Happy Martin Luther King, Jr. Day

Happy Martin Luther King, Jr. Day

The FEHBlog hopes that everyone is having an enjoyable, contemplative holiday.

Both Houses of Congress are back at legislative grindstone this week. Here is a link to the brief Committee schedule. CNN reports

The top two Senate leaders are nearing a power-sharing agreement to hash out how the evenly divided chamber will operate, with Democrats in charge of setting the schedule but both parties likely to hold an equal number of seats on Senate committees, according to sources familiar with the talks.

The negotiations between Democratic Leader Chuck Schumer and Republican Leader Mitch McConnell have been built largely around how the Senate operated the last time the body was split 50-50: When George W. Bush initially became president in 2001. Final details are still being sorted out between the two leaders, sources said.

Similar to those rules, set in January 2001, Schumer and McConnell aides are discussing allowing bills and nominations to advance to the Senate floor even if they are tied during committee votes, something that could become common given that each party is expected to have the same number of seats on committees. Democrats will hold the chairmanships of the committees, giving them power to set the agenda, and Schumer will be granted the title of majority leader since Vice President-elect Kamala Harris will cast tiebreaking votes on the floor.

The Senate ultimately must approve these rules.

The FEHBlog noticed today that on January 13, 2021, the President signed into law the bill (H.R. 1418), now Pub. Law No. 116-327, that exposes health and dental insurers to federal antitrust liability.

On the COVID-19 front, NBC News discusses the new COVID-19 mutations that have cropped up in our country.

Dr. Dan Jones, vice chair of the division of molecular pathology at Ohio State University Wexner Medical Center, told NBC News that vaccination is key to both stop the spread of variants, as well as reduce the odds of new variants emerging.

“The larger your pool of [susceptible] patients, the more possibility for a mutation to survive and emerge,” he said. “It has to pass from person to person, so if you’re not getting a lot of infection in the population [because of vaccination], then even an important mutation may just peter out, because the person who was infected doesn’t transmit the virus to anyone else.”

Even “having an optimally fit, pathogenic change in the virus doesn’t do any good if it keeps meeting a wall of vaccinated people,” Jones added.

Well put, Dr. Jones.

Saturday Stats and More

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 52nd weeks of this year (beginning April 2 and ending December 30; 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 30):

The CDC’s COVID-19 Vaccine tracker has not been updated since last Wednesday morning At that time roughly 2.8 million initial doses had been administered. The American Hospital Association and the American Medical Association have posted helpful information about the currently available COVID-19 vaccines. The Food and Drug Administration offers a comprehensive year end report.

The CDC’s FluView continues to report that “Seasonal influenza activity in the United States remains lower than usual for this time of year.”

The FEHBlog took a look at a couple of the hospital chain websites and could not find the price information required by the HHS hospital price transparency rule. However, FEP Blue, the largest FEHB plan, announced the availability of their FEP Cost Advisor Tool.

Today is the last day of the 116th Congress. The Wall Street Journal informs us that among the provisions in the Consolidated Appropriations Act, 2021, is the following

Flexible spending accounts. Many workers with FSAs that allow them to use pretax dollars to pay for unreimbursed health expenses (like glasses) or dependent-care expenses (like summer camp) didn’t use all the money in their 2020 accounts because of the pandemic. The IRS had limited ability to ease FSA rules, but Congress has now done so. 

Participants in such plans can carry over unused funds from 2020 to 2021 and 2021 to 2022, or for up to 12 months for companies with fiscal years. For dependent-care accounts, the law extends the age limit from 12 to 13 for some carried-over funds. For workers to take advantage of these changes, company plans must often opt into the new rules.

OPM typically does adopt such changes for FSAFeds.

Federal News Network reports that yesterday the Senate joined the House of Representatives in overriding the President’s veto of the FY 2021 National Defense Authorization Act. The Senate did not join the House in approving a $2000 direct stipend COVID relief proposal.

Federal News Network also reports that

With hours to spare before the new year, President Donald Trump signed an executive order Thursday night implementing a federal pay raise for civilian employees and military members in 2021. Civilian employees will receive a 1% across-the-board federal pay raise in 2021. There are no additional locality pay adjustments this year.

Midweek update

Photo by Manasvita S on Unsplash

Per the Office of Personnel Management, “The effective date of the Open Season change is the first day of the first full pay period in January. For annuitants this date will always be January 1.” It turns out that Sunday January 3, 2021, is the first day of the first full pay period in January 2021. How convenient.

The Consolidated Appropriations Act, 2021, does include the three standard FEHBP appropriations provisions — a prohibition on applying full Cost Accounting Standards coverage to FEHB contracts (Sec. 611), an abortion coverage restriction (Secs. 613, 614), and a limited contraceptive coverage mandate (Sec. 726) which the Affordable Care Act has overridden. What’s more this new law extends the option of FEHBP and FEGLI coverage to 120 tribal grant schools thereby filling a coverage gap erroneously created by the Affordable Care Act. This option is exercised by the tribal employers who must make the minimum federal civil servant government contribution toward the benefit coverage.

For the past 20 years or so, the FEHBP has offered plan members transitional care protection pursuant to President Clinton’s Bill of Consumer Rights which states in pertinent part as follows:

Consumers who are undergoing a course of treatment for a chronic or disabling condition (or who are in the second or third trimester of a pregnancy) at the time they involuntarily change health plans or at a time when a provider is terminated by a plan for other than cause should be able to continue seeing their current specialty providers for up to 90 days (or through completion of postpartum care) to allow for transition of care.

FEHB plan carriers intending to terminate a network provider for cause generally could comply with this requirement by giving affected members 90 days advance notice of the change.

It turns out that Section 113 Division BB of the Consolidated Appropriations Act, 2021, includes an Affordable Care Act amendment ensuring continuity of care. The requirements of this new law bear similarities to the FEHBP’s transitional care protections. However, as always, the devil is in the details. For example, the new law’s transitional care provisions apply to any provider contract termination, including passive non-renewals, whether triggered by the provider or the payer, with the limited exception of payer termination for fraud or failure to meet applicable quality standards. FEHB plans and OPM have a year to sort out the details before the new requirements take effect on January 1, 2022.

In other news —

The Senate moved forward today on overriding President’s veto of the FY 2021 National Defense Authorization Act but not on the $2000 COVID-19 relief direct stipend per the Wall Street Journal:

Moving through the procedural steps for overriding Mr. Trump’s veto of the National Defense Authorization Act could take up much of the Senate’s time before Sunday. Sen. Bernie Sanders (I., Vt.), in a push for a stand-alone vote on increasing the size of the direct checks, has stopped Mr. McConnell from fast-tracking votes on the NDAA override. As a result, the final vote on the NDAA may not take place until Saturday due to a series of procedural steps.

The Senate took one of those steps late Wednesday, voting 80-12 to move forward with the bill, in another show of broad, bipartisan support for the legislation Mr. Trump vetoed.

Bleeping Computer updated us on how the federal government is addressing the SolarWinds backdoor hack.

The Cybersecurity and Infrastructure Security Agency (CISA) has ordered all US federal agencies to update the SolarWinds Orion platform to the latest version by the end of business hours on December 31, 2020. CISA’s Supplemental Guidance to Emergency Directive 21-01 demands this from all agencies using Orion versions unaffected in the SolarWinds supply chain attack.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion today affirming a district court holding that the Trump Administration’s hospital price transparency rule is lawful. The rule takes effect on Friday January 1. Needless to say the Court also denied the appellant American Hospital Association’s motion for an emergency stay of the rule.

On a similar note, one of the transparency provisions included in the Consolidated Appropriations Act, 2021, amendments to the Affordable Care Act (Section 114 of Division BB) states:

‘‘A group health plan or a health insurance issuer offering group or individual health insurance coverage shall offer price comparison guidance by telephone and make available on the Internet website of the plan or issuer a price comparison tool that (to the extent practicable) allows an individual enrolled under such plan or coverage, with respect to such plan year, such geographic region, and participating providers with respect to such plan or coverage, to compare the amount of cost-sharing that the individual would be responsible for paying under such plan or coverage with respect to the furnishing of a specific item or service by any such provider.’’’

This new requirement, which applies to FEHB plans, takes effect with the first plan year beginning on or after January 1, 2022. The recently finalized Trump Administration’s payer transparency rule kicks in a year later. We will have to see how the Biden Administration handle this.

As the FEHBlog just picked up a couple of delicious Christmas cookies, it is time to consider the joint HHS and Department of Agriculture Dietary Guidelines for Americans 2020-2025 released today. The announcement described the publication as “the nation’s trusted resource for evidence-based nutrition guidance. The guidelines are designed for use by healthcare professionals and policy makers for outreach to the general public and provide the nutritional foundation for federal nutrition programs. The dietary guidelines should not be considered clinical guidelines for the treatment of disease.” The announcement notes that

Steeped in scientific evidence, the key recommendations look similar to those of the past and address two topics that garnered much attention throughout the development of the guidelines – added sugars and alcoholic beverages. Dietary Guidelines for Americans, 2020-2025 carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law. As in previous editions, limited intake of these two food components is encouraged. In fact, this sentiment remains prominent throughout the policy document and complements 

For consumers, USDA’s MyPlate translates and packages these principles of dietary guidance for Americans in a way that is handy and accessible. To share these messages broadly, USDA offers the Start Simple with MyPlate campaign and a new MyPlate websiteto help individuals, families, and communities make healthy food choices that are easy, accessible, and affordable, in addition to helping prevent chronic disease. For more information, please visit www.myplate.gov.

Funny, the FEHBlog no longer sees Christmas cookies on his plate.

P.S. The Senate did not vote on the stipend increase or the NDAA veto today per the Wall Street Journal. This session of Congress ends on Saturday.

Monday Roundup

Photo by Sven Read on Unsplash

Today, the House of Representatives voted 322-87 to override the President’s veto of the Fiscal Year 2021 National Defense Authorization Act. Govexec notes that “The NDAA contains several provisions for federal employees, such as making technical corrections to the paid parental leave policy from last year’s bill and waiving the normal annual cap for unused leave from year to year.” The Senate is expected to complete the veto action in a vote tomorrow. This would be the first time that Congress has overridden one of President Trump’s vetoes.

The House of Representatives also voted in favor of a “clean bill” to amend the latest COVID-19 relief law (H.R. 133) by increasing the direct stipend from $600 to $2000 per person. That bill now goes to the Senate.

The FEHBlog noted earlier this month that the American Hospital Association had asked Congress not to disrupt payer / provider network contracting in the COVID-19 relief bill. Of course, the surprise billing restrictions may encourage in-network providers to make the jump to out-of-network status particularly if the surprise billing arbitration decisions favor the providers. Time will tell on that one, but the following ACA amendment in H.R. 133 reminded the FEHBlog of the AHA’s warning.

Division BB, SEC. 108. IMPLEMENTING PROTECTIONS AGAINST PROVIDER DISCRIMINATION.

Not later than January 1, 2022, the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury shall issue a proposed rule implementing the protections of section 2706(a) of the Public Health Service Act (42 U.S.C. 300gg-5(a)). The Secretaries shall accept and consider public comments on any proposed rule issued pursuant to this subsection for a period of 60 days after the date of such issuance. Not later than 6 months after the date of the conclusion of the comment period, the Secretaries shall issue a final rule implementing the protections of section 2706(a) of the Public Health Service Act

Congress has set the fuse on another one of the Affordable Care Act’s time bombs directed at provider networks. Section 2706(a) reads as follows:

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

The Obama Administration on April 29, 2013, issued the following ACA FAQ on this law:

Q2:  Will the Departments be issuing regulations addressing PHS Act section 2706(a) prior to its effective date?

No.  The statutory language of PHS Act section 2706(a) is self-implementing and the Departments do not expect to issue regulations in the near future.  PHS Act section 2706(a) is applicable to non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage for plan years (in the individual market, policy years) beginning on or after January 1, 2014. 

Until any further guidance is issued, group health plans and health insurance issuers offering group or individual coverage are expected to implement the requirements of PHS Act section 2706(a) using a good faith, reasonable interpretation of the law.  For this purpose, to the extent an item or service is a covered benefit under the plan or coverage, and consistent with reasonable medical management techniques specified under the plan with respect to the frequency, method, treatment or setting for an item or service, a plan or issuer shall not discriminate based on a provider’s license or certification, to the extent the provider is acting within the scope of the provider’s license or certification under applicable state law.  This provision does not require plans or issuers to accept all types of providers into a network.  This provision also does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.

The Departments will work together with employers, plans, issuers, states, providers, and other stakeholders to help them come into compliance with the provider nondiscrimination provision and will work with families and individuals to help them understand the law and benefit from it as intended. 

The FEHBlog recalls that ancillary providers such as chiropractors were particularly exercised by, and insurers were relieved by, the Administration’s statement that “This provision does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.” While the statute does not expressly mention consideration of “market standards and considerations,” such a fine point has not stopped federal agencies from elaborating on statutory standards in the past. The FEHBlog expects that this mandated rule making will be a tug of war over statutory interpretation that will wind up in the courts If the providers win this tug of war and the surprise billing arbitrations, then healthcare spending will resume its upward curve.

And there’s more to follow tomorrow. If you want to find the text of H.R. 133 visit this Congress.gov website and download the PDF of the enrolled bill. The ACA amendments may be found in Division BB. You can search for Division BB using the Adobe Acrobat find tool.

Weekend update

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

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.

Tuesday Tidbits

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

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

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.