Weekend Update

Congress

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. 

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Electronic health records, No Surprises Act, U.S. Healthcare, Uncategorized–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s updated weekly chart of new Covid cases:

Not quite as low as we were in early July but very much moving in the right direction. So is the FEHBlog’s updated weekly chart of new Covid deaths, which is considered a lagging indicator.

The epidemiologists have a keen eye out for new worrisome variants. For example, for other troubling variants, Becker’s Hospital News tells us about a relatively new combination of Delta and Omicron known as Deltacron.

The recombinant variant appears unlikely to spread as easily as delta or omicron, William Lee, PhD, vice president of science at Helix, told USA Today. “We have not seen any change in the epidemiology with this recombinant,” WHO COVID-19 technical lead Maria Van Kerkhove, PhD, said of deltacron during a March 9 media briefing. “We haven’t seen any change in severity. But there are many studies that are underway.” 

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the start of the Covid vaccination era in late 2020 until the week ended this past Wednesday.

It is noteworthy that this week, the percentage of Americans aged 18 and older who are fully vaccinated (two doses of mRNA vaccine) cracked 75%. The same cadre is closing in on being 50% boostered. The most at risk, over age 65 cadre is 89% fully vaccinated and 66.7% boostered.

The American Hospital Association adds

In a study of 1,364 children aged 5-15, two doses of the Pfizer COVID-19 vaccine reduced the risk of omicron infection by 31% in those under 12 and 59% in older children, the Centers for Disease Control and Prevention reported today. CDC said the study reinforces the importance of vaccination to keep children and teens protected from severe disease, noting that another recent study found the vaccine 92%-94% effective against COVID-19 hospitalization in adolescents during the delta surge and 74% effective against hospitalization in younger children during omicron.

Here’s a link to the CDC’s weekly review of its Covid statistics. This week’s issue focuses on protecting folks at high risk for Covid, such as the immunocompromised.

Who is most likely to become very sick or die from COVID-19?  Your chances increase with age and underlying medical conditions like cancer, diabetes, heart conditions, dementia, and obesity, particularly if you’re not up to date on vaccinations. People with weakened immune systems,* some disabilities, some mental health conditions, and some chronic diseases are also at higher risk. A lot of people might not know they’re at risk for severe illness—review the list to find out if you could be.

Here’s a link to the CDC’s weekly Fluview report, which states that flu activity is increasing in “most of the country.” In this regard, the American Medical Association inform us

Healio (3/10, Downey, Gallagher) reports “interim estimates published Thursday in” the CDC’s Morbidity and Mortality Weekly Report “indicate that this season’s influenza vaccine has not been effective.” Based on the data “from more than 3,600 children and adults,” researchers “estimated that the vaccine has been 16% effective against mild or moderate influenza caused by the predominant circulating virus, influenza A(H3N2), with a 95% confidence interval…that suggests vaccination ‘did not significantly reduce the risk of outpatient medically attended illness’ caused by H3N2.”

From Capitol Hill and closing the loop on Thursday’s post, the Senate did pass the fiscal year 2022 omnibus appropriations act Thursday night. Roll Call reports

On a 68-31 vote, the Senate passed the 2,700-page, $1.5 trillion omnibus containing all 12 fiscal 2022 spending bills, $13.6 billion in supplemental appropriations to address the crisis in Ukraine and a lengthy list of unrelated measures fortunate enough to ride on the must-pass vehicle. 

From the No Surprises Act front, the FEHBlog had been concerned that the federal regulators were giving up on using the Qualified Payment Amount as a rebuttable presumption in NSA arbitrations which would help tremendously to control out of network benefit and plan legal costs. The FEHBlog therefore was encouraged to find that the federal government has filed a brief with the federal district court for the District of Columbia defending that position in a case raising the same issue. An oral argument on this issue will be heard by District Judge Richard Leon on March 21, 2022, at 3 pm. The FEHBlog will keep an eye on this and the other federal cases raising this issue.

From the electronic health record front, MedCity News interviews the CEO of Epic Systems at the Vive conference. The interview covers interoperability, artificial intelligence and other timely topics.

From the opioid epidemic front, STAT News reports

It was in the mid-2010s, the researchers heard, when “tranq dope” — opioids that contained the veterinary tranquilizer xylazine — took off in Philadelphia. But now, in some places across the U.S., it was appearing in 1 in 5 overdose deaths. A recent study also found the powerful synthetic opioid fentanyl in nearly every xylazine-involved death as well, indicating it wasn’t just the tranquilizer causing these overdoses. Experts are still trying to understand the risks of xylazine, but they’re worried because the drug is not an opioid but acts as a sedative, which can increase the risk of a fatal overdose. It might also make it harder to reverse those overdoses with naloxone, which is designed to work on opioids. STAT’s Andrew Joseph has more on how adulterated — and in turn, increasingly dangerous — the U.S. drug supply has become.

Rur roh.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–

From Capitol Hill, the Hill reports

The Senate has locked in a deal to quickly pass a massive government funding bill that includes $13.6 billion in Ukraine aid.

The agreement, announced by Senate Majority Leader Charles Schumer (D-N.Y.), puts the funding bill on a glide path to pass on Thursday night, capping off hours of would-they-won’t-they drama. 

Mazaal tov to Congress.

Also on Capitol Hill today, the Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for Krista Boyd, the President’s nominee to serve as OPM Inspector General. Fedweek notes that “Ms. Boyd is a senior staff member of the House Oversight and Reform Committee with long experience on Capitol Hill in federal workplace matters.”

From the Omicron front, Becker’s Hospital Review informs us “The rate of new COVID-19 cases involving the omicron subvariant BA.2 appears to be slowing in the U.S., according to variant proportion estimates from the CDC.”

Also, the Justice Department announced “Effective immediately, Associate Deputy Attorney General Kevin Chambers will serve as the Director for COVID-19 Fraud Enforcement.”

From the litigation front, Reuters reports “The judge overseeing Purdue Pharma’s bankruptcy on Wednesday approved a $6 billion opioid settlement funded by its Sackler family owners, overruling objections from the Department of Justice and 20 states that opposed the deal.”

From the healthcare business front

Healthcare Dive tells us

Anthem plans to change its name to Elevance Health, if the move is approved by shareholders, the company said Thursday.

The new name is meant to reflect the company’s offerings beyond traditional health insurance. “Elevance Health’s companies will serve people across the entire care journey, connecting them to the care, support, and resources they need to lead healthy lives,” Anthem CEO Gail Boudreaux said in a statement.

Elevance was chosen as a combination of the words “elevate” and “advance.” There will not be any changes to leadership or organizational structure accompanying the new name.

If approved, the Elevance name will start being used at the end of the second quarter of this year. Anthem Blue Cross and Blue Shield plans will still use the Anthem name.

From the telehealth front, Healthcare Dive reports

[Virtual care vendor] Amwell and LG Electronics are teaming up to jointly develop new digital health devices and tools, starting with hospital care in the U.S., the companies announced Wednesday.

South Korea-based LG, which manufactures a wide range of devices from refrigerators to computer monitors, already provides smart TVs for inpatient rooms.

Now, through the partnership, LG will also create devices that can host services from Amwell’s virtual care platform, Converge.

PYMTS.com reports this electronic health records news from the Vive conference being held in Miami

Electronic health records containing some of the most guarded personal data about people are making headlines again as a consortium of players join forces to create a universal single sign-in, allowing patients secure access to unified health data via digital identity.

Coming out of the ViVE health technology conference happening this week in Miami Beach, the effort is led by consumer-directed healthcare advocacy group the CARIN Alliance, working together with the Department of Health and Human Services (HHS) and other stakeholders.

On Tuesday (Mar. 8), Politico reported that HHS “is working with several health systems, insurers and health tech groups to roll out a single way for patients to log in and access their medical records across multiple systems. The launch later this month will set up a test environment for integrating the technology, said Ryan Howells, principal at Leavitt Partners and program manager at the CARIN Alliance, which is spearheading the efforts.”

CARIN is working with the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services (CMS), which will act as “government observers.”

From the FEHB front, benefits consultant Tammy Flanagan writes in Govexec about the Postal Service Health Benefits Program which will launch in 2025 as part of the Postal Reform Act of 2022. She observes

The version of the postal bill that eventually passed balances the risk pools, and the Office of Personnel Management now estimates premiums should go down for postal and non-postal employees and retirees alike.

The new law keeps all postal workers in FEHB, in their own group. All workers will be able to keep their current plans and avail themselves of the annual open season to choose other options within FEHB. 

Future postal retirees will be required to enroll in Medicare A and B at 65. Retiree health coverage will then become a combination of Medicare and FEHB. 

The question now is whether that requirement will eventually be extended to all federal employees, and what effect that would have on the premiums retirees pay. If that happens, at least federal employees will face one less tough decision at the time of retirement.

The FEHBlog expects that PSHBP premiums will be materially lower than FEHB premiums because PSHBP will accept Medicare funding for prescription drug benefits in the form of Part D EGWPs. Federal law has permitted the FEHB to offer premium-reducing Part D EGWPs for nearly twenty years. Nevertheless, OPM and a string of Administrations from George W. Bush to Joe Biden have refused to implement that law. Implementing that law in 2005 when it first took effect likely would have avoided the balkanization of the FEHB that we will soon experience with the PSHBP.

The FEHBlog does not expect the FEHB to adopt the mandatory Part B approach being taken by the PSHBP. Fewer retiring federal employees are picking up Part B because of the income-adjusted Part B premiums. As basic and income-adjusted Part B premiums continue to climb and climb, the FEHBlog expects that the PSHBP will liberalize, and then do away with, mandatory Part B. Meanwhile, the PSHBP’s undoubtedly favorable experience with Medicare funding of prescription drugs will lead OPM to allow FEHB the same opportunity.

With both branches of the Program using Part D EGWPs and integrated Medicare Advantage plans, everyone will enjoy reasonable premiums for high-quality healthcare. That in turn could lead to a reunion of the two branches. Hopefully, the PSHBP will be a relatively brief experiment that leaves the FEHB Program stronger.

The saving grace of the FEHB Program is that everyone in a plan option pays the same premium and the premiums are pooled to cover all plan option enrollees. That’s the bedrock principle of group health insurance that the FEHB Program has shown to work.