FEHBlog

Jingle Bells

David Ermer–COVID-19 vaccine–

person holding multicolored baubles
Photo by James Lee on Unsplash

The FEHBlog is taking a brief holiday hiatus until next Sunday December 27. He will leave you with this encouraging CDC news as of 9 am ET this morning:

COVID-19 Vaccinations in the United States​
Doses Distributed 9,465,725
People Initiating Vaccination (1st dose received) 1,008,025

  • Total doses distributed are cumulative counts of COVID-19 vaccine doses recorded as shipped in the Centers for Disease Control and Prevention’s (CDC) Vaccine Tracking System (VTrckS) since December 13, 2020. Cumulative totals reflect data available as of 9:00am ET on the day of reporting.
  • People initiating vaccination (1st dose received) are cumulative counts of individual COVID-19 vaccine first doses administered as reported to the CDC by state, territorial, and local public health agencies and five federal entities (Bureau of Prisons, Veterans Administration, Department of Defense, Department of State, and Indian Health Services) since December 14, 2020. Cumulative doses administered reflect current data available as of 9:00am ET on the day of reporting.
  • Doses distributed and people initiating vaccination (1st dose received) are for both Moderna and Pfizer BioNTech COVID-19 vaccine.

Not bad for 12 days since the Pfizer-BioNTech vaccine received the FDA’s emergency use authorization.

Have yourself a merry little Christmas.

Tuesday Tidbits

David Ermer–Congress, COVID-19, U.S. Healthcare–
assorted-color figurine collection bokeh photography
Frankfurt Christmas Market, Frankfurt am Main, Germany
beautifully hand crafted christmas figures and imps, seen at the Frankfurt City Christmas Market in Germany. cmophoto.net on unsplash.com

The Continuing Appropriations Act, 2021, includes hundreds of pages of amendments to the Affordable Care Act. The premier change is the No Surprises Act which is principally a patient protection measure. NPR lays out this new law’s requirements which take effect for plan years beginning on or after January 1, 2022.

Over the remaining posts of 2020, the FEHBlog will point out other new health plan obligations for 2022 created by this bill, which the President will sign into law within the week. Many of those provisions were drawn from the Senate Health Education and Labor Committee’s S. 1785 from the last Congress. Suffice it to say that 2021 will be very busy year for health plans and their vendors.

Federal News Network discusses how the Continuing Appropriations Act, 2021, impacts federal government agencies and their employees. Of note, the bill

  • “silent[ly] endorse[s] the president’s 1% across-the-board federal pay raise for civilian employees in 2021;”
  • “allow[s} those subject to the president’s payroll tax deferral to pay back the deferred taxes — worth 6.2% of their income — throughout the entire year of 2021;”
  • “appropriates to the Office of Personnel Management $36 million more [in the current federal fiscal year] to make up for the revenue it lost when it transferred the governmentwide security clearance business to the Defense Department,” and
  • “contains a provision requiring OPM to establish a new occupational series for artificial intelligence positions, or update an existing series to more accurately account for those kinds of skills needed in the federal government.”

On the COVID-19 front, Kaiser Health News helpfully gathers stories about the variant of the COVID-19 virus that recently cropped up in Britain. Fierce Healthcare adds

Moderna * * * said in a statement provided to other media outlets that it expects “that the Moderna vaccine-induced immunity would be protective against the variants recently described in the U.K.,” and that it “will be performing additional tests in the coming weeks to confirm this expectation.”

Pfizer pointed out that when SARS-CoV-2, the virus that causes COVID-19, first emerged a year ago, it was clear there was more than one strain of it, and that it was mutating as it spread. SARS-CoV-2 is an RNA virus, and as such, it has “exceptionally high [mutation] rates” because the enzymes it uses for replication are “prone to errors when making new virus copies,” the company said.

“One of the reasons Pfizer and BioNTech chose to utilize a mRNA platform is because of the potential for the flexibility of the technology in comparison to traditional vaccine technologies,” including the ability to change the RNA sequence in the vaccine, should a strain emerge that’s not covered by the current shot,” Pfizer added.

Both COVID-19 vaccine manufacturers urged public calm.

In October 2020, the FEHBlog noted that Walmart preemptively had sued the federal government over its opioid crisis policy shortcomings. Nevertheless the other shoe dropped today when the federal government sued Walmart in Delaware’s federal court.. According to Justice Department’s press release.

In a civil complaint filed today, the Department of Justice has alleged that Walmart Inc. unlawfully dispensed controlled substances from pharmacies it operated across the country and unlawfully distributed controlled substances to those pharmacies throughout the height of the prescription opioid crisis. 

The complaint alleges that this unlawful conduct resulted in hundreds of thousands of violations of the Controlled Substances Act (CSA).  The Justice Department seeks civil penalties, which could total in the billions of dollars, and injunctive relief.

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.

Friday Stats and More

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

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 50th weeks of this year (beginning May 14 and ending December 16; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noted that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2 through December 9). The FEHBlog extended this chart from April 2 to May 14 in order to display the previous high for this sad metric.

The CDC’s current Fluview report continues to state “Seasonal influenza activity in the United States remains lower than usual for this time of year.” So Americans must be doing something right.

The CDC issued a health advisory yesterday reporting

1) substantial increases in drug overdose deaths across the United States, primarily driven by rapid increases in overdose deaths involving synthetic opioids excluding methadone (hereafter referred to as synthetic opioids), likely illicitly manufactured fentanyl;
(2) a concerning acceleration of the increase in drug overdose deaths, with the largest increase recorded from March 2020 to May 2020,coinciding with the implementation of widespread mitigation measures for the COVID-19 pandemic;
(3) the changing geographic distribution of overdose deaths involving synthetic opioids, with the largest percentage increases occurring in states in the western United States;
(4) significant increases in overdose deaths involving psychostimulants with abuse potential (hereafter referred to as psychostimulants) such as methamphetamine; and

That’s the twin pandemic that the CDC feared.

The Wall Street Journal reports that

The House [of Representatives] passed a two-day spending bill Friday evening, sending it over to the Senate in a bid to prevent a partial government shutdown after midnight, as congressional leaders struggled to wrap up negotiations on a coronavirus relief package. 

In the Covid-19 talks, negotiators were still wrestling Friday to close differences on the Federal Reserve’s emergency lending powers among other final snags. Leaders have aimed to pair the passage of the Covid-19 aid bill with a broader spending bill.

The FEHBlog expected a little bit longer extension but a two day extension suggests that the compromise on the COVID-19 relief bill is near. The FEHBlog cannot believe that with the Georgia Senate primary approaching on January 5 that either party would risk a government shutdown or not COVID-19 relief. But we shall see.

In that regard, the FEHBlog read on the American Hospital Association’s daily report about this health system letter to Congress, delivered today, suggesting that there is some crazy language in that bipartisan surprise billing proposal. Again, we shall see.

HHS’s Office for Civil Rights issued “guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges to disclose protected health information (PHI) for the public health activities of a public health authority. The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA that is engaged in public health activities.”

Thursday Miscellany

David Ermer–Uncategorized–
Photo by Juliane Liebermann on Unsplash

According to the Wall Street Journal and Bloomberg, legislative negotiations continue over the latest COVID-19 relief bill. This bill will be added to the omnibus spending bill for the federal government’s current fiscal year. That bill is ready to go. In order to allow time for the relief bill negotiations to conclude successfully, it’s likely that tomorrow Congress will extend the current continuing resolution into next week.

On the COVID-19 front —

  • The Food and Drug Administration yesterday “issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset, when an adult collects the sample.The BinaxNOW COVID-19 Ag Card Home Test is being offered in partnership with eMed Labs, LLC., a telehealth service that will take users step-by-step through the sample collection process, explain how to perform the test, and provide assistance in reading and understanding the results.”
  • Today the Centers for Disease Control (“CDC”) released a report concluding that the COVID-19 virus can be transmitted person to person on a commercial airline. The report was based on an analysis of a commercial airline trip that occurred in Australia last March before people began to take protective measure seriously. The CDC’s point though is well taken. Be careful.

In other Health and Human Services Department news —

  • Today HHS released “the first-ever national plan to address the public health crisis caused by alarming increases in rates of sexually transmitted infections (STIs) in the United States over the past six years. The STI National Strategic Plan 2021-2025 (STI Plan) sets national goals, objectives, and strategies to respond to the STI epidemic. The plan will serve as a roadmap to help federal and non-federal stakeholders at all levels and in all sectors reverse the sharp upward trends in STI rates.”
  • Also today, “the Office for Civil Rights (OCR) at HHS released its 2016-2017 HIPAA Audits Industry Report that reviewed selected health care entities and business associates for compliance with certain provisions of the HIPAA Privacy, Security, and Breach Notification Rules.” Although the report is somewhat dated, the summary of findings likely are still relevant, in the FEHBlog’s view:
  • Most covered entities met the timeliness requirements for providing breach notification to individuals;
  • Most covered entities that maintained a website about their customer services or benefits satisfied the requirement to prominently post their Notice of Privacy Practices on their website;
  • Most covered entities failed to provide all of the required content for a Notice of Privacy Practices;
  • Most covered entities failed to provide all of the required content for breach notification to individuals;
  • Most covered entities failed to properly implement the individual right of access requirements such as timely action within 30 days and charging a reasonable cost-based fee;
  • Most covered entities and business associates failed to implement the HIPAA Security Rule requirements for risk analysis and risk management. 

The announcement concludes — “The audit results confirm the wisdom of OCR’s increased enforcement focus on hacking and OCR’s Right of Access initiative,” said OCR Director Roger Severino. “We will continue our HIPAA enforcement initiatives until health care entities get serious about identifying security risks to health information in their custody and fulfilling their duty to provide patients with timely and reasonable, cost-based access to their medical records.”

ArsTechnica offers a comprehensive update on the SolarWinds hack.

The supply chain attack used to breach federal agencies and at least one private company poses a “grave risk” to the United States, in part because the attackers likely used means other than just the SolarWinds backdoor to penetrate networks of interest, federal officials said on Thursday. One of those networks belongs to the National Nuclear Security Administration, which is responsible for the Los Alamos and Sandia labs, according to a report from Politico.

“This adversary has demonstrated an ability to exploit software supply chains and shown significant knowledge of Windows networks,” officials with the Cybersecurity Infrastructure and Security Agency wrote in an alert. “It is likely that the adversary has additional initial access vectors and tactics, techniques, and procedures (TTPs) that have not yet been discovered.” CISA, as the agency is abbreviated, is an arm of the Department of Homeland Security.

Elsewhere, officials wrote: “CISA has determined that this threat poses a grave risk to the Federal Government and state, local, tribal, and territorial governments as well as critical infrastructure entities and other private sector organizations.”

So the hacking effort may expand beyond the identified Solarwinds “backdoor.” Wow.

COVID-19 Vaccine Update

David Ermer–COVID-19 vaccine–

The FEHBlog just watched the Food and Drug Administration’s (“FDA”) Vaccines and Biological Products Advisory Committee unanimously recommend by a 20-0 vote (one abstention) that the FDA grant emergency use authorization (EUA) to the Moderna COVID-19 vaccine. Last week the same Committee appro/ved the Pfizer-BioNTech vaccine by a 17-4-1 vote. Both vaccines rely on mRNA technology. In the FEHBlog’s view, the difference between the votes is that Moderna limited its EUA application to people aged 18 or older while Pfizer’s extension of the EUA to sixteen and seventeen year old people was controversial. If recent history is any guide, the FDA can be expected to grant the EUA tomorrow and over the weekend the CDC’s Advisory Committee on Immunization Practices will trigger health plan coverage of the vaccine effective fifteen days later.

Politico reports that the Johnson & Johnson vaccine will be presented to this FDA committee in late January 2021. “The vaccine is the only one among the frontrunners that is given as a single dose. “Because it’s a one dose vaccine, they can really scale up very quickly,” said Moncef Slaoui, the chief adviser to Operation Warp Speed.

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.