Midweek update

COVID-19

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.

Monday Roundup

David Ermer–Congress, COVID-19, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Bloomberg reports that “[COVID-19 relief bill] talks over the weekend and on Monday have not made enough progress to release final details yet, according to congressional aides.” “Senate Republican leaders made clear Monday evening that the package must have liability reforms [to protect businesses from COVID-19 lawsuits] that [Senate Majority Leader Mitch] McConnell supports in order for Republicans to consider any state and local aid [which is a Democrat priority]. Accordingly as Forbes reports, “The House [of Representatives] will vote on a one-week stopgap spending bill Wednesday, pushing back a looming December 11 government shutdown deadline to give lawmakers more time to come to an agreement on a new coronavirus relief package.”

The FEHBlog is attending the American Bar Association’s virtual Washington Health Law Summit (“WLS”) which runs from today through Wednesday. (Ermer & Suter is a bronze sponsor.) He heard one of the speakers tout the Health Care Cost Institutes’s Healthy Marketplace Index.

Using nearly 2.5 billion commercial claims from 2013 to 2017, HCCI tracks drivers of health care spending across 124 U.S. cities through the Healthy Marketplace Index (HMI) project. Our full report presents an interactive exploration of each HMI metric and a deep dive into each metro area. Collectively, they comparing how spending drivers varied across and even within cities, as well as over time

HMI is easy to navigate, and the information is on point but somewhat dated. Not bad for free though.

TechRepublic courageously offers seven predictions for how technology will shape healthcare next year. One of the predictions is continued demand for telehealth. One of the WLS speakers sagely commented about the public health importance of mental health services provided by telehealth She noted that while four out of five doctors in medical / surgical practices join health plan networks, only one out of five psychiatrists and psychologists join those networks. Telemedicine makes the in-network psychiatrists and psychologists more widely available. That’s an important consideration.

Another WLS speaker predicted that Congress will pass a big infrastructure bill next year that will include healthcare priorities such as expanding reliable internet access in rural areas of the country in order to facilitate telehealth there.

Fierce Healthcare reports that

While the continued climb of COVID-19 cases in the U.S. is pushing many Americans’ resiliency to the limits, there are signs that some are adapting to the challenging circumstances, a new study from Cigna shows.

Daniel Ober, M.D., chief medical officer for Cigna Global Health Benefits, told Fierce Healthcare that because the U.S. never really entered a lull in the pandemic that allowed it to reopen the way some other regions did, many Americans have “adapted somewhat” to life under COVID-19. For example, people who are unwilling to wear masks in public, as is recommended by experts, are largely an exception to the rule, not the norm, he said. “We’re adapting to this new normal and will continue to do so,” he said.

It’s nice to read encouraging news on this first Monday in a while without big COVID-19 vaccine news. The FDA committee considers the Pfizer BioNTech application for emergency use authorization of its COVID-19 vaccine on Thursday.

Weekend update

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

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

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

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

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

Summary
What is already known about this topic?

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

What is added by this report?

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

What are the implications for public health practice?

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

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

The FEHBlog ran across a Bloomberg report which adds

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

FINAL. Avoid the 3 Cs Poster

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

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

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

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

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

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

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

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

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

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

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

Finally the Salt Lake City [UT] Tribune reports that

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

Intermountain offers an FEHB plan under the SelectHealth name.

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.

Thursday Miscellany

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

Midweek Update

David Ermer–AHRQ, Congress, COVID-19–

FYI this is the 3,001st FEHBlog column since 2006. My how time does fly.

The Wall Street Journal reports tonight that

Democratic leaders signaled Wednesday they were prepared to reduce their demands for the next round of coronavirus relief, fueling hopes that an agreement could be reached with Republicans by year’s end to boost struggling businesses and households.

Congressional leaders have been mired in disagreements for months. In a sign that the partisan standoff was easing, however, House Speaker Nancy Pelosi (D., Calif.) and Senate Minority Leader Chuck Schumer (D., N.Y.) said that a new, bipartisan $908 billion relief proposal released Tuesday should serve as the starting point for talks with GOP leaders and the White House. 

If a compromise is reached, those COVID-19 relief provisions would be included in the omnibus spending bill for the current federal fiscal year which must pass before December 12. The only alternative would be to pass a short term funding bill in order to punt the COVID-19 relief provisions into the next Congress which begins on January 3, 2021.

The Journal explains that “Few lawmakers want to linger in the Capitol beyond what is necessary. House Majority Leader Steny Hoyer (D., Md.) said Wednesday that congressional leaders hoped to finish up by the end of next week to give lawmakers time to quarantine before Christmas.” How 2020 is that?

The Centers for Disease Control released updated guidance today on COVID-19 quarantine periods (approaches to reducing the quarantine period for 14 to 10 days) and domestic holiday travel (don’t do it).

A friend of the FEHBlog shared this interesting Health and Human Services infographic on COVID-19 testing in our country.

This friend also pointed out this news about

A free online course developed by the Johns Hopkins Bloomberg School of Public Health on the basics of contact tracing has enrolled more than one million people over the past six months, teaching hundreds of thousands of individuals around the world how to deploy an epidemiological tool considered critical to slowing the spread of COVID-19.

The six-hour course, COVID-19 Contact Tracing, is hosted by Coursera and is open to anyone. Since its launch in May, it has attracted participants from every U.S. state and territory as well as more than 150 countries around the world. To date, more than 520,000 people have completed the course.

Pretty cool effort.

The Agency for Healthcare Quality and Research informs us about its partnership with Google to develop

a new online tool to help patients plan for medical visits. The new Google visit planning tool is built on the same evidence behind AHRQ’s QuestionBuilder app. It makes it easy for patients and those who care for them to privately list and prioritize their questions in preparation for a medical visit. When people use Google to search for a healthcare provider, they will have the option to create their own private visit plan.

Asking the right questions—and making sure you understand the answers—has always been at the heart of AHRQ’s “Questions Are the Answer” public education initiative. Launched in 2007 through a series of public service announcements with the Ad Council, the Questions Are the Answer message highlights the vital role patients and families play as part of their healthcare team.

That’s a helpful tidbit for health plans to share with their members.

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.

Weekend Update

David Ermer–ACA, Congress, COVID-19–

Congress returns to committee work and floor action this coming week for an expected two more weeks of the its lame duck session.

Top House and Senate appropriators on Tuesday [November 24] clinched a deal on a bipartisan set of funding levels, paving the way for a $1.4 trillion spending package to avert a government shutdown next month. The agreement on the funding allocations, confirmed by a House Democratic aide, establishes overall totals for 12 appropriations measures that will be rolled into one massive omnibus bill that would boost federal budgets for the rest of the fiscal year. Negotiators plan to keep the numbers — known as 302(b)s — under wraps until a bipartisan, bicameral omnibus is finalized, the aide said.

This means that Congress remains on track to pass an FY 2021 omnibus spending bill before the current continuing resolution funding the federal government expires on December 12.

Negotiations on another Covid-19 relief bill are at an impasse. Some measures may get attached to a spending package that must pass by Dec. 11 to avert a government shutdown. Another weekly boost to unemployment benefits would most likely be part of the mix, according to unemployment and policy experts.  The subsidy would probably fall between $250 and $600 a week and be retroactive to early September, they said.

  • The Wall Street Journal reports that “President Trump’s decision to defer payroll taxes until the end of the year is leaving challenges for lawmakers to manage after he leaves office in January, and they haven’t figured out what—if anything—to do. * * * [P]ayroll processor Paychex Inc. said take-up has been very low. The one big exception—which could create pressure for Congress to act—is the federal workforce, including many members of the military. Mr. Trump required executive-branch employees to participate. Lawmakers, particularly those from the Washington [D.C.] area, support legislation to let employees decide whether their taxes can be deferred. As the weeks tick by toward the year’s end, that becomes less feasible.

Late Wednesday, the Department of Health and Human Services released the proposed ACA Notice of Benefit and Payment Parameters for 2022. Of note, to community rated FEHB plan carriers HHS proposes to make the following changes to the medical loss ratio (“MLR”) calculation:

We propose to amend the MLR regulation to establish the definition of prescription drug rebates and other price concessions that issuers must deduct from incurred claims for medical loss ratio (MLR) reporting and rebate calculation purposes beginning with the 2022 MLR reporting year (MLR reports filed in 2023). We additionally propose to explicitly allow issuers the option to prepay a portion or all of the estimated MLR rebate for a given MLR reporting year in advance of the deadlines set forth in §§ 158.240(e) and 158.241(a)(2) and the filing of the MLR Annual Reporting Form. We also propose to establish a safe harbor allowing such issuers, under certain conditions, to defer the payment of any remaining rebates owed after prepayment until the following MLR reporting year beginning with the 2020 MLR reporting year (MLR reports filed in 2021). In addition, we propose to allow issuers to provide MLR rebates in the form of a premium credit prior to the date that the rules currently provide and beginning with the 2020 MLR reporting year (MLR reports filed in 2021). Lastly, we propose to clarify MLR reporting and rebate requirements for issuers that choose to offer temporary premium credits during a public health emergency declared by the Secretary of HHSfor future benefit years, beginning with the 2021 MLR reporting year (MLR reports filed in 2022). 

Of note to all FEHB plan carriers, HHS proposes to make the following changes to the out of pocket (“OOP”) cost sharing ceilings for in-network care:

The proposed 2022 maximum annual limitation on cost sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 6.4 percent increase above the 2021 parameters of $8,550 for self-only coverage and $17,100 for other than self-only coverage. Similar to the proposal for the premium adjustment percentage index, for the 2023 benefit year and beyond, we propose to release the maximum annual limitation on cost sharing in guidance by January of the year preceding the applicable benefit year. 

For more details on the Notice check out Katie Keith’s columns on the Health Affairs Blog.

The Biden Administration’s HHS will finalize the Notice next year. HHS has a good deal of statutory discretion over the MLR calculation but very little discretion over (“OOP”) cost sharing ceiling calculations in the FEHBlog’s opinion.

The FEHBlog has learned that a two step process exists for approval a COVID-19 vaccine for individual and group health plan coverage.

  • First, as discussed in the FEHBlog, the FDA must give emergency use authorization to the vaccine. The relevant FDA advisory committee is meeting December 10 to consider the Pfizer – BioNTech vaccine. The Committee’s recommendation goes to the FDA Commissioner for final approval.
  • Once FDA approval has been given, the CDC’s relevant advisory committee the Advisory Committee on Immunization Practices (ACIP) must add its approval.
  • Fifteen days after ACIP approval is given, individual and group health plans, including FEHB plans will become obligated to cover the administration of the approved vaccine in and out of network without member cost sharing. That effective date will be in late December at the earliest. 
  • An emergency use authorization can only trigger plan health plan coverage of a vaccine during a related public health emergency. The current COVID-19 public health emergency period expires on January 20, 2021, unless as expected HHS extends that period for another 90 days before then,