Weekend update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Telehealth–
Photo by Clarisse Meyer on Unsplash

According to the Wall Street Journal, the House of Representatives will be voting tomorrow to override the President’s veto of the National Defense Authorization Act, 2021 (H.R. 6395). Under the Constitution the voting threshold for an override is 2/3s of the body. If the House votes to override, the Senate will hold its vote on Tuesday.

Tomorrow December 28 is the deadline for the President to sign the Consolidated Appropriations Act 2021 (H.R. 133) without an intervening government shutdown. Congress presented the bill to the President for his signature on Christmas Eve. The President has expressed his preference for a $2,000 direct stipend instead of the bill’s $600 stipend and opposition to certain foreign aid appropriations. The Hill reports that “A bipartisan group of lawmakers from both chambers of Congress on Sunday reissued their call for President Trump to sign a nearly $1 trillion COVID-19 relief package [which is part of H.R. 133]— or to immediately veto it.” The House likely will pass a separate bill with the $2000 stipend tomorrow.

P.S. The Wall Street Journal and the Washington Post report Sunday night that the President has signed the Consolidated Appropriations Act into law, thereby releasing COVID-19 relief and avoiding a government shutdown. Tomorrow the FEHBlog will continue his discussion of the Affordable Care Act changes in this law.

Today December 27 is the effective date for health plan coverage of the Pfizer-BioNTech vaccine to plan members under the CARES Act. Precision Vaccinations reports that the Centers for Disease Control released updated guidance on the Pfizer-BioNTech and Moderna mRNA based vaccines over the weekend. The widely used guidance states that

‘Until experts learn more about the protection that COVID-19 vaccinesprovide under real-life conditions, people who decide to get vaccinated should continue to follow all current guidance to protect themselves against COVID-19 after they are vaccinated.’

As of 9 am on December 26, the CDC reported that nearly 2 million first dose of one these vaccine have been administered to subgroup 1a — front-line healthcare workers and nursing home patients.

Govexec reports that frontline postal workers will receive the COVID-19 vaccine in subgroup 1b which currently is in the on deck circle.

The exact timing of the distributions for postal workers and the logistics of delivering the shots remain in flux and will be subject to availability and state plans. States are still in their initial Phase 1a distribution to frontline health care workers and nursing home residents. Unlike several other federal agencies such as the Veterans Affairs Department and Indian Health Service, USPS was not slated to receive its own distribution of doses to vaccinate employees directly. CDC’s advisory group recommended bringing vaccination sites close to workers such as those at the Postal Service to ensure ease of access.  

The FEHBlog mentioned hearing a Doctors on Demand medical director talking about the challenge in retaining mental health practitioners to handle the surge in telehealth requests for those services. The FEHBlog noted that this hub and spoke telehealth approach helpfully expands mental health provider networks for plan members.

Fierce Healthcare informs us about a research study concluding

The growth in telehealth [during the public health emergency] was not fueled by COVID-19 concerns but by visits for behavioral health issues and chronic conditions, according to a new study of Doctor On Demand data.

The largest increases in telemedicine visits during the COVID-19 pandemic were attributable to scheduled behavioral health appointments, such as therapy and psychiatry visits, and chronic illness visits, according to a peer-reviewed study published in the Journal of Medical Internet Research this month.

It is the FEHBlog’s hunch that garden variety med surg telehealth visits were conducted via direct connections between doctor and patient rather than via a hub and spoke service like Doctors on Demand. From a quality standpoint, it likely is better for the hub and spoke service to gap fill rather than serve as a primary care provider.

Saturday Stats and More

David Ermer–Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, 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 14th through 51st weeks of this year (beginning April 2 and ending December 23; 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 23):

The latest CDC FluView will be available on Monday December 28. Next week the FEHBlog will begin to include COVID vaccines in these charts.

The FEHBlog had planned to start reviewing the Affordable Care Act changes in the Consolidated Appropriations Act, 2021, but because the status of that bill unfortunately is in limbo, he instead will note two other Congressionally passed bills that are expected to receive the President’s signature:

H.R. 1418

The McCarran-Ferguson Act of 1945 “limited the application of [federal] antitrust laws to the business of insurance as long as and to the extent state law regulated the business of insurance. However, if states would not regulate insurance, the Sherman and Clayton Acts, as well the Federal Trade Commission Act still applied.” Needless to say the States with the assistance of the National Association of Insurance Commissioners made sure that the States did not unwittingly create such a regulatory gap. In any event. the McCarran- Ferguson Act continued to apply federal anti-trust law, specifically the Sherman Act of 1896, to prohibit “any agreement to boycott, coerce, or intimidate, or act of boycott, coercion, or intimidation” (15 U.S.C. Sec. 1013).

H.R. 1418 adds to the McCarran- Ferguson Act a further exception for health insurance, dental insurance and limited scope dental benefits. In other words health insurers and dental insurers will be subject to both federal and state laws against restraint of trade. The garden variety exceptions to extension of federal anti-trust law appear quite narrow to the FEHBlog.

“(A) to collect, compile, or disseminate historical loss data; (B) to determine a loss development factor applicable to historical loss data; (C) to perform actuarial services if such contract, combination, or conspiracy does not involve a restraint of trade; or (D) to develop or disseminate a standard insurance policy form.”

ThinkAdvisor adds

Matt Eyles, president of America’s Health Insurance Plans (AHIP), said in a statement about passage of H.R. 1418 that implementation of the bill would add layers of bureaucracy to health insurers and destabilize markets.

“Removal of this exemption adds tremendous administrative costs while delivering absolutely no value for patients and consumers,” Eyles said.

Consumer Reports put out a commentary welcoming passage of H.R. 1418.

“The antitrust exemption has essentially allowed health insurers to act as a monopoly, making demands in lockstep on the terms they will offer consumers and health care providers,” the advocacy organization said in a comment on bill passage. “The resulting squeeze puts pressure on providers to cut corners on service in order to increase the profits the health insurers can extract.”

How much can insurers extract when those profits are strictly regulated by the Affordable Care Act?

H.R. 7898

This bill, which the FEHBlog previously has mentioned, requires HHS’s Office for Civil Rights to consider whether 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, when imposing penalties or other remedies for HIPAA Security Rule violations.

The bill defines “Recognized security practices” to mean

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).

The bill expressly does not create liability for HIPAA covered entities and business associates which decide not to adopt such practices. The bill is retroactive to the effective date of the 21st Century Cures Act of 2016.

In other healthcare legal news:

  • Reuters reports that on December 23, 2020, a federal district judge in Maryland “blocked a last-minute Trump administration rule aimed at lowering drug prices as of next week. The rule, scheduled to take effect on Jan. 1, would have tied reimbursements for 50 drugs by Medicare, a U.S. government insurance program, to the lowest prices paid by certain other countries. U.S. District Judge Catherine Blake in Maryland ruled that the administration had rushed the rule without giving the public a chance to comment, in violation of federal law.” Case No. 1:20-cv-03531 (D. Md). The temporary restraining order is effective for 14 days.
  • MedCity News reports that

The American Hospital Association, along with several other organizations, filed an emergency stay of enforcement motion to prevent the Department of Health and Human Services’ hospital price transparency rule from going into effect Jan. 1. The rule requires each hospital operating in the U.S. to make public pricing information, including the prices they negotiate with commercial health insurers. Last week, the Centers for Medicare and Medicaid issued a bulletin announcingits plans to audit a sample of hospitals for compliance with the rule starting in January.

The motion was filed with the U.S. Court of Appeals for the D.C. Circuit in its appeal of a lower court order affirming the legality of this rulemaking (Case No. 20-5193). In its opposition to this motion, the Justice Department observed that

This Court granted plaintiffs’ request for an expedited briefing and argument schedule to “allow the Court to hear and decide this case before” January 1, 2021. Pls. Mot. to Expedite, at 5 (July 3, 2020). The Court is likely to rule on the merits of this appeal imminently, thereby resolving plaintiffs’ legal challenge. Should the Court affirm the district court’s rejection of plaintiffs’ claims, plaintiffs would not be entitled to any relief, including a stay of the agency’s rule. Should the Court agree with plaintiffs’ legal challenge, by contrast, plaintiffs would be entitled to appropriate relief.

The FEHBlog will keep an eye out for this opinion next week.

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.