Friday Stats and More

COVID-19 vaccine

Friday Stats and More

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

Based on the CDC’s COVID Data Trackers website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 49th weeks of this year (beginning May 14 and ending December 9; 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:

It’s interesting that the weekly rate dropped two weeks in a row. Typically the chart would show a one week drop which the FEHBlog discounted.

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 period (May 14 through December 9):

The FEHBlog’s record high for weekly deaths remains 13,504 for the week ended April 22 which we now are approaching.

On the brighter side, the Wall Street Journal reports that

The U.S. Food and Drug Administration said it was finalizing the work needed to clear a Covid-19 vaccine developed byPfizer Inc. and German partner BioNTech SE, after the injection was endorsed by an expert panel.  “We could see people getting vaccinated Monday, Tuesday of next week,” Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America.”

Fierce Healthcare reports that “CVS [Health] is planning to begin administering COVID-19 vaccines in nursing homes beginning on Dec. 21, a top executive told Reuters.”

Govexec.com reports that “Civilian federal personnel are likely to begin receiving COVID-19 vaccinations as soon as Monday, officials said on Friday, though only [healthcare] employees at certain offices will receive the doses directly from their agencies.  Govexec.com offered the most details on the Defense Department’s plans which provide a helpful perspective

The Defense Department also anticipates vaccinating 44,000 employees next week, officials said on Wednesday, the vast majority of whom will be health care staff. The Pentagon plans to provide vaccines to both military and civilian staff, though it has not committed to vaccinating to its entire civil service workforce. 

“The eligibility we defined in terms of dependents, select contractors, civilian employees, and it’s going to be then how do they match up in terms of the prioritization tiers,” said Tom McCaffery, the assistant secretary of Defense for Health Affairs. 

In the initial phase, Defense will target health care workers who are closest to patients, early emergency responders and public security staff. Defense will distribute vaccines to 16 sites in that phase, 13 of which are located within the United States. McCaffery said the department recently held a “virtual tabletop exercise” to go through the first phase “in great detail to ensure seamless distribution and dissemination” of the vaccine. Defense will ultimately be responsible for vaccinating millions of individuals, including active duty personnel, civilian workers, at-risk dependents and some contractors. 

All told, Defense maintains 83 sites that have ultra-cold storage, including all 13 of those in the initial distribution.

HHS announced that the federal government

will purchase an additional 100 million doses of COVID-19 vaccine candidate, called mRNA-1273, from Moderna.

If authorized by the U.S. Food and Drug Administration for emergency use as outlined in agency guidance, doses of the vaccine will begin shipping immediately. The vaccine would be provided at no cost to Americans. Vaccine administration costs for private-sector administration partners will be covered by healthcare payers: private insurance, Medicare or Medicaid, and an HHS program to cover COVID-19 costs for the uninsured which is reimbursing the provider at Medicare rates from the provider relief fund.

Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered today provide for continuous delivery through the end of June 2021. This strategy will help meet the anticipated demand for mRNA-1273 and safely accelerate the delivery schedule for all 200 million doses the U.S. government is purchasing.

“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” said HHS Secretary Alex Azar. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”

In other news,

  • Congress approved the one week long extension of the continuing resolution funding the federal government. The new deadline is December 18 and Federal News Network reports that “Negotiators on a $1.4 trillion catchall spending bill appeared to be moving in a positive direction, said the chairman of the Senate Appropriations Committee, Sen. Richard Shelby, R-Ala.. This bill would serve as a vehicle to carry any year-end virus assistance.” Negotiations over that COVID-19 relief bill continue.
  • The HHS, the Labor Department, and the Treasury Department (a/k/a the tri-agencies) “announced a final rule that amends the [Affordable Care Act] requirements for grandfathered group health plans and grandfathered group health insurance coverage to preserve their grandfather status.”
  • The U.S. Supreme Court unanimously rejected an ERISA preemption challenge to an Arkansas state law regulating prescription benefit manager pricing of drugs. Here is Healthcare Dive’s report. This decision will raise healthcare prices in the FEHBlog’s opinion.
  • Govexec.com reports that President Trump is giving a half day off to federal employees on Christmas Eve.

The FEHBlog’s link to the HHS fact sheet on the proposed HIPAA Privacy Rule changes (posted yesterday) was inoperable until the FEHBlog fixed it tonight. Here’s a link. Have a good weekend.

Happy Hannukah

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, U.S. Healthcare–
Hanukkah greeting template. Nine candles and wishing. Hand drawn sketch illustration. White, yellow and blue colors

The eight day long Jewish holiday of Hannukah begins tonight. Best wishes to those who are celebrating this holiday.

This evening. STAT News reports

A panel of outside experts on Thursday recommended the Food and Drug Administration issue an emergency use authorization to the Covid-19 vaccine being developed by Pfizer and BioNTech, a vaccine that appeared to be highly efficacious in a Phase 3 clinical trial.

The 17-4 vote came after a long day in which members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, discussed a wide range of issues related to the vaccine, including concerns about vaccinating people with severe allergies and 16- and 17-year-olds, as well as issues regarding vaccination during pregnancy or lactation.

Although the FDA does not have to follow the panel’s recommendation, it is widely expected to do so. The rollout of Covid-19 vaccine could then begin in the United States in a matter of days.

The FEHBlog watched on You Tube a good chunk of the discussion preceding the vote. The FEHBlog was surprised that the motion presented to the Committee would extend the emergency use authorization to 16 and 17 year olds. He thought that the the minimum age would be 18 years old, and the committee members who voted against the bill were pediatricians concerned about the 16 to 17 year olds. Another member who was not a physician argued that the emergency use authorization use authorization should be limited to health care workers and nursing home residents, the initial phases approved by the CDC’s Advisory Committee on Immunization Practices. In any event, the FEHBlog was pleased by the decisive vote. At the close of the virtual committee meeting the Chairman reminded the members that they would be meeting next Thursday December 17 to consider an emergency use authorization for the Modern vaccine.

Speaking of voting, the Senate did not take up today the one week long extension of continuing resolution funding the federal government or the FY 2021 national defense authorization act which the House approved yesterday. The Senate needs to act on the continuing resolution tomorrow. The Wall Street Journal reports that negotiations over another COVID-19 relief bill continue.

A friend of the FEHBlog called to his attention the Department of Health and Human Services website on combatting the COVID-19 virus. It’s quite comprehensive.

In other news today, the HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, proposed changes to the Privacy Rule.

The proposed changes to the HIPAA Privacy Rule include strengthening individuals’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or threatening circumstances, such as the Opioid and COVID-19 public health emergencies; and reducing administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals’ health information privacy interests.

A friend of the FEHBlog shared this HHS fact sheet on this proposed rule. The proposal has a 60 day comment deadline which will end during the Biden Administration.

HHS’s Centers for Medicare and Medicaid Services proposed new rules to crack down on prior authorization practice by Medicaid, CHIP, and QHP marketplace plans. (Medicare does not permit prior authorization.)

The rule would require payers in Medicaid, CHIP and QHP programs to build application programming interfaces (APIs) to support data exchange and prior authorization. APIs allow two systems, or a payer’s system and a third-party app, to communicate and share data electronically  Payers would be required to implement and maintain these APIs using the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard. 

Building on that foundational policy, this rule would require impacted payers to implement and maintain a FHIR-based API to exchange patient data as patients move from one payer to another. In this way, patients who would otherwise not have access to their historic health information would be able to bring their information with them when they move from one payer to another, and would not lose that information simply because they changed payers.  

These proposed changes would also allow payers, providers and patients to have access to more information including pending and active prior authorization decisions, potentially allowing for fewer repeat prior authorizations, reducing burden and cost, and ensuring patients have better continuity of care.

The proposals are expected to take effect in January 2023. Good ideas. The pubic comment period ends on January 4, 2021, but the final rule no doubt will be in the hands of the Biden administration. The American Medical Association must be happy though.

In Govexec, benefits consultant Tammy Flanagan discusses FEHBP options for annuitants with primary Medicare A and B coverage. The FEHBlog is always impressed by the creative benefit designs that FEHB plan carriers offer members.

Midweek update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine–
Photo by Manasvita S on Unsplash

Govexec reports that

The House on Wednesday [December 9] passed a stopgap funding bill 343-67 that would give lawmakers an additional week to come up with full-year spending legislation and avoid a government shutdown later this month.  The continuing resolution would last for one week, setting a new funding deadline of Dec. 18. The Senate must still pass the CR and President Trump must sign it by Friday to avoid a government shutdown, which both are expected to do. 

The Wall Street Journal adds that “A flurry of competing proposals for another coronavirus relief package ricocheted around the Capitol Wednesday, as lawmakers hunted for ways to resolve a thorny debate over liability protections that has stymied progress for weeks.” A December 9 fact sheet on the bipartisan proposal was made available today. Check it out.

In Presidential transition news, President-elect Biden announced the following additional healthcare appointments earlier this week:

  • Vivek Murthy, M.D., for a second tour of duty as surgeon general
  • Rochelle Walensky, MD, Harvard professor, as CDC director
  • Marcella Nunez-Smith, MD, Yale Professor, as COVID-19 Equity Task Force Chair
  • Jeff Zients, Deputy OMB Director for Management in Obama Administration, as Covid-19 czar.
  • Anthony Fauci, MD, as Coordinator of COVID-19 response and Counselor to the President
  • Sidebar — Still waiting for FDA Commissioner appointment
  • Added Cathie McQuiston, AFGE Deputy GC, to the OPM review team

Tomorrow December 10 is the date set for the FDA Vaccines and Related Biological Products Advisory Committee virtual meeting on the Pfizer-BioNTech emergency use authorization application for its COVID-19 vaccine. The CDC’s Advisory Committee on Immunization Practices will meet on Friday December 11 and vote on Sunday December 13 per Reuters. “

Dr. William Schaffner, an infectious disease expert and non-voting member of the CDC’s ACIP, said the gap between the two ACIP meetings will allow the FDA time to draft and issue an emergency use authorization (EUA) before the ACIP vote. That schedule could change, however, if FDA advisers have questions or request more data [tomorrow], he said.

Today the FDA announced that it has

authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.

This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

Most excellent.

Health Payer Intelligence reports that

Blue Cross and Blue Shield is calling on payers to bolster vaccination rates by expanding access to care, connecting with members through digital platforms, hosting free flu vaccine clinics, and utilizing data to target support for at-risk communities The effort comes in response to a drastic decrease in the number of vaccinations this year, compared with 2019 data.

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports tonight that

The Trump administration made a $916 billion coronavirus relief offer to Democrats, opening yet another front in the multi-track effort to reach an agreement in talks that rank-and-file lawmakers have been leading in the final weeks of the year. The proposal, announced in a brief statement by Treasury Secretary Steven Mnuchin, came after Democrats rejected an effort by Senate Majority Leader Mitch McConnell (R., Ky.) to narrow the scope of a coronavirus relief bill by excluding aid for hard-hit state and local governments prioritized by Democrats and liability protections sought by Republicans. 

The President’s proposal reportedly includes $600 per person direct payments. The FEHBlog will be surprised if the COVID-19 relief bill negotiations are unsuccessful, but it would be hardly be the first time that Congress surprises the FEHBlog.

Also according the Wall Street Journal, the House of Representatives tonight passed the FY 2021 National Defense Authorization Act by a veto proof 335-78 margin. As the FEHBlog noted last week this bill includes goodies for federal employees. Federal News Network identifies policy winners and losers in this must pass bill which now goes over to the Senate.

Federal News Network columnist Mike Causey touts the FEHBlog’s personal favorite health plan design the high deductible health plan with health savings account (“HSA”). Mr. Causey aptly describes the HSA as a “Roth IRA on steroids” because and HSA is triple tax favored — tax exempt on the way in and out and grows tax free while in the account. The Federal Benefits Open Season ends on Monday December 14.

Fierce Healthcare informs us that

The FDA has released its internal review documents ahead of the closely watched COVID-19 vaccine advisory committee meeting scheduled for Thursday [December 10] —and they bode well for Pfizer and partner BioNTech’s prospects for securing a quick emergency use authorization (EUA). The FDA meeting briefing, published (PDF) on Tuesday, confirmed the efficacy and safety profile of Pfizer and BioNTech’s BNT162b2, reiterating that the shot was 95% effective at preventing COVID-19 after two doses with no serious safety concerns.

The Moderna vaccines turn before this panel occurs one week later on December 17.

Healthcare Dive reminds us that

Hospitals are readying for Jan. 1, [2021] when they expect they will have to publicly disclose the negotiated prices they reach with insurers for services performed inside their facilities — barring any intervention from a federal appeals court. [Such intervention in the FEHBlog’s humble opinion, is highly unlikely.]

The policy requires hospitals to share two streams of information. First, hospitals will have to share a machine-readable format of its negotiated prices with every insurer and every insurance product — a sizable pool of information. 

Then they will also have to prepare a list of 300 “shoppable services.” A total knee replacement would be a good example. It’s a procedure a consumer likely has time to plan and prepare for, unlike an emergency surgery due to an accident or failing health. The idea is to provide the price information so consumers can shop around for the best deal. 

The FEHBlog attended the second day of the American Bar Association’s Washington Health Law Summit (“WLS”). It’s worth noting that every panelist (six or seven in total) who has opined on the outcome of the Supreme Court’s California v. Texas case on the ACA’s constitutionality shares the FEHBlog’s opinion that the Supreme Court will preserve the ACA expect perhaps for the individual mandate which Congress effectively repealed in 2017.

The FEHBlog listened to three hours of discussion about behavioral telehealth and artificial intelligence during the WLS. It turns out that two types of healthcare AI exist admin AI and operational AI. AI can be assistive to the user’s decision making or can yield autonomous decisions. The Food and Drug Administration oversees the AI devices and the operational devices typically are used with imaging procedures. The FDA has approved two autonomous operational AI devices. The radiologists however has doubts about those devices.

The most interesting thing that the FEHBlog heard during this discussion was a remark from a Doctors on Demand speaker that telehealth companies are facing challenges in filling provider slots for psychiatrists and psychologists because of the enormous demand for mental health telemedicine. That’s a good thing. He noted that the explosion in telehealth use in 2020 is principally due to the government permitting a doctor or psychiatrist licensed in state A to treat a telehealth patient in state B.

The other speakers added that healthcare providers were quick to pick up on telehealth due to the licensing flexibilities and Medicare equivalent payments. They expressed their understanding that telehealth changes the personal dynamics between doctors and patients. Patients feels more in charge in a tele heath setting than they do in the office setting, and providers get social determinants of health data from seeing where the patient lives.

Friday Stats and More

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 48th weeks of this year (beginning May 14 and ending December 2; 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 dip of the right side of this chart always happens and is not indicative of a drop in hospitalizations.

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 period (May 14 through December 2):

This week’s dips on the right sides of the COVID 19 new cases and deaths charts are valid.

It’s worth adding that as of November 28, 2020, the Centers for Disease Control’s Fluview reports that “Seasonal influenza activity in the United States remains lower than usual for this time of year.” If anything proves that people are using masks and social distancing effectively this statistic does. COVID-19 simply is a stronger virus than the flu but it would be bad news to have a twin pandemic.

From the COVID-19 vaccine front, Fierce Healthcare reports that

After a bombshell report Thursday from the Wall Street Journal claiming Pfizer and BioNTech suddenly scaled back distribution targets for their mRNA-based coronavirus vaccine in 2020, the drugmaker said those revised plans were nothing new and, in fact, had been laid out last month. In announcements since, the company has quoted the new numbers. * * *

Pfizer is planning to distribute up to 50 million doses of its shot, dubbed BNT162b2, by the end of the year, a significant cut from the 100 million doses the drugmaker initially intended. Back in November, those plans were revised due to a slower-than-expected manufacturing scale-up and raw material shortages, a Pfizer spokesman said. 

Also, on the bright side, “Antibody levels stayed elevated in the 90 days after people received the second dose of Moderna’s COVID-19 vaccine, raising hopes that the prophylactic can provide protection for one year.” Keep hope alive.

From the COVID-19 relief front, the Wall Street Journal reports that “A sharp decline in job growth in November further prodded lawmakers to reach an agreement on coronavirus relief, as negotiators hurried to craft a bill before a government funding deadline at the end of next week. * * * Rank-and-file lawmakers are still negotiating the details of the bipartisan proposal, including the language specifying how to distribute aid to state and local governments and the duration of a legal liability shield for businesses, health-care providers and schools. They are expected to continue crafting the text of the agreement, which also puts money toward schools, vaccine distribution and small business, through the weekend.” It will be telling if the negotiators release legislative language on Monday.

Also from Congress, Federal News Network informs us that

Federal employees who put off travel plans or simply didn’t have the time or flexibility to take time off this year will have a little more leeway with their unused annual leave in 2021. The latest version of the National Defense Authorization Act includes a provision that will allow federal employees to carry over an additional 25% of their annual leave into 2021. Conferees unveiled the details of their agreement for the 2021 NDAA, which is considered must-pass legislation, Thursday evening. * * *

[Also, ]Nearly a year after Congress passed paid parental leave benefits into law for federal employees, lawmakers are poised to correct a few mistakes with the original bill and expand coverage to the entire workforce.

The final NDAA agreement includes a provision that will ensure paid parental leave coverage to workers at the Federal Aviation Administration, non-screener personnel at the Transportation Security Administration and health professionals at the Veterans Health Administration, as well as any other Title 38 employees. Congressional employees, Article I judges, presidential appointees and employees of the District of Columbia courts and Public Defender Service are also covered in the final NDAA provisions.

The provision would go in effect as if they were immediately enacted after the passage of last year’s NDAA, meaning that an FAA or VHA employee expecting a new child on or after Oct. 1 should be entitled to receive paid parental leave benefits.

Finally, the Health and Human Services Department announced today “the creation of a False Claims Act Working Group (Working Group) that enhances its partnership with the Department of Justice (DOJ) and the HHS Office of Inspector General (OIG) to combat fraud and abuse by identifying and focusing resources on those who seek to defraud the American taxpayers. HHS regulates over a third of the United States economy. In 2020, HHS provided over $1.5 trillion in grants and other payments to public and private recipients, including for healthcare items and services. In addition, HHS is one of the largest government contractors, paying over $170 billion in 2020 to thousands of contractors. In combating COVID-19, HHS has administered unprecedented levels of taxpayer support for private individuals and organizations.” OPM and its Inspector General, to their credit, have maintained a similar working group with FEHBP carriers for decades.

Tuesday Tidbits

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

David Ermer–CDC, COVID-19, COVID-19 vaccine, Wellness–
Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Friday Stats and More

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

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 47th weeks of this year (beginning May 14 and ending November 25; 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 ending drop, which is found in every weekly chart, is not meaningful. The CDC’s Fluview was not updated today.

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 period (May 14 through November 25).

You will notice that FEHBlog has figured out how to more clearly present the two axes in these charts.

Although weekly new deaths continue to rise sharply, that weekly total remains below the heights reached in the Spring (shown below) even though the number of new cases in the fall (over 1 million last week) eclipse the number of new cases in the Spring (April 2 through May 13, always under 200,000 weekly):

The FEHBlog was happy to read in the Wall Street Journal that United Airlines has begun “operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.”

The FEHBlog plans a special Federal Benefits Open Season issue tomorrow. Stay tuned.

Tuesday Tidbits

David Ermer–COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the COVID-19 vaccination front —

  • It turns out that, according to Precision Vaccinations, the Food and Drug Administration’s “Advisory Committee on Immunization Practices (ACIP) held an out-of-schedule, emergency meeting to discuss various issues related to experimental COVID-19 vaccine candidates.” Rather than tackle the Pfizer / BioNTech vaccine emergency use authorization request the Committee primarily considered vaccination allocation issues. “During the ACIP’s Phase 1a proposed allocation plan, healthcare workers and those seniors living in Long-Term Care Facilities (LTCF), and those working for these facilities, would be the 1# priority group for vaccinations. As of November 6, 2020, LTCF residents and staff accounted for 6 percent of COVID-19 cases and 39 percent of related fatalities in the USA.”
  • STAT News adds that “Essential workers are likely to move ahead of adults 65 and older and people with high-risk medical conditions when the Centers for Disease Control and Prevention signs off on Covid-19 vaccine priority lists, coming after health care workers and people living in long-term care facilities, a meeting of an expert advisory panel made clear Monday. * * * Essential workers include people who work in meat packing plants and other food processing facilities, in municipal wastewater management operations, and in transport. It also includes police and firefighters and, in the current iteration of the ACIP’s plan, teachers. The CDC estimates there are roughly 87 million people in jobs designated as essential services.”
  • Fierce Healthcare reports that “The U.S. federal government aims to distribute 6.4 million doses of a COVID-19 vaccine to states 24 hours after it gets emergency approval, and officials are in the midst of dry runs to prepare for the shipments, officials said Tuesday. The White House’s Operation Warp Speed, a joint initiative between the departments of Health and Human Services (HHS) and Defense that aims to distribute the vaccine, gave an update to reporters Tuesday on the initial allocations of a vaccine. The update comes as emergency approval from the Food and Drug Administration (FDA) could come in the middle of December.”

MHealthIntelligence.com provides a helpful overview of the Stark, Anti-kickback Act changes rule.

According to Carrie Nixon, co-founder and managing partner of Nixon Gwilt Law, the  OIG’s Final Rule “gives healthcare providers and digital health companies more flexibility to enter into new business arrangements that incentivize care coordination and patient engagement as a means of improving outcomes and reducing the overall cost of care.”

“These new protections allow players in the digital health space – including Remote Patient Monitoring companies, telehealth companies, and healthcare predictive analytics platforms – to take on an unprecedented role in helping healthcare providers move the needle on patient outcomes and costs by providing in-kind and even monetary remuneration to these providers in the form of free or reduced cost items/services or shared savings arrangements,” she summarized in a recent article on her law firm’s website.

Deregulation is a very good thing. The FEHBlog prays that the Biden Administration does not back away from it.

The FEHBlog found OPM’s Fiscal Year 2020 Financial Report on its website today. Here’s a link.

Happy National Rural Health Day

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

It is National Rural Health Day which HHS’s Health Resources and Services Administration is proud to celebrate.

The Defense Department reports on yesterday’s Operation Warp Speed press conference. The Wall Street Journal adds that

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines. “When you see vaccines start to equal or exceed demand is when you’ll see it out of the pharmacies,” said Ms. Whicker.

According to Endpoint News, “BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday [/ tomorrow].

The Wall Street Journal further reports on the COVID-19 front that

U.S. hospitals say they are facing the pandemic’s largest surge armed with treatment improvements that allow them to save lives, care for more patients and accelerate the recovery of coronavirus sufferers.

HCA Healthcare Inc., one of the nation’s largest hospital chains with 186 hospitals, has more intensive-care capacity as the sickest patients recover more quickly. At the Mayo Clinic’s hospital in Rochester, Minn., coronavirus patients now stay a median of five days, half as long as in March. The time Covid-19 patients spend at Advocate Aurora Health’s 26 Midwestern hospitals has fallen 25% on average since May.

The shift could be a result of several factors and more study is needed, said doctors and researchers. But the results are consistent with anecdotal reports from doctors saying that new tools and a better understanding of how Covid-19 attacks the body are helping to improve medical outcomes.

Also HHS announced today launching

a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

The Centers for Disease Control and the American Medical Association, the American Hospital Association and the American Nursing Association are encouraging Americans to curb holiday travel and scale back holiday gatherings due to the recent surge in COVID-19 cases. That’s a useful message for health plans circulate to members and employees.

Following up on this week’s launch of Amazon’s online Pharmacy, the Drug Channels blog comments that

This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks. Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter. For now, Amazon is choosing to join the drug channel, not fundamentally change it.

Healthcare Dive lets us in other expert insights on this development.

In other prescription drug coverage news, the Wall Street Journal reports this evening that

The Trump administration is planning on Friday [/ tomorrow] to roll out two final rules aimed at lowering drug prices—one curbing rebates paid to middlemen in Medicare and another pegging the prices of certain prescription drugs in the U.S. to their prices in other developed countries, according to a person familiar with the planning. The plans, slated to be announced in the White House Rose Garden, have been a signature pledge of President Trump’s since his 2016 election campaign. Both rules are expected to be final, meaning they have completed the required public comment period and can take effect immediately.

“Immediately” in this setting would not prevent the incoming Biden Administration from putting the brakes on the iniative without trouble, in the FEHBlog’s opinion.

In other news —

  • According to a press release, “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association (BCBSA) to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.” Helpful.
  • According to Fierce Healthcare, “While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service. The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report. Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.”