Monday Roundup

Congress

Monday Roundup

David Ermer–ACA, Congress, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Sven Read on Unsplash

Tonight the House is voting on the Consolidated Appropriations Act, 2021(Amendment to H.R. 133), which includes the Fiscal Year 2021 omnibus spending bill, COVID-19 relief measures, and a whole lot more. After the House votes, the Senate will vote and send the Congressionally approved bill along to the President for his expected signature.

Late this afternoon, the FEHBlog found, thanks to the Hill, a complete version of the bill which included 400 pages of complicated amendments to the Affordable Care Act (Division BB). However, when the FEHBlog tried to find that version on the House Rules Committee website tonight in connection with this post, he couldn’t. There’s no sense delving into those healthcare provisions until a law is passed. In the words of John Godfrey Saxe (according to WikiQuotes), “Laws, like sausages, cease to inspire respect in proportion as we know how they are made.”

(P.S. This morning Bloomberg reports that Congress passed H.R. 133 by wide margins. Congress wisely also passed a seven day extension of the current continuing resolution funding the federal government because as Bloomberg reports)

Before the president can sign the full package, it must be enrolled on parchment paper, physically delivered to the White House and reviewed by administration lawyers — a process complicated by the pandemic and coming Christmas holiday.)

Moving on, under current law, a prescription drug manufacturer cannot sell a prescription drug at a price below the best price paid by Medicaid. Only Medicare Part D is excepted from that rule. Today, the Centers for Medicare and Medicare Services (“CMS”) finalized a rule that creates a second exception for value based pricing arrangement. CMS explains:

Under current regulations, prescription drug manufacturers face challenges accounting for VBP arrangements in their Medicaid best price reporting to CMS. This has the unintended consequence of hindering providers, insurers and prescription drug manufacturers in their efforts to develop innovative payment models for new drug therapies and other innovative treatments. Current regulations also discourage payers and manufacturers from designing new payment arrangements based on the value their product may provide.

With the new flexibilities under this final rule, manufacturers will be more willing to negotiate with payers, including Medicaid, with drug pricing being driven by the value of their drug to the individual patient. This is significant, especially in the era of new genetic-based treatments which may initially be expensive, yet in the long run offer significant value to the patient and payer. Payers will be able to negotiate prices with manufacturers for these genetic-based treatments based upon outcomes and evidence-based measures such as reduced hospitalizations, lab visits, and physician office visits, ensuring that if such measures fail to support the value of a drug, the payer is not held accountable for the full price. 

Today’s final rule codifies a broad definition of VBP, which can better align pricing and payment to observed or expected evidence and/or outcomes-based measures in a targeted population. The final rule also allows manufacturers to report multiple best prices instead of a single best price when offering their VBP arrangements to all states. By making these changes, effective in January 2022, CMS hopes to encourage VBP arrangements and negotiations to help make new, innovative therapies more available to all patients. As a result, it is estimated that these new VBP approaches could save up to $228 million in Federal and state dollars through the year 2025.  

Bravo. This action will support FEHB plan efforts to control drug costs.

On the Solarwinds backdoor hack front, Federal News Network discusses its impact on federal government cybersecurity efforts.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, U.S. Healthcare, Uncategorized–
green pine trees during snow season
Snow trees on trail by Ian Schneider on Unsplash.com

The Wall Street Journal reports that

Lawmakers raced to put finishing touches on a roughly $900 billion coronavirus aid package, pushing up against a midnight deadline to complete the agreement and pass it through Congress. 

With a disagreement on the Federal Reserve’s emergency lending powers settled earlier in the weekend, negotiators on Sunday were finalizing details for the rest of the bill. Senate Majority Leader Mitch McConnell (R., Ky.) said Sunday afternoon that negotiators were hours away from completing the deal. * * *

The emerging agreement is expected to provide $300 a week in enhanced federal unemployment benefits, a $600 direct check to many Americans, as well as aid for schools, vaccine distribution and small businesses. Final votes in the House and Senate could occur as early as Sunday.

Lawmakers raced to put finishing touches on a roughly $900 billion coronavirus aid package, pushing up against a midnight deadline to complete the agreement and pass it through Congress. 

With a disagreement on the Federal Reserve’s emergency lending powers settled earlier in the weekend, negotiators on Sunday were finalizing details for the rest of the bill. Senate Majority Leader Mitch McConnell (R., Ky.) said Sunday afternoon that negotiators were hours away from completing the deal. * * *

The emerging agreement is expected to provide $300 a week in enhanced federal unemployment benefits, a $600 direct check to many Americans, as well as aid for schools, vaccine distribution and small businesses. Final votes in the House and Senate could occur as early as Sunday.

The House is expected to vote on a 24-hour extension of government funding Sunday evening, setting up votes on the relief agreement and broader spending bill for Monday. The aid package is tied to a roughly $1.4 trillion annual spending package and Congress has passed a series of temporary spending bills in recent days to keep the government funded while it finished the negotiations.

Significantly, Politico reports that “Congress is set to include a long-elusive ban on “surprise” medical bills as part of a major spending deal lawmakers were working to finalize Sunday evening.”

(P.S. Govexec.com confirms that Congress passed a one day extension of the continuing resolution Sunday night.)

On the COVID-19 front —

The Centers for Disease Control now has a COVID-19 vaccines website which indicates that as of 1 pm today 2,838,225 doses of vaccine have been distributed and 556,208 doses have been administered in the first week.

In accordance with CDC Advisory Committee on Immunization Practices recommendations, the current phase 1A of distribution is directed at healthcare personal and nursing home residents, The Wall Street Journal reports that ACIP today approved phases 1B and 1C as follows:

The next group would include people ages 75 and older, whose hospitalization and death rates are the highest of all age groups. It would also include teachers, factory workers, police and firefighters, grocery store workers and others who are considered essential to the functioning of the economy and at high risk of exposure to Covid-19.

Another group would follow them, comprised of people between the ages of 65 and 74, anyone age 16 or over with a medical condition that puts them at high risk of complications from Covid-19, and other essential workers. They include people who work in transportation and logistics, food service, water and wastewater, and energy sectors.

The ACIP vote was 13-1. State governors are the ultimate decision makers in their states but the FEHBlog understands the governors generally defer to ACIP. As the FEHBlog has noted the vaccines are being directly distributed to federal agencies too.

On the COVID-19 treatment front, the Wall Street Journal reports that

Doctors are treating a new flood of critically ill coronavirus patients with treatments from before the pandemic, to keep more patients alive and send them home sooner.

Last spring, with less known about the disease, doctors often pre-emptively put patients on ventilators or gave powerful sedatives largely abandoned in recent years. The aim was to save the seriously ill and protect hospital staff from Covid-19.

Now hospital treatment for the most critically looks more like it did before the pandemic. Doctors hold off longer before placing patients on ventilators. Patients get less powerful sedatives, with doctors checking more frequently to see if they can halt the drugs entirely and dialing back how much air ventilators push into patients’ lungs with each breath.

“Let us go back to basics,” said Dr. Eduardo Oliveira, executive medical director for critical-care services for AdventHealth Central Florida, which recommends its doctors stick with pre-pandemic guidelines for ventilator use. “The less you deviate from it, the better.”

Advances also include new drugs, most notably steroids, for severely ill patients.

In other healthcare news, Health Payer Intelligence informs us that

Payers may consider promoting ambulatory surgery centers as the ideal site of care for joint replacement surgeries, UnitedHealth Group’s recent research findings suggested.

“Findings from new UnitedHealth Group research underscore the importance of optimizing sites of care to improve patient safety and reduce costs,” the report summarized.

The study analyzed data 2018 and 2019 procedures conducted at Optum’s ambulatory surgery centers. The researchers used low- and medium-severity surgeries to from the baseline and gauge shifts in costs and savings. They used the Ambulatory Surgery Centers Quality Collaboration’s recommended outcome measures to assess quality of care.

On the SolarWinds backdoor hack front, check out this ArsTechnica article:

Of the 18,000 organizations that downloaded a backdoored version of software from SolarWinds, the tiniest of slivers—possibly as small as 0.2 percent—received a follow-on hack that used the backdoor to install a second-stage payload. The largest populations receiving stage two were, in order, tech companies, government agencies, and think tanks/NGOs. The vast majority—80 percent—of these 40 chosen ones were located in the US.

These figures were provided in an update from Microsoft President Brad Smith. Smith also shared some insightful and sobering commentary on the significance of this almost unprecedented attack. His numbers are incomplete, since Microsoft sees only what its Windows Defender app detects. Still, Microsoft sees a lot, so any difference with actual numbers is likely a rounding error.

The FEHBlog had been wondering why not all of the victims of the backdoor hack were breached. It was a conscious decision by the hackers.

COVID-19 Vaccine update and more

David Ermer–Congress, COVID-19, COVID-19 testing, HIPAA Privacy and Security Rules–

Last night, the FDA granted Moderna emergency use authorization for administering its mRNA based COVID-19 vaccine to Americans aged 18 and older. About an hour ago, the CDC’s Advisory Committee seconded this decision which means that health plans, including FEHB plans, must begin to provide in-network and out-of-network coverage for administration of the Moderna vaccine on January 3, 2021. That is certainly good news.

Last night, as CBS News reports, the Senate joined the House of Representatives in approving a two day extension of the continuing resolution funding the federal government, and the President signed the resolution into law. The Hill adds this afternoon that

Speaker Nancy Pelosi (D-Calif.) told Democratic House members during a conference call Saturday that a deal is within reach as soon as negotiators hammer out an agreement on language being pushed by Sen. Pat Toomey(R-Pa.) to wind down the Federal Reserve credit lending facilities. Pelosi told colleagues that the “good news” is “we’re right within reach” of resolving that disagreement.

In other news —

  • The American Medical Association offers advice on which masks work best in warding off COVID-19.
  • The federal government’s Cybersecurity and Infrastructure Security Agency (“CISA”) offered updated guidance today on the SolarWinds backdoor hack.
  • Bloomberg provided this interesting observation on the scope of this hack:

At least 200 organizations, including government agencies and companies around the world, have been hacked as part of a suspected Russian cyber-attack that implanted malicious code in a widely used software program, said a cybersecurity firm and three people familiar with ongoing investigations.

The number of actual hacking victims has been one of many unanswered questions surrounding the cyber-attack, which used a backdoor in SolarWinds Corp.’s Orion network management software as a staging ground for further attacks.

As many as 18,000 SolarWinds’ customers received a malicious update that included the backdoor, but the number that was actually hacked — meaning the attackers used the backdoor to infiltrate computer networks — is likely to be far fewer.

Midweek update

David Ermer–Congress, Electronic health records, U.S. Healthcare–
Portrait of Ludwig Van Beethoven Vintage portrait of famous classical composer, Ludwig Van Beethoven. ludwig van beethoven stock illustrations

It’s the 250th anniversary of the birth of that great composer Ludwig van Beethoven. Speaking of birthdays, the FEHBlog heard today that Dr. Anthony Fauci turns 80 on December 24. According to the Washington Post, he is urging Americans to have a merry little Christmas. Touche.

On the omnibus/COVID-19 relief bill front, Bloomberg reports that

Congressional leaders are still haggling over the final details of nearly $900 billion in coronavirus aid as staff members try to write the legislative language needed for House and Senate votes this week. 

If the aid deal, combined with a spending bill needed to fund the government, isn’t ready to get a vote in both chambers by Friday, another stopgap measure will be needed to avert a partial government shutdown after midnight Friday.

People briefed on the negotiations say the draft of the plan includes $600 in payments for individuals, $300-per-week in supplemental unemployment insurance payments and aid for small businesses, but it omits aid to state and local governments and lawsuit liability protection. It also includes roughly $17 billion for airlines.

Senate Majority Leader Mitch McConnell, House Speaker Nancy Pelosi, Senate Democratic leader Chuck Schumer and House Republican leader Kevin McCarthy continued negotiations on Wednesday, although the deal is more likely to come together by Thursday, according to a lawmaker briefed on the talks.

The FEHBlog expected the legislative language today but good things come to those who wait, right?

The CMS actuary released his annual report on the previous year’s healthcare spending. “Total national healthcare spending in 2019 grew 4.6%, which was similar to the 4.7% growth in 2018 and the average annual growth since 2016 of 4.5%.” 2020 may be the outlier.

Healthcare Dive reports that

HHS began distributing the third phase of COVID-19 relief funding for providers Wednesday, with $24.5 billion to go to more than 70,000 providers through the end of January. The amount exceeds the original $20 billion planned for this tranche as officials realized more would be needed to get providers close to whole from coronavirus-related losses. HHS said up to 88% of applicants’ reported losses are being reimbursed.

In that regard, Fierce Healthcare reports that major healthcare systems which own a health insurer are weathering the COVID-19 storm better than most health systems according to a PwC report. “PwC pointed to major health systems such as Intermountain, Kaiser Permanente and Presbyterian Healthcare Services that used health plans to help bolster their finances.” It’s not surprising to the FEHBlog that hedges like this work. Large health insurers similarly are acquiring healthcare providers.

In other news —

  • The EEOC offers guidance for employers who want to make sure that their employee are vaccinated again COVID-19 and also want to comply with federal anti-discrimination law. This new guidance is Q&A K.
  • EHR Intelligence discusses the Gravity Project’s efforts to introduce social determinants of health data into electronic health records.
  • Health Payer Intelligence informs us about a PwC Health Research Institute report concluding that “Payers and stakeholder collaborators have the opportunity to rebuild the healthcare system into a more effective and consumer-centric system in 2021 by honing virtual care and other strategies.”
  • Krebs on Security details the malicious hack on the SolarWinds/Orion platform used by federal agencies and Fortune 500 companies “to monitor the health of their IT networks.”

Tuesday Tidbits

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

More good news on the COVID-19 vaccine front:

  • Becker’s Health IT reports that “Healthcare workers in Indiana who tried signing up for the first round of COVID-19 vaccinations Dec. 14 overwhelmed the state’s enrollment website, resulting in down time, according to Indianapolis NBC affiliate WTHR.” Why is this good news? Because now that the COVID-19 vaccine is a reality, people will want the jab as the call it in Britain. That’s human nature.
  • The Wall Street Journal reports that “The Food and Drug Administration [“FDA’] said Tuesday that the Covid-19 vaccine developed by Moderna Inc. was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.” Here’s a link to the Moderna briefing document for Thursday’s meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee.

A friend of the FEHBlog pointed out the following encouraging FDA announcement

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 

The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. 

On the omnibus / COVID-19 relief bill front, the Wall Street Journal reports

The top four congressional leaders discussed a coronavirus relief package and sweeping spending bill on Tuesday and planned to return for another meeting in the evening, as lawmakers raced to reach an agreement before critical support programs expire at year’s end.

House Speaker Nancy Pelosi (D., Calif.), Senate Majority Leader Mitch McConnell (R., Ky.), Senate Minority Leader Chuck Schumer (D., N.Y.) and House Minority Leader Kevin McCarthy (R., Calif.) first conferred in the afternoon, with the meeting of both parties’ leaders a signal that they could be ready to make the difficult decisions needed to cut a deal. 

The group will meet again late Tuesday. 

“We’re continuing to work. I think there’s progress. We’ll get back together,” Mr. McCarthy said following the afternoon meeting.

Treasury Secretary Steven Mnuchin, who spoke to Mrs. Pelosi earlier Tuesday for more than an hour, also joined the first meeting by phone. 

The legislative text must be released tomorrow if Congress want to stick with the current December 18 deadline for action.

A friend of the FEHBlog pointed out the Office of Management and Budget’s Office of Information and Regulatory Affairs has issued its Fall 2020 Unified Agenda of “Regulatory and Deregulatory Actions. Here’s a link to the OPM agenda. The FEHBlog noticed a FEHBP centralized enrollment proposed rule and a final FEHBAR rule involving the Truth in Negotiations Act threshold change which the FEHBlog called to OPM’s attention.

In other healthcare news

  • Health Payer Intelligence offers “Five Pivotal Payer Industry Trends To Watch in 2021.”
  • Healthcare Finance News reports that various healthcare trade associations have asked a federal district court in Maryland to preliminarily enjoin implementation of the Trump Administration’s Medicare Part B international drug price index pilot scheduled for January 1, 2021. The motion was filed on December 10 and the government filed its opposition today.
  • A friend of the FEHBlog pointed out this NIH press release on the state of bad teenager habits.

Findings released today from the most recent Monitoring the Future (MTF) survey of substance use behaviors and related attitudes among teens in the United States indicate that levels of nicotine and marijuana vaping did not increase from 2019 to early 2020, although they remain high. The annual MTF survey is conducted by the University of Michigan’s Institute for Social Research, Ann Arbor, and is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

In the four years since the survey began including questions on nicotine and marijuana vaping, use of these substances among teens have increased to markedly high levels From 2017 to 2019, the percentage of teenagers who said they vaped nicotine in the past 12 months roughly doubled for eighth graders from 7.5% to 16.5%, for 10th graders from 15.8% to 30.7%, and for 12th graders from 18.8% to 35.3%. In 2020, the rates held steady at a respective 16.6%, 30.7%, and 34.5%. However, somewhat encouragingly, daily, or near daily (20 occasions in the past 30 days), nicotine vaping declined among 10th and 12th graders from 2019 to 2020, by close to half — from 6.8% to 3.6% in 10th grade and from 11.6% to 5.3% in 12th grade.

Monday Roundup

David Ermer–Congress, COVID-19 vaccine, HIPAA Privacy and Security Rules–
Photo by Sven Read on Unsplash

STAT News offers a portrait of the COVID-19 virus at one year — what scientists know about how it spreads, infects, and sickens. Meanwhile, the AP provides its perspective on today’s first COVID-19 vaccinations, which should be view as a miracle as vaccines normally take at least four years to develop.

Healthcare Dive and Revcycle Intelligence discuss industry reaction to the bipartisan, bicameral surprise billing legislation introduced in Congress last week. The articles make it clear that neither providers nor payers are entirely happy with the legislation and that the legislators’ goal is to attach the bill to this week’s must pass omnibus spending bill (“the omnibus”). It could go.

A friend of the FEHBlog pointed out today another bill that could get attached to the omnibus. Last week the House passed H.R. 7898 which would permit HHS’s Office for Civil Rights to mitigate HIPAA fines and other remedies when the covered entity or business associate has adequately demonstrated that it “had, for not less than the previous 12 months, recognized security practices in place.” “The term ‘recognized security practices’ means the standards, guidelines, best practices, methodologies, procedures, and processes developed under section 2(c)(15) of the National Institute of Standards and Technology Act, the approaches promulgated under section 405(d) of the Cybersecurity Act of 2015, and other programs and processes that address cybersecurity and that are developed, recognized, or promulgated through regulations under other statutory authorities. Such practices shall be determined by the covered entity or business associate, consistent with the HIPAA Security rule (part 160 of title 45 Code of Federal Regulations and subparts A and C of part 164 of such title).” That’s quite reasonable and equitable.

Bloomberg reports today that legislative work on the omnibus itself remains on track. Also the FEHBlog appreciated Bloomberg’s insights into the COVID-19 relief bill which would be the key measure to be attached to the omnibus. What better time than now for Christmas tree legislation” In any event, according to Bloomberg,

[U.S Senator John] Cornyn [R TX] said the $908 billion bipartisan proposal unveiled Monday isn’t likely to go forward by itself but will be used as jumping-off point for the leaders from both parties in both chambers. ”It’s having a positive influence on what will ultimately included,” Cornyn said of the bipartisan proposal. 

Forbes provides more background on the status of the COVID-19 relief legislation for those who are interested (as the FEHBlog is).

While the FEHBlog is a subscriber to the WSJ, Bloomberg and STAT News, among others, he does not subscribe to Modern Healthcare. That’s difficult at this time of year because he does get a kick out of their list of the 100 people who have most influence on U.S. healthcare. Fortunately, AHIP provided a list of their members’ executives who made the list. Congratulations to them.

Weekend update

David Ermer–Congress, OPM, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

The Federal Benefits Open Season for 2021 ends tomorrow. OPM explains on its website that

The Federal Benefits Open Season ends at 11:59pm Eastern Time on Monday December 14, 2020 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59pm, in the location of your electronic enrollment system, on Monday December 14, 2020.

Both Houses of Congress have scheduled Committee hearings / meetings and floor voting for this week. The Hill reports that

A bipartisan group of lawmakers is splitting its $908 billion coronavirus relief proposal into two packages as it prepares to release text on Monday. 

The plan, confirmed by a source familiar with the talks, will include a $160 billion proposal that ties together the two most controversial elements: more money for state and local governments and protections against coronavirus-related lawsuits. 

The second proposal will total $748 billion and include ideas that garner broader support, including another round of Paycheck Protection Program funding for small businesses, unemployment benefits, and more money for vaccine distribution, testing and schools. 

Sen. Joe Manchin (D-W.Va.), a member of the group, announced earlier Sunday that it would release text on Monday. “The plan is alive and well, and there is no way we’re going to leave Washington without taking care of the emergency needs of our people,” Manchin said on “Fox News Sunday.” “We’ll have a bill produced for the American people tomorrow, $908 billion.”

Congress is quickly running out of time to cut a big deal on coronavirus relief, with lawmakers having until Friday to pass a government funding bill that will act as the vehicle for any agreement. But the bipartisan group has been negotiating for weeks, including over the weekend, to try to finalize its bill after announcing a framework earlier this month. 

A friend of the FEHBlog called to his attention this bipartisan, bicameral surprise billing relief proposal. The House Ways and Means Committee released the bill and the President expressed his support for it on Thursday December 11. It’s certainly not clear to the FEHBlog whether this bill will be dropped into the must pass spending bill later this week as the President suggests.

Healthcare Dive reports that

  • Amazon has rolled out a new data aggregation and standardization service for healthcare and life sciences organizations, the tech giant announced Tuesday.
  • The goal of the HIPAA-eligible tool, called Amazon HealthLake, is to make it simpler for healthcare organizations to manipulate, structure and search their data.
  • In other Amazon news, the e-commerce behemoth has expanded its network of health clinics for employees with four additional locations in the Dallas-Fort Worth area, the company said last week.

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.