Thursday Miscellany

Medicare

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

President Biden today announced a strategy for sharing “at least 80 million U.S. [COVID 19] vaccine doses globally by the end of June.

On the U.S. COVID-19 vaccination front

  • David Leonhardt reports in the New York Times that

When the C.D.C. reversed its Covid-19 guidelines last month and said that vaccinated Americans rarely needed to wear masks, it caused both anxiety and uncertainty.

Many people worried that the change would cause unvaccinated people to shed their masks and create a surge of new cases. On the flip side, a more optimistic outcome also seemed possible: that the potential to live mostly mask-free would inspire some vaccine-hesitant Americans to get their shots.

Almost three weeks after the change, we can begin to get some answers by looking at the data. So far, it suggests that the optimists were better prognosticators than the pessimists.

  • HR Dive informs us that “Vaccine mandates are not a consideration for 83% of employers responding to law firm Fisher Phillips’ recent pulse survey. That figure is up from January, when the firm recorded 64% of respondents saying they would not impose a vaccine requirement. At that time, 27% of employers said they had yet to decide if they would mandate vaccinations. “Most employers — 75% — said they are encouraging workers to get their vaccines, the May 25 survey results revealed.”

Fortune Magazine released its Fortune 500 and sitting in the top 10 are four healthcare companies (CVS Health (4), United Health Group (5), McKesson (7) and AmerisourceBergen (8). For the second year in a row the top two companies are Walmart and Amazon, both of which are attempting to break into the healthcare market.

In his latest FedWeek column, Reg Jones discusses continuing FEHB coverage of unmarried children of enrollees beyond age 26 provided the child is incapable of self-support. “The term “incapable of self support” generally means that the child earns less than the equivalent of GS-5, step 1 [$30,414 in 2021]. However, this is not a hard and fast rule. In making a decision, consideration is given to the child’s earnings and condition or prognosis.”

From the Centers for Medicare and Medicaid Services front:

  • Kaiser Health News reports that expanding health insurance coverage is the top priority of the newly installed CMS Administrator, Chiquita Brooks-Lasure.
  • Healthcare Dive tells us that Elizabeth Fowler, head of the Center for Medicare and Medicaid Innovation, said that CMMI’s ongoing strategy review has resulted in more conscious choices in where it should invest, which includes pivoting away from voluntary models. “Voluntary models are subject to risk selection, which has a negative impact on the ability to generate system-level savings. Providers that aren’t generating the extra revenue tend to exit the program, and those that are tend to stay,” Fowler, now on her third month at the job, said at a Health Affairs briefing. “So we are exploring more mandatory models.”
  • Fierce Healthcare informs us that Congress wants CMMI to be more transparent in its spending. A bipartisan letter “said CMMI’s authorizing statute, which was part of the Affordable Care Act, calls for the center to gather input from interested parties. However, this requirement has often been shunted aside by the center and rarely observed.”

Medcity News reports that the Labor Department’s top health benefits law enforcement priority is compliance with the federal mental health parity law.

To uphold the law and ensure parity in coverage, the labor department has two strategies in place, [Secretary of Labor] Walsh said.

The department’s Employee Benefits Security Administration agency has created a task force that focuses on enforcement of the act, he said. The task force is reviewing its inventory of case files, looking to identify potential violations and send out requests to payers for data on parity analyses, which they are required to maintain to show their compliance with the law.

Further, the Department of Labor, along with other government agencies involved in this work such as the Department of Health and Human Services and Internal Revenue Service, is providing regular reports to Congress on their findings and enforcement actions, Walsh said. This can help inform legislation on insurance coverage moving forward.

Govexec provides the latest Postal Service news, including a confirmed report that the FBI is investigating Postmaster General DeJoy “for allegations that he illegally pressured employees at his former company to donate to Republican candidates while promising to later reimburse them through bonuses.”

The Wall Street Journal reports today that

A drug sold by AstraZeneca PLC and Merck & Co. reduced the recurrence of breast cancer in women with an early but aggressive form of the disease, a long-running [blinded] international study found. The finding, which on Thursday was published online by the New England Journal of Medicine and released at a major cancer-research meeting, marked the latest advance in cancer treatments targeting the genetic traits of tumors. It could expand the arsenal of weapons against a hereditary form of breast cancer. The result also helps validate the pharmaceutical industry’s investment in a pricey new class of drugs that target cancer cells, known as PARP inhibitors.  * * *

PARP inhibitors work by blocking cancer cells from relying on a survival tactic: the ability to repair their own DNA after their DNA is damaged naturally or by other drug treatments. This, in turn, contributes to cancer-cell death.

Health regulators have approved these types of drugs in recent years to treat ovarian, breast, prostate and pancreatic cancers. The drugs have been found to be particularly useful against cancers associated with harmful mutations in genes known as BRCA1 and BRCA2. Women with these hereditary mutations have a higher risk of developing breast cancer, and often at a younger age than is typical. The BRCA mutations account for about 5% of the estimated 281,000 cases of breast cancer diagnosed annually in the U.S.

Weekend update

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

The House of Representatives will be conducting Committee business this week and is not expected to resume floor voting until June 14. The Senate will be conducting Committee business and floor voting this week. Tomorrow the Senate will begin the voting process for confirmed President Biden’s nominee for Centers for Medicare and Medicaid Services Administrator, Chiquita Brooks-LaSure.

The Supreme Court will hold another opinion day tomorrow which may be the occasion for the release of the California v. Texas Affordable Care Act constitutionality decision. Lexology discusses the fallout from the Surpreme Court’s December 2020 opinion in Rutledge v. PCMA narrowing the scope of ERISA preemption with respect to prescription benefit manager law. State legislatures have jumped on the opportunity created by the Rutledge opinion.

In 2021 alone, at least eight states have enacted some sort of PBM reform legislation, including Alabama, Arizona, Arkansas, Mississippi, New York, North Dakota, West Virginia and Wisconsin. PBM reform regulation has passed both the state house and senate in Texas and is on its way to the governor. These bills run the gamut of regulating the PBM industry, from prohibiting PBMs from charging pharmacies fees during and after the claims adjudication process, prohibiting PBMs from reimbursing their own affiliated pharmacies at a higher level than independent pharmacies to banning PBM discrimination against pharmacies participating in the Federal 340B medication discount program. This trend is likely to continue with almost 100 bills introduced across 39 states similarly aimed at regulating the PBM industry

Cost curve up. ERISA decisions like this one impact FEHB preemption because courts have interpreted the two preemption laws as generally analogous in scope.

In other news and opinions:

  • Medpage Today offers an op-ed about the importance of primary care. The FEHBlog agrees that “Patients need support for mental and physical health all in one place” and accordingly health plans should encourage the use of primary care.
  • Fierce Healthcare reports that “There was a significant increase in pharmacy fraud and abuse under the pandemic, analysts at OptumRx say. The pharmacy benefit manager giant recovered $300 million in fraud, waste and abuse spend in 2020 and documented the largest ever increase in fraudulent claims, which were up 300% compared to 2019. In addition, Optum’s investigative audits led to an increase of 135% in fraud recoveries last year from 2019. The average audit recovery per case was also 70% higher in 2020 than in 2019, Optum found. Optum found the fraudulent behavior concentrated among independent pharmacies and rarely found similar activity among retail chains, [Optum analysts] said. Due to the findings, the PBM axed 112 pharmacies from its network.
  • Kaiser Health News informs us that “Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down. The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services. At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals. The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs. But that rarely happened. Instead, these emergency rooms — not physically connected to hospitals — generally set up in affluent suburban communities, often near hospitals that compete with the free-standing ERs’ owners. And they largely treated patients who did not need emergency care, but still billed them and their insurers at expensive ER rates, several studies have found.” Good luck Colorado as this approach also may reduce surprise billing issues.

Midweek Update

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

Tomorrow morning the House Oversight and Reform Committee will mark up its bipartisan Postal Reform Act (H.R. 3076) and the Postal Improvement Act (HR 3077). H.R. 3076 would eliminate the Postal Service’s unique obligation to pre-fund the cost of FEHB coverage for its annuitants. It also would create a subprogram with the FEHB for postal service employees and annuitants that would be fully integrated with Medicare Parts A (hospital), B (professional services) and D (prescription drugs) for annuitants over age 65.

Existing FEHB plans largely receive the financial benefit of Medicare Parts A and B integration, but OPM does not permit FEHB plans to offer Medicare Part D integration known as EGWPs. The FEHBlog expects H.R. 3076’s mandatory use of Part D EGWPs in the subprogram will unleash a gusher of new benefit savings for subprogram plans. Fingers crossed that successful adoption of Part D EGWPs in this subprogram leads OPM to allow carriers to add them in existing FEHB too. However, as currently drafted, the subprogram would launch on January 1, 2023, which is aggressive timing in the FEHBlog’s view.

Today according to the Wall Street Journal

The Centers for Disease Control and Prevention recommended that 12- to 15-year-olds receive the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, expanding the nation’s vaccination campaign. 

The CDC took the step after its vaccination advisory panel voted to recommend the shot at a meeting Wednesday after reviewing clinical trial data and other relevant information. The vote by the Advisory Committee on Immunization Practices, or ACIP, was 14-0, with one voting member recusing. * * *

Covid-19 cases are rising in adolescents, and as older Americans have gotten vaccinated, adolescents make up an increasing proportion of the overall U.S. case count, Sara Oliver, a CDC medical officer, said. Adolescents accounted for 9% of reported cases in April, a larger proportion than cases involving people 65 years and older as more adults have been vaccinated, she said.

According to the CARES Act of 2020, health plans, including FEHB plans, must begin to cover the Pfizer vaccine without member cost sharing for this age group no later than fifteen days from today, May 27, 2021. According to the Journal, “Pfizer anticipates asking the FDA in September to authorize its vaccine’s use in children 2 to 11 years old should ongoing studies prove positive. The company said It plans to make a similar request for children 6 months to 2 years of age in the fourth quarter.”

In Biden Administration news, the American Hospital Association reports that

Health and Human Services Secretary Xavier Becerra today swore in Andrea Palm as deputy secretary. Confirmed by the Senate yesterday, Palm previously served as secretary-designee of Wisconsin’s Department of Health Services and in several leadership roles at HHS during the Obama-Biden administration.  
“My focus will be on improving the lives and livelihoods of the American people: tackling the COVID-19 pandemic, efficiently and equitably distributing vaccines, expanding access to affordable health care, addressing the epidemic of substance use disorders, and improving mental health care,” she said. 
Biden’s nominee to serve as Centers for Medicare and Medicaid Services administrator, Chiquita Brooks-LaSure, today moved one-step closer to confirmation with the Senate voting 51-48 to discharge the nomination. The Senate could hold a final vote on her confirmation next week.  

STAT News informs us

  • “Telehealth companies, flush with cash after the Covid-19 pandemic spiked both demand and investment, are now embarking on massive lobbying efforts to secure their interests on Capitol Hill. The goal is clear: Lawmakers are weighing whether to permanently loosen regulations that were temporarily eased during the pandemic. Among other changes, providers have been allowed to practice in states where they are not licensed, and Medicare has been permitted to pay providers the same for virtual visits as in-person ones. Lobbyists for the rapidly growing industry are determined to keep those changes intact.” Watch for this result the big infrastructure bill.
  • Amazon’s objectives for its nascent pharmacy business are straightforward: “better selection, better convenience, and better prices,” according to TJ Parker, the vice president of pharmacy at the company.“ It really is the Amazon playbook,” he said during a Wednesday panel at STAT’s Health Tech Summit. * * * “Customers really want more Amazon and less pharmacy and so our work from here is to make pharmacy truly as seamless to us as amazon.com [is] for other categories,” Parker said. Among Amazon’s latest offerings: a new price-comparison tool for medications, which launched Tuesday. Now, when someone searches for a prescription drug on Amazon, Amazon Pharmacy’s price for a drug is listed alongside the cost for Prime members at other pharmacies like CVS, Walgreens, Walmart, and Costco.” Watch out GoodRx.

On a related note, the Drug Channels blog assesses how Cigna’s growing pharmacy platform expands its channel power.

Last week, Cigna released its earnings for the first quarter of 2021. I was struck by how quickly Cigna’s Express Scripts PBM business has increased revenues and prescriptions from its retail pharmacy network. Our second chart below highlights this growth. The businesses in Cigna’s Evernorth segment—especially Express Scripts, Ascent Health Services, and InsideRx—are already providing rebate negotiation, network management, and/or a sourcing platform for Prime Therapeutics, Kroger, Humana, GoodRx, and Amazon.”

Midweek Update

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Mark Tegethoff on Unsplash

Govexec reports that at the Senate Homeland Security and Governmental Affairs Committee’s business meeting today, the Committee advanced to the Senate floor the nominations of Kiran Ahuja to be OPM Director along party lines and the three nominations of Postal Service Governors with bipartisan margins. The FEHBlog expects these nominations to be brought to the Senate floor next month.

From the COVID-19 front:

  • The Wall Street Journal informs us that “Vaccines appear to be starting to curb new Covid-19 infections in the U.S., a breakthrough that could help people return to more normal activities as infection worries fade, public-health officials say. By Tuesday, 37.3% of U.S. adults were fully vaccinated against Covid-19, with about 2.7 million shots each day. * * * With the U.S. recently averaging at least 50,000 new daily cases, the pandemic is far from over. But the U.S. is nearing a nationwide benchmark of having 40% of adults fully vaccinated, which many public-health experts call an important threshold where vaccinations gain an upper hand over the coronavirus, based on the experience from further-along nations such as Israel.”
  • Today the Centers for Disease Control released a report on the mRNA vaccines. Here are the highlights which support the Journal’s report particularly as over 2/3s of Americans over age 65 are fully vaccinated.

Clinical trials suggest high efficacy for COVID-19 vaccines, but evaluation of vaccine effectiveness against severe outcomes in real-world settings and in populations at high risk, including older adults, is needed.

What is added by this report?

In a multistate network of U.S. hospitals during January–March 2021, receipt of Pfizer-BioNTech or Moderna COVID-19 vaccines was 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged ≥65 years.

What are the implications for public health practice?

SARS-CoV-2 vaccines significantly reduce the risk for COVID-19–associated hospitalization in older adults and, in turn, might lead to commensurate reductions in post-COVID conditions and deaths.

  • The Wall Street Journal also reports that “Covid-19 tests for people to use to get quick results at home are finally becoming available to buy at pharmacies and retailers. Yet an obstacle might stand in the way of regular use: cost. * * * The U.S. Food and Drug Administration recently cleared over-the-counter sales of two of these rapid at-home screening tests, one from Abbott Laboratories and another from Quidel Corp. 

Major pharmacies recently said they plan to sell a two-pack of Abbott’s test for nearly $24, while Walmart says it will charge just under $20. The price for Quidel’s test hasn’t been released, though Quidel has indicated it will be less than $30 for a pair.

“Twenty-five dollars for a Covid test, I think most people would pay that once. But would they pay it every week or every two weeks?” says Zoe McLaren, a health economist and an associate professor in the School of Public Policy at the University of Maryland, Baltimore County. “It’s not designed to be a one-time cost.”

Dr. McLaren and medical-testing experts expressed hope that prices would drop if more companies get clearance to sell paper-strip tests. * * * Public-health authorities say they are glad to see the tests in stores, and the tests will be valuable tools for checking symptoms or for specific occasions, such as traveling or visiting relatives.

From the Medicare front

  • The Centers for Medicare and Medicaid Services released yesterday a proposed fiscal year 2022 Medicare Part A inpatient prospective payment system rule. “The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.8 percent. This reflects the projected hospital market basket update of 2.5 percent reduced by a 0.2 percentage point productivity adjustment and increased by a 0.5 percentage point adjustment required by legislation.”
  • Healthcare Dive provides its perspective on the proposal which evidently was well received by the hospital industry. “[T]he American Hospital Association applaud[ed] the provision that removes the requirement that hospitals report privately negotiated rates with Medicare Advantage payers on Medicare cost reports and another that repeals market-based weight methodology for determining payments.”

On the FEHB front

  • FedSmith advises that “Federal employees facing a future with children aging out of TRICARE should consider enrolling in an FEHB policy. This is because FEHB plans provide coverage for children in the family option up to age 26. Additionally, the family FEHB premium for the employee, spouse, and children may be less than the cost of the TYA option for one individual. FEHB employees who are eligible for TRICARE and interested in having their children covered in an FEHB plan have to enroll during Open Season. Federal employees with TRICARE also need to enroll in a plan at least a year ahead of retirement for the FEHB plan to be continue in retirement.” Interesting.

On the artificial intelligence front, Forbes lists its top 50 AI companies to watch. Enjoy.

Friday Stats and More

David Ermer–CMS, COVID-19, COVID-19 vaccine, Medicare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 9th week of this year (beginning April 2, 2020, and ending April 7, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through April 7, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through April 7, 2021 which also uses Thursday as the first day of the week:

That is quite a sharp increase in distributed doses of the COVID-19 vaccine.

Bloomberg reports that

The U.S. recorded 4 million vaccine doses on Friday, returning the pace of inoculations almost to the level before a post holiday lull, according to the Bloomberg Vaccine Tracker. It was the third straight day of increases, with the seven-day average now at 3.03 million doses a day. So far, 179 million doses have been administered. At this pace, it’s estimated to take another 3 months to cover 75% of the population.

Pfizer and BioNTech announced today that they have “requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech [2 dose mRNA] Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age.” That’s a good sign for an in-person teaching in high schools next year.

Bloomberg also reports this evening that

The U.S. Centers for Disease Control is working with health departments in four states to evaluate symptoms experienced after Johnson & Johnson vaccinations but has “not found any reason for concern,” a spokeswoman said in a statement.

“Many people don’t have any side effects after Covid-19 vaccines, but some people will have pain or swelling at the injection site or fever, chills, or a headache,” spokeswoman Kristen Nordlund said. “These typically don’t last long and are signs that your body is building protection.”

She said the states are Colorado, North Carolina, Georgia and Iowa. The symptoms include “dizziness, light headedness, feeling faint, rapid breathing, and sweating.” She said the CDC “is aware of other instances of these symptoms occurring with the other Covid-19 vaccines.”

The Wall Street Journal cautions that “Deliveries of Johnson & Johnson’s JNJ -1.06% Covid-19 vaccine doses throughout the U.S. are expected to plunge by more than 80% next week, according to state officials and federal data, as J&J grapples with manufacturing challenges.”

Whither the emergency use application for the other adenovirus based COVID-19 from AstraZeneca/Oxford University?

Under the and More subheading —

  • Yesterday the CDC Director Rochelle Walensky issued a statement on her “Commitment to Addressing Racism as an Obstacle to Health Equity.” “To build a healthier America for all, we must confront the systems and policies that have resulted in the generational injustice that has given rise to racial and ethnic health inequities. We at CDC want to lead in this effort—both in the work we do on behalf of the nation’s health and the work we do internally as an organization.” Well said.
  • The Biden Administration released an abbreviated version of its Fiscal Year 2022 federal budget today.

The Office of Management and Budget (OMB) today submitted to Congress President Biden’s discretionary funding request for Fiscal Year 2022. As Congress prepares to begin the annual appropriations process, the request lays out the President’s discretionary funding recommendations across a wide range of policy areas and outlines a strategy for reinvesting in the foundations of our country’s resilience and strength. The request — which represents only one element of the Administration’s broader agenda — includes key investments in K-12 education, medical research, housing, civil rights, and other priorities that are vital to our future. Later this spring, the Administration will release the President’s Budget, which will present a unified, comprehensive plan to address the overlapping challenges we face in a fiscally and economically responsible way.

The Wall Street Journal adds that “The preliminary plan released Friday by the White House would raise discretionary spending by 8.4%, or $118 billion, from the $1.4 trillion authorized last year, excluding emergency measures to combat the Covid-19 pandemic. Discretionary spending is the part of the budget that Congress shapes through the appropriations process.”

  • Yesterday, the FEHBlog discussed the Center for Medicare and Medicaid Service’s proposal rule for the Fiscal Year 2022 Medicare prospective payment and quality system for psychiatric hospitals. Becker’s Hospital CFO Report informs us that in addition CMS issued three other pricing rules for rehabilitation hospitals, hospices, and skilled nursing facilities.
  • Finally, Fierce Healthcare reports that

While hospitals post a mixed record on complying with a major price transparency rule [that took effect on January 1, 2021],the Biden administration has not announced how they are going to keep facilities in line.

Several studies and analyses have shown that larger health systems have not done a good job fully complying with the rule to post payer-negotiated rates online. The results come as the Centers for Medicare & Medicaid Services (CMS) has not announced major enforcement actions against hospitals not meeting the controversial rule’s requirements.

“So far with the current administration, we haven’t seen the agency put out any information on the auditing process or changes to the reporting requirements or changes to the penalties for noncompliance,” said Caitlin Sheetz, director and head of analytics for consulting firm ADVI, in an interview with Fierce Healthcare. “Unless that changes, I don’t think we are going to see large shifts in hospital behavior.”

Tuesday Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–

Happy National Doctors’ Day “It is a day to celebrate the contribution of physicians who serve our country by caring for its’ citizens.”

The American Hospital Association reports that

Anticipating possible congressional action to extend the moratorium on the 2% sequester cut to all Medicare payments, the Centers for Medicare & Medicaid Services today said it has instructed Medicare administrative contractors to hold all claims with dates of service on or after April 1, 2021, for a short period. The MACs will automatically reprocess any claims paid with the reduction applied if necessary, the agency said. 
  
The Senate last week passed a bill that, among other health care provisions, would eliminate the 2% cut to all Medicare payments, known as sequestration, until the end of 2021. The House is expected to take up the Senate-passed bill the week of April 13 when it returns to Washington D.C.

Bloomberg News informs us that

The World Health Organization’s chief said a mission to study the origins of the coronavirus in China was too quick to dismiss the theory of a lab leak, with the U.S. and other governments joining in criticism of the investigation.

WHO Director-General Tedros Adhanom Ghebreyesus said the probe didn’t adequately analyze the possibility of a lab accident before deciding it’s most likely the pathogen spread from bats to humans via another animal. In a briefing to member countries Tuesday, he said he is ready to deploy additional missions involving specialist experts.

“Although the team has concluded that a laboratory leak is the least likely hypothesis, this requires further investigation,” Tedros said in a statement. The WHO chief has consistently said all lines of inquiry are open, but Tuesday’s comments mark the first time he’s speculated about the possibility of an accidental escape.

The American Medical Association offers a podcast in which Christopher J.L. Murray, MD, director of the Institute for Health Metrics and Evaluation at the University of Washington offers his perspective on the future course of COVID-19 in the U.S. this year.

A physician and health economist whose career has focused on improving health globally by improving health evidence, Dr. Murray outlined these three challenges to making herd immunity a reality and preventing another wave of illness this fall or winter:

Vaccines will not be as effective at preventing infection from the SARS-Co-V-2 B.1.351 variant that emerged in South Africa or the P.1 variant that emerged in Brazil, or future variants.

Not enough individuals will receive the vaccine to achieve herd immunity.

Those who had previous COVID-19 infections from one variant may not have protection from being reinfected with a new variant.

When vaccines were approved, everyone thought the U.S. would get to herd immunity by late summer or the fall because the number of people who have been vaccinated combined with the 20% of Americans who had already been infected and had immunity would push America to the level needed for herd immunity, preventing another wave next winter, Dr. Murray said.

“But if it turns out there isn’t cross-variant immunity, then the only way to get to the point where you don’t have a third wave next winter is through vaccination,” he said.

In related news, Kaiser Health News reports that “A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.”

Closing tidbits —

  • Fierce Healthcare identifies the Centers for Medicare and Medicaid Services “payment models the Biden administration has pulled for review or delayed.”
  • Health Payer Intelligence discusses large insurer platforms designed to help their self-funded customers coordinate their health benefit offerings.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare–

Photo by JOSHUA COLEMAN on Unsplash

Both the House of Representatives and the Senate are attending to committee and floor business this coming week. The House is expected to vote on the $1.9 trillion COVID-19 relief budget reconciliation bill this week. The Hill provides access to the text of the “mammoth” legislation here.

From the COVID-19 front —

  • On Friday February 26, “[t]he [Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory] committee will meet in open session to discuss [emergency use authorization] EUA of the [single dose] Janssen Biotech Inc. [a/k/a Johnson & Johnson] COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.” This committee’s meetings on the Pfizer and Moderna vaccines were held on Thursdays, and the FDA EUA approval was issued within 48 hours after those meetings. The only turmoil was in the Pfizer hearing because Pfizer sought and received EUA for people beginning at age 16. That was a helpful move in terms of getting colleges back open in the fall.
  • Medicity News reports that the FDA late last week approved consumer purchase of the Everywell COVID-19 test without a prescription. “Users swab their nose and send in the sample, which is then processed at one of Everlywell’s partner labs. It takes one to two days to get results from the rt-PCR test. If users have a positive or an undetermined result, they’re contacted by a clinician. On Everlywell’s website, tests are priced at $109 — generally more costly than most antigen test alternatives. The company also plans to partner with retailers to sell it over the counter.”
  • NPR Shots now offers a website for COVID-19 vaccine hunters.
  • The Kaiser Family Foundation offers a COVID-19 vaccine site that covers a number of significant topics, including vaccine hesitancy, distribution, and messaging.

In other healthcare news, Kaiser Health News reports that

The federal government has penalized 774 hospitals for having the highest rates of patient infections or other potentially avoidable medical complications. Those hospitals, which include some of the nation’s marquee medical centers, will lose 1% of their Medicare payments over 12 months.

The penalties, based on patients who stayed in the hospitals anytime between mid-2017 and 2019, before the pandemic, are not related to covid-19. They were levied under a program created by the Affordable Care Act that uses the threat of losing Medicare money to motivate hospitals to protect patients from harm. * * *

“The all-or-none penalty is unlike any other in Medicare’s programs,” said Dr. Karl Bilimoria, vice president for quality at Northwestern Medicine, whose flagship Northwestern Memorial Hospital in Chicago was penalized this year. He said Northwestern takes the penalty seriously because of the amount of money at stake, “but, at the same time, we know that we will have some trouble with some of the measures because we do a really good job identifying” complications.

Other renowned hospitals penalized this year include Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles; UCSF Medical Center in San Francisco; Beth Israel Deaconess Medical Center and Tufts Medical Center in Boston; NewYork-Presbyterian Hospital in New York; UPMC Presbyterian Shadyside in Pittsburgh; and Vanderbilt University Medical Center in Nashville, Tennessee.

There were 2,430 hospitals not penalized because their patient complication rates were not among the top quarter. An additional 2,057 hospitals were automatically excluded from the program, either because they solely served children, veterans or psychiatric patients, or because they have special status as a “critical access hospital” for lack of nearby alternatives for people needing inpatient care.

Thursday Miscellany

David Ermer–Congress, COVID-19, Medicare, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the COVID-19 front —

  • Politico reports that “Johnson & Johnson filed Thursday for emergency use authorization [“EUA”] of its single-dose coronavirus vaccine, readying for a pivotal third option in the battle to immunize hundreds of millions of Americans.” This is the single dose vaccine that can be stored in regular pharmacy refrigerators. Following the same pattern as the first two EUA applications for COVID-19 vaccines, the Food and Drug Administration has set an advisory committee hearing on the Johnson & Johnson EUA for February 26. This indicates that the FDA will approve the application on February 28 / this month. That is very good news.
  • Healthcare coaching service TrestleTree has made available its useful “State-by-State COVID-19 Vaccination Access Guide.” Muchos gracias.
  • The American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association (ANA) released a [joint] public service announcement (PSA) today urging the American public to get the COVID-19 vaccination when it is their turn. 
  • Reuters reports that “Almost all people previously infected with COVID-19 have high levels of antibodies for at least six months that are likely to protect them from reinfection with the disease, results of a major UK study showed on Wednesday. Scientists said the study, which measured levels of previous COVID-19 infection in populations across Britain, as well as how long antibodies persisted in those infected, should provide some reassurance that swift cases of reinfection will be rare.”

From Capitol Hill, CBS News informs us that “The Senate is expected to vote on a budget resolution sometime before the weekend, an important step to passing President Biden’s $1.9 trillion COVID-19 relief proposal through the process of reconciliation, which allows legislation to pass with only a simple majority instead of the typical 60-vote threshold.  But before there can be a final vote on the resolution, Republicans are forcing Democrats to go on the record with a series of votes on a slew of amendments in a politically painful process known as a “vote-a-rama.” Bloomberg adds that this afternoon, “[t]he Senate backed by 99-1 a non-binding call to oppose stimulus checks going to “upper-income taxpayers” — one of a series of messaging votes the chamber is taking in a complex process of preparing President Joe Biden’s $1.9 trillion Covid-19 relief plan for passage through Congress.”

Health Payer Intelligence tells us about health plan trade association efforts to convince the Biden Administration to undo certain Trump Administration actions.

In healthcare corporate news, Healthcare Dive reports

  • Cigna’s net income for the fourth quarter of 2020 was $4.1 billion, a huge increase from the $977 million in the fourth quarter of 2019, partly because of the $6.2 billion sale of its life insurance business, which was completed on Dec. 31. The payer’s medical cost ratio in the fourth quarter was 85.8%, up from 82.3% the prior year because of COVID-19 treatment and testing costs and above Wall Street expectations. In a call with investors Thursday morning, CFO Brian Evanko said deferred care increased in the latter part of the quarter but was outweighed by COVID-19 costs.

and

  • UnitedHealth CEO Dave Wichmann is retiring and will be replaced as chief executive by Andrew Witty, currently the CEO of health services unit Optum. Witty will continue running Optum and become CEO immediately, with Wichmann assisting in a transition period through March, UnitedHealth announced Thursday. Dirk McMahon, CEO of payer business UnitedHealthcare, will become president and chief operating officer, and joins CFO John Rex to round out the Minnetonka, Minnesota-based healthcare behemoth’s C-suite.

From the opioid front

  • The Wall Street Journal reports that “State attorneys general intensified pressure on drug companies to settle claims over the opioid crisis, following consulting firm McKinsey & Co.’s agreement to pay nearly $600 million over its advice to pharmaceutical companies to rev up sales. * * * States have been negotiating since 2019 with the nation’s three largest drug distributors, McKesson Corp. , AmerisourceBergen Corp. , Cardinal Health Inc., as well as drugmaker Johnson & Johnson. The companies have publicly disclosed that they have set aside a collective $26 billion for the deal, most of it to be paid over 18 years, but no final agreement has been reached. In news conferences Thursday, attorneys general said they hoped the McKinsey deal would provide momentum for a bigger settlement, if others facing litigation follow the consulting company’s lead.”
  • Late last month, the Bloomberg School of Public Health announced that “A coalition of 31 professional and advocacy organizations has released a set of principles aimed at guiding state and local spending of the forthcoming opioid litigation settlement funds. The coalition, coordinated by faculty at the Johns Hopkins Bloomberg School of Public Health, is urging state and local officials to avoid the mistakes of the 1998 tobacco settlement and use the expected settlement funds to support evidence-based strategies that save lives. The need for evidence-based funding strategies is especially urgent now, as deaths due to opioid drug overdoses have significantly increased since the COVID-19 pandemic began, with some states reporting increases of 30%.”
  • The Health and Human Services Office of Inspector General today released a report on opioid use in Medicare Part D during the first phase of the COVID-19 public health emergency. “As the pandemic took hold, about 5,000 Medicare beneficiaries per month suffered an opioid overdose during the first 8 months of 2020.”

Thursday Miscellany

David Ermer–CDC, Medicare, OPM, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

In the wake of the Democrat victories in the Georgia Senate elections, Katie Keith in the Health Affairs blog provides her insightful thoughts on what a Democratic Congress means for the Affordable Care Act.

The Robert Wood Johnson Foundation offers for our consideration five experts reflecting on the health equity implications of the COVID-19 public health emergency.

When Medicare pricing changes the healthcare industry takes notice.

  • The American Hospital Association reports today that ” The Centers for Medicare & Medicaid Services has recalculated the Medicare [Part B] Physician Fee Schedule payment rates and conversion factor for calendar year 2021 to reflect changes effective Dec. 27 under the Consolidated Appropriations Act. The new conversion factor is $34.89, which is 3.3% less than the CY 2020 conversion factor of $36.09 but more than the $32.26 conversion factor finalized in the PFS final rule, which would have represented a 10.2% net decrease in PFS payments for CY 2021. This change affects what FEHB plans pay for Medicare prime annuitants. Also where an annuitant over 65 does not pick up Medicare Part B, fee for service FEHB plans pay for doctors services using Medicare Part B payment rates.
  • Beckers Payer Issues reports that “A change in how Medicare pays laboratories for COVID-19 diagnostic tests took effect Jan. 1 * * * Medicare lowered the base payment for COVID-19 tests that use high-throughput technology to $75. Labs can get an additional $25 if they provide results in two days or less.” Medicare testing rates are sound benchmark for out-of-network COVID-19 labs which fail to comply with internet price post requirements.

The Centers for Disease Control yesterday issued an initial report concerning allergic reactions to the COVID-19 vaccines. Here’s the report’s summary:

What is already known about this topic?

Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination.

What is added by this report?

During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.

What are the implications for public health practice?

Locations administering COVID-19 vaccines should adhere to CDC guidance for use of COVID-19 vaccines, including screening recipients for contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended postvaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine.

The Department of Health and Human Services announced today

a national plan to address the serious, preventable public health threat caused by viral hepatitis in the United States. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 sets national goals, objectives, and strategies to respond to viral hepatitis epidemics. Building on three prior National Viral Hepatitis Action Plans over the last 10 years, the Viral Hepatitis National Strategic Plan is the first to aim for elimination of viral hepatitis as a public health threat in the United States by 2030.  This plan serves as a roadmap for stakeholders at all levels and across many sectors, both public and private, to guide development of policies, initiatives, and actions for viral hepatitis prevention, screening, care, treatment, and cure.  

Federal News Network reports that

Federal payroll providers and agencies are beginning to detail exactly how and when federal employees and servicemembers will repay the Social Security taxes that were deferred from their paychecks during the last four months of 2020. The latest omnibus spending package, which the president signed into law last week, allows those subject to the president’s payroll tax deferral to repay the deferred taxes — worth 6.2% of their income — throughout the entire year of 2021, rather than the first four months of the year.

The article provides examples but generally the services are collecting in equal installments over the course of 2021.

Weekend update

David Ermer–Congress, COVID-19, Medicare, OPM, U.S. Healthcare–
Photo by Clarisse Meyer on Unsplash

Congress is in session this week for committee business and floor voting. The big item is the omnibus spending bill which is expected to include the bipartisan COVID-19 relief package. The legislative language for this bill should be released tomorrow if everything remains on track. An omnibus or short term spending measure must be passed by 11:59 pm on December 11. The FEHBlog thought that both Houses of Congress were set to adjourn this week but it turns out that the Senate is scheduled to continue working through December 18.

The Federal Employee Benefits Open Season continues through next Monday December 14, while the Medicare Open Season ends tomorrow December 7. Let’s not forget that December 6 though 12 is the Centers for Disease Control’s (“CDC”) National Flu Vaccination Week.

The press is reporting tonight that President-elect Biden intends to appoint California Attorney General Xaxier Becerra to be his Secretary of Health and Human Services, which is a very powerful position when it comes to healthcare in the U.S. Speaking of healthcare leaders, Fierce Healthcare identifies six health plan executives to watch in 2021.

The CDC released updated COVID-19 protection guidance on Friday.

Summary
What is already known about this topic?

The United States is experiencing high levels of SARS-CoV-2 transmission.

What is added by this report?

COVID-19 pandemic control requires a multipronged application of evidence-based strategies while improving health equity: universal face mask use, physical distancing, avoiding nonessential indoor spaces, increasing testing, prompt quarantine of exposed persons, safeguarding those at increased risk for severe illness or death, protecting essential workers, postponing travel, enhancing ventilation and hand hygiene, and achieving widespread COVID-19 vaccination coverage.

What are the implications for public health practice?

These combined strategies will protect health care, essential businesses, and schools, bridging to a future with high community coverage of effective vaccines and safe return to more activities in a range of settings.

The figure shows icons describing ways to slow COVID-19 spread and speed up economic recovery.

The FEHBlog ran across a Bloomberg report which adds

Harvard disease expert Willam Hanage says that the science to date points to the primary risk coming from what he calls the three C’s — close contact, closed spaces and crowds. He says in Japan, where they’ve had few Covid-19 deaths, people are advised to avoid these — not just to wear masks in these situations but to limit them or avoid them altogether.

FINAL. Avoid the 3 Cs Poster

In much better but nevertheless thought provoking news, the Wall Street Journal reports that

Drug development for sickle-cell disease, largely overlooked for decades, is becoming a crowded field: Two papers published Saturday in the New England Journal of Medicine report promising results from studies of experimental therapies, including Crispr gene editing, for the disease.

In addition, Beam Therapeutics Inc. on Saturday presented lab and mouse data at the American Society of Hematology annual meeting to support the safety of another approach to using Crispr gene editing for sickle-cell disease. The company said it hopes to open a trial next year.

More than a dozen companies are competing to develop experimental treatments for sickle-cell disease, an inherited form of anemia that affects 100,000 mainly Black Americans.

The article points that Crispr gene editing is an expensive technology. “What good are new therapies for a disease if many patients suffering with it are unable, or choose not, to access them?” That is an issue for health plans to contemplate now, in the FEHBlog’s opinion.

The FEHBlog took a look at the CDC’s Center for National Health Statistics website today, and he ran across these interesting recent reports

The FEHBlog was surprised by the facts that “Prepregnancy obesity [measured as body mass index of 30 or higher] in the United States rose from 26.1% in 2016 to 29.0% in 2019 and increased steadily for non-Hispanic white, non-Hispanic black, and Hispanic women” and that “In 2019, more than one in four children had one or more visits to an urgent care center or retail health clinic (26.4%) in the past 12 months.” These reports further find that college educated women are less likely to be obese and that insured children are more likely to us retail health clinics.

The prepregnancy obesity report led the FEHBlog to consult OPM’s available statistics on federal employee demographics which date back to 2017. Roughly 52% of federal employees have at least college degree. The FEHBlog also found a May 2020 Pew Research report on Postal Service employee demographics which does discuss Postal employee education levels but does point out that

  • About six-in-ten of the agency’s employees – including mail carriers, postal clerks, and mail sorters and processors – are non-Hispanic white (57%), compared with 78% of the overall U.S. workforce. Around a quarter (23%) of Postal Service workers are black, 11% are Hispanic and 7% are Asian. In contrast, black Americans make up 13% of the national workforce, Hispanics 17% and Asian Americans 6%.
  • In 18 states and the District of Columbia, women make up half or more of Postal Service employees. In D.C., 74% of Postal Service workers are women, and women account for around six-in-ten postal workers in Idaho, Alabama and South Dakota. Nationally, slightly fewer than half of postal workers are women (45%), in line with the U.S. workforce.
  • The Postal Service, as of 2018, employs more than 100,000 military veterans, who make up 16% of its workers nationally. Veterans account for just 5.8% of all employed Americans, according to data for 2019.

The percentage of women Postal employees basically aligns with the percentage of women federal employees. However, the percentage of military veteran Postal Service employees is nearly double the percentage of military veteran federal employees. (The FEHBlog also found this recent, helpful Congressional Research Service report on “Federal Workforce Statistics Sources: OPM and OMB.”)

The FEHBlog points this out because as the COVID-19 public health emergency has ably illustrated race, ethnicity, age and gender, among other demographic factors, impact healthcare and while OPM provides age and gender information to FEHB plans, the agency does not provide race or ethnicity date to those FEHB plans.

Finally the Salt Lake City [UT] Tribune reports that

More than a week after Sanford Health parted ways with its longtime CEO, the health system announced that it has indefinitely suspended merger talks with Utah-based Intermountain Healthcare. Sanford Health and Intermountain Healthcare made the announcement Friday [December 4], saying that with the leadership change, Sanford decided to put merger talks on hold while other organizational needs are addressed.

Intermountain offers an FEHB plan under the SelectHealth name.