Weekend Update

CDC

Weekend Update

David Ermer–CDC, Congress, COVID-19, Uncategorized–
Photo by Clarisse Meyer on Unsplash

Congress continues it floor and committee work this coming week. Committees are in engaged in organizational meetings on both sides of Congress. Senate Committees principally will be engaged in holding hearings on Presidential cabinet nomination.

The House Oversight and Reform Committee, whose jurisdiction includes the FEHBP, holds its organizational meeting tomorrow at 2 pm. The Chair will continue to be Rep. Carolyn Maloney (D NY) and the Ranking Member will be Rep. James Comer (R KY). The party ratio will be 25 Democrats and 20 Republicans.

Meanwhile, Bloomberg reports that

Joe Biden’s presidency began at a choreographed sprint, with a series of executive actions to erase Donald Trump’s legacy and reset the nation’s course. But as his first full week in office came to a close, the new president was discovering the limits of his power.

His administration’s efforts to bolster vaccine production ran into the same hurdles that plagued the Trump administration — bottlenecks both at factories and in clinics — and Biden’s advisers had to clean up after the president said any American would be able to get inoculated by the spring. * * *

[FEHBlog note — Per the CDC’s Vaccinations site, on average 1.3 million doses of COVID-19 vaccine were administered on Friday and Saturday.]

He’s meanwhile encountering familiar roadblocks in Congress, where just four of his cabinet nominees have been confirmed 12 days into his presidency, and he’s found no traction among congressional Republicans for another big stimulus bill. * * *

Ten GOP senators wrote to Biden on Sunday with an alternative proposal for a slimmed-down stimulus bill. The White House says it will review the offer. A smaller plan that passed with bipartisan support would leave Democrats free to pursue more contentious elements using a partisan budget tool.

The Wall Street Journal adds

The offer is the first Republicans have forwarded since Mr. Biden proposed the $1.9 trillion plan, which Republicans have said is too costly and includes unneeded initiatives, and tests whether the Biden administration and Democrats in Congress will seek compromise or try to pass the relief package themselves. Democratic leaders have said they plan to begin a legislative process that would bypass the need for Republican support this week, with the first step coming as soon as Monday.

FEHBlog Public Service Announcement: The Centers for Disease Control on Saturday implemented one of the President’s executive orders by requiring

the wearing of masks by all travelers into, within, or out of the United States, e.g., on airplanes, ships, ferries, trains, subways, buses, taxis, and ride-shares. The mask requirement also applies to travelers in U.S. transportation hubs such as airports and seaports; train, bus, and subway stations; and any other areas that provide transportation.  Transportation operators must require all persons onboard to wear masks when boarding, disembarking, and for the duration of travel. Operators of transportation hubs must require all persons to wear a mask when entering or on the premises of a transportation hub.

This order will be effective on February 2, 2021. For more information on the Order or to view frequently asked questions, visit: https://www.cdc.gov/quarantine/masks/mask-travel-guidance.html

Thursday Miscellany

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

As the FEHBlog mentioned on Sunday, today was healthcare day at the White House. Here are links to the President’s executive order intended to strengthen Medicaid and the Affordable Care Act and the related fact sheet. Health Payer Intelligence explains that

In response to the executive order, the Department of Health and Human Services (HHS) will open a special enrollment period on the federal health insurance marketplace platform. The special enrollment period will last from February 15, 2021 through May 15, 2021.

This move will give the uninsured or underinsured individuals more time to enroll on the Affordable Care Act marketplace. Not only will it open up the federally-facilitated marketplace, but this executive order will also allow state-based marketplaces on the federal platform to have a special enrollment period.

“The President will also direct federal agencies to reconsider rules and other policies that limit Americans’ access to health care, and consider actions that will protect and strengthen that access,” said the fact sheet.

The Wall Street Journal adds “Mr. Biden’s sweeping call to review decisions that could limit access to health care marks the start of a tougher battle that is likely to spur political conflict between his administration and Republicans.”

The FEHBlog did watch the Washington Post’s online Prognosis 2021 today. Dr. Vivek Murthy, the President’s nominee for Surgeon General, commented that the President’s goal of 100,000,000 doses of COVID-19 vaccine in his first 100 days in office / April 30, 2021 is a floor not a ceiling. The ultimate goal of achieving herd immunity “goes beyond” April 30. On January 26 and 27, over 2.65 million doses were administered according to the CDC. Progress is being made.

Prognosis 2021 also featured BCBSA CEO Kim Keck, who discussed the Affordable Care Act. She accurately quipped that the Affordable Care Act should be known as the Access to Care Act as we are still waiting for a law that would reduce healthcare costs.

Prognosis 2021 also included an interview with U.S. Senator and Doctor Bill Cassidy (R La.). He touted the recently enacted No Surprises Act intended to protect patients against out of network surprise billing in emergency care, air ambulance and ancillary care at in-network hospital situations. While this law will be a heavy lift to implement, the FEHBlog does expect it to be effective. Video highlights of Prognosis 2021 are available here.

Speaking of healthcare costs Healthcare Dive reports that “U.S. hospitals lost more than $20 billion from suspending elective surgeries over three months at the beginning of the COVID-19 pandemic’s onset in this country, according to an article published recently in the Annals of Surgery.” Holy smoke.

Patient safety advocate the Leapfrog Group announced

“Recognizing Excellence in Diagnosis, a new national initiative to publicly report and recognize hospitals for preventing patient harm due to diagnostic errors. Developed in collaboration with The Society to Improve Diagnosis in Medicine (SIDM) and key experts, the project is funded with a two-year grant of $1.2 million by the Gordon and Betty Moore Foundation. * * *

Joining Leapfrog in leading this effort is SIDM, a nationally recognized organization focused on catalyzing efforts to improve diagnostic quality and safety, as well as convener of the Coalition to Improve Diagnosis, of which Leapfrog is a member. SIDM will develop resources to guide health systems and clinicians on improving diagnostic safety. * * *

Recognizing Excellence in Diagnosis will be conducted over two years. As a first step, the initiative will convene an advisory group of Leapfrog and SIDM representatives, patient and payor stakeholders, and experts in diagnosis and performance analysis. With guidance from the advisory group, the project will identify best practices in diagnosis and put together a roadmap for hospitals and health systems to achieve excellence. SIDM will facilitate the development of training and educational materials to support hospitals and health systems in their adoption of the best practices. In year two, Leapfrog will pilot test a national survey, similar to the annual Leapfrog Hospital Survey, to collect data from up to 100 hospitals and health systems on their adoption of identified best practices. A national report will be issued on the current status of diagnostic safety, best practices for achieving excellence, and strategies for payors and patients to incentivize improvement.

Good luck with this initiative.

Friday Stats and More

David Ermer–CDC, 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 14th week of 2020 through third week of this year (beginning April 2, 2020, and ending January 20, 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 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 period (April 2, 2020, through January 20, 2021):

Finally here is a COVID-19 vaccinations chart for the past month which also uses Thursday as the first day of the week:

Here’s more from the COVID-19 vaccine front —

Bloomberg reports

As of Thursday, 940,000 shots a day were administered on average over a seven-day period, according to data from the Bloomberg Vaccine Tracker. The most recent two days topped a million doses.

Anthony Fauci, Biden’s chief medical adviser, said on Thursday that vaccinating 70% to 85% of the country by the end of the summer would enable a return to normalcy. To do so would mean administering 460 million to 560 million doses, since the current vaccines require a first shot followed by a booster. That’s more than double the rate of Biden’s 100-day goal.

The President’s goal cannot be considered a stretch goal and the FEHBlog is not suggesting that he had been doing so. Bloomberg adds

The U.S. spent more than any country in the world to help speed up the development and deployment of [COVID-19] vaccines. It secured more than 1 billion doses from six companies before any of the shots had been approved. For all the criticism that has been directed at the early fumbles of the vaccine rollout, the U.S. still leads the world in shots administered and is fifth in the world on per-capita basis.

The American Hospital Association reports in its daily email about “rare” levels of allergic reactions to the COVID-19 vaccines:

The Centers for Disease Control and Prevention today reported 10 cases of anaphylaxis, a life-threatening allergic reaction, among the more than 4 million people who received a first dose of the Moderna COVID-19 vaccine between Dec. 21, 2020, and Jan. 10, 2021. That’s an estimated 2.5 cases per 1 million doses. Nine cases occurred within 15 minutes of vaccination and one after 30 minutes. All of the individuals received emergency treatment with epinephrine; four were treated in an emergency department and six were hospitalized. All eight for whom follow-up information was available reportedly recovered. On Jan. 6, CDC reported 21 cases of anaphylaxis among the nearly 1.9 million people who received a first dose of the Pfizer COVID-19 vaccine between Dec. 14 and 23. That’s an estimated 11.1 cases per 1 million doses, but still a rare outcome, according to Nancy Messonnier, M.D., director of CDC’s National Center for Immunization and Respiratory Diseases. CDC recommends that locations administering COVID-19 vaccines adhere to its guidance, including screening recipients for contraindications and precautions, implementing recommended post-vaccination observation periods and immediately treating suspected anaphylaxis with intramuscular epinephrine injection.

Bloomberg reports on second dose timing:

People may receive their follow-up doses of the Covid-19 vaccines up to six weeks later if it’s not feasible to get them in the recommended interval, the Centers for Disease Control and Prevention said.

The guidance posted in a Jan. 21 update to the CDC website said a second dose should be administered as close to the recommended schedule as possible, either three weeks for the Pfizer Inc.–BioNTech SE vaccine or four weeks for the Moderna Inc. shot.

But if it’s impossible to get the follow-up shot on time, the CDC says people may schedule it as much as six weeks, or 42 days, after their initial dose. There is “limited data on efficacy” of the vaccines beyond that interval, according to the guidance, but if the second dose is administered later “there is no need to restart the series.”

Bloomberg adds

Vaccine supply and the pace of vaccinations could accelerate rapidly when new shots are cleared for use. A vaccine by Johnson & Johnson has enough data to begin analyzing now, and could have results in a week or two, Fauci said this week. The Food and Drug Administration has moved within days to authorize vaccine applications based on early results. 

The U.S. has secured contracts with J&J for enough vaccine to inoculate 100 million people—the same as its agreements with Pfizer and Moderna. Unlike the two vaccines that are currently available in the U.S., J&J’s vaccine requires only one dose — which could accelerate the pace of vaccinations. It also can be stored in standard refrigerators, unlike Pfizer’s vaccine, which requires special freezers to keep temperatures below -94 degrees Fahrenheit.

Two other vaccines, from AstraZeneca Plc and Novavax Inc., have yet to be cleared for use in the U.S. but could add hundreds of millions of additional doses to the effort to stop the pandemic. 

In other encouraging COVID-19 vaccine news, FiercePharma reports that “Americans are back on the COVID-19 vaccine bandwagon. Sixty-nine percent now plan to get a COVID-19 vaccine, close to the previous high of 73% in April, according to the latest data from The Harris Poll.”

Catchup Sunday

David Ermer–ACA, CDC, Congress, Federal employment benefits, OPM, U.S. Healthcare–

Happy Martin Luther King, Jr. Day weekend.

HHS issued several final rules on Thursday and Friday last week, none of which apply directly to the FEHBP:

  • The Centers for Medicare and Medicaid Services (CMS”) issued a final rule intended to streamline health plan prior authorization request to providers. America’s Health Insurance Plans, the health insurer trade association, was unimpressed. This rule applies to HHS’s own programs, e.g., Medicare, Medicaid, CHIP, the Qualified Health Plans in the ACA marketplace.
  • CMS also a final Calendar Year (CY) 2022 Medicare Advantage and Part D Rate Announcement, finalizing Medicare Advantage (MA) and Part D payment methodologies for CY 2022. Here’s a link to the fact sheet.
  • HHS also issued part of the final CY 2022 Notice of Benefit and Payments Parameters required by the Affordable Care Act. Katie Keith outlines the notice on the Health Affairs blog, noting

On January 14, 2021, the Centers for Medicare and Medicaid Services (CMS) released its final 2022 Notice of Benefit and Payment Parameters rule, joined in part by the Treasury Department. Historically, the “payment notice” adopts major changes for the next plan year in areas such as the exchanges and the risk adjustment program. Here, however, the final 2022 payment notice adopts only a subset of the policies considered in the proposed 2022 payment notice. This subset of policies includes the most controversial changes that had been included in the proposed rule. The final rule was accompanied by a fact sheet and a press release.

  • A friend of the FEHBlog called to his attention the fact that the Trump Administration HHS never published its proposed HIPAA privacy rule changes, announced December 10, 2020, in the Federal Register. (The HIPAA Privacy Rule does apply to the FEHBP.) What’s more the rule making cannot be found on the Federal Register’s latest public inspection list. The Biden Administration HHS will now have the opportunity to reconsider these “final actions” as well as what to do if anything with the proposed privacy rule changes.

The FEHBlog noticed that on January 7, 2021, the HHS Secretary extended the opioid crisis public health emergency another 90 days into April 2021.

Healthcare Dive informs us that

  • The Federal Trade Commission sent orders to six health insurance companies to obtain patient-level claims data for inpatient, outpatient, and physician services from 2015 to 2020, the agency said Thursday.
  • The FTC wants to figure out how hospitals’ acquisitions of physician practices has affected competition.  
  • The agency sent orders to some of the nation’s largest insurance companies, including UnitedHealthcare, Anthem, Aetna, Cigna, Florida Blue and Health Care Service Corporation.

Federal government personnel moves:

  • The Boston Globe reports that “President-elect Joe Biden on Friday nominated Eric Lander, a pioneer in the study of the human genome and the founding director of the Broad Institute of MIT and Harvard, to be his chief science adviser in a newly created Cabinet position. If confirmed by the Senate, Lander will be the first science adviser to serve in a presidential Cabinet * * *.
  • Medical Design and Resourcing reports that Food and Drug Administration (“FDA”) “veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports.” Dr. Woodcock currently serves as the FDA’s Director of the Center for Drug Evaluation and Research.
  • Bloomberg Law reports that Dr. “Francis S. Collins will stay on as NIH director under the Biden administration, making him one of the few biomedical agency directors to span three presidents.”
  • Govexec.com reports that “President-elect Joe Biden has named Jason Miller as his government management czar, tapping a former Obama administration economic adviser for the key role in setting the president’s management and federal workforce agenda. * * * Should Miller be confirmed by the Senate, he would serve under OMB Director-designate Neera Tanden if she is confirmed and replace Michael Rigas, who is serving in the OMB management role—and that of Office of Personnel Management director—in an acting capacity. The last Senate-confirmed official to hold the management position was Margaret Weichert, a Trump nominee who served concurrently as acting OPM director. Biden has yet to name a head of OPM.”
  • The Washington Post and the Partnership for Public Service offer a Biden Administration political appointee tracker.

As this is the FEHBlog, it is worth noting that Federal News Network has reported on the OPM’s Inspector General’s report on the impact of COVID-19 on the FEHBP. The OIG’s analysis was found in its September 2020 semi-annual report to Congress. Federal News Network queries “What about 2022, or future years for that matter, when FEHB enrollees flock back to their doctor’s offices again for those checkups and preventative procedures they’ve been putting off?”

Bear in mind that all health U.S. plans including FEHB plans experienced a V shaped drop in claims at the height of the great hunkering down last Spring. Many preventive tests are not required annually. The FEHBlog got his routine physical last summer by a combination of a holding a televisit with the doctor and giving blood etc. at the doctor’s office. Furthermore, prescription drug claims have held steady throughout the pandemic and flu cases remain “unusually low” during this winter. We will get through this together. When we reach the new normal, the healthcare sky will not fall in, at least in the FEHBlog’s view.

Friday Stats and More

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

Based on the CDC’s COVID Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through the second week of this year (beginning April 2, 2020 and January 13, 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 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 April 2, 2020 through January 13, 2021:

Finally here is a COVID-19 vaccinations chart for the past month which also uses Thursday as the first day of the week:

The CDC reports that as of today at 9 am roughly 10.6 million American have received one dose of either the Pfizer or Moderna vaccine and 1.6 million American have received both doses. 1.1 million doses of the vaccines were administered yesterday in total.

President-elect Biden announced additional members of his COVID-19 response team today, including

David Kessler, Chief Science Officer of COVID Response
David A. Kessler, M.D., who serves as a co-chair of the COVID-19 Task Force for President-elect Joe Biden, was the Commissioner of the Food and Drug Administration from 1990 to 1997, under Presidents George H. W. Bush and Bill Clinton. 

Per the American Hospital Association, this role will assume the responsibilities of the current head of Operation Warp Speed.” Beckers Hospital Review informed us on January 13 that “Moncef Slaoui, PhD, chief advisor of Operation Warp Speed, submitted his resignation at the request of President-elect Joe Biden’s team, although he’ll stay on for another month to oversee the transition to the new administration, CNBC reported Jan. 12. To close the loop NPR reports that the Biden Administration plans to retire the Operation Warp Speed moniker.

Also on the COVID-19 vaccine front, the Wall Street Journal reports tonight that

If manufacturing projections previously put forth by companies hold up, Mr. Biden’s pledge to administer 100 million doses of Covid-19 vaccines during the first 100 days of his presidency should be possible, according to manufacturing and supply chain experts. But efforts to significantly ramp up vaccines and curtail spread of the virus will depend on state partnerships and public buy-in for some public health measures. * * *

The success of the vaccination push rests in part on available supplies and the ability of a workforce to provide shots. Mr. Biden’s plan seeks to address both challenges through the expanded use of the Defense Production Act and a call for letting more people, including retired medical professionals, administer vaccines with training. He would also expand the use of pharmacies to provide vaccines.

The federally backed community vaccination centers would involve the Federal Emergency Management Agency, the National Guard and state and local teams. The administration would use federal resources and its emergency contracting authority to help launch the centers.

Monday Roundup

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

The Centers for Medicare and Medicaid Services has released a COVID-19 Vaccine Toolkit for health insurance issuers and Medicare Advantage plans. The toolkit’s purpose is as follows:

CMS is committed to ensuring that the private health insurance industry has the necessary tools to respond to the COVID-19 public health emergency (PHE). As safe and effective COVID- 19 vaccines become available, CMS issued this toolkit to help health insurance issuers and Medicare Advantage plans identify the issues that need to be considered and addressed in order to provide coverage and reimbursement for vaccine administration. Because COVID-19 vaccines will be federally purchased, this toolkit primarily focuses on vaccine administration. CMS remains available to provide technical assistance to issuers, Medicare Advantage plans, and other stakeholders. This toolkit:
• Provides a list of operational considerations for issuers and Medicare Advantage plans as they design their approach to promoting COVID-19 vaccinations and information on how issuers and Medicare Advantage plans can communicate with providers and enrollees on vaccinations and coverage;
• Outlines legislative and regulatory provisions applicable to issuers that ensure that enrollees can receive a COVID-19 vaccine in a convenient setting, with no out-of-pocket costs;
• Encourages issuers and Medicare Advantage plans to implement streamlined processes to quickly administer COVID-19 vaccine coverage; and • Describes how issuers and Medicare Advantage plans can maximize the number of their enrollees who get vaccinated once a COVID-19 vaccine becomes available

Meanwhile the Centers for Disease Control have released facts sheets on what to expect after you receive your first dose of COVID-19 vaccine and how to improve ventilation in your house during the great hunkering down.

Benefits Pro reports that the Equal Employment Opportunity Commission is poised to release proposed rules addressing the level of incentives employers may lawfully offer to encourage employee participation in wellness programs that require disclosure of medical information. “

Because the {Americans with Disabilities Act] ADA and [Genetic Information Non-Discrimination Act] GINA do not define “voluntary,” the NPRM proposes that in order to comply with the acts, employers may offer no more than a “de minimis” incentive to encourage participation in wellness programs. The exception would be for “wellness programs that are part of, or qualify as, group health plans and that require employees to satisfy a standard related to a health factor to receive a reward or avoid a penalty,” according to the proposed rule under the ADA.

Under the GINA regulation, the proposed rule makes an exception that would allow incentives for genetic information “when a wellness program offers an employee an incentive in return for his or her family member providing information about the family member’s manifestation of disease or disorder.”

Thursday Miscellany

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

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

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

When Medicare pricing changes the healthcare industry takes notice.

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

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

What is already known about this topic?

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

What is added by this report?

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

What are the implications for public health practice?

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

The Department of Health and Human Services announced today

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

Federal News Network reports that

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

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

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.

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.”

Monday Roundup

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

Perhaps at last we are beginning to see the light at the end of the COVID-19 tunnel. Pfizer announced positive initial results from the phase three trial of its two dose COVID-19 vaccine.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The Wall Street Journal explains (in part) that ‘

“When will the Pfizer vaccine be ready for [emergency use] authorization?

“It will be several more weeks at the earliest, because researchers and regulators still need to make sure the shot is safe. The U.S. Food and Drug Administration has said it wants to see two months’ worth of safety outcomes after vaccination for at least half of the people participating in any large, final-stage clinical trial before it considers authorizing a Covid-19 vaccine. The FDA says this will allow identification of any side effects, such as neurological or heart conditions, that weren’t apparent immediately after vaccination. So far, no serious safety issues have been found, Pfizer says. It expects the two months of safety data later this month, and can ask the FDA to authorize the vaccine soon thereafter. It isn’t yet clear how long the FDA will take to make a decision.

“When will people start getting vaccinated?

“Shots from Pfizer and BioNTech could start becoming available before the end of the year, as production has already begun, but initial supplies will be limited. Pfizer says it expects to produce up to 50 million doses globally in 2020—enough for 25 million people because the vaccine is given in two doses—and up to 1.3 billion doses in 2021. This means only the highest risk groups, such as front-line health care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population. Other Covid-19 vaccines in development will likely be needed for everyone to get vaccinated. Their makers have projected they could produce billions of doses next year if their vaccines are successful in clinical testing.”

The Centers for Disease Control released a study of hospital readmissions of COVID-19 patients from March through July 2021.

Among 126,137 unique patients with an index COVID-19 admission during March–July 2020, 15% died during the index hospitalization. Among the 106,543 (85%) surviving patients, 9% (9,504) were readmitted to the same hospital within 2 months of discharge through August 2020. More than a single readmission occurred among 1.6% of patients discharged after the index hospitalization.

The CDC also offered us guidance on avoiding COVID-19 during the Thanksgiving holidays.

The Centers for Medicare and Medicaid Services (“CMS”) released Affordable Care Act medical loss ratio rebate data from the latest health insurer reports for the three year period ending in 2019. The medical loss ratio data is broken out into three cohorts — individual insurance (minimum MLR 80%), small group insurance (minimum MLR 80%), and large group insurance (minimum MLR 85%). Each cohort then is further broken down state by state which no doubt increase the rebates. FEHB plan insurer rebates sensibly are paid to the the carrier’s contingency reserve, which is FEHB lingo for a premium stabilization fund.

Katie Keith in the Health Affairs blog offers her insights into tomorrow’s California v. Texas oral argument before the U.S. Supreme Court. C-SPAN will play the audio live on radio and the internet.

“The main issues to listen for are:

  • “Do the challengers—a coalition of states led by Texas and two individuals—have standing to challenge the ACA?
  • “Is the individual mandate, with a $0 penalty, unconstitutional?
  • “If the mandate is unconstitutional, is it severable from the rest of the ACA? If not, which other ACA provisions should be struck down alongside the mandate?”