Midweek update

Midweek update

Photo by Manasvita S on Unsplash

From the OPM front, Federal News Network reports on the Senate Homeland Security and Governmental Affairs September 29, 2022, confirmation hearing for Robert Shriver, whom the President has nominated to serve as OPM Deputy Director.

From the Fourth Quarter 2022 front

  • STAT News provides “The Q4 health tech tracker: 17 key industry events and milestones to watch.”
  • The Society for Human Resource Management offers “4th Quarter 2022 ‘Quick Hits’ for Plan Sponsors.” This quick hit grabbed the FEHBlog’s attention:

Making a splash across the headlines was the Inflation Reduction Act of 2022(IRA), which President Biden signed on Aug. 16, 2022. The 273 pages of text make sweeping changes. However, few will affect employer-sponsored benefit plans, and most of those will have only indirect effects. 

One change that does directly affect a High Deductible Health Plan (HDHP) is the exception added to Section 223 of the Internal Revenue Code effective for plan years beginning after Dec. 31, 2022, to enable HDHPs to cover the cost of insulin without first meeting the deductible. This first dollar coverage for insulin will protect Health Savings Account (HSA) eligibility for those who require an insulin regimen. Employers should determine if their plan requires an amendment to implement this change.

On a related note, TRI-AD calls to our attention the “2022 FSA relief provisions will no longer apply in 2023.”

From the public health front —

  • The American Hospital Association informs us that “Increasing bivalent COVID-19 booster vaccinations this year to 2020-2021 flu vaccination rates could prevent an additional 75,000 deaths and 745,000 hospitalizations and avert $44 billion in medical costs over the next six months, researchers estimate in a Commonwealth Fund blog post. Increasing COVID-19 booster coverage to 80% of eligible Americans aged five and older this year could prevent about 90,000 deaths and over 936,000 hospitalizations and avert $56 billion in medical costs, they add.”
  • CNBC reports

* The CDC, in a report, said monkeypox could spread indefinitely at a low level in the U.S.

* Monkeypox is unlikely to be eliminated from the U.S. in the near future, according to the CDC. 

* The outbreak is slowing as the availability of vaccines have increased and people have become more aware of how to avoid infection.

  • The New York Times gives us a briefing and advice on the upcoming flu season.
  • Beckers Hospital Review discusses patient safety wins obtained this year by five health systems.

From the innovations front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services seeks comments through Dec. 6 on creating a National Directory of Healthcare Providers and Services to help patients locate providers and compare health plan networks, and reduce directory maintenance burden on providers and payers.

CMS seeks feedback on the concept and potential benefits; provider types and data elements to include; the technical framework for a national directory; priorities for a possible phased implementation; and prerequisites and actions CMS should consider to address potential challenges and risks.

Friday Stats and More

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases:

The CDC’s weekly review of its Covid statistics indicates

As of August 3, 2022, the current 7-day moving average of daily new cases (117,351) decreased 7.3% compared with the previous 7-day moving average (126,537).

CDC Nowcast projections* for the week ending July 30, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 85.5% (95% PI 83.8-87.0%).

Here’s the CDC’s chart of “Daily Trends in Number of New COVID-19 Hospital Admissions in the United States”:

The CDC’s weekly review notes “The current 7-day daily average for July 27–August 2, 2022, was 6,112. This is a 4.4% decrease from the prior 7-day average (6,396) from July 20–26, 2022.”

The Wall Street Journal observes

U.S. hospitalization data indicate the latest Covid-19 surge is starting to cool, marking a hopeful sign after months of sustained, high virus transmission due to BA.5 and other Omicron subvariants.

The seven-day average for people hospitalized with Covid-19 has recently flattened, while numbers of newly admitted patients have mostly trended lower since late July, federal data show. Though Covid-19 cases are loosely tracked now, as people test more at home, hospital data can reflect how much the virus is spreading in communities.

“We definitely have hit the plateau,” said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, Calif.

The news is welcome, he said, as the U.S. nears the weeks in which most children will be crowding back into schools. Colleges are scaling back Covid-19 precautions for the fall as they prepare for an influx of students on campus.

Here’s the FEHBlog’s latest weekly chart of new Covid deaths:

The CDC’s weekly review states “The current 7-day moving average of new deaths (378) has decreased 4.9% compared with the previous 7-day moving average (397).” The Wall Street Journal adds

The U.S. has recently averaged 377 reported Covid-19 deaths a day, the CDC data show, far below all-time highs but above the low hit last summer. Known cases recently averaged about 117,000 a day, down slightly over the past week, though epidemiologists believe the true number of infections is significantly higher.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era, the 51st week of 2020, through the 31st week of this year.

Covid vaccines administered dropped to around 500,000 last, a new low.

The Wall Street Journal reports

As of Thursday there were 1,344 counties—about 42% of the total—that have high Covid-19 community levels based on case and hospitalization trends, according to the Centers for Disease Control and Prevention. This is down 133 counties from the CDC’s count a week earlier.

About 55% of the U.S. population is now in a high-ranked county with elevated levels of disease, still significantly up from levels below 1% in March and April, but down from 61% a week earlier.

In sum, things are looking up from a Covid era perspective.

From the monkeypox front, the CDC released an information sheet on Monkeypox and Safer Sex.

From the patient safety front, Cardiovascular Business informs us

In 1999, the Institute of Medicine published a shocking report on medical errors that led to in-hospital deaths, noting that as many as 98,000 people per year were dying due to preventable errors. 

Now, more than two decades later, are things any better? A team of researchers explored that very questions in JAMA, drawing mostly optimistic conclusions.[1] 

To determine whether adverse in-hospital events are on the decline, Noel Eldridge, MS, of the U.S. Department of Health and Human Services, and coauthors looked at data from the Medicare Patient Safety Monitoring System from the years 2010 and 2019. The total number of adverse events dropped from 218 to 139 adverse events per 1,000 discharges for acute myocardial infarction (AMI), and from 168 to 116 adverse events per 1,000 discharges for heart failure, suggesting a significant improvement over time. 

Congrats!

And for the Friday wrap up

Roll Call reports from Capitol Hill

The Senate is “on track” to start debating a roughly $300 billion deficit-reducing budget package Saturday after Democrats reached agreement late Thursday on changes to the bill needed to secure 50 votes, Senate Majority Leader Charles E. Schumer said. 

The changes, the New York Democrat said at a news conference Friday, include dropping a provision modifying the taxation of “carried interest,” providing exemptions to the 15 percent corporate minimum tax that would reduce its estimated revenue raised over 10 years from $313 billion to $258 billion, and adding some climate provisions related to drought. 

“We’re feeling pretty good,” Schumer said, noting he believes the agreement will have the votes to pass.

If so, the bill would then go to the House, which is expected to reconvene Aug. 12 to vote on it, according to a notice Friday from Majority Leader Steny H. Hoyer, D-Md.

Fierce Health summarizes the second quarter results of publicly traded health insurers.

A STATS News journalist provides three takeaways from the this year’s Alzheimer’s Association International Conference, which he attended.

Memorial Day Weekend Update

Photo of a Fallen or Missing Comrades Table
by Selena Morar on Unsplash

Today as we remember those who have fallen for our Country, let’s also note that today is the 100th anniversary of the dedication of the Lincoln Memorial located on the Mall in Washington DC.

The Senate and the House of Representatives are holding a State / District work period this week. Insurance News Net adds that the House Oversight and Reform Committee has “requested information regarding insurers’ and PBMs’ compliance with the ACA and CMS guidance [on contraceptive coverage] by June 8, 2022.

From the Omicron and siblings front —

The Wall Street Journal reports

Pfizer’s antiviral drug, called Paxlovid, totaled more than 412,000 prescriptions through May 6, compared with about 110,000 prescriptions of molnupiravir, an antiviral from Merck & Co. and Ridgeback Biotherapeutics LP [called Lagevrio], according to drug-data firm Iqvia Holdings Inc. * * *

“Now that Paxlovid has become much easier to obtain, by and large relative to where it was before, Paxlovid is mine and the majority of my colleagues’ first choice,” said Ali Khan, chief medical officer of value-based strategy at Oak Street Health Inc., which has more than 140 primary-care clinics in 20 states across the U.S. * * *

“Doctors have become more comfortable with Paxlovid and more regularly prescribing the more effective drug,” said Zenobia Brown, medical director of health solutions at Northwell Health, a major New York healthcare provider.

Paxlovid, like Lagevrio, has been shown through lab studies to remain effective against Omicron and its subvariants. That has allowed doctors to prescribe it and reserve antibody treatments for other people who can’t take Paxlovid because of the potentially harmful drug interactions.

Federal News Network tells us

The White House earlier this month announced that households can now order a third round of free COVID-19 rapid tests on COVIDTest.gov.

Households can now receive eight new tests, double what households could order in the previous two rounds. USPS has delivered at least 380 million free tests through the program so far.

Bravo, USPS.

From the unusual viruses front —

  • STAT News updates us on monkeypox. “The ongoing monkeypox outbreak currently poses a moderate risk to global public health, the World Health Organization said Sunday in a statement that nevertheless raised the specter of the virus becoming entrenched as a pathogen that spreads from person to person. * * * To date most of the [257 confirmed] cases have been diagnosed in Europe and North America. The United States had detected 12 cases as of Friday. “Currently, the overall public health risk at [a] global level is assessed as moderate considering this is the first time that monkeyp ox cases and clusters are reported concurrently in widely disparate WHO geographical areas,” the global health agency said.”
  • The World Health Organization updates us on “Six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children [that] have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The majority of reported cases (n=374; 58%) are from the WHO European Region (22 countries), with 222 (34%) cases from the United Kingdom of Great Britiain and Northern Ireland alone. Probable cases and cases pending classification have also been reported from the Region of the Americas (n=240, including 216 cases in the United States of America) * * *.

From the miscellany department

  • The American Medical Association offers an article about what doctors wish their patients knew about living with migraines.
  • MedPage Today informs us “Using artificial intelligence (AI) during screening colonoscopy could be a cost-savings strategy that also could boost the prevention of colorectal cancer (CRC) incidence and mortality, a researcher reported.”
  • MedPage also tells us “Physical therapy-based rehabilitation frequently leads to better outcomes using fewer resources for patients with MSK pain when compared to operative procedures. But physical therapy must be a part of the treatment conversation early on, while surgery should be positioned as a last resort with the patient made well aware of surgery’s risks and complications. This is currently not the case in many patient-provider interactions.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

  • The Wall Street Journal has updated its article on Covid boosters.
  • The Institute for Clinical and Economic Review (ICER) today released “a Final Evidence Report assessing the comparative clinical effectiveness and value of [specific] outpatient treatments for COVID-19 [, principally Pfizer’s pill Paxlovid and Merck’s pill molnupiravir ].

A majority (11-2) found current evidence is not adequate to demonstrate a net health benefit when molnupiravir is compared to symptomatic care alone.

All panelists (13-0) found that current evidence is adequate to demonstrate a net health benefit when Paxlovid is compared to symptomatic care alone.

Due to uncertainty in the net health benefit for molnupiravir, a majority of panelists voted that it represents “low-to-intermediate” long-term value for money.

A majority of panelists found that Paxlovid represents “high” long-term value for money.

  • ICER presented at the OPM/AHIP carrier conference last month. ICER “is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.”
  • Speaking of the Covid pills, STAT News discusses the use of telehealth services to prescribe them. The upshot, as the FEHBlog understands it, is while using telehealth for this purpose is convenient for patients, experts are unsure whether the telehealth service provides adequate follow-up care to the patient.

Also, from the Rx coverage front, the Food and Drug Administration issued a news roundup today.

From the healthcare business front, BioPharma Dive reports

Pfizer has agreed to acquire Biohaven Pharmaceuticals for $11.6 billion in a deal that turns an existing alliance on a fast-selling migraine drug into a big bet on its future growth.

Pfizer will pay $148.50 per share in cash for each Biohaven share it doesn’t already own, representing a roughly 79% premium to the company’s Monday closing price and a 33% premium to its average share price of $111.70 over the last three months. The deal, which is expected to close early next year, is by far the biggest biotech buyout of 2022, according to data compiled by Biopharma Dive.

Announced Tuesday, the acquisition hands Pfizer full rights to Nurtec ODT, a pill that’s approved in the U.S. and other countries for the treatment and prevention of migraines. Biohaven’s pipeline also includes an experimental nasal spray for migraines, zavepegant, that’s been submitted to U.S. regulators, as well as five additional, preclinical treatments that block the same protein target.

From the mental health parity front, the Labor Department’s Employee Benefits Security Administration announced that the agency will be holding a mental health parity compliance assistance webcast on May 24 from 2-3 pm ET. Here is a link to the announcement which explains how to register for the webcast.

From the patient safety front, the Leapfrog Group “released the spring 2022 Leapfrog Hospital Safety Grade, which assigns a letter grade to nearly 3,000 U.S. general hospitals based on over 30 measures of patient safety.”

At HospitalSafetyGrade.org, the public can find detailed information about a hospital’s performance on patient experience and other safety measures used to grade hospitals.

Across all states, highlights of findings from the spring 2022 Leapfrog Hospital Safety Grade include:

Thirty‐three percent of hospitals received an “A,” 24% received a “B,” 36% received a “C,” 7% received a “D,” and less than 1% received an “F.”

Five states with the highest percentages of “A” hospitals are North Carolina, Virginia, Utah, Colorado, and Michigan.

There were no “A” hospitals in Wyoming, West Virginia, the District of Columbia, or North Dakota.

From the medical research department, Medscape informs us

Eight modifiable risk factors were linked to more than one in three cases of Alzheimer’s disease and related dementia in the U.S., a cross-sectional analysis showed.

The eight risk factors — midlife obesity, midlife hypertension, physical inactivity, depression, smoking, low education, diabetes, and hearing loss — were associated with 36.9% (95% CI 36.5-37.3) of Alzheimer’s and dementia cases, reported Roch Nianogo, MD, PhD, of the University of California Los Angeles, and Deborah Barnes, PhD, MPH, of the University of California San Francisco, and co-authors.

The factors most prominently associated with Alzheimer’s and dementia were midlife obesity, at 17.7% (95% [Confidence Interval] CI 17.5-18.0); physical inactivity, at 11.8% (95% CI 11.7-11.9); and low educational attainment, at 11.7% (95% CI 11.5-12.0).

“We published a similar study a little more than 10 years ago, and the most important risk factors then were physical inactivity, depression, and smoking,” Barnes told MedPage Today.

“Today, the top three risk factors are midlife obesity, physical inactivity, and low education,” she observed. “This is important because it suggests that the growing number of people who are obese in the U.S. could have a major long-term impact on dementia rates.”

From the clarification front, the FEHBlog often reminds folks that federal employees who retired under the Civil Service Retirement System before 1984 are not eligible for free Medicare Part A. The FEHBlog dug into this issue today, and he discovered this 2013 Reg Jones Q&A on this topic that the Federal Times published.

Q. I retired in 2009 under CSRS. I am close to 65, and the answer to one of the questions asked states that people in CSRS are not eligible for Medicare because they didn’t pay into Social Security.

I was in CSRS before the change to FERS and stayed with CSRS. I had Medicare deductions taken from my pay from 1983-84 till I retired in 2009.

Do the Medicare funds I paid since 1983 make me eligible for Medicare or just part of it?

So which is right? I need to know so I can do what needs to be done — enroll or not. I’m currently insured under federal BCBS.

A. CSRS employees who retired before Dec. 31, 1983, aren’t eligible for Medicare Part A. Nor are CSRS employees who retired after that date but before having Medicare deductions taken from their pay for 10 years.

On the other hand, they are eligible to enroll in Medicare Part B, which is open to everyone 65 or older.

Consequently, the cadre of 65 and older federal annuitants without Medicare A is larger than the FEHBlog understood. This cadre is relevant to the Postal Reform Act because that law keeps Postal annuitants over aged 65 without Medicare Part in the legacy FEHBP.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, Fierce Healthcare reports

Several bipartisan senators are clamoring for more transparency into how pharmacy benefit managers conduct their business, potentially foreshadowing action on legislation to require new disclosures for the industry.

A subcommittee of the Senate Commerce Committee held a hearing Thursday on PBMs and their role in the pharmaceutical marketplace. Senators claimed there is an absence of competition in the industry and potential conflicts of interest.

“PBMs are not the only cause of drug price inflation and excessive pricing, but they are integral to this system,” said Sen. Richard Blumenthal, D-Connecticut, the subcommittee’s chairman. “They are part of an increasingly integrated, uncompetitive system involving PBMs owned or owning insurers and constraining pharmacies in the amount of information that they give to consumers. That is one slice of a broken system.”

Healthcare Dive informs us

Members of the healthcare industry are once again pressuring Congress to remove what they say is a major pain point in their operations and in the delivery of patient care: the ban on a nationwide unique patient identifier.

Almost 120 health IT groups, EHR vendors, hospitals, physicians and health insurers sent letters on Wednesday to House and Senate appropriators urging them to remove decades-old rider language in a 2023 appropriations bill that prevents the HHS from spending federal dollars to create or adopt a UPI standard.

Signees, including payer lobby AHIP, software companies Cerner and Epic, and health systems Banner Health and Intermountain, called the ban “archaic” in the letters. However, regulators have noted a UPI is unlikely to be a silver bullet against the nation’s patient matching problem.

The patient identifier strikes the FEHBlog as a key to interoperability as well as improving patient safety. Fund it, Congress!

From the Omicron and siblings front, Medpage Today reports

Use of Johnson and Johnson’s (J&J) COVID-19 vaccine should only be limited to certain adults, the FDA said on Thursday.

Due to an updated analysis of the rare cases of thrombosis with thrombocytopenia syndrome (TTS), which typically occur 1 to 2 weeks after vaccination, use of the J&J vaccine should be restricted to those for whom mRNA vaccines are “not accessible or clinically appropriate,” or who would not get vaccinated if not for the J&J vaccine, the agency said.

It’s unfortunate that the only one-shot vaccine, which helped public health authorities reach underserved communities, is now knocked down for the mandatory eight count.

From the healthcare innovations front, Fierce Healthcare informs us

UnitedHealthcare has partnered with Kaia Health on a new virtual physical therapy program.

The program aims to offer 24/7, on-demand exercise feedback to eligible members with musculoskeletal conditions, the health insurance giant said. Members who are recovering from surgery or an injury will be asked to complete an assessment of current issues and will be referred to the program based on that assessment.

Eligible members will then be able to download Kaia’s app to access its physical therapy tools, which use artificial intelligence to support patients through physical therapy exercise and monitor progress.

and

Cigna is launching a new provider consult service that aims to improve outcomes for patients with cancer.

The program, backed by the capabilities of the insurer’s Evernorth subsidiary, allows community oncologists to connect with cancer subspecialty experts at centers designated by the National Cancer Institute (NCI). These connections will allow patients to benefit from the latest innovations in cancer care while also keeping their care close to home, Cigna said.

In a pilot, community oncologists had their treatment plans reviewed by experts and in 40% of cases reviewed, patients were recommended alternative tests or treatment based on new advancements in research.

Also a ZDNet reporter discusses his experience of wearing a continuous glucose monitor for 40 days.

I learned a lot about my body and how it reacts, and that’s information I can and do still use on a daily basis even if I don’t have an app yelling at me. Since I stopped wearing the Signos and getting insight, I’ve stuck to a healthier diet and routine exercise.

Good read.

From the healthcare business front, Healthcare Dive tells us

Centene said Thursday it has inked separate agreements to sell two of its pharmacy businesses in deals totaling $2.8 billion.

The payer plans to sell Magellan Rx to Prime Therapeutics and Pantherx to The Vistria Group, General Atlantic and Nautic Partners.

The deals are subject to regulatory approval. Magellan Rx is expected to close in the fourth quarter while Pantherx is anticipated to close in the next two to four months.

Thursday’s news builds on Centene’s plan to sell off non-core assets as it looks to sharpen its focus on its main [health insurance] business.

From the federal employment front, Govexec identifies the agencies who scored best and worst on the key employee morale questions of the recently released OPM 2021 Federal Employee Viewpoint Survey.

The National Science Foundation, Federal Energy Regulatory Commission, General Services Administration and the Pension Benefit Guaranty Corporation each landed in the top five on questions related to employees’ job satisfaction, senior leaders’ ability to motivate the workforce, and whether employees believe their agency will use Federal Employee Viewpoint Survey results to improve the workplace.

On the other hand, four agencies found themselves consistently near the bottom on these same questions. The Homeland Security Department, Social Security Administration, as well as the Justice and State departments all found themselves in the bottom five of at least two of these three questions.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omnicron and siblings front

The Centers for Disease Control today posted updated websites for the following topics that include updated or new tools:

AHIP informs us

The White House and the U.S. Department of Health and Human Services (HHS) are hosting an upcoming meeting entitled, Conversations on Encouraging COVID-19 Vaccinations, a virtual program that is part of the “We Can Do This” COVID-19 public education campaign.

The virtual Summit will feature conversations among leading doctors, medical professionals, parents, and community leaders about COVID-19 vaccines and how the broader medical community can encourage vaccination among pregnant people, children, teens, and young adults.

The event will be held on Friday, April 22 at 12:00 PM – 2:30 PM ET.  You can join the meeting here.

Speaking of AHIP, the FEHBlog noticed today that the OPM AHIP FEHB carrier conference website is fully built out. The virtual conference will be held on April 27 and 28.

Speaking of OPM, OPM announced today “the Combined Federal Campaign (CFC) will conduct a special solicitation that will allow the federal community to support charities serving and affected by the war in Ukraine and the resulting humanitarian and refugee crisis. This special solicitation will run through June 30, 2022.”  Thoughtful step on OPM’s part.

Roll Call reports

The Biden administration Monday said it would not enforce the mask mandate for airplanes and transit after a federal judge in Florida struck it down.

In a 59-page order, U.S. District Judge Kathryn Kimball Mizelle said the Centers for Disease Control and Prevention overstepped its authority by requiring passengers to wear masks on public transportation, saying the mandate ”exceeds the CDC’s statutory authority and violates the procedures required for agency rulemaking.”

The Biden administration responded late Monday with a statement saying that the agencies are reviewing the decision and assessing possible next steps. * * *

The CDC recommended that people continue to wear masks in indoor public transportation settings.

USA Today adds

United, American, Southwest, Delta and Alaska and other airlines late Monday said they were dropping their face mask requirement effective immediately given a federal judge’s ruling in Florida and the White House response to it.

From the Medicare front, the Centers for Medicare Services announced

a proposed rule for inpatient and long-term hospitals that builds on the Biden-Harris Administration’s key priorities to advance health equity and improve maternal health outcomes. In addition to annual policies that promote Medicare payment accuracy and hospital stability, the FY 2023 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) rule includes measures that will encourage hospitals to build health equity into their core functions, thereby improving care for people and communities who are disadvantaged and/or underserved by the healthcare system. The rule includes three health equity-focused measures in hospital quality programs, seeks stakeholder input related to documenting social determinants of health in inpatient claims data, and proposes a “Birthing-Friendly” hospital designation.

For acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users, the proposed increase in operating payment rates is projected to be 3.2%. This reflects a FY 2023 projected hospital market basket update of 3.1% reduced by a projected 0.4 percentage point productivity adjustment and increased by a 0.5 percentage point adjustment required by statute. Under the LTCH PPS, CMS expects payments to increase by approximately 0.8% or $25 million. * * *

For a fact sheet on the proposed payment rule visit: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps

For a fact sheet specific to the maternal health and health equity measures included in the proposed payment rule visit: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps-0

The American Hospital Association’s statement on the proposed rule may be found here. The regulatory battle has been joined.

From the medical research front

  • Medpage Today offers access to “a video [in which], Scott Weiner, MD, MPH, director of the Brigham Comprehensive Opioid Response and Education (B-CORE) Program at Brigham and Women’s Hospital in Boston, discusses his recent study on the risks of chronic use and overdose with hydrocodone versus oxycodone and how providers can keep their patients safe when prescribing these medications.” A transcript of the video also is provided.

Higher levels of “good” cholesterol in the fluid surrounding your brain and spinal cord may help protect you from Alzheimer’s disease, a new study suggests.

“This study represents the first time that small HDL particles in the brain have been counted,” said study co-author Dr. Hussein Yassine. He is an associate professor of medicine and neurology at the University of Southern California’s Keck School of Medicine in Los Angeles.

For the study, Yassine and his colleagues analyzed concentrations of high-density lipoproteins (HDL) — often referred to as “good cholesterol” — in the cerebrospinal fluid of 180 healthy volunteers with an average age of nearly 77.

The study linked a higher number of small HDL particles in cerebrospinal fluid with two key indicators that they might protect against Alzheimer’s. * * *

The results suggest that small HDL particles may point the way to treatments for early Alzheimer’s, long before mental decline occurs.

From the Rx coverage front, STAT News reports

The nation’s preeminent cancer hospitals are charging commercial health insurers anywhere from double to seven times their costs of acquiring cancer drugs, a new study shows.

Most top cancer institutions also are keeping their drug prices secret in direct violation of federal law, potentially exposing themselves to fines.

The findings reinforce how cancer care, especially the drugs, generates significant revenue for hospitals, and how markups on drugs potentially put insured cancer patients in financially perilous situations. * * *

Ultimately, researchers found the amount of money that a hospital gets from an insurance company, just for the cancer therapy, often is more than what the drug company receives.

So it’s not just insulin. No bueno.

Tuesday Tidbits

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 EuropeAfrica 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

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.

Midweek update

Photo by Josh Mills on Unsplash

From the Omicron front —

MedCity News reports

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster. 

This news bears similarities to the reports about the Novavax Covid vaccine already submitted to the Food and Drug Administration for emergency use authorization.

The American Hospital Association informs us

The Food and Drug Administration yesterday listed all over-the-counter COVID-19 diagnostic tests authorized for home use, including links to home use instructions for each test.

Fierce Healthcare adds

Walmart has administered tens of millions of COVID-19 vaccines to date, with 80% delivered in medically underserved communities, the retail giant announced Wednesday.

The company released a report (PDF) looking back at its progress in providing vaccines over the course of 2021. Cheryl Pegus, M.D., executive vice president of health and wellness at Walmart, told Fierce Healthcare the company has focused on connecting with people who may not otherwise have been able to get the shot.

From the health equity front —

The American Hospital Association tells us

The U.S. maternal mortality rate increased to 23.8 deaths per 100,000 live births in 2020 from 20.1 in 2019 as rates for Black and Hispanic women increased, according to data released today by the Centers for Disease Control and Prevention. The maternal mortality rate for Black women was nearly three times the rate for white women. Mortality rates increased with maternal age, with the rate for women aged 40 and over nearly eight times higher than the rate for women under 25.

The AHA’s Better Health for Mothers and Babies initiative offers resources to help hospitals and health systems eliminate maternal mortality and address health disparities for mothers and babies. 

What can be more tragic than a baby losing a mother?

Beckers Payer Issues adds from the mental health perspective

Work-sponsored health plans aren’t addressing the growth of loneliness, which leads to employees missing work and decreased productivity, according to data from Cigna’s Loneliness Index shared with Becker’s

The data, which is slated to be published in the Journal of Organizational Effectiveness: People and Performance, surveyed nearly 6,000 employees between July 16 and Aug. 2, 2019. 

Six insights:

1. The widespread presence of loneliness affected 3 in 5 (62 percent) adults before the COVID-19 pandemic. Feelings of loneliness play key roles both in employee health and work performance, according to the study.

2. On average, preventable, stress-related absences caused lonely employees to miss about five more work days than their counterparts who did not identify as lonely.

3. Employees who reported higher levels of loneliness were almost twice as likely to consider quitting their current job than employees who were less lonely. 

4. The study estimates that absenteeism and productivity losses tied to preventable loneliness cost employers $154 billion each year. 

5. The study said work-based factors like communication, work-life balance and social companionship play key roles in determining employee loneliness. Personal resilience and a feeling of connection outside of the workplace also play a role. 

6. Employers looking to combat employee loneliness should consider actions that hit on these factors, including flexible work hours, email “blackout” periods and forming employee resource groups.

From the Black History Month department, Everywell, an at-home testing service, celebrates ten Black pioneers who improved healthcare in our country. Bravo.

From the U.S. healthcare front, Healthcare Finance News reports

Including federal government support, national health spending grew by 3.4% in 2021, according to new data released by Altarum.

This growth in spending, the analysis found, reflected the fact that support from the federal government was strong in 2020, likely in response to the recession caused by the COVID-19 pandemic, and was lower in 2021.

Taking these support dollars out of both 2020 and 2021 estimates, spending growth from 2020 to 2021 would have been 8.4%, as the economy continued to recover.

From the healthcare business front —

Healthcare Dive informs us

Despite worries that demand for telehealth could fall as the U.S. emerges from the COVID-19 pandemic, virtual care giant Teladoc beat Wall Street expectations with its 2021 financial results, and issued strong future growth projections Tuesday.

The New York-based vendor posted revenue of more than $2 billion in 2021, 86% higher than in 2020. Total visits were up 38% to 15.4 million, and Teladoc closed out the year with 53.6 million U.S. paid members, up just slightly from the year prior.

Beckers Hospital Review identifies 92 U.S. health systems with CMS-approved “hospital at home” programs.

Managed Healthcare Executive tells us

Tired of grappling with the rising costs and poor quality of healthcare, a coalition of major healthcare purchasers is taking things into its own hands, establishing a company that is designing healthcare products to meet its members’ needs. “There’s an incredibly high frustration level among buyers of healthcare,” says Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health (PBGH) in San Francisco. 

The nonprofit PBGH represents almost 40 large private employers and public entities that together spend $100 billion each year on healthcare services for more than 15 million Americans and their families. PBGH members include Microsoft, Walmart and American Airlines.

The decision to create the company, Emsana Health, was made about two years ago, with the initial focus on “really understanding the needs on a deep level,” Mitchell says. The company officially launched in the fall, and its first venture is setting up a pharmacy benefit manager (PBM), EmsanaRx, which went started operating on Jan. 1.

Finally, in a troubling tidbit, the Wall Street Journal reports

U.S. life insurers, as expected, made a large number of Covid-19 death-benefit payouts last year. More surprisingly, many saw a jump in other death claims, too.

Industry executives and actuaries believe many of these other fatalities are tied to delays in medical care as a result of lockdowns in 2020, and then, later, people’s fears of seeking out treatment and trouble lining up appointments.

Some insurers see continued high levels of these deaths for some time, even if Covid-19 deaths decline this year.

Thursday Miscellany

In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.

This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.

The Secretary of Labor who oversees OSHA commented that

“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation. 

“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”

In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:

Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.

The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.

The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.

Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.

In that regard, Bloomberg Law reports that

The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine. 

The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December. 

The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.

Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.

From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”

From the Covid vaccine front, the AP reports that

Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.

As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.

Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.

The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”

Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.

From the telehealth front, STAT News informs us that

A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move  companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.

Execs from companies like Heartbeat Health and Teladoc say they’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story

From the healthcare cost front, STAT News tells us that

— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.

— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.

— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.

From the miscellany department —

  • The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
  • Biopharma Dive considers five questions facing gene therapy in 2022.
  • Fierce Healthcare notes that

As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.

The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.

  • AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.

While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).

  • Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.