of workers who are offered affordable self-only coverage but unaffordable family coverage may qualify for premium tax credits to buy ACA coverage.” In the FEHBlog’s personal experience, the unaddressed family glitch is that that small employers (generally under 50 employees) must pay for each family member’s coverage on an age rated basis instead of the plus one or plus and family rates that large employers are permitted to use. Pre-ACA, all employers could use the bucket approach to family member rating. The proposed regulation won’t fix that problem.

agencies (as described in section 3502(1) of title 44, United States Code, except for the agencies described in section 3502(5) of title 44, United States Code) with responsibilities related to Americans’ access to health coverage shall review agency actions to identify ways to continue to expand the availability of affordable health coverage, to improve the quality of coverage, to strengthen benefits, and to help more Americans enroll in quality health coverage.  As part of this review, the heads of such agencies shall examine the following:

(a)  policies or practices that make it easier for all consumers to enroll in and retain coverage, understand their coverage options, and select appropriate coverage;

(b)  policies or practices that strengthen benefits and improve access to healthcare providers;

(c)  policies or practices that improve the comprehensiveness of coverage and protect consumers from low-quality coverage;

(d)  policies or practices that expand eligibility and lower costs for coverage in the ACA Marketplaces, Medicaid, Medicare, and other programs;

(e)  policies or practices that help improve linkages between the healthcare system and other stakeholders to address health-related needs; and

(f)  policies or practices that help reduce the burden of medical debt on households.

These are interesting objectives, but FEHB typically is not considered to be a employee benefit program and not a government health program.

From the healthcare business front

  • Beckers Hospital Review tells us “Walmart Health will open five new clinics in Florida, according to an April 5 press release.” Healthcare Dive offers a deep dive into Walmart’s healthcare efforts in the Sunshine State.

UnitedHealth Group’s Optum and Change Healthcare have further extended their merger agreement to Dec. 31. The extension comes ahead of a two-week trial to determine the deal’s fate.

The Department of Justice sued to block the merger in late February, alleging that the combination could allow UnitedHealth to get a leg up on its competitors in the insurance space. The deal was first announced in January 2021 and is valued at $8 billion in cash and $5 billion in debt.

The trial is set to begin on Aug. 1.

“The extended agreement reflects our firm belief in the potential of our combination to improve healthcare and in our commitment to contesting the meritless legal challenge to this merger,” the companies said in a joint statement Tuesday.

From the tidbits department

  • Shatterproof offers alcohol awareness resources in recognition of April being Alcohol Awareness Month.
  • Per Health Day, “Significantly higher average body mass index (BMI) and obesity prevalence rates were seen among U.S. adults during the COVID-19 pandemic, according to a study published online April 4 in the American Journal of Preventive Medicine.” The complete journal article is available here.
  • The same preventive medicine journal also offers an article on mortality rates of childbearing aged women in our country. “Given the high correlation between pregnancy-related mortality and all-cause mortality at the state level, addressing the structural factors that shape mortality risks may have the greatest likelihood of improving women’s health outcomes across the life course.”
  • The HHS Inspector General has created a website on telehealth.

The Office of Personnel Management last week offered guidance to agencies on how they should implement the recently enacted benefit providing federal workers with up to two weeks of paid bereavement leave following the death of a child.

The new leave was adopted as part of the 2022 National Defense Authorization Act, signed by President Biden last December.

In a memo to agency heads, OPM Director Kiran Ahuja wrote that although each agency is responsible for its own implementation of the new benefit, her agency wants to ensure that it is provided to employees across government “in an equitable and uniform way.”

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports

Senate negotiators have reached agreement on a $10 billion pandemic relief package that includes funding for domestic needs but not international aid, according to two Senate aides who were not authorized to speak publicly.

The deal crystallizes an informal “agreement in principle” the parties reached last week to provide $10 billion for near-term pandemic needs by repurposing unspent funds from prior relief laws.

The Wall Street Journal adds

The White House backed the deal and urged Congress to pass the bill promptly, while noting it was less than the $22.5 billion the administration had requested for vaccines, boosters, treatments and testing.

“We will continue to work with Congress to fund our remaining domestic needs,” said Press Secretary Jen Psaki in a statement. She added that the White House would continue to press for funding global vaccination efforts.

The FEHBlog noticed that the Senate Homeland Security and Governmental Affairs Committee held a business meeting last Wednesday. The Committee favorably reported the President’s nomination of Kristin Boyd to be OPM Inspector General by voice vote (with Sen. Hawley (R Mo.) voting no). The next step for Ms. Boyd’s nomination is the Senate floor.

Last week, the House of Representatives passed a Secure 2.0 bill applicable to private sector defined contribution plans. The Senate is likely to approve the bill too. The Society for Human Resource Management has reviewed the bill’s provisions.

From the Omicron and siblings front —

  • Becker’s Hospital Review informs us “The World Health Organization is monitoring a new omicron variant — dubbed XE — that’s a hybrid of BA.1, the original omicron strain, and BA.2, a highly transmissible subvariant.” The hybrid is estimated to be 10% more contagious that BA.2.
  • American Hospital Association tells us “Beginning today through the end of the public health emergency, Medicare Part B beneficiaries may obtain up to eight free over-the-counter COVID-19 tests per month through eligible health care providers and pharmacies, the Centers for Medicare & Medicaid Services announced.” Medicare Part B beneficiaries can obtain the free tests by showing their Medicare identification card.
  • The American Medical Association discusses “How we will know when COVID-19 has become endemic.” The FEHBlog tends to think that we are there.
  • The Centers for Disease Control announced

The new nationwide Test to Treat initiative provides quick access to free treatment for COVID-19. Through this program, people can get tested and – if they are positive and treatments are appropriate for them – receive a prescription from a health care provider, and have their prescription filled all at one location. 
These “One-Stop Test to Treat” sites are available at hundreds of locations nationwide, including pharmacy-based clinics, federally qualified health centers, and long-term care facilities. 
People can continue to be tested and treated by their own health care providers who can appropriately prescribe these oral antivirals at locations where the medicines are distributed. 
A call center 1-800-232-0233 is available every day from 8:00 am to midnight ET to get help in more than 150 other languages.
The Disability Information and Access Line is available to help people with disabilities access services. Call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

From the CMS front, the agency announced that “the updated MMSEA Section 111 GHP User Guide version 6.5 has been posted to the GHP User Guide page on CMS.gov. Refer to Chapter 1 for a summary of updates.” Section 111 is a system that has been in place for about 12 years. Section 111 helps CMS keep tabs on Medicare beneficiaries and beneficiaries using data group health plans, including FEHB plans, automobile and liability insurers, and attorneys for injured Medicare beneficiaries.

CMS also released “the Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement).”

From the healthcare conference front, Fierce Healthcare tells us about the 2022 Health Datapalooza and National Health Policy Conference being held today and tomorrow in Arlington, VA.

From the federal employment front, Govexec reports

Federal employees can hold elected partisan office while also working at their agencies, a key panel found in a ruling setting a new precedent for civil servants. 

Rodney Cowan did not have to give up his role as a county commissioner in Tennessee or be removed from his job with the U.S. Postal Service, the recently reconstituted central body of the Merit Systems Protection Board said in a decision last week. It was one of the first decisions of MSPB’s central board as it addresses its backlog of more than 3,500 cases that have piled up during its five years without a quorum. 

The FEHBlog doubts that we have heard the last word on this issue.

Weekend Update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

This week, the House of Representatives and the Senate will be in session for flooring voting and Committee business. In addition, the House and the Senate will be taking District and State work breaks for two weeks beginning next Monday.

From the Omnicron and siblings front, the New York Times Well column advises on preparing now for the next surge. Of course, as we lawyers say, the Times is assuming facts not in evidence. Nevertheless, given the huge Omnicron surge last winter, an ounce of prevention may become a pound of cure.

Last week, Bloomberg updated its Covid resiliency ranking of the world’s countries. The U.S ranks 24. Norway, the United Arab Emirates, and Ireland hold the top three spots. Mainland China ranks 48, and Russia and Hong Kong have the last two spots, 52 and 53.

From the Rx coverage front, STAT News brings us up to date on the Mark Cuban Cost Plus Drug Company.

Mark Cuban’s drug company started with an ambitious premise: to circumvent middlemen to offer cheaper costs to patients.

To do so, the company has had to grapple with which parts of the supply chain to develop themselves, and which to outsource using unusually transparent contracts, Mark Cuban Cost Plus Drug Company Founder and CEO Alex Oshmyansky said Thursday at STAT’s Breakthrough Science Summit.

“We decided that the only way to really ensure that pricing for our products actually reaches the patient, the most important part at the end of the day, was to build essentially a parallel supply chain,” Oshmyansky said.

But the company’s ambitions to entirely recreate the pharmaceutical supply chain have started smaller in the process of exploring what’s possible, and what’s profitable.

For example, instead of manufacturing many drugs to sell them cheaply, the company is choosing to focus on manufacturing drugs in shortage to ensure there’s a market for them, and working directly with existing generic manufacturers to keep costs down.

“​​We basically said, ‘Hey, why don’t we, instead of going through the effort of manufacturing these products ourselves, why don’t we just purchase them and just sell them close to their actual price?’” Oshmyansky said.

A lofty plan to create their own pharmacy benefit manager has also been shelved for the moment, though Oshmyansky insisted it’s not off the table entirely. Instead of creating its own PBM, the company instead chose to whitelist PBMs that behave well for the moment.

From the health plan front —

  • OPM and AHIP will hold the annual FEHB Carrier Conference later this month. Recently AHIP posted the conference agenda. In addition, the early registration discount ends on Friday, April 8.
  • Last week, AHIP provided a lengthy list of health insurer actions to address social determinants of health. Bravo.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill

Roll Call tells us

Senators negotiating a COVID-19 supplemental funding package have an “agreement in principle” to provide roughly $10 billion for the Department of Health and Human Services to stock up on waning domestic supplies for combating the virus, according to Sen. Roy Blunt, R-Mo.

Blunt, the top Republican on the Senate Labor-HHS-Education Appropriations Subcommittee, said both parties have tentatively agreed to offsets for the $10 billion that would repurpose unspent funds from prior pandemic relief laws.

The offsets negotiators agreed to include $2.2 billion from unused grant funds for venues like zoos and theaters and $2 billion in untapped assistance to the aviation and manufacturing industry, Blunt said. His comments to reporters came after a Republican Conference lunch in which lead GOP negotiator Sen. Mitt Romney of Utah briefed his colleagues on the agreement in principle. 

Fierce Healthcare informs us

The House [of Representatives] passed a bill on Thursday that caps the out-of-pocket cost of insulin at $35 a month for beneficiaries in Medicare Part D and for certain group and individual plans.

The Affordable Insulin Now Act, which passed the House via a 232 to 193 vote, comes as work in the Senate continues on a bipartisan alternative that could bring additional changes. * * *

Private plans would also be required to offer first-dollar coverage of insulin without any deductible, according to an analysis from the Congressional Budget Office. 

The cap on cost-sharing for private insurance plans would implement in 2023.

The Hill offers a related article explaining why insulin prices are so “troubling” high.

HR Dive reports

Among the provisions of this month’s $1.5 trillion omnibus spending bill, Congress included a revival of an exemption that allowed high-deductible health plans to cover telehealth before individuals meet their deductible.

The provision was originally created by the Coronavirus Aid, Relief, and Economic Security Act, which sunset at the end of 2021. The provision will resume April 1 but will again sunset at the end of this year.

From the Omicron and siblings front, the Wall Street Journal discusses the state of Covid treatments and offers its advice on who should seek out a second Covid booster besides the immunocompromised.

From the OPM front, Govexec projects OPM’s actions over the next 18 months based on the FY 2022 to FY 2026 strategic plan released last Monday. In short, “Hire, Hire, Hire.”

Govexec also discusses efforts underway by OPM, the Social Security Administration and the Thrift Savings Plan to improve the customer service experience of federal employees and retirees. Good luck with that.

From the research front the National Institutes of Health announced

Scientists have published the first complete, gapless sequence of a human genome, two decades after the Human Genome Project produced the first draft human genome sequence. According to researchers, having a complete, gap-free sequence of the roughly 3 billion bases (or “letters”) in our DNA is critical for understanding the full spectrum of human genomic variation and for understanding the genetic contributions to certain diseases. The work was done by the Telomere to Telomere (T2T) consortium, which included leadership from researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health; University of California, Santa Cruz; and University of Washington, Seattle. NHGRI was the primary funder of the study.

Analyses of the complete genome sequence will significantly add to our knowledge of chromosomes, including more accurate maps for five chromosome arms, which opens new lines of research. This helps answer basic biology questions about how chromosomes properly segregate and divide. The T2T consortium used the now-complete genome sequence as a reference to discover more than 2 million additional variants in the human genome. These studies provide more accurate information about the genomic variants within 622 medically relevant genes. * * *

The now-complete human genome sequence will be particularly valuable for studies that aim to establish comprehensive views of human genomic variation, or how people’s DNA differs. Such insights are vital for understanding the genetic contributions to certain diseases and for using genome sequence as a routine part of clinical care in the future. Many research groups have already started using a pre-release version of the complete human genome sequence for their research.  

From the mental healthcare front, the American Hospital Association calls our attention to a new GAO report.

Consumers with health coverage experience challenges finding in-network mental health providers, who may not be accepting new patients or have long wait times to see them, according to a new report from the Government Accountability Office. Factors contributing to these challenges include low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks, GAO said. The report also looks at ongoing and planned federal efforts to address these challenges, for example by increasing the mental health workforce, mental health system capacity and oversight of health plan compliance with mental health parity laws.

This squib caused the FEHBlog to recall a comment that he heard at a conference — Four out of five doctors are in-network but only one out of five mental health providers are in-network with the notable exception of hub and spoke telemental services.

Yesterday the FEHBlog suggested that in return for three free primary care visits and three behavioral health visits, plan members should name and use their in-network primary care provider and primary mental health provider. The FEHBlog is sticking with this idea for the in-network primary care provider but he recognizes the idea may be premature for the in-network primary mental health provider. Of course, creating a looser standard for free mental health care compared to primary care is compliant with the federal health parity rule. The reverse would violate the often fuzzy non-quantitative treatment limitations created by the law.

From the miscellany department —

  • STAT News tells us “With Medicare expected to cover a projected 80 million people by 2030,He entrepreneurs and investors are cashing in on what analysts see as an inevitable shift in health care away from the hospital and into the homes of aging patients.” The publication identifies five related technology trends.
  • Fierce Healthcare reports “Virtual care startup Hims & Hers is teaming up with Carbon Health to offer patients in California with direct access to providers for in-person medical appointments at clinics. The collaboration will provide easy and comprehensive access to a broader range of care options through the Hims & Hers platform, company executives said.”
  • Health Payer Intelligence informs us “Large employers are investing more in their wellness program design in 2022 and their programs revolve around hybrid work environments, job satisfaction, and equity, the Business Group on Health found in a survey.”

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The House of Representatives and the Senate will be in session for Committee business and floor voting on Capitol Hill this week.

The President will send his fiscal year 2023 federal budget to Capitol Hill tomorrow. The Wall Street Journal offers an explanatory article about this process.

From the federal employment front, Federal News Network discusses the progress of recalling federal employees to their offices.

Also, the FEHBlog noticed that the Federal Times offers a 2022 Federal Benefits Guide — “Answers to commonly asked questions from federal employees, helpful resources, and more.”

From the vaccines front —

  • Precision Vaccines informs us “After decades of false starts, new research indicates four Respiratory Syncytial Virus (RSV) vaccine candidates are nearing the completion of late-stage trials. According to the U.S. CDC, RSV vaccines could drastically reduce hospital and intensive-care admissions for young children and seniors.” Fingers crossed.

[T]here is now a growing body of research that’s offering at least some reassurance for those who do end up getting infected — being fully vaccinated seems to substantially cut the risk of later developing the persistent symptoms that characterize long COVID.

While many of the findings are still preliminary, the handful of studies that have emerged in the past half year are telling a relatively consistent story.

“It may not eradicate the symptoms of long COVID, but the protective effect seems to be very strong,” says epidemiology professor Michael Edelstein, of Bar-Ilan University in Israel, who’s studying long COVID.

From the mental healthcare front —

  • The Wall Street Journal reports “Telemedicine startups make it easier to get ADHD Drugs. That made some [startup] workers anxious. Digital companies such as Cerebral and Done seized on looser pandemic rules for prescribing ADHD drugs like Adderall. Some workers said they felt pressure to provide the medications.”
  • Health Payer Intelligence points out

Employee mental healthcare spending rose, and employer mental healthcare spending fell after employers transitioned their workers from preferred provider organizations to high deductible health plans, a study from the Employee Benefit Research Institute (EBRI) found.

The researchers focused on individuals who had been diagnosed with one of three specific mental health conditions to assess the impact of transitioning from a preferred provider organization to a high-deductible health plan: anxiety, attention deficit hyperactive disorder (ADHD), and major depressive disorder (depression).

The study received funding from a handful of organizations, including the Blue Cross Blue Shield Association, the Independent Colleges and Universities Benefits Association (ICUBA), Pfizer, and PhRMA.

[T]he researchers indicated that high deductible health plans could be improved if employers apply value-based care to their high deductible health plan benefit design.

“Smarter deductibles accommodating services preventing the exacerbation of chronic conditions might be a natural evolution of health plans,” the study concluded. “Interventions that improve patient-centered outcomes while maintaining affordability may be found in the form of a clinically nuanced health plan that better meets workers’ clinical and financial needs.”

Because it remains National Kidney Month, the FEHBlog wishes to draw attention to this Fierce Healthcare article about how CVS Health offers personalized kidney care for health plan members.

CVS Kidney Care aims to provide an end-to-end experience to manage kidney care in the long term before it reaches chronic kidney disease or end-stage renal disease. It takes a home-first approach to its care model and is currently co-developing a hemodialysis device that is built specifically with home care in mind.

The device is co-developed by Deka Research & Development and is currently in clinical trials. [CVS Kidney Care President Lisa] Rometty said CVS expects to complete the trial by the end of this year, with anticipated approval and launch sometime in 2023.

CVS chose to get involved in developing the tool, she said, because the company saw an unmet need in the market for a device that’s built from the ground up for in-home dialysis rather than adapted to it. Existing tools are not designed to be easy for a senior patient to understand, for example, Rometty said.

“We did it because we really felt strongly at the time that there wasn’t at the time a device that would meet the unique experience and ease of use and also the safety and clinical aspects,” Rometty said.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

Readers — The FEHBlog wrote the Weekend Update post yesterday, but the publish button didn’t do the job. As a result, the Weekend update post was not emailed out yesterday but you can read it on our firm’s website.

From Capitol Hill, Roll Call updates us on Administration efforts to obtain additional Covid funding.

House Majority Leader Steny H. Hoyer, D-Md, said last week that lawmakers were looking at other previously appropriated pandemic funding that could be reallocated to pay for the $15.6 billion package lawmakers had agreed on.

The White House is urging Congress to pass the supplemental package [totallling $22.5 billion] without offsets, as it did with bipartisan support early in the pandemic.

But Republicans are unlikely to back any COVID aid package without sufficient offsets.

From the Omicron and siblings front —

  • The Wall Street Journal seeks to inform its readers about available Covid treatments.
  • Medscape explains why doctors are finding hurdles to use Covid pills to treat the disease. “Doctors hailed the pills as a huge advance in the fight against COVID-19 partly because of their convenience compared to other treatments that require infusions or injections. But patients can miss the pills’ short window if they dismiss symptoms like a headache or sniffles and wait [more than five days after symptoms present] to see if they go away before seeking help.” This appear to be where the test to treatment program can help, but where is promised website?

In other healthcare news —

  • Healthcare Dive considers what is holding up the widespread adoption of hospital at home programs.
  • Fierce Healthcare offers an interview with Javier Rodriguez, the CEO of the leading dialysis company DaVita.
  • Health Payer Intelligence discusses AHIP’s views on the advantages of applying value based care approaches to maternity services.

From the upcoming events front

  • AHIP informs us

The Office of Intergovernmental and External Affairs will host a virtual event on Tuesday, March 22nd – 3:30pm-4:30pm to hear from Josh Peck, Deputy Assistant Secretary for Public Engagement, about communications resources to encourage those who are eligible to get their COVID- 19 booster.

Deputy Assistant Secretary Peck will share background and information on how to access resources to support your efforts. Following the presentation there will be time for Q & A.

PEC Brief: Payers

Tuesday, March 22nd | 3:30 – 4:30 PM EDT

Zoom Meeting Link | Passcode: 591497 Meeting ID: 160 756 9170

Dial by your location

+1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York) +1 551 285 1373 US

  • The Centers for Disease Control tells us

Tuesday, March 22nd is Diabetes Alert Day—an annual wake-up call to inform the public about the seriousness of diabetes. Did you know:

  • More than 37 million people in the United States have diabetes, and 1 in 5 of them don’t know they have it.
  • 96 million US adults have prediabetes, but more than 8 in 10 of them don’t know they do.
  • In the last 20 years, the number of adults diagnosed with diabetes has more than doubled as the American population has aged and obesity has increased.

If you have diabetes, you’re not alone! Join us on social media this Diabetes Alert Day to share your tips on living well with diabetes and learn what others are doing too.

WHO: We’ll be talking to our followers (that means YOU too) to hear their tips and strategies on managing diabetes, diabetes-friendly food hacks, and more!

WHEN: Tuesday, March 22nd from 9:30 AM to 5 PM ET.

WHERE: You can find us on Twitter or Facebook when you use or search for #TipsForDiabetes.

WHY: To spread awareness and connect with others who are living with diabetes.

Weekend Update

David Ermer–Congress, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Today has been the first day of Spring. But, it is the first day of Fall for my youngest son, who is studying medicine at Queensland University in Brisbane, Australia.

The House of Representatives is on a district work break this week. Meanwhile, the Senate will be engaged in committee business and floor voting on Capitol Hill.

Fedweek discusses the highlights of the call letter for 2023 benefit and rate proposal letters that OPM released last week.

OPM has told FEHB carriers to continue with increased levels of telehealth and other services related to the pandemic in the 2023 plan year, while also either ordering or encouraging them to expand benefits for certain other conditions.

While Fedweek gets the facts right, its article overlooks that OPM’s orders diminish FEHB competition which Congress relies upon to control premiums.

From the cost management front, Fierce Healthcare tells us

While prior authorization is a key tool in an insurer’s arsenal as it thinks about managing costs, the process remains a key source of friction with physicians.

Amid a nationwide conversation around addressing physician burnout and stress, plans are seeking ways to grow automated and virtual prior auth technologies to ease those barriers. At eviCore Healthcare, the benefit management arm of Cigna’s Evernorth subsidiary, the team has found one of the keys to success in this endeavor is bringing physicians into the conversation early on.

Eric Gratias, M.D., eviCore’s chief medical officer, told Fierce Healthcare that prior authorization programs are often built by people who, while well-intentioned, lack first-hand knowledge of what a clinical encounter is like.

The company’s own prior authorization technology, intelliPath, is built on collaboration with physicians who are actively practicing, he said.

“That partnership with our provider clients is absolutely critical for our success,” Gratias said.

Good point.

From the Rx coverage front

  • NPR Shots points out significant problems with the distribution of Covid treatments.

[D]ata on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. 

“We are still in a public health emergency,” said Dr. Derek Eisnor, who leads the government’s distribution of COVID drugs, on a call with national health organizations on March 16. He urged health leaders to try to get the drugs to communities that have a demand for them, rather than let them go to waste. 

“There’s an assumption that there’s not enough of [these drugs] around but it does seem when you look at the numbers that there is a lot around — it’s just not being used,” says Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They clearly are not getting to people at high enough rates to have their maximum impact.” * * *

It can be hard to know which pharmacies have the pills in stock or which infusion clinics have appointments available. A patient needs to be able to quickly find a clinician, get a diagnosis and prescription, and be able to access the treatment, all within a few days. 

“It’s multifactorial why these drugs are underutilized,” Adalja says. “It’s likely all of those things are playing some role in the discrepancies between what’s been ordered and and what’s actually been administered.”

The Biden administration launched the Test to Treat initiative this month to address these gaps. “We know the challenges that are involved with patients obtaining therapeutics,” said Dr. Meg Sullivan, acting chief medical officer for HHS’ Office of the Assistant Secretary for Preparedness and Response, in a call with clinicians on March 12. The program aims to improve access to rapid testing and to bolster public and provider awareness of available COVID treatments and how to get them.

Here is a link to the HHS website that offers a U.S map that “displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The long-acting antibody combination, Evusheld; monoclonal antibody treatments, bebtelovimab and sotrovimab; as well as the oral antiviral therapies, Paxlovid and molnupiravir are products authorized by the FDA for either prevention (Evusheld) or treatment (Paxlovid, sotrovimab, bebtelovimab, and molnupiravir) of COVID-19.   The locations displayed in the locator have reported available courses within the last seven days.”

The test to treat program’s website is not online yet as far as the FEHBlog can tell.

On March 30, the Food and Drug Administration is bringing together outside experts in neurology to review an experimental drug from Amylyx for the treatment of amyotrophic lateral sclerosis, or ALS. The hearing is expected to be closely watched by ALS patients and their advocates, given the significant need for new treatments for the disease.

But the hearing is likely to garner extra attention because it’s the first meeting of the FDA advisory group since it met in November 2020 and voted unanimously against the approval of Aduhelm, Biogen’s drug for Alzheimer’s disease. The FDA later ignored that recommendation and approved the medication, leading to the resignation of three members of the panel and an uproar over whether the agency had compromised its standards.

Sixteen months removed from all the Aduhelm drama, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, restocked with new members, is back to tackle another high-stakes review of a drug targeting a progressive, fatal nervous system disease. The Amylyx treatment — called AMX0035 — isn’t likely to generate the same acrimony as Aduhelm, but it could similarly force the FDA to bend its standards.

Here’s what you need to know about AMX0035, the data from its single clinical trial, and the issues that are likely to take center stage at the FDA advisory panel meeting.

Tuesday Tidbits

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Happy Ides of March. The President signed the Consolidated Appropriations Act 2022 into law today. The Postal Reform Act of 2022 continues to await the President’s signature.

From the Omicron front, David Leonhardt reports on COVID surges in China and Europe. He concludes

Even if [Covid] cases rise [in the U.S. again], as seems likely, there are good reasons not to panic. Vaccination tends to turn Covid into a mild illness, especially for people who have received a booster. For the unvaccinated and unboosted, BA.2 is another reason to get a shot.

It’s also a reason for the federal government and states to expand access to both Evusheld — a drug that can help protect the immunocompromised — and Paxlovid — a post-infection treatment. Finding either is often difficult today. (If you’re looking for one of them, click on this link for Evusheld and this one for Paxlovid.)

The bottom line: Covid isn’t going away, but vaccination and other treatments can keep future increases manageable. The biggest problem remains the millions of people who remain unvaccinated, many of them by choice. That’s the case in the U.S., in Hong Kong and across much of Europe, Africa and the rest of the world.

Inducing more people to get shots — through persuasion or mandates — would probably save more lives than any other Covid policy.

What is the FDA’s hold up in reviewing the standard Covid vaccines for which emergency use authorizations have been filed? As previously noted, the traditional vaccines may be appealing to those resistant to the state-of-the-art mRNA vaccines.

The Wall Street Journal reports

Pfizer Inc. and partner BioNTech SE have asked U.S. health regulators to authorize a second booster dose of its Covid-19 vaccine for people 65 years and older.

The companies said Tuesday that they had filed the application. The Food and Drug Administration is expected to make a decision in time for the Biden administration to begin a potential fall vaccine campaign.

The FDA has been reviewing data and looking at potentially authorizing a fourth dose of the shot for use in the fall, The Wall Street Journal reported last month.

From the Rx coverage front —

STAT News informs us

The prices pharmacy benefit managers and insurers pay for Sanofi medicines have decreased for a sixth consecutive year, yet patient out-of-pocket costs are rising. Once again, there is further evidence that focusing solely on lowering the list price of medicines doesn’t guarantee lower costs for patients. Sanofi pulls back the curtain on the impact of list and net prices and more in its annual pricing report.

and

Back in 2019, when the Senate Finance Committee called seven drug industry CEOs to testify, it seemed like proof that Washington was within striking distance of actually reining in the industry’s high prices. “It’s past time to get beyond the excuses and make prescription drugs affordable,” Sen. Ron Wyden, the top Democrat on the committee, told drugmakers that day. Tomorrow, almost exactly three years later, Wyden will chair another hearing on prescription drug pricing. He’s billing the hearing as “an opportunity for members to discuss how high drug prices have impacted seniors and families in their states and identify solutions” — even though lawmakers have had more than a dozen such hearings to “discuss” high drug prices over the past three years. STAT’s Nicholas Florko tallies what’s at stake in STAT+.

In FDA News, the agency reports approving today “the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.”

From the opioid epidemic front, “the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced two grant programs totaling $25.6 million that will expand access to medication-assisted treatment for opioid use disorder and prevent the misuse of prescription drugs. By reducing barriers to accessing the most effective, evidence-based treatments, this funding reflects the priorities of HHS’ Overdose Prevention Strategy, as well as its new initiative to strengthen the nation’s mental health and crisis care systems.”

From the patient front, HHS’s Agency for Healthcare Research and Quality announced the agency’s

Support for Patient Safety Awareness Week. Ongoing investments in safety research, the development of safety toolkits and training resources, and a growing emphasis on improving diagnostic safety are all part of a mission to make healthcare safe for all Americans. Access more information about AHRQ’s support of Patient Safety Awareness Week, including a special introductory video from Jeff Brady, M.D., director of the Center for Quality Improvement and Patient Safety; information about how to get involved in Patient Safety Awareness Week activities; and recent patient and diagnostic safety resources, including:

— Diagnostic Safety Supplemental Items for the Surveys on Patient Safety Culture (SOPS) Medical Office Survey

— Safer Together: A National Action Plan to Advance Patient Safety

— Making Healthcare Safer III: A Critical Analysis of Existing and Emerging Patient Safety Practices

— AHRQ QuestionBuilder App (also available in Spanish) 

From the HIMSS conference in Orlando, Healthcare Dive tells us

The Biden administration has been working on additional rulemaking to address issues with the payer-to-payer data exchange requirements set out in sweeping interoperability rules finalized in early 2020, and “we look forward to sharing this rule with you soon,” CMS administrator Chiquita Brooks-LaSure told attendees at the HIMSS annual conference in Orlando on Tuesday.

CMS decided not to enforce those provisions when they kicked in this year, after health insurers raised concerns about operational challenges and risks to data quality given a lack of specificity in the rule.

The new rule will incorporate extensive public comment to try to address stakeholder concerns, and will standardize how payers exchange data through application programming interfaces, Brooks-LaSure said.

and

An online tool that allows patients in markets across the country to compare prices for hundreds of hospital services before getting treatment has launched in its beta development stage.

Turquoise Health’s platform uses cost data from machine-readable files made public by hospitals as part of compliance with a federal price transparency rule that went into effect in January 2021.

The San Diego-based startup’s platform includes a scorecard that lets users assess price transparency compliance with the CMS requirements for nearly 6,000 hospitals, Turquoise Health said Monday. Hospitals receive a score based on an algorithm-driven five-star rating system.

Fierce Healthcare reports from the SXSW Conference in Austin, TX.

Samsung and Best Buy executives shared why they place big bets on tech to help elderly Americans age at home.

Experts are laying out the business case to invest in care for underserved communities.

Leaders in women’s health say empowering female patients is key to addressing gender biases in healthcare.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, Mental health care, Patient safety, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front

Medpage Today offers an interesting discussion of the test to treat program.

The Wall Street Journal informs us

A new Covid-19 pill from Merck & Co. and Ridgeback Biotherapeutics LP has been more widely used than expected since rolling out late last year, though regulators and many doctors consider it a last resort. 

Many doctors and health officials anticipated a rival pill, Pfizer Inc.’s Paxlovid, would be the Covid-19 drug of choice. Paxlovid was found to be far more effective than Merck-Ridgeback’s molnupiravir in clinical trials, and regulators and guidelines recommended using Paxlovid if possible.

Prescriptions for the two antivirals have been running about equal since their authorization in December, however. The larger-than-expected use is a sign of the high demand for easy-to-use coronavirus treatments that can be taken at home, especially during surges like the recent Omicron wave.

Govexec tells us

Federal agencies are not restricted on the size of events they host, unless under certain conditions, according to new guidelines. 

The Biden administration’s Safer Federal Workforce Task Force issued updated and new guidance on March 11, most of which reflects the Centers for Disease Control and Prevention’s new framework released in late February. That framework “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” as CDC Director Dr. Rochelle Walensky said on a briefing call. 

There are no “restrictions on the size of agency-hosted in-person meetings, events, or conferences,” said one of the new “frequently asked question” prompts. “Should an agency intend to host a meeting, conference, or event that will be attended in-person by more than 50 participants at a facility in a county where the COVID-19 Community Level is HIGH, the agency should first seek the approval of its agency head or official to which this responsibility has been delegated, in consultation with the agency’s COVID-19 coordination team.” 

From the Rx coverage front –

BioPharma Dive reports good news

The Food and Drug Administration has approved AstraZeneca and Merck & Co.’s drug Lynparza for people with a genetic form of early breast cancer, a decision that could spur greater use of DNA testing in diagnosing and treating the disease.

Lynparza is already used to treat metastatic breast cancer in patients with so-called BRCA gene mutations. The new approval makes Lynparza available earlier in their disease, after surgery to remove a tumor and standard drugs like chemotherapy and radiation. People with cancers that are “HER2-negative” and at a high risk of relapsing are eligible for treatment.

The decision is based on the results of a large study published last year in The New England Journal of Medicine last year. In it, Lynparza reduced the risk of disease progression or death by 42% versus placebo after a median of 2.5 years of follow-up. Updated results show the drug cut the risk of death by about a third, a finding the companies will detail at a medical meeting on Wednesday.

The National Institutes of Health announced launching “a Phase 1 clinical trial evaluating three experimental HIV vaccines based on a messenger RNA (mRNA) platform—a technology used in several approved COVID-19 vaccines.” mRNA developers were working on HIV vaccines before the pandemic struck. Fingers crossed.

Healthcare Dive reports from Capitol Hill

Sen. Chuck Grassley (R Iowa) is urging the Federal Trade Commission to “find consensus” and vote again to launch a study into the business practices of pharmacy benefit managers, according to a letter he sent to FTC Chairwoman Lina Khan dated March 9.

“PBMs operate with little to no transparency, making it very difficult if not impossible to understand the flow of money in the prescription drug marketplace,” the Republican senator from Iowa said in his letter, nodding to the bipartisan consensus for such an examination.

Grassley urged the commissioners to come up with a more targeted focus for the study and suggested narrowing a review to the impact on consumers and their out of pocket costs.

From the patient safety front, Beckers Hospital Review explains

Staffing shortages are the top threat to patient safety in 2022, according an annual report on patient safety concerns from ECRI, an organization that conducts independent medical device evaluations, published March 14. 

Researchers identified the top threats to patient safety by analyzing a wide range of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI. 

Ten top patient safety concerns this year: 

1. Staffing shortages

2. COVID-19 effects on healthcare workers’ mental health

3. Bias and racism in addressing patient safety 

4. Vaccine coverage gaps and errors

5. Cognitive biases and diagnostic error

6. Nonventilator healthcare-associated pneumonia 

7. Human factors in operationalizing telehealth

8. International supply chain disruptions

9. Products subject to emergency use authorization

10. Telemetry monitoring 

From the mental healthcare front, the Department of Health and Human Services announced

A new U.S. Department of Health and Human Services (HHS) study published in the American Medical Association’s journal JAMA Pediatrics  reports significant increases in the number of children diagnosed with mental health conditions. The study, conducted by the Health Resources and Services Administration (HRSA), finds that between 2016 and 2020, the number of children ages 3-17 years diagnosed with anxiety grew by 29 percent and those with depression by 27 percent. The findings also suggest concerning changes in child and family well-being after the onset of the COVID-19 pandemic.

No bueno.

Weekend Update

David Ermer–Congress, Mental health care, Telehealth, U.S. Healthcare–

From Capitol Hill, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Healthcare Dive reminds us that the Healthcare Information and Management Systems Society will hold its annual conference in Orlando, Florida, this week. In addition, Healthcare Dive notes several headliner presentations planned for that conference.

From the health equity front, the Wall Street Journal reports

The fatal overdose rate among Black people surpassed that for white people in the first year of the pandemic, as an increasingly lethal drug supply and Covid-19’s destabilizing effects exacted a heavy toll on vulnerable communities in the U.S.

The proliferation of the potent opioid fentanyl, and a pandemic that has added hazards for people who use drugs, are driving new records in U.S. overdose deaths, and Black communities have been hit especially hard. Black people often have uneven access to healthcare including effective drug treatment, putting them at high risk, researchers and public-health experts say. 

The most recent full-year of federal data, through 2020, shows the rate of drug deaths among Black people eclipsed the rate in the white population for the first time since 1999, researchers at the University of California, Los Angeles recently demonstrated.

What is an effective treatment for substance use disorder? The Journal adds

Researchers at the University of Michigan examining outpatient visits for substance use in recent years found white patients were three to four times as likely as Black patients to receive buprenorphine, a prescription medication to treat opioid dependence that is more readily available to people with health insurance or the means to pay out of pocket.

Health providers are more likely to direct Black patients to methadone, which is delivered by highly regulated opioid-treatment programs that often require daily visits to obtain the medication, researchers have found.

According to Sam Quinones’s books on the opioid and fentanyl problems plaguing our country, drug dealers hang out at methadone clinics.

On a related note, The Psychiatric Times informs us

The positive implications for screening for and treating individuals with SUDs are vast, from preventing HIV and hepatitis in injection-drug users to improving patients’ physical health, mental health, employment, and housing.

Elisa Gumm, DO, who is presenting on “Screening for Addiction in a 20-Minute Appointment” at the “Psychiatry for Non-Psychiatrists: The University of Arizona Update in Behavioral Medicine for Primary Care” conference, stated that “offering addiction interventions at every level reduces the overall costs to the person and society

Also, the New York Times reports on today’s front page about the serious logistical problems facing the federal and state governments as they seek to launch the new 988 suicide hotline on July 1, 2022.

Fierce Healthcare discusses the advantages of using teledentistry with rural patients.

Teledentistry enables rural access to care, lowers costs and helps provide preventive services, a new study has found. 

The CareQuest Institute looked at data for patients in Oregon and Washington. The study included data from more than 60,100 individuals who had a dental visit either in person or through teledentistry in the second half of 2020.

Most (79%) patients with a teledentistry visit had a follow-up visit sometime in 2021, the vast majority of which were in person. Most (60%) had this visit within three weeks of their teledentistry visit, which primarily consisted of diagnostic and restorative services.