Tuesday Tidbits

CMS

Tuesday Tidbits

David Ermer–ACA, CMS, FDA, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

November is awareness month for diabetes and C. Diff. Looking back at October, Medscape informs us

Maintaining a healthy body weight, being physically active, and following a healthy dietary pattern can help women live longer after breast cancer diagnosis, according to a major new analysis of the latest research.

From the Federal Employee Benefits Open Season front, the Federal Times offers its consumer guide.

It was a big day on the Medicare front —

The American Hospital Association reports

The Centers for Medicare & Medicaid Services [CMS] late today posted a final rule on its website that will increase Medicare hospital outpatient prospective payment system rates by a net 3.8% in calendar year 2023 compared to 2022. This update is based on a market basket percentage increase of 4.1%, reduced by 0.3 percentage points for productivity. [AHA calls the increase insufficient.] * * *

CMS finalized the payment policy for CY 2023 of average sales price (ASP) +6% for drugs and biologicals acquired through the 340B Program as a result of the unanimous Supreme Court decision in American Hospital Association v. Becerra.

CMS also finalized proposals to establish the Rural Emergency Hospital (REH) model, a new provider type for eligible critical access hospitals and small rural hospitals beginning in Jan. 1, 2023. The rule finalized proposals related to model payment, covered services, conditions of participation, and quality measurements.

[and]

The Centers for Medicare & Medicaid Services today released on its website its calendar year 2023 final rule for the physician fee schedule. The rule will cut the conversion factor to $33.06 in CY 2023 from $34.61 in CY 2022, which reflects the expiration of the temporary 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment.

From HHS.gov

For a fact sheet on the CY 2023 OPPS/ASC Payment System Final Rule (CMS-1772-FC), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2

For a fact sheet on Rural Emergency Hospitals, please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-1

For a fact sheet on the CY 2023 Physician Fee Schedule Final Rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule

For a fact sheet on final changes to the CY 2023 Quality Payment Program, please visit: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2136/2023%20Quality%20Payment%20Program%20Final%20Rule%20Resources.zip 

For a fact sheet on final changes to the Medicare Shared Savings Program, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule-medicare-shared-savings-program

For a CMS blog on behavioral health poliices, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare-0?check_logged_in=1

What’s more, Beckers Hospital Review informs us

CMS evaluated two and a half years of readmission cases for Medicare patients through the Hospital Readmissions Reduction Program and penalized 2,273 hospitals that had a greater-than-expected rate of return, according to a Nov. 1 report from Kaiser Health News.

The average payment reduction was 0.43 percent, the lowest rate reduction since 2014. Reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 through next September. It is expected to cost the hospitals $320 million over the 12-month period. 

The report notes that the COVID-19 pandemic caused turmoil in hospitals and that CMS decided to exclude the first half of 2020 from the report due to the chaos. CMS also excluded Medicare patients who were readmitted with pneumonia across all three years because of the difficulty distinguishing them from COVID patients. 

From the Affordable Care Act preventive services front, Healio tells us

The U.S. Preventive Services Task Force has released two final recommendations on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal people.

The recommendations advocate against the use of menopausal hormone therapy (MHT) through a combination of estrogen and progestin in postmenopausal people, and MHT through estrogen alone in postmenopausal people who have had a hysterectomy.

Both are D-grade recommendations and are consistent with the USPSTF’s previous recommendations on the treatment made back in 2017.

James Stevermer, MD, MSPH, a task force member, also noted in the press release that the recommendations are only for those who are considering hormone therapy to prevent chronic conditions following menopause. 

“Those who wish to manage symptoms of menopause with hormone therapy are encouraged to talk with their health care professional,” he said.

From the prescription drug and vaccine development front —

STAT News reports

Pfizer’s maternal vaccine against the respiratory syncytial virus [RSV] reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study.

The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.

RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to infants. Currently, the pertussis vaccine and the influenza vaccine are given during pregnancy for this reason.

Bloomberg Prognosis tells us

Vertex Pharmaceuticals, a Boston-based biotech company, * * * is testing a non-opioid drug for acute pain. Vertex’s drug, VX-548, aims to block the Nav1.8 sodium channel, which acts like a gate allowing pain signals to travel from the nerves to the brain.

VX-548 met its goals in late-stage trials evaluating the drug in people who underwent a bunionectomy or an abdominoplasty, the formal name for a tummy tuck. Vertex will run the same studies with more patients before seeking regulatory approval. The company hasn’t disclosed when data will be available beyond saying the trials will be quick since patients receive the drug for only 48 hours. Vertex is also testing VX-548 in nerve pain and eventually wants to see if it works for chronic pain.

If VX-548 passes its next big tests, it could offer a new option for people recovering from surgery or other medical procedures. Of course, plenty of other pain drugs that looked promising early on in testing never reached the market.

Fortunately, scientists are investing time and money on a variety of alternatives for pain.

From the Rx coverage front, BioPharma Dive relates

Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.

U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.

“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts. 

Lilly is also conducting a study to support an FDA marketing application for Mounjaro to be prescribed for weight loss.

Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.

Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive. 

In U.S. healthcare business news, MedTech Dive reports

Johnson & Johnson agreed to acquire Abiomed, a Danvers, Mass.-based maker of heart pumps, for $16.6 billion. 

The deal will contribute to J&J’s cardiovascular portfolio, complementing its Biosense Webster electrophysiology business, BTIG Analyst Marie Thibault wrote in a research note on Tuesday. 

The deal has already been approved by both companies’ boards of directors and is expected to close before the end of the first quarter of 2023.

Finally, check out the NIH Director’s blog discussing “How the Brain Differentiates the ‘Click,’ ‘Crack,’ or ‘Thud’ of Everyday Tasks.”

If you’ve been staying up late to watch the World Series, you probably spent those nine innings hoping for superstars Bryce Harper or José Altuve to square up a fastball and send it sailing out of the yard. Long-time baseball fans like me can distinguish immediately the loud crack of a home-run swing from the dull thud of a weak grounder. 

Our brains have such a fascinating ability to discern “right” sounds from “wrong” ones in just an instant. This applies not only in baseball, but in the things that we do throughout the day, whether it’s hitting the right note on a musical instrument or pushing the car door just enough to click it shut without slamming.

Now, an NIH-funded team of neuroscientists has discovered what happens in the brain when one hears an expected or “right” sound versus a “wrong” one after completing a task. It turns out that the mammalian brain is remarkably good at predicting both when a sound should happen and what it ideally ought to sound like. Any notable mismatch between that expectation and the feedback, and the hearing center of the brain reacts.

Friday Stats and More

David Ermer–CDC, CMS, COVID-19, Medicare, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

As the late Kenny Rogers sang, “You need to know when to hold them and when to fold them.” The FEHBlog tried to revive his Covid charts, but alas, it was infeasible because the FEHBlog could not show the stats in seven-day weeks as FEHBlog had been doing.

In any event, the Centers for Disease Control continues to issue weekly interpretations of Covid statistics so here we go:

New Reported Cases

As of October 26, 2022, the current 21-day average of weekly new cases (37,683) decreased 25.1% compared with the previous 21-day average (50,328). A total of 97,329,787 COVID-19 cases have been reported in the United States as of October 26, 2022.

CDC Nowcast projections* for the week ending October 29, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are eight lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6, BA.2.75, and BA.2.75.2. The predominant Omicron lineage is BA.5, projected to be 49.6% (95% PI 45.3-53.9%).

The New York Times report on a study finding that Covid rebounds can happen to people have not taken Paxlovid.

“Symptom return is common,” said Dr. Davey Smith, the chief of infectious diseases and global public health at the University of California, San Diego School of Medicine, who led the study. “It doesn’t mean that things are going south. It’s just the natural way the disease goes.” What is surprising, however, is how many people may experience a rebound, he said. * * *

“The good news is that nobody who had their symptoms return needed to go to the hospital or died or even got severe symptoms,” Dr. Smith said. Eighty-five percent of those who had a rebound reported that their symptoms were mild; 15 percent had at least one moderate symptom. * * *

Concerns about rebound symptoms when taking Paxlovid — and another antiviral drug called molnupiravir — appear to have reduced people’s interest in using treatments for Covid. But the new study shows that you can have a rebound with untreated Covid as well. “I hope this can help people to be less afraid of a potential rebound,” Dr. Smith said.

If you do experience a rebound after treatment, there is no evidence that you need to start another course of Paxlovid. Isolate a while longer in case you are contagious to others. And try to manage symptoms with pain and fever-reducing medicines, home remedies and time, Dr. Smith said. “I recommend staying hydrated, watching ‘The Golden Girls’ and eating chicken soup.”

New Covid Hospitalizations

The current 7-day daily average for October 19–25, 2022, was 3,249. This is a 1.0% increase from the prior 7-day average (3,217) from October 12–18, 2022.

New Reported Deaths

The current 21-day average of new deaths (373) decreased 13.7% compared with the previous 21-day average (432). As of October 26, 2022, a total of 1,066,351 COVID-19 deaths have been reported in the United States.

Covid Vaccinations

As of October 26, 2022, 636.9 million vaccine doses have been administered in the United States. Overall, about 266.0 million people, or 80.1% of the total U.S. population, have received at least one dose of vaccine. About 226.9 million people, or 68.4% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 111.8 million people have received a booster dose,* and more than 22.88 million people have received an updated (bivalent) booster dose. But 49.3% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition.

CDC Community Levels

As of October 27, 2022, there are 73 (2.3%) counties, districts, or territories with a high COVID-19 Community Level, 705 (21.9%) counties with a medium Community Level, and 2,439 (75.8%) counties with a low Community Level. Compared with last week, this represents a minor increase (+0.8 percentage points) in the number of high-level counties, a minor increase (+4.4 percentage points) in the number of medium-level counties, and a minor decrease (-5.2 percentage points) in the number of low-level counties. Overall, 46 out of 52 jurisdictions** had high- or medium-level counties this week. California, Delaware, the District of Columbia, Hawaii, North Carolina, and South Carolina are the only jurisdictions to have all counties at low Community Levels.

Here’s this week’s CDC FluView.

Key FluView Points for the week ended October 22:

  • Influenza activity continues to increase. Regions 4 (southeast) and 6 (south-central) are reporting the highest levels of flu activity.
  • The first influenza-associated pediatric death of the 2022-2023 season was reported this week.
  • CDC estimates that, so far this season, there have been at least 880,000 flu illnesses, 6,900 hospitalizations, and 360 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 42 during previous seasons going back to 2010-2011.
  • An annual flu vaccine is the best way to protect against flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually.
  • There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

The Wall Street Journal adds

  • An estimated 21% of adults have gotten a flu vaccine this year, similar to estimates from the same time last year, the CDC said, basing its estimates off an Ipsos survey conducted in early October. An estimated 22% of children have also gotten a flu shot, according to the CDC’s national immunization survey.
  • It is too early to tell how effective this year’s vaccine will be, the CDC said. But the influenza virus that is being most often reported, a strain of influenza A called H3N2, matches well with the formation of this year’s shot, health experts said.

The CDC has an updated RSV page with prevention and symptom guidance. Yahoo News adds “U.S. officials are working on a respiratory syncytial virus (RSV) vaccine, but until one is available people should exercise caution, especially seniors and parents of young children, the nation’s top infectious disease official said.”

In other virus news, Prescision Vaccinations discusses the severe impact that monkeypox infections can have on immunocompromised people, such as those with HIV or AIDs.

Following up on yesterday’s note on the Kaiser Family Foundation’s 2022 Employer Health Benefit Survey

  • Beckers Payer Issues calls four figures to our attention.
  • Kaiser Family Foundation delves into the survey’s findings about employer sponsored mental health programs.

From the U.S. healthcare business front, BioPharma Dive reports on Gilead’s third quarter earnings report.

The results [which exceeded Wall Street expectations] were, in part, tied to growing sales from Gilead’s cell therapy business, which consists of the marketed cancer drugs Yescarta and Tecartus. Together, sales from the two drugs totaled $398 million in the third quarter, a nearly 80% increase from the same three-month period a year prior. * * *

Third quarter sales of Tecartus were up 72% year over year, reaching $81 million, while those for Yescarta rose 81% to $317 million. Gilead cited the approval of Yescarta as a “second-line” therapy for a type of hard-to-treat lymphoma, which happened in April, as a main reason for the uptick.

Other cell therapy developers have recorded larger sales from their products as well, though not to the same extent as Gilead.

From the Medicare front, the Centers for Medicare and Medicaid Services announced issuing a

final rule that updates Medicare enrollment and eligibility rules to expand coverage for people with Medicare and advance health equity. The final rule, which implements changes made by the Consolidated Appropriations Act, 2021 (CAA), makes it easier for people to enroll in Medicare and eliminates delays in coverage. Among these changes, individuals will now have Medicare coverage the month immediately after their enrollment, thereby reducing any delays in coverage. In addition, the rule expands access through Medicare special enrollment periods (SEPs) and allows certain eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty.

To view a fact sheet on the final rule, visit: https://www.cms.gov/newsroom/fact- sheets/implementing-certain-provisions-consolidated-appropriations-act-2021-and- other-revisions-medicare-2

To view the final rule, visit: https://www.federalregister.gov/public-inspection

From the OPM front, Federal News Network offers insights into the recently released Federal Employee Viewpoint Survey.

Midweek update

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, NIH, OPM, U.S. Healthcare–
Lincoln Memorial in the Fall

From the Federal Employee Benefits Open Season front —

  • FedWeek offers its Open Season report.

  • My Federal Retires explains Open Season options available to those with Medicare coverage.
  • Govexec promotes healthcare flexible savings accounts, which are only available to federal and Postal employees. The FEHBlog was surprised to learn that “less than 20% of active feds have an FSA.” The article explains the mechanics of the FSA, among other things.

In other federal employee benefits news, Reg Jones, writing in the Federal Times, tells us how to calculate federal disability retirement benefits and answers a question about survivor annuitant coverage.

In other OPM news, Govexec tells us how the OPM Director is celebrating Work and Family Month.

From the Omicron and siblings front, Beckers Hospital Review informs us that “Omicron subvariants BQ.1 and BQ.1.1 — dubbed “escape variants” for their immune evasiveness — are steadily gaining prevalence in the U.S. and now account for more than 16 percent of all COVID-19 cases confirmed nationwide, CDC data shows.”

Beckers adds

Data analysis from the Los Angeles-based Smidt Heart Institute at Cedars-Sinai found heart attack deaths rose significantly with COVID-19 surges, including omicron surges.

Heart attack deaths were on the decline before the pandemic. However, during COVID-19 surges, deaths increased — especially among individuals ages 25-44, according to an Oct. 24 release shared with Becker’s.

In other public health news

A new national study has suggested that chemical hair straighteners could pose a small risk for uterine cancer. Rates of the disease are still relatively low, said Dr. Alexandra White, head of the environment and cancer epidemiology group of the National Institute of Environmental Health Sciences and the lead author on the study. The research also did not definitively show that hair straighteners cause cancer. But the findings are cause for concern, she said.

Rates of uterine cancer have been increasing in the United States, particularly for Black and Hispanic women. The number of cases diagnosed each year rose to 65,950 this year, compared to 39,000 15 years ago. Black women are also more likely to have more aggressive cases of the cancer, Dr. White said, and the study showed they were disproportionately more likely to use hair straighteners.

If you have used chemical hair straighteners, you do not need to seek out medical attention or consult your doctor unless you have symptoms for uterine cancer, said Dr. Otis Brawley, an oncologist at Johns Hopkins University. But women should regularly see a gynecologist, and be aware of the risk factors and early signs of the disease. [The article also explains uterine cancer risk factors and symptoms.]

Roll Call tells us

The Biden administration is preparing a comprehensive initiative to fight hepatitis C that would streamline testing and treatment and secure an agreement with drugmakers to bring down the cost of treatment of the disease, which has spiked during the pandemic.

Francis Collins, special project adviser to President Joe Biden and former longtime director of the National Institutes of Health, said Monday the administration hopes to secure some funding this year for the yet to be formally unveiled initiative.

He said he has briefed Biden on the plan, and the Office of Management and Budget is “enthusiastic about figuring out how to fit this into the budgetary requests.”

The National Institutes of Health announced

Long-term use of electronic cigarettes, or vaping products, can significantly impair the function of the body’s blood vessels, increasing the risk for cardiovascular disease. Additionally, the use of both e-cigarettes and regular cigarettes may cause an even greater risk than the use of either of these products alone. These findings come from two new studies supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).  

From the Food and Drug Administration front —

BioPharma Dive informs us

The Food and Drug Administration on Tuesday approved a first-of-its-kind treatment for multiple myeloma from Johnson & Johnson, but put restrictions on its use due to the drug’s potentially dangerous side effects.

Healthcare providers offering the drug, which will be sold as Tecvayli, will need to follow guidelines set up in a Risk Evaluation and Mitigation Strategy, or REMS. Prescribers and pharmacies must be certified in the Tecvayli REMS program, which will focus on monitoring and counseling for patients.

The FDA has required REMS for dozens of medicines since the program was authorized by Congress in 2007. The list includes Bristol Myers Squibb’s cell therapy Abecma, which won approval for multiple myeloma last year.

Fierce Pharma relates

AstraZeneca’s long-troubled cancer immunotherapy tremelimumab has finally secured its first FDA approval, but the regulatory blessing comes in what could be an increasingly competitive tumor type.

To be sold under the brand name Imjudo, tremelimumab has won an FDA go-ahead in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi for treating unresectable hepatocellular carcinoma, the most common type of liver cancer.

The FDA nod officially puts an end to the streak of clinical trial failures that tremelimumab endured over recent years in multiple cancer types, including non-small cell lung cancer, head and neck cancer and bladder cancer. But while the CTLA-4 inhibitor has now crossed the regulatory finish line, a commercial fight lies ahead.

From the Medicare front – –

  • STAT News discusses a new CMS policy aimed at controlling dialysis prices.
  • Fierce Healthcare tells us “Starting next year, insurers will not be able to air any television ads for Medicare Advantage (MA) plans before getting approval from federal regulators.” Tough break for Joe Namath.  

From the ACA marketplace front —

  • The Department of Health and Human Services discusses its plans for the upcoming Open enrollment period.
  • Benefits Pro discusses the popularity of alternative health reimbursement accounts which allow employers to offer marketplace coverage to their employees.

Speaking of account-based health plans, the Plan Sponsors Council of America released its 2022 benchmarking survey of health savings accounts.

From the U.S. healthcare business front —

  • Health Data Management assesses whether Amazon and Walmart can build effective value based care models.

Weekend update

David Ermer–ACA, CDC, CMS, Congress, COVID-19, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–

Congress remains on the campaign trail this week.

This is Red Ribbon Week, “an ideal way for people and communities to unite and take a visible stand against drugs.”

Speaking of illegal drugs, the Wall Street Journal tells the stories of three “high achieving” New York City dwellers who died on one day in March 2021 due to fentanyl-laced cocaine delivered by a single dealer.

New York City authorities have been warning of the risks of unknowingly taking fentanyl in cocaine and of its increased presence in cocaine seized by police. Health officials put up posters and sent drink coasters to clubs warning cocaine users to start with a small dose and to have naloxone, an opioid reversal drug, on hand to counter an overdose. They are handing out fentanyl testing strips that can be used to test cocaine and other drugs for fentanyl’s presence.

Multiple people died within hours from tainted cocaine in Long Island, N.Y., and in Newport Beach, Calif., last year. Nine were killed in Washington, D.C., in January. Law-enforcement officials said dealers often use coffee grinders or other basic equipment to cut drugs and prepare them for sale, which can result in deadly batches.

From the FEHB front, Tammy Flanagan, writing in Govexec, advises federal and postal employees and annuitants on how to prepare for the upcoming Federal Employee Benefits Open Season. The FEHBlog’s advice is to stack your plan’s summary of benefits and coverage which is available on all FEHB plan websites against other plans in which you are interested. The summary of benefits and coverage, which is an Affordable Care Act requirement, is four double-sided pages including consumer-tested practical information.

From the Omicron and siblings’ front

  • STAT News reports “FDA’s vaccines chief [Peter Marks, MD] sees the possibility of more Covid boosters — sooner than he’d like.”

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private market.

The pharmaceutical company is targeting between $110 and $130 per adult vaccine dose after that transition, said Angela Lukin, Pfizer’s head of global primary care and U.S. president, on an analyst and investor call Thursday.

“We feel confident that this range will be seen as highly cost effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine,” Lukin said on the call. Discussions with insurers are still in early stages, she added.

No doubt this charming development seeks to pressure Congress to add more federal Covid dollars in the lame-duck session following the November 8 Congressional election.

In other vaccine news, MedPage Today reports

  • The CDC’s vaccine advisors updated their recommendations to clarify when to administer the 20-valent conjugate pneumococcal vaccine (PCV20; Prevnar 20) in adults who previously received the 13-valent conjugate vaccine (PCV13; Prevnar 13).
  • Three doses of hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG; Heplisav-B) notched a perfect mark when it came to seroprotection for people with HIV who had never before been vaccinated against the hepatitis B virus (HBV), early results of a phase III trial showed.

In prescription drug development news, Fierce Healthcare points out “three drugs are set for FDA determinations soon.” The article explains why Optum says payers should take notice.

From the monkeypox front, Medpage Today adds

Cases of monkeypox are continuing to decline in the U.S., but the disease is still disproportionately affecting people of color, a White House official said.

“In the U.S., about 27,635 cases were reported as of yesterday,” Demetre Daskalakis, MD, White House National Monkeypox Response deputy coordinator, said at an online briefing Thursday. “We continue to have a decrease over time — we’re about 85% down from where we were at the peak of the outbreak. So that’s a lot of hopeful news, that we continue to see monkeypox going under better and better control.”

From the mental healthcare front, the Department of Health and Human Services “through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. BSCA, signed into law by President Biden earlier this year, provided unprecedented funding to address the nation’s mental health crisis and make our communities safer.”

From the maternal care front, Health Payer Intelligence informs us Blue Cross and Blue Shield of Michigan has “decided to go beyond traditional maternal healthcare benefits, such as prenatal and postpartum care coverage. They teamed up with a virtual care provider for women and family health, Maven, to offer a suite of solutions that integrated family care and maternal healthcare.”

From the SDOH front, Beckers Payer Issues relates

In a letter to HHS Secretary Xavier Becerra and Management and Budget Office Director Shalanda Young, AHIP explained its vision for how demographic data can be improved and standardized across the healthcare system. 

Five things to know about the association’s recommendations for improving demographic data:  

1. Current challenges with demographic data include the lack of specificity for questions on race. AHIP highlights that current census and HHS standards do not include an option for people to identify as Arab, Middle Eastern or North African. Additionally, AHIP recommends options should be tailored to the local area, depending on the populations that live there. 

2. Current demographic questions do not have an “I choose not to respond” option. AHIP advises that a lack of information about how demographic information is used can lead to a lack of trust from patients. 

3. Current regulations that require multiple providers and payers to collect demographic information lead to inconsistent results and greater burden on patients, AHIP says.

4. To reduce burdens on providers and patients, AHIP wants demographic data to be electronic and able to be shared with other places in the healthcare system with patient consent. 

5. AHIP wants a wide range of government agencies to adopt its recommendations for demographic data collection, which include questions on race, ethnicity, language preference, sexual orientation, gender, diability status, veteran status and spirtual beliefs. 

Read the full letter here.

Interesting approach.

From the miscellany department —

  • STAT New discusses weaknesses in traditional Medicare catastrophic coverage. FEHBlog suggests that Congress stop permitting Medicare supplemental plans to impose pre-existing condition limitations unless circumscribed by state law.
  • The Society for Human Resources Management tells us

Employee 401(k) contributions for 2023 will top off at $22,500—a $2,000 increase from the $20,500 cap for 2022—the IRS announced on Oct. 21. Plan participants age 50 or older next year can contribute an additional $7,500, up $1,000 from 2022. * * *

he limit on total employer-plus-employee contributions to defined contribution plans will increase to $66,000 in 2023, up by $5,000 from $61,000 in 2022. “This limit usually increases by $1,000 at a time but now it’s jumping five steps in one year,” Sit said.

The IRS announced the 2023 adjustments for 401(k) and similar defined contribution plans, and for defined benefit pension plan, in Notice 2022-55.

  • The American Hospital Association reports “The AHA and American Medical Association Oct. 19 filed a friend-of-the-court brief in support of a Texas Medical Association lawsuit claiming the revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in ways that violate the compromise Congress reached in the Act.”
  • Business Insurance tells us “The U.S. Department of Justice has asked for more details on CVS Health Corp.’s proposed $8 billion deal to buy Signify Health, in a possible indication that the transaction will face a longer deal review rather than a quick approval, Reuters reports. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts.”
  • Following up on last Thursday’s post, RSV is a type of common cold according to the CDC.

Midweek update

David Ermer–CDC, CMS, COVID-19, Mental health care, NCQA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From the Omicron and siblings front —

Novovax announced that

the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

Reuters adds

Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.

Omicron-tailored shots by Pfizer Inc  and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.

The New York Times provides an update on the new Omicron variants, including this critical point

Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.

Health Payer Intelligence reports

Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.

The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.

Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.

From the U.S. healthcare business front —

Fierce Healthcare tells us

Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds. 

Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff. 

“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report. 

and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.

In the regard

  • A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
  • STAT News reports on another SDOH study

When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.

Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”

One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.

  • The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.

In other U.S. healthcare business news, Healthcare Dive reports

As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.

“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.

Job losses spurred by a recession could cut into commercial enrollment for insurers who generate revenue from selling health coverage to employers of all sizes. About half of the U.S. population relies on employer-based insurance for coverage.

Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.

Becker’s Payer Issues tells us

Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.

As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13. 

Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.

Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.

“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”

The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.

STAT News reports

A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.

Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.

The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.

From the Rx coverage front —

STAT News informs us

After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.

The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.

The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.

The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”

The FDA Commissioner, Robert Califf, MD, is the final decision maker.

The NCQA has created

A new website adds two key resources in the fight against antibiotic resistance:

* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.

* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.

From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.

Weekend update

David Ermer–CDC, CMS, COVID-19, FDA, Medicare, Rx coverage–

Congress remains on the campaign trail this week.

From the public health front —

  • Fortune Well considers a change in the spread of Omicron. “COVID has splintered into multiple variants dominating different countries at the same time. Experts say these are some scenarios could play out.”
  • The American Medical Association answers patient FAQs about the upcoming winter in which Covid is not expected to eclipse the flu.
  • The FDA encourages Americans, including children, to get the flu vaccine.
  • Fortune Well provides advice on who is a candidate for the monkeypox vaccine now that this vaccine is more widely available.

The Bill and Melinda Gates Foundation says it will commit $1.2 billion to the effort to end polio worldwide.

The money will be used to help implement the Global Polio Eradication Initiative’s strategy through 2026. The initiative is trying to end the polio virus in Pakistan and Afghanistan, the last two endemic countries, the foundation said in a statement Sunday.

The money also will be used to stop outbreaks of new variants of the virus. The announcement was made Sunday at the World Health Summit in Berlin. 

The foundation says in a statement on its website that it has contributed nearly $5 billion to the polio eradication initiative. The initiative is trying to integrate polio campaigns into broader health services, while it scales up use of the novel oral polio vaccine type 2. 

The group also is working to make national health systems stronger so countries are better prepared for future health threats, the statement said. 

From the price transparency front, two consultants from the Berkley Research Group advise in Healthcare Dive

Payers can use hospital transparency data to gain insights regarding the rates hospitals have negotiated with other payers, which potentially can be used during contract negotiations. For example, payers can evaluate the negotiated rates for specific hospitals compared to their competitor health plans to gauge alignment with their proposed rates and discounts. This is illustrated in Figure 2, which shows the average negotiated rates for a CT scan of the abdomen (CPT 74177) for each payer who contracts with Loyola University Medical Center near Chicago, compared to the hospital’s standard billed charge for the procedure. As shown in the graph, the average negotiated rate as a percentage of billed charges (list price) ranges from 3% to 24% (about $200 to $1,800).

The article offers other approaches to using hospital transparency data, e.g., geographic methods.

From the Rx coverage front

Beckers Hospital Review tells us

CVS Health wants to be in charge of the “entire spectrum of someone’s health journey,” the company’s chief executive said at an Oct. 12 event in Boston reported on by the Boston Business Journal.

CEO Karen Lynch pointed to how the company already delivers medication at the pharmacy, finances treatments through insurance company Aetna, provides low-cost urgent care at its MinuteClinics, and now intends to give care at home through its planned $8 billion acquisition of Signify Health, she reportedly said at the Boston College Chief Executives Club meeting.

Ms. Lynch said the company also plans to expand into primary care and expects to announce an acquisition later this year, the Business Journal reported Oct. 13. CVS is rumored to be in exclusive talksto buy Cano Health, a primary care firm focused on seniors.

Ms. Lynch told the crowd CVS has advantages over fellow healthcare disruptor Amazon, which recently agreed to acquire primary care chain One Medical for $3.9 billion, according to the story. “[Customers] really want to trust and engage with companies that have earned the right to be in healthcare,” she said. “I think about Amazon as sort of a transactional company today.”

The American Hospital Association informs us

President Biden today directed the Center for Medicare and Medicaid Innovation to consider new payment and delivery models to lower drug costs and promote access to innovative drug therapies for beneficiaries, and report within 90 days on its plan and timeline for testing selected models. AHA will update members as more information on the plan becomes available.

The White House also released a fact sheet on this executive order.

The American Medical Association issued a research report titled “Competition in Commercial PBM Markets and Vertical Integration of Health Insurers with PBMs.” The report is chock-a-block full of various PBM rankings.

Speaking of the CMS innovation center, the American Hospital Association reports

The Centers for Medicare & Medicaid Services will extend through 2025 the Bundled Payments for Care Improvement Advanced model, which was set to expire this year. CMS launched the alternative payment model in 2018 to test whether bundling Medicare payments for certain inpatient and outpatient care reduces spending and improves quality. The agency expects early next year to request applications from Medicare providers, suppliers and accountable care organizations to participate in the two-year extension, which will include changes to the pricing methodology.

Thursday Miscellany

David Ermer–CMS, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the COLA front —

Federal News Network informs us

Federal retirees and Social Security recipients are about to get the largest increase in their cost-of-living adjustment (COLA) in over four decades.

The COLA will increase 8.7% for 2023, the Social Security Administration announced on Oct. 13. But not all federal retirees will see that amount added to their checks. Those in the Federal Employee Retirement System (FERS) will receive a 7.7% COLA starting in January.

In contrast to the Civil Service Retirement System, whose annuitants receive the 8.7% COLA, FERS is integrated with Social Security retirement benefits. Consequently, FERS annuitants will receive the 8.7% COLA on their Social Security benefits. Here’s the government’s Social Security 2023 Changes Fact Sheet.

The Society for Human Resource Management offers Social Security tax changes information relevant to employers and employees.

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

The retooled Covid-19 booster from Pfizer Inc. and BioNTech SEgenerated a strong immune response against the Omicron substrains BA.4 and BA.5, the companies said. 

The data, which the companies reported in a news release Thursday, offer the first window into how the new shots rolling out across the U.S. perform.

An early look at data from ongoing testing in people at least 18 years old found the booster generated higher levels of neutralizing antibodies against the two substrains compared with levels measured before the extra shot, the companies said.

Researchers also found the vaccine, called bivalent because it targets both the Omicron substrains as well as the original strain of the virus, was well-tolerated and worked safely.

From the monkeypox front, the New York Times Morning column assesses the lessons that “Monkeypox’s decline has for future disease outbreaks.”

Ultimately, monkeypox in the U.S. has been contained to a narrow demographic, mostly gay and bisexual men with multiple partners. It was never very deadly; there were just 28 confirmed deaths globally out of more than 72,000 reported cases. (I wrote earlier about the virus and how it spreads.)

Four factors explain monkeypox’s decline, experts said. First, vaccines helped slow the virus’s spread (despite a rocky rollout). Second, gay and bisexual men reduced activities, such as sex with multiple partners, that spread the virus more quickly.

The third reason is related: the Pride Month effect. Monkeypox began to spread more widely around June, when much of the world celebrated L.G.B.T.Q. Pride. Beyond the parades and rallies, some parties and other festivities involved casual sex. As the celebrations dwindled, so did the increased potential for monkeypox to spread.

And finally, the virus simply burned out. Monkeypox mainly spreads through close contact, making it harder to transmit than a pathogen that is primarily airborne, like the coronavirus. “Because of that, monkeypox is a self-limiting virus,” Apoorva told me. That made it less likely to grow into a larger outbreak.

Much of this explanation may sound familiar after more than two years of Covid: A virus can be tamed by vaccines and behavioral changes.

From the public health front, the UnitedHealth Foundation released the Sixth edition of its U.S. Health Rankings for Women and Children.

The 6th edition of America’s Health Rankings® Health of Women and Children Report shines a light on the health challenges faced by the nation’s women and children. The report builds on United Health Foundation’s commitment to support better health and encourages others to join in building healthier communities.

Visit the Health of Women and Children Report Action Toolkit to access additional resources that can help you share the data with relevant stakeholders and enact change.

This year, the Health of Women and Children Report finds that:

* Rates of mental and behavioral health challenges have increased broadly among women and children across the nation in recent years, though rates vary widely based on geography, race/ethnicity and socioeconomic factors.
* The overall mortality rate among women ages 20-44 increased dramatically during the first year of the COVID-19 pandemic, exacerbating existing disparities.
* The pandemic underscored the need to address long-standing disparities in maternal mortality and morbidity, which continue to disproportionately burden Black and American Indian/Alaska Native women.
* In the first years of the COVID-19 pandemic, several socioeconomic and environmental conditions that shape health worsened. Women experienced record-high unemployment and markers of health related to children’s neighborhoods and home environments declined.
* The healthiest states are Minnesota, Massachusetts, Vermont, New Jersey and Utah. Louisiana had the most opportunity to improve, followed by Arkansas, Mississippi, Oklahoma and Alabama.

STAT News adds

In the numbers game of disease statistics, type 1 diabetes takes a back seat to type 2 diabetes, which accounts for more than 95% of diabetes cases around the globe. But the impact of type 1 diabetes (T1D), which tends to emerge earlier in life and can quickly kill an individual if it goes unrecognized or untreated, is huge. Its global burden, however, hasn’t been well understood — until now.

With the proper care and treatment, including access to insulin, which people with type 1 diabetes must use every day, individuals can live long and healthy lives with this disease. But many in the United States and countries around the world do not have access to even the most basic treatments.

To assess the impact of type 1 diabetes, JDRF, the organization [the author] lead[s], and its global partners created the Type 1 Diabetes Index (T1D Index), a first-of-its-kind tool, to identify and address the wide gaps in knowledge about the incidence and impact of type 1 diabetes country by country. With this knowledge, interventions can be developed that will save lives and improve the health of those living with the disease.

From the U.S health care business and innovations front —

Healthcare Dive reports

Walgreens expects its U.S. Healthcare division, which includes primary care chain VillageMD, specialty pharmacy company Shields Health Solutions and at-home care provider CareCentrix, to reach profitability in 2024, CEO Roz Brewer told investors on a Thursday call for Walgreens’ fourth-quarter results.

Walgreens is also increasing its long-term sales outlook for the new division to between $11 billion and $12 billion in sales by 2025, with VillageMD being the largest contributor. In the 2022 fiscal year, U.S. Healthcare brought in $1.8 billion in sales.

Despite a net loss in the fourth quarter, the Deerfield, Illinois-based pharmacy chain beat analyst expectations for both earnings and revenue.

and

GoodRx — the consumer-facing, digital drug discount startup — is launching a new version of its platform that is tailored for providers.

Doctors, medical office staff and other healthcare workers have already been using the consumer-facing version to help patients find discounts and programs to help them afford prescribed medications, GoodRx Executive Medical Director Preeti Parikh, said.

Targeting providers directly is a pivot from GoodRx’s traditional consumer focus, but the company found it necessary and sees an opportunity to capture more pharmaceutical advertising revenue in the process, she said.

Fierce Healthcare tells us

The hospital industry’s recent shift toward fewer, but larger, merger and acquisition deals continued through the third quarter of 2022, according to a new report.

There were 10 hospital and health system transactions announced from July through September by advisory firm Kaufman Hall’s count—up slightly from last year’s seven announced deals but still well below the 19 from 2020 or the 25 from 2019.

The total transacted value of those 10 deals, however, exceeded nearly all of the third-quarter totals measured by the firm in the last seven years.

The past three months’ $8.3 billion handily outpaced 2021’s $5.2 billion and 2020’s $7.4 billion, the firm wrote, and is only beaten by the $10.8 billion recorded among 19 deals back in 2018.

and

Pacific Northwest insurer Regence is teaming with MultiCare Connected care to roll out a new tool that aims to ease the administrative burden of prior authorization.

Regence and MultiCare, an accountable care organization, will be the first in the nation to roll out new prior authorization standards backed by HL7’s Fast Healthcare Interoperability Resources, or FHIR. As FHIR is supported by most electronic health records, the tool can be embedded directly in physicians’ workflows and enables them to receive near real-time determinations.

Finally, OPM announced

The U.S. Office of Personnel Management (OPM) announced that the Honorable Denis McDonough, Secretary of the U.S. Department of Veterans Affairs (VA) and U.S. Office of Personnel Management (OPM) Director Kiran Ahuja will be serving as the National Honorary Co-Chairs of the [ongoing] 2022 Combined Federal Campaign (CFC). 

 The CFC is a 61-year annual giving tradition that allows the Federal workforce to donate directly to thousands of eligible charities and causes locally, nationwide, and throughout the world. Through the contributions of Federal employees, military employees, and retirees, the 2021 CFC raised over $80 million. An additional Special Solicitation took place earlier this year to benefit those affected by the war in Ukraine.   

The campaign run from September 1st, 2022 through January 14, 2023. 

Thursday Miscellany

David Ermer–CDC, CMS, Federal employment benefits, Medicare, Rx coverage, Uncategorized–

From the FEHB front, the Federal Times discusses one of OPM’s 2023 FEHB initiatives, coverage of gender-affirming care.

OPM announced

The Office of Personnel Management (OPM) migrated from the legacy application responsible for the financial management activities of over $1.1+ trillion-dollar trust fund assets to a modernized financial system platform that is managed and maintained by the Department of the Treasury, Bureau of the Fiscal Service’s Administrative Resource Center (ARC).

The partnership between OPM and ARC will result in millions of taxpayer dollars saved, and enable a modernized, secure financial management solution and re-engineered processes to support the administration of the earned benefits program which includes retirement, health, and life insurance. As a result, millions of federal employees, retirees, and their families should have increased confidence in the programs that ensure they can meet their retirement and healthcare and life insurance needs.

Here’s the related ARC press release. ARC is a federal government center of excellence. The FEHBlog is interested in reading more details on the benefits of this new system.

From the public policy front, here are links to AHIP’s press releases from this week on the ACA individual non-discrimination rule, Section 1557, and its favorable reaction to CMS’s idea to create a national provider directory.

Healthcare Dive tells us

A regulatory deadline kicked in Thursday requiring providers and other healthcare entities to be able to share a significantly larger scope of data with patients, despite major provider groups arguing they’re not ready to comply.

As of Thursday, information blocking regulations apply to all electronic health information in a record that qualifies as protected health information under the Health Insurance Portability and Accountability Act.

Previously, providers only had to make available data elements in a specific dataset called United States Core Data for Interoperability.

Time will tell us about the rule’s effect.

From the Medicare front, Forbes offers a deep dive into 2023 adjustments to the Medicare Parts B and D beneficiary income premium adjustments known as IRMMA. IRMAA impacts many federal annuitants, which causes an ongoing material reduction in new federal annuitants signing in for Part B. The kick in the pants is that when an annuitant’s income declines below that IRMMA level which typically happens over time, the Part B premium is unaffordable due to the late enrollment penalty.

From the public health front —

The Centers for Disease Control is calling attention to its patient and provider education materials on sepsis.

The American Hospital Association informs us

More than 2.5 million students in grades 6-12 reported using electronic cigarettes in the past 30 days when surveyed this year, including 14% of high school students and 3% of middle school students, the Centers for Disease Control and Prevention reported today. One in four students who used e-cigarettes used them daily, 8 in 10 used flavored e-cigarettes and over half used disposable e-cigarettes. Since 2014, U.S. youth have used e-cigarettes more than any other tobacco product.

“It’s critical that we work together to prevent youth from starting to use any tobacco product — including e-cigarettes — and help all youth who do use them, to quit,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health. 

For more information, see the CDC fact sheet for health care providers and tools to help teens quit.

From the Rx coverage front,

The New York Times informs us

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

The Institute for Clinical and Economic Research has observed

Last week, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis. Even in the absence of definitive proof of efficacy, there are clear benefits to ensuring patients with a rapidly fatal disease have early access to a safe therapy. In a situation like this, we believe the manufacturer has an obligation to price responsibly. ICER concluded that an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works. While awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio.

Ruh roh.

Fierce Health reports

Beginning this month, the Pennsylvania-based plan and Mark Cuban’s drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company’s online pharmacy. 

The online pharmacy launched earlier this year, aiming to disrupt skyrocketing prescription drug prices in the U.S. It currently offers nearly 1,000 generic prescription drugs that it says reflect manufacturer prices plus a 15% fee.  * * *

While initially, MCCPDC was planning to launch its own pharmacy benefit manager, it then scrapped those plans, announcing its first PBM partnership last week. The PBM has no rebates and no spread pricing. Some experts have cautioned that while the company’s effort is effective, it isn’t tackling a more pressing problem—brand-name drug prices, given generic drugs are up to 85% less expensive. The company is hoping to offer brand-name drugs down the line, CNBC reports.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, HSA, OPM, Patient safety, U.S. Healthcare–
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.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

Congress has left Capitol Hill after the Congressional election on November 8. The Wall Street Journal reports from the Congressional campaign trail.

Tomorrow, the Supreme Court opens its October 2023 Term. The Journal discusses the legal issues that the Court will be considering this term.

Amy Howe adds

When the justices return to the bench next week to begin the 2022-23 term, members of the public will be able to attend oral arguments for the first time since the COVID-19 pandemic began in 2020. The court also announced on Wednesday that it will continue to provide a live audio feed of oral arguments, a practice that it began during the pandemic.

Masking will be optional at oral arguments, the court said in a press release, and the court’s building will otherwise remain closed to the public.

From the Omicron and siblings front, Forbes reports

As COVID-19 regulations continue to ease across the U.S., some Americans want more protection. Nearly two-thirds (63%) of adults familiar with the recently updated booster shot, which specifically targets the virus’ Omicron variant, say they are likely to get one.

That’s according to the latest Forbes Health-Ipsos Monthly Health Tracker, which polled 1,120 adults between Sept. 27 and 28, 2022. Of those in favor of the new shot, 25% say they are “somewhat likely” to get it, while 38% indicate they are “very likely” to get the booster.

Additionally, about 9% of polled individuals have already received the latest booster, and 28% say they aren’t likely to get this particular booster at all.

Perhaps it’s time for health plans to reach out to members on the bivalent booster.

From the healthcare costs front, the Congressional Budget Office offers “Policy Approaches to Reduce What Commercial Insurers Pay for Hospital and Physician Services.” How timely!

From the Rx coverage front —

Fierce Healthcare tells us

A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%. 

The report and a second report on price trends released Friday by the Department of Health and Human Services (HHS) underline how a new provision in the Inflation Reduction Act—an inflationary cap on Part D costs—will affect prices right as the cap is implemented Oct. 1. 

NPR shots provides patient and expert reaction to the FDA’s decision to approve a new drug to treat amyotrophic lateral sclerosis (“ALS”).

The Food and Drug Administration has approved a controversial new drug for the fatal condition known as ALS, or Lou Gehrig’s disease. 

The decision is being hailed by patients and their advocates, but questioned by some scientists.

Relyvrio, made by Amylyx Pharmaceuticals of Cambridge, Mass., was approved based on a single study of just 137 patients. Results suggested the drug might extend patients’ lives by five to six months, or more. * * *

A much larger study of Relyvrio, the Phoenix Trial, is under way. But results are more than a year off.

The Institute for Clinical and Economic (ICER) review adds

Yesterday, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis (ALS). According to ICER’s analysis, the therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.

We also recommended that manufacturers should seek to set prices of new medications that will foster affordability and access for all patients by aligning prices with the patient-centered therapeutic value of their treatments, and not based on the price of existing ALS medications. This is especially important for ALS since new drugs are anticipated to be used in combination with other very expensive drugs, creating the highest risk for financial toxicity due to health care costs.

From the telehealth front, mHealth Intelligence informs us

While researching the effects of telehealth and in-person care within a large integrated health system, a study published in JAMA Network Open found that virtual care methods can expand healthcare capabilities, performing on par or better than in-person care on most quality measures evaluated.

Researchers conducted a retrospective cohort study that included 526,874 patients, 409,732 of whom received only in-person care, and 117,142 participated in telehealth visits. Of those who received only in-person care, 49.7 percent were women, 85 percent were non-Hispanic, and 82 percent were White. Of those who received care via telehealth, 63.9 percent were women, 90 percent were non-Hispanic, and 86 percent were White.

Researchers noted that patients in the in-person-only group performed better on medication-based measures. But only three of the five measures had significant differences: patients with cardiovascular disease (CVD) receiving antiplatelets, those with CVD receiving statins, and those with upper respiratory infections avoiding antibiotics.

Researchers also noted that patients participating in telehealth performed better than those in the -person-only group on four testing-based measures. These four measures included patients with CVD with lipid panels, patients with diabetes with hemoglobin A1c testing, patients with diabetes with nephropathy testing, and blood pressure control.

Further, those participating in telehealth performed better than their counterparts on seven counseling-based measures, including cervical cancer screening, breast cancer screening, colon cancer screening, tobacco counseling and intervention, influenza vaccination, pneumococcal vaccination, and depression screening.

Based on these study findings, researchers concluded that telehealth could augment care for various conditions, especially chronic diseases. The study also supplies information that could assist providers in determining an ideal ratio of in-person and telehealth visits.

But researchers also noted several limitations associated with the study. These included their inability to control for the number of in-person and telehealth visits, potential inaccuracies associated with the EMR data used, and sampling limitations.