Friday Stats and More

Friday Stats and More

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

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

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

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

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

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.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

The Wall Street Journal reports that Senate minority leader Chuck Schumer and House Speaker Nancy Pelosi have expressed their support for the $980 million bi-partisan COVID-19 relief bill.

[Further] Senators said Thursday that they were trying to work out the details of a rough agreement the bipartisan group of nine senators and members of the Problem Solvers Caucus, a group of 50 centrist House lawmakers, had unveiled earlier this week.  * * * The bipartisan proposal, which would run through March 2021, includes $160 billion in state and local funding and would provide a short-term suspension of liability lawsuits related to Covid-19 at the state or federal level, giving states time to put in place their own protections. Lawmakers said the details of both contentious issues were being worked out before Monday [December 7], when the group hopes to release legislative text. * * * The bipartisan proposal also includes $288 billion for small-business relief, including for the Paycheck Protection Program, $16 billion for the distribution of a coronavirus vaccine, $82 billion for schools, $25 billion for rental assistance and $180 billion for additional unemployment insurance, including $300 a week through March, aides said. In addition, the plan would give $17 billion to airlines.

From the COVID-19 vaccine front

The co-leader of the US government’s Operation Warp Speed coronavirus vaccine initiative on Wednesday outlined the most ambitious timeline yet for vaccinating the most vulnerable Americans against COVID-19.

Moncef Slaoui, Warp Speed’s chief advisor, predicted that 100 million Americans would be immunized by the end of February.

Twenty million Americans should be vaccinated in December, followed by 30 million more in January and 50 million more in February, the former pharmaceutical executive said in a press briefing.

By then, “we will have potentially immunized 100 million people, which is really more or less the size of the significant at-risk population: the elderly, the healthcare workers, the first-line workers, people with comorbidities,” Slaoui said.

As of last year 255 million Americans were over age 18 which is the minimum age to receive the Pfizer – BioNTech and Moderna COVID-19 vaccines. (The total U.S. population is around 330 million currently.) Moderna has started a study of its COVID-19 vaccine on younger people aged 12 to 17.

  • CNN reports on the government’s plan to track COVID-19 immunizations and ensure that people who receive the first dose also get the second.
  • The New York Times offers an online tool to help you figure where is your place in line to receive the COVID-19 vaccine once they receive FDA emergency use authorization. Here’s the answer that the FEHBlog received:

Based on your risk profile, we believe you’re in line behind 118.5 million people across the United States. When it comes to Maryland, we think you’re behind 2.2 million others who are at higher risk in your state. And in Montgomery County, you’re behind 304,800 others.

In other COVID-19 news, Beckers Payer Issues reports that large health plans generally are tying their COVID-19 benefit flexibilities to the end date of the COVID-19 public health emergency which conforms to the FFCRA and CARES Act requirement. The current end date is January 21, but it is a safe bet that the Department of Health and Human Services extends that end date for another 90 days early next month.

There has been a lot of action at the Department of Health and Human Services (“HHS”):

  • Today, HHS “issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.” Principally, the amendment permits telehealth providers of care with prescription authority who are licensed in State A to prescribe COVID-19 testing and other COVID-19 counter measures for patients contacting them from State B. HHS initiated this change because “While many states have decided to permit healthcare personnel in other states to provide telehealth services to patients within their borders, not all states have done so.”
  • Also HHS “released an important HHS Action Plan and announced a partnership to reduce maternal deaths and disparities that put women at risk prior to, during, and following pregnancy. The U.S. Surgeon General Jerome M. Adams issued a complementary Call to Action to Improve Maternal Health outlining the critical roles everyone can play to improve maternal health.” Bravo.
  • Health Payer Intelligence explains that

CMS has introduced a new Medicare value-based contracting model that encourages greater care coordination and requires participants to take full risk for Medicare fee-for-service beneficiaries based on region.

The Geographic Direct Contracting Model uses outcomes-based payment models to address care quality, healthcare spending, care coordination, clinical management, and program integrity in targeted regions.

“Within each region, organizations with experience in risk-sharing arrangements and population health will partner with health care providers and community organizations to better coordinate care,” the press release explained.

Beneficiaries will not have to switch providers or payers. They will continue to have their Original Medicare benefits as well as their enhanced benefits and they may receive reduced cost-sharing for Medicare Part A and Part B, including Part B premium subsidies.

Finally Healthcare Dive explains that in HHS’s CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule 

CMS is eliminating the inpatient-only list that requires roughly 1,700 medical procedures to occur inside a hospital for Medicare members. The inpatient-only list will be completely phased out by 2024, according to the outpatient payment final rule released Wednesday. The hospital lobby balked at the change, contending the list is there to protect patients as the list of procedures can be complex and need hospital resources.

Ultimately, the list expands the options of where certain surgeries can be performed and may ultimately reduce out-of-pocket expenses for Medicare members as surgeries performed in an outpatient setting, such as an ambulatory surgery center, can be less costly, CMS said.

Also, the agency is moving forward with reimbursement cuts for 340B-acquired drugs, a hit to some hospitals. Meanwhile, the rule also loosens restrictions on some physician-owned facilities, also drawing ire from the hospital lobby.

Isn’t wild that in 2020 Medicare still requires 1700 surgeries to be performed on an inpatient basis. The FEHBlog hopes that the Biden Administration’s HHS continues the Trump Administration’s practice of re-evaluating and when appropriate long term practices that have outlived their value.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the COVID-19 vaccine front —

The first two vaccines against the novel coronavirus could be available to Americans before Christmas, Health Secretary Alex Azar said on Monday, after Moderna Inc became the second vaccine maker likely to receive U.S. emergency authorization. The Food and Drug Administration’s outside advisers will meet on Dec. 10 to consider authorizing Pfizer Inc’s COVID-19 vaccine. That vaccine could be approved and shipped within days, with Moderna’s following one week behind that, Azar said.

  • The Wall Street Journal reports on this afternoon’s CDC Advisory Committee on Immunization Practices (“ACIP”) meeting

The [ACIP] panel voted 13-1 in favor of giving the first [COVID-19] vaccines to about 21 million health-care workers and three million residents of long-term care facilities. 

Secretary of Health and Human Services Alex Azar has said federal officials will consider the committee’s recommendations, but that state governors may make final decisions about whom to vaccinate first with the doses that the federal government allocates to them based on their adult populations. He also has said he supports vaccinating vulnerable residents of nursing homes among the first groups.

States wouldn’t have to follow the CDC recommendations, but state and local authorities are expected to rely on them as guideposts for deciding who gets the vaccine first. States have until Friday to indicate to the federal government where they want their initial doses sent.

  • Becker’s Hospital Review informs us that “Any American who wants a COVID-19 vaccine will be able to get one by the end of June 2021, retired U.S. Army Lt. Gen. Paul Ostrowski, director of supply, production and distribution for Operation Warp Speed, said in an Nov. 30 interview with MSNBC. We will have over 300 million doses available to the American public, well before [June],”Mr. Ostrowski said.”

In other news, “Today the Centers for Medicare & Medicaid Services (CMS) released the annual [Medicare Part B] Physician Fee Schedule (PFS) final rule, prioritizing CMS’ investment in primary care and chronic disease management by increasing payments to physicians and other practitioners for the additional time they spend with patients, especially those with chronic conditions. The rule allows non-physician practitioners to provide the care they were trained and licensed to give, cutting red tape so healthcare professionals can practice at the top of their license and spend more time with patients instead of on unnecessary paperwork.” Here’s a link to the CMS fact sheet on the final rule.

The final rule is relevant to the FEHBP for two reasons — (1) a large cadre of Medicare prime annuitants is enrolled in the FEHBP and if any of them have not enrolled for Part B, fee for service plans use the Medicare PFS to pay their doctors and (2) the Medicare PFS is widely used to set payments for out-of-network providers because doctors are so familiar with the PFS. In that case, commercial health plans typically use a higher dollar modifier than Medicare which gives you an idea of how low the Medicare modifier is.

Finally, a friend of the FEHBlog called his attention to this FAIR Health analysis of the number telehealth claims which found that the number of telehealth claims jumped nearly 3000% from September 2019 to September 2020. Wow.

Monday Roundup

Photo by Sven Read on Unsplash

Another Monday, another COVID-19 vaccine — the newest from Oxford University (UK) and Astrazeneca. The Times of London reports that

Oxford University scientists said this morning that they had created “a vaccine for the world” as trial results showed that their Covid-19 jab worked well enough to apply immediately for regulatory approval.

The vaccine involves two injections, administered at least a month apart, and the results suggest that using a lower first dose could boost efficacy to 90 per cent. However, that finding relied on limited data and may be amended.

Overall, a trial involving 24,000 people suggested that the vaccine was about 70 per cent effective.

It prevented severe disease and the need to be admitted to hospital, and there are promising early signs that it might also block transmission of the virus. No dangerous side-effects were reported, and the British medical regulator has begun to review safety and efficacy data.

Britain has ordered 100 million doses, and Astrazeneca, the drug company that is working with Oxford, said this morning that four million of those would be ready to be sent to care homes, GP clinics and other vaccination centres by the end of the year.

The Oxford vaccine can be stored in a normal fridge, making it easier to handle than Pfizer’s competing inoculation, which must be stored at about minus 70C. It is also considerably cheaper, costing a few pounds per dose. It is possible that the first doses could be administered before Christmas.

The FEHBlog heard on Fox Business this morning that a separate phase three trial for the Oxford vaccine is ongoing in our country. Oxford and Astrazeneca will present an emergency use authorization request to our Food and Drug Administration (“FDA”) based on that as yet uncompleted trial. The trial referenced in the Times of London article was conducted in the United Kingdom and Brazil. The FDA does not require that the phase three trials be conducted in the U.S. For example, the agency approved the Ebola vaccine based on a phase three trial conducted in Africa, but of course there’s no problem finding COVID-19 patients here.

Reuters reports that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet on December 10 to review the Pfizer / BioNTech emergency use application for its COVID-19 vaccine. The FDA is not bound by the Committee’s recommendation. Here is a link to the full FDA press release.

A friend of the FEHBlog recommended the 20 minute long Journal podcast interview with the founder of BioNTech Dr. Ugur Sahin. The FEHBlog found that podcast fascinating listening.

Govexec.com reports that “The departments of Defense and State, as well as the Veterans Affairs Department’s Veterans Health Administration, the Bureau of Prisons and Indian Health Service, will all receive a direct allocation of vaccines from the Centers for Disease Control and Prevention. The plan was spelled out in a COVID-19 Vaccination Program Interim Playbook, which was first reported by CNBC.” 

Following up on the major Health and Human Services rule makings on Fridays here are article with industry reaction:

  • As the FEHBlog expected, Fierce Healthcare reports that “A hurried final rule aimed at tying drug prices to those paid by foreign countries could lead to providers paying more for drugs than what they will get reimbursed by Medicare, according to several providers and experts.” It really makes you wonder why the American Medical Association’s House of Delegates conditionally endorsed adding a public option to the ACA marketplace earlier this month.
  • Fierce Healthcare further informs us that “CMS’ Stark, anti-kickback updates draw praise from hospitals, concern from physician groups.”
  • Health Payer Intelligence discusses the Medicare rule restricting the use of prescription drug rebates in Medicare Part D effective January 1, 2022. The FEHBlog cannot understand why if drug manufacturers want to end the rebate practices, it does not assure (with an enforcement mechanism) the health insurance industry and the government that the price reductions will balance out the lost rebates.

Friday Stats and More

Based on the CDC’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 46th weeks of this year (beginning May 14 and ending November 18, roughly six months; using Thursday as the first day of the week in order to facilitate this weekly update):

The upward surge in COVID-19 cases is reflected the CDC’s latest overall weekly hospitalization rate chart for COVID-19 (disregards the dip at the right side of the chart):

The FEHBlog has noted 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 same six month long period (May 14 through November 18) (the dip at the tail of this chart is accurate information).

Meanwhile the CDC’s weekly flu surveillance report continues to inform us that “Seasonal influenza activity in the United States remains lower than usual for this time of year.” Better one epidemic than two.

On the bright side, according to the Wall Street Journal, Pfizer and BioNTech did file an emergency use authorization request for their COVID-19 vaccine today.

Now it will be up to the U.S. Food and Drug Administration to decide whether the two-shot vaccine works safely enough to roll out to millions of people.

It is unclear how long the agency will take to review the vaccine, which Pfizer and BioNTech just days earlier said was 95% effective and well-tolerated in a 44,000-subject trial.

Given the urgency, the FDA is expected to move quickly. The timing of the filing is in line with industry and government officials’ projections for authorization and distribution to begin next month. Pfizer said the filing could allow for distribution to begin the middle to end of December.

The Health and Human Services Department (“HHS”) released a string of final rules today affecting Medicare prescription drug plans and both hurting and helping the finances of doctors participating in Medicare and certain other federal health programs (but thankfully not the FEHBP). As the saying goes, he who lives by the sword can die the sword.

  • HHS issued a final rule generally barring the use of prescription drug rebates in the Medicare Part D program effective January 1, 2022.
  • HHS issued another final rule that implements, effective January 1, 2021, a pilot program”, known as the Most Favored Nation (MFN) Model, [that] will test [for seven years] an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries.”
  • Finally. HHS issued a final rule which loosens up on self-referral a/k/a Stark Act rules that inhibit the entrepreneurial spirit of doctors participating in Medicare. The purposes of the change is to facilitate value based pricing and coordinated care. Doctors should like this one but the FEHBlog wonders whether the AMA will think that it goes far enough.

Of course, we also will have to wait to see the incoming Biden Administration’s reaction to these rules.

Healthcare Dive discusses conflicting viewpoints on AHIP’s position which the FEHBlog shares that the COVID-19 relief law Wild West approach to health plan coverage of out-of-network COVID-19 leads to price gouging. Only Congress can fix this problem.

Speaking of Congress, Govexex.com reports that

Congressional leaders have voiced early speculation in recent days that lawmakers will be able to set line-by-line funding levels for agencies throughout government before the end of the year without the need for another stopgap measure. 

Top negotiators in the House and Senate met on Thursday to discuss a potential compromise for the rest of fiscal 2021 appropriations. On Friday, House Speaker Nancy Pelosi, D-Calif., was the most recent leader to cautiously express optimism that Congress can pass a full-year, omnibus spending bill before the current continuing resolution expires Dec. 11. 

“The anticipation was that it was really about the omnibus,” Pelosi said of the meeting. “You have to remember, we have to have an omnibus bill. We must keep government open.” She added it was a “very important responsibility” during the lame duck session of the 116th Congress. “We don’t want another continuing resolution. I don’t think they do either.”

Finally, the FEHBlog was impressed by Humana CEO Bruce Broussard’s call for health system interoperability without further delay. Mr. Broussard is Board Chair of America’s Health Insurance Plans for 2021. Here’s a snippet.

Change requires reforming the incentive structure to encourage and require vendors to create and sell systems that can talk to each other. Health care systems, hospitals, and physician practices — guided or encouraged by the market and the federal government — should choose interoperable systems. Public and private payers should implement value-based payment models that reward the purchase and use of interoperable systems. It’s also up to the federal government to implement and enforce standards for EHR vendors that promote interoperability while simultaneously strengthening the protection of personal health information.

If industry and government don’t lead the charge to make America’s health care system interoperable, consumers will bear the challenge of piecing together their own health data across the system — a dangerous prospect that could hinder patient care in the midst of a global pandemic. The free flow of protected data across the health care system ensures that treatment decisions are informed safely and effectively by the most current information available and tailored to the individual. A clinician with complete information at her fingertips can easily see the full picture and manage her patient’s care from the hospital to the pharmacy to long-term follow-up care.

This pandemic will eventually end. But the need for interoperability will remain urgent as we seek long-term solutions to bring down costs, improve care delivery, and increase efficiency in our health care system.

There’s no time like the present.