The FEHBlog

Monday Roundup

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

On the COVID-19 front

  • Researchers continue to make progress in developing a convalescent plasma treatment for COVID-19. Specifically, “Mayo Clinic researchers and collaborators have found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 hospitalized patients transfused with investigational convalescent plasma as part of the U.S. Food and Drug Administration’s national Expanded Access Program (EAP) for COVID-19.” Testing continues on the efficacy of the treatment.
  • In view of the FEHBlog’s concern about super spreader events, he also calls attention to this Society for Human Resource Management article on thermal scanners. The scanners are an early warning device for use at “airports, sporting events, concerts or food-processing plants.” The particular article discusses the use of these devices by large and medium sized business.

For a change of pace, the FEHBlog takes note of these Wall Street Journal reports from the cybersecurity front

The health-care sector reported far less [cybersecurity] vulnerability than other areas. Health care is sometimes seen as one of the most targeted sectors. Yet, while 63% of construction and infrastructure companies admitted cybersecurity breaches on one or more occasions in the past 12 months, only 17% of health-care organizations said they had been compromised.

“We think the reduction is due to a combination of factors, including improvements in the cybersecurity posture of health-care organizations,” says Dave Wong, vice president with cyber-incident response provider Mandiant, a division of FireEye Inc., “but the behavior of attackers had also changed.”

In 2017, health care was the third-most-targeted sector, according to Mandiant’s annual threat report. By 2019, security improvements and evolution of the attackers’ tactics led to the sector dropping to eighth place. Cybercriminals follow the money, Mr. Wong says, and when fewer ransoms were being paid, they shifted their focus elsewhere. “Ransomware operators previously targeted hospitals knowing that the operational disruption could potentially cost patients’ lives,” he says. “Now, the same ransomware operators target larger companies with deeper pockets.”

  • and a list of five books “recommended by cybersecurity experts” that are accessible to all readers, just in time for the summer reading season. The FEHBlog plans to put at least one on his Kindle.

Weekend Update

David Ermer–CDC, Congress, COVID-19, Employee Wellness Programs, OPM, SCOTUS–

Happy Fathers’ Day.

The House and Senate are holding committee hearings and floor votes this week. On Tuesday the Senate Health Education Labor and Pensions Committee will hold a hearing on applying lessons learned from the current COVID-19 emergency to prepare for the next pandemic emergency.

Speaking of the current pandemic:

  • The FEHBlog was wondering about whether there has been an uptick in COVID-19 related hospitalizations to accompany the uptick in COVID-19 cases over this month. The FEHBlog was delighted to find this handy CDC website on COVID-19 related hospitalizations which shows that new hospitalizations have continued to trend down this month.
  • On Friday, OPM released guidance on the relationship paid leave / other time off and COVID-19 work by Federal employees. According to the guidance, OPM plans to issue “regulations [that ] will deem the COVID-19 national emergency to be an exigency of the public business for the purpose of restoring forfeited annual leave. The regulations [among other things] will provide that employees who would forfeit annual leave in excess of the maximum annual leave allowable carryover because of their essential work during the national emergency will have their excess annual leave deemed to have been scheduled in advance and subject to leave restoration.”

The U.S. Supreme Court has 15 decisions left to issue before its summer break. The Court is expected to issue some of those decisions tomorrow at 10 am. The Court is continuing to hold its Thursday conferences so all of 15 of the decisions may not be ready for issuance.

Georgetown Law Professor Katie Keith provided a welcome Health Affairs blog analysis of a complicated topic — federal regulation of employee wellness programs. The key complicating factor is that there are so many different applicable federal laws in play.

Friday Stats and More

David Ermer–COVID-19, Mental health care–

Happy Juneteenth!

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, over the past five weeks the numbers of new cases had taken a downward path for the first three weeks and then turned up for the past two weeks. New deaths have seen consistent weekly reductions over the same time span.

Week endingNew CasesNew Deaths
May 22159,4968,160
May 29148,2107,561
June 5142,8296,553
June 12155,3715,850
June 19161,2894,865

The FEHBlog had been wondering when the current COVID-19 emergency period expires. The American Hospital Association informs us that the expiration date is July 25. The AHA is seeking an extension.

In other news —

  • The Labor Department’s Employee Benefits Security Administration released “a proposed Self-Compliance Tool intended to help improve compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA) and additional related requirements under the Employee Retirement Income Security Act of 1974 (ERISA). The tool [which was last updated in 2018[ will enable group health plans, plan sponsors, plan administrators, health insurance issuers and other parties determine whether a group health plan or a health insurance issuer complies with the provisions in both laws. EBSA is requesting public comments on the MHPAEA’s Self-Compliance Tool proposed revisions by July 24, 2020
  • The Labor Department’s Occupational Safety and Health Administration released non-essential business re-opening guidance.

Thursday Miscellany

David Ermer–COVID-19, Electronic health records, Rx coverage–

The Centers for Disease Control updated their guidance on how COVID-19 spreads earlier this week. Here’s the main takeaways from the FEHBlog’s standpoint:

COVID-19 is thought to spread mainly through close contact from person-to-person. * * * Some people without symptoms may be able to spread the virus. The virus that causes COVID-19 is spreading very easily and sustainably between people. Information from the ongoing COVID-19 pandemic suggests that this virus is spreading more efficiently than influenza, but not as efficiently as measles, which is highly contagious. In general, the more closely a person interacts with others and the longer that interaction, the higher the risk of COVID-19 spread.

Check it out.

Healthcare Dive reports

The Trump administration on Wednesday proposed changes to how drugmakers can report their prices to Medicaid, seeking to make it easier for pharmaceutical companies and insurers to enter into contracts that tie payment to patient outcomes. Typically, drug contracts are linked to the volume of product sold, providing for larger manufacturer rebates the more a product is prescribed and covered by an insurer. Increasingly, however, drugmakers and insurers have been exploring alternative approaches centered on some measure of a medicine’s value.

Why is this relevant to the FEHBP? “The Medicaid best price policy requires drug manufacturers to give Medicaid programs the best price among nearly all purchasers [Medicare Part D is excepted].” So for example, if a prescription drug manufacturer cuts a deal for value based drug pricing, the VBD pricing cannot drop below the Medicaid price. If the manufacturer can cut the same deal with Medicaid under this proposed rule, then everyone benefits. This is a proposed rule that won’t go into effect until later this year at best.

Fierce Healthcare reports that

Health Care Service Corp., which owns and operates Blue Cross plans in five states, has tapped Epic to develop a data exchange platform between health plans and providers. HCSC health plans will be able to exchange medical information with health providers in its networks that use Epic’s electronic health record (EHR) software. The contract is one of the first of its kind between Epic and a large insurer, according to the companies.

Given the importance of clinical data in government and large employer healthcare quality programs imposed on health plans, including OPM’s Plan Performance Assessment, this certainly won’t be the last such deal.

Midweek update

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

On the COVID front —

  • Forbes reports on a new Centers for Disease Control analysis confirming that the disease has hit racial minority and ethnic groups, the elderly, and people with multiple chronic conditions harder than others. Also “Incidence was highest among people 80 and older (902 cases per 100,000), while it was lowest among children 9 and younger (51), but surprisingly people between the ages of 40 to 59 saw higher incidence (between 541 and 550) than people between 60 and 79 (478 and 464).”
  • The Department of Health and Human Services has posted a fact sheet on its Operation Warp Speed which “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).”
  • The FEHBlog also ran across the Food and Drug Administration’s COVID-19 resources website. Check it out.

The Senate Health Education Labor and Pensions Committee held a telehealth hearing today. Healthcare IT news reports on the hearing. “HELP Committee Chairman Sen. Lamar Alexander, R-Tenn., advocated for two particular policy changes to be made permanent: the originating site rule, allowing physicians to be reimbursed for telehealth appointments wherever a patient is located, including a patient’s home, and the expansion of Medicare- and Medicaid-reimbursable telehealth services.” Also Health Payer Intelligence identifies three telehealth challenges for payers one of which is on Sen. Alexander’s short list: “Discerning how to provide coverage for many different sites of care and for various types of telehealth technologies as well as complying with state and federal regulatory barriers can put a damper on the telehealth boom.”

Fierce Healthcare reports that two Northeastern Blue Cross licenses Highmark and HealthNow have announced a merger. “[upper New York State’s]”HealthNow will bring nearly 1 million additional members into the [central Pennsylvania based] Highmark fold and boasted $2.8 billion in revenue for 2019. It will join the fourth largest Blues organization in the country, building on Highmark’s 5.6 million members and $18 billion in operating revenue for 2019.” The affiliation agreement is subject to regulatory approval.

Tuesday Tidbits

David Ermer–COVID-19, Medicare, SCOTUS–

On the COVID-19 front —

  • The Wall Street Journal reports about the importance of exercising common sense during the COVID-19 emergency:

Six months into the coronavirus crisis, there’s a growing consensus about a central question: How do people become infected?

It’s not common to contract Covid-19 from a contaminated surface, scientists say. And fleeting encounters with people outdoors are unlikely to spread the coronavirus.

Instead, the major culprit is close-up, person-to-person interactions for extended periods. Crowded events, poorly ventilated areas and places where people are talking loudly—or singing, in one famous case—maximize the risk.

  • The Boston Globe reports about a new treatment:

Researchers in England say they have the first evidence that a drug can improve COVID-19 survival: A cheap, widely available steroid called dexamethasone reduced deaths by up to one third in severely ill hospitalized patients.

Results were announced Tuesday and researchers said they would publish them soon. The study is a large, strict test that randomly assigned 2,104 patients to get the drug and compared them with 4,321 patients getting only usual care.

The drug was given either orally or through an IV. After 28 days, it had reduced deaths by 35% in patients who needed treatment with breathing machines and by 20% in those only needing supplemental oxygen. It did not appear to help less ill patients.

  • The Harvard Business Review offers an interesting article concerning the ongoing role of employers and employer sponsored healthcare in addressing the COVID-19 emergency.

In other news

  • The Congressional Budget Office made a presentation on how its factors preventive care savings into federal budget calculations. This could be helpful for health plan actuaries and underwriters.
  • Georgetown University Law Professor Katie Keith discusses the impact of yesterday’s Supreme Court opinion on the Department of Health and Human Service’s revised Section 1557 rule. By the way that rule will be published in the Friday June 19 Federal Register which means that it is currently scheduled to take effect on August 18, 2020. The FEHBlog expects HHS to pull back the final rule for re-evaluation in view of the Supreme Court opinion.
  • Today, the U.S. Court of Appeals for the D.C. Circuit upheld a district court decision striking down a Centers for Medicare and Medicare Services rule that would have required prescription drug manufacturers to disclose the average manufacturer price for their drugs in related television advertisements. The Court held that “the Disclosure Rule’s blunderbuss operation falls beyond any reasonable exercise of the Secretary’s statutorily assigned power.” If you find administrative law interesting, you should read the opinion.

Monday Roundup

David Ermer–ACA, OPM, SCOTUS, Telehealth–

Health Payer Intelligence reports that “Major payers and payer organizations objected to the finalized HHS nondiscrimination rule—Affordable Care Act Section 1557—saying that the rule eliminates much of the specific language in the original rule, particularly relating to gender and sexual discrimination.” In that regard, this morning, per the Wall Street Journal, “The Supreme Court ruled that bedrock federal civil-rights law [Title VII of the Civil Rights Act of 1964] prohibits employers from discriminating against workers on the basis of their sexual orientation or gender identity, a decision that for the first time extends federal workplace protections to LGBT employees nationwide.”

The FEHBlog expects that this ground breaking Supreme Court decision will cause the Department of Health and Human Services to reconsider last Friday’s revised final Section 1557 rule either on its own initiative or upon a federal court order. That rule does not take effect until late August 2020.

In other news

  • The International Foundation of Employee Benefit Plans reports that the Centers for Medicare and Medicaid Services has created flexibilities to allow insurers to advance 2019 medical loss ratio rebates to individual policyholders. The 2019 medical loss ratio report normally would be due on June 30, 2020.
  • The American Hospital Association evaluates whether legislation or regulations can be used to extend various current telehealth flexibilities beyond the end of the COVID-19 emergency.
  • Govexec.com informs us that “Officials at the federal government’s 401(k)-style retirement savings program announced Monday that the Thrift Savings Plan has implemented provisions of the CARES Act coronavirus response package making it easier for participants impacted by the pandemic to access money in their accounts.” Here’s a link to this announcement.

Weekend Update

David Ermer–Congress, SCOTUS, Telehealth, U.S. Healthcare–

Happy Flag Day.

Both Houses of Congress will be conducting committee and floor business this week. The House had added floor voting days for Thursday and Friday next week as well as all of the following week (except for next Friday which is the work holiday associated with the Fourth of July.)

The Senate Health Eduction Labor and Pensions Committee is holding a committee hearing of relevance to the FEHBP — Telehealth: Lessons from the COVID-19 Pandemic — on June 17 at 10 am.

The Supreme Court has nineteen more opinions to release before its summer break. This week the Court is releasing opinions tomorrow and Thursday, both days at 10 am ET.

Here are a couple of non-COVID-19 research items that caught the FEHBlog’s attention over the weekend:

  • Precision Vaccinations reports that “With a surprisingly simple approach in which cancer cells are first grown, ruptured and converted into nanoparticles, and then used as a vaccine, Vanderbilt University researchers say they have developed what appears to be a promising treatment for breast cancer metastasis. Metastasis is the last stage of cancer, responsible for about 90 percent of cancer-related deaths.
  • The Wall Street Journal reports that

Scientists may be just a few years away from delivering new treatments for age-related macular degeneration (AMD), the leading cause of irreversible vision loss in people more than 50 years old.

Over the past 15 years there has been only one class of successful AMD drugs, known as anti-VEGF agents, and they have worked for a minority of AMD sufferers. Now researchers are having success fighting AMD from new directions. They include an immune-system inhibitor and stem-cell therapy, which show promise for treating the dry form of AMD in its advanced stage, for which there is currently no treatment approved by the U.S. Food and Drug Administration.

“I’m cautiously optimistic that we will have markedly improved treatments for both wet and dry AMD within two to three years,” says Joshua Dunaief, professor of ophthalmology at the Scheie Eye Institute at the University of Pennsylvania.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, OPM–

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, over the past four weeks the numbers of new cases had taken a downward path until this week. New deaths have seen consistent weekly reductions.

Week Ending5/225/296/56/12
New Cases155,596148,210142,829153,371
New Deaths8,1607,5616,5635,850

The Wall Street Journal report discussed in yesterday’s FEHBlog post suggested that we would see an uptick in new cases this week. Today, the Centers for Disease Control released COVID-19 considerations for events and gatherings as we emerge from the great hunkering down.

Today, the Department of Health and Human Services announced its revised final rule on Section 1557 of the Affordable Care Act which concerns individual non-discrimination. Here’s a link to the Department’s fact sheet. The 2016 final rule imposed extensive and expensive non-discrimination notice requirements on insured FEHB plans. The revised final rule scales down those requirements dramatically. What’s more the preamble to the revised final rule (p. 53) states

The Department continues to take the position that FEHB plans are not covered under this rule. Even if FEHB plans were considered “contracts of insurance,” as suggested by some commenters, they still would not fall under the scope of this rule because the contract would be with the Office of Personnel Management (OPM),which operates the FEHB Program, not with the Department. As noted above, this final rule does not extend the Department’s enforcement authority to a covered entity that is not principally engaged in the business of providing healthcare to the extent of its operations that do not receive financial assistance from the Department. The Department agrees that this final rule will accomplish the Department’s goal of reducing regulatory burden.

Being excepted from the HHS Section 1557 enforcement rule does mean that insured FEHB plans would not be subject to an HHS non-discrimination notice requirements. That status does not necessarily lead to the conclusion that FEHB plans are exempt from the statute. In any event, the revised final rule takes effect 60 days from publication in the Federal Register and you can expect federal court litigation over the revised final rule which likely would be reversed if we get a new President in 2021.

In other news —

  • Healthcare Dive reports on a recent study concluding that the air ambulance billing process is dysfunctional and produces big surprise bills. The article suggests that a federal surprise billing law is not in the offing but no one expect the counter productive ACA taxes to be repealed last year. Keep the faith.
  • Govexec.com reports on a GAO study finding that 60% of new hires left federal employment within only two years following hire during the years 2011-2017. Holy guacamole.
  • The Wall Street Journal reports that U.S. blood banks are “critically low.” “Covid-19 shutdowns have emptied community centers, universities, places of worship and other venues where blood drives typically occur.” Here’s a link to the American Red Cross blood donation site. This is a site worth promoting.

Thursday Miscellany

David Ermer–CDC, COVID-19, Mental health care–

Regrettably, the Wall Street Journal reported today a spike in COVID-19 cases in States, like Texas, Utah, Arizona, and Arkansas, that were not hard hit early on in the COVID-19 emergency.

Experts analyzing states with worrisome trends in serious cases are largely pointing to the onset of summer, when people began to congregate in resort spots. [FEHBlog note: Super-speader events are risky.]

Some also suspect that officials who allowed businesses to reopen after a relatively calm few weeks might have sent an inadvertent message that the problem had largely passed.

As if responding to the suspicious “some,” the Centers for Disease Control has released a social media toolkit to spread COVID-19 related advice on Facebook, Instagram, Twitter etc.

It’s worth noting that the Wall Street Journal editorial page’s observation that “More infections are inevitable as states reopen, and there will be much trial and error. States need to be vigilant for outbreaks and protect high-risk areas and the vulnerable. But the costs of shutting down the economy are so great, in damage to lives and livelihoods, that there is no alternative to opening for the broader public good.”

In other news —

A new study published in the Journal of the American Medical Association found that one-fifth of patients who read ambulatory care notes reported finding a mistake in those notes, and 40% of those regarded the error as serious.

“Among patient-reported very serious errors, the most common characterizations were mistakes in diagnoses, medical history, medications, physical examination, test results, notes on the wrong patient, and sidedness,” the study authors explained.

That’s worrisome for patient healthcare as well as for other doctors and health plans who rely on these reports.

  • Health Payer Intelligence offers a thought provoking article on four data points that illustrate mental health parity. The rub is that “Mental and behavioral healthcare parity is about more than just equal reimbursement with similar medical and surgical services. It includes ensuring access to care by having enough providers in-network and making sure that the right types of specialists are available for members.”