Tuesday Tidbits

SCOTUS

Tuesday Tidbits

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

Happy 100th anniversary of American women’s suffrage to all. It seems to the FEHBlog that the British women’s suffrage movement overshadows the American women’s suffrage movement in history. (Perhaps the FEHBlog watch too much English television). The FEHBlog was favorably struck by the fact that American women got the same right to vote as men about ten years before British women did.

The FEHBlog discovered today that the OPM Inspector General has posted his semi-annual report to Congress for the period ended March 31, 2020, and OPM has posted its management response thereto. The first page of the Inspector General’s report following the cover is particularly flashy.

The Department of Health and Human Services released today its Health People 2030 report which “features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health.” Check it out.

In a related action, the Wall Street Journal reports that the federal government is in the midst of crafting its five year plan for American diets. The alcohol committee is proposing that men meet the same daily consumption standard set for women — one alcoholic beverage per individual. This reminds the FEHBlog of another action that happened a century ago but only lasted a thirteen years — prohibition. The Department of Agriculture will finalize the five year diet plan later this year.

On the prescription drug front —

  • Medscape offers a description of the 35 prescription drugs that the Food and Drug Administration has approved so far in 2020.
  • Drug Channels to the FEHBlog’s surprise informs us that “nine out of ten large hospitals now operate a specialty pharmacy. Hospitals and other healthcare providers account for one-third of all U.S. accredited specialty pharmacies. Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth. The enormous profit opportunities from the 340B Drug Pricing Program offer further encouragement for hospitals. In-house specialty pharmacies are also a valuable hedge against the potential loss of contract pharmacies.”

Speaking of hospitals, Beckers Hospital Review reports that the Centers for Medicare and Medicaid Services announced yesterday that “Hospitals will get a [20%] payment boost on Sept. 1 for caring for Medicare beneficiaries diagnosed with COVID-19. A positive COVID-19 laboratory test must be documented in the patient’s medical record for the hospital to receive the higher payment.”

Finally, on the Postal Service front, the Federal News Network reports that “Postmaster General Louis DeJoy says the Postal Service will hold off on ‘longstanding operational initiatives’ to reduce costs until after this November’s election.” The Wall Street Journal adds that

The House plans to vote Saturday on a bill that would give $25 billion in additional funding to the agency, which is what the Postal Service requested to meet budget shortfalls and costs related to the coronavirus pandemic. The bill would also prohibit the agency from implementing any changes to operations or service levels it had in place on Jan.1 until the end of the Covid-19 emergency or Jan. 1, 2021, whichever comes later.

Senate Republicans are preparing a pared-down coronavirus aid package that would include $10 billion for the Postal Service as well as money for the unemployed and for testing and combating the coronavirus.

The Postmaster General will appear before the Senate Homeland Security and Governmental Affairs Committee on Friday August 21 at 9 am and the House Oversight and Reform Committee on Monday August 24 at 10 am.

Tuesday Tidbits

David Ermer–ACA, COVID-19 vaccine, SCOTUS–

Good news! STAT News reports that “Moderna’s Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.” The FEHBlog will take it. What’s more, “The [Moderna] data roughly mirror the results from a similar vaccine being produced by Pfizer and BioNTech, which were released July 1.” Fingers remain crossed.

Healthcare Dive informs us about a FairHealth analysis which concludes that 

The median charge for hospitalized COVID-19 patients aged 23-30 was about $35,000, while those aged 51-60 had median charges of about $46,000.
The most common other illness found in those patients is chronic kidney disease or kidney failure. Nationally, those patients accounted for 13% of all hospitalized COVID-19 patients during the study period from January to May. The second most common comorbidity in all but one region is Type 2 diabetes, according to the study that looked at private healthcare claims. The exception, the South, had hypertension in that rank.
The report also found the most common venue for an initial COVID-19 diagnosis nationally was a traditional doctor's office. About 33% of COVID-19 patients sought help from an office, while 23% went to an inpatient facility, such as an emergency room. In the Northeast, about 7% of COVID-19 diagnoses in that region came via telehealth appointments, versus 6.2% from ER visits.

The Health Affairs Blog provides details on how the COVID-19 virus impacts people differently when viewed from a racial or ethnic perspective. These disparities deserve the attention of the healthcare industry.

We used data from the Medical Expenditure Panel Survey to explore potential explanations for racial-ethnic disparities in coronavirus disease 2019 (COVID-19) hospitalizations and mortality. Black adults in every age group were more likely than whites to have health risks associated with severe COVID-19 illness. However, whites were older on average than blacks. Thus, when all factors were considered, whites tended to be at higher overall risk compared to blacks, with Asians and Hispanics having much lower overall levels of risk compared to either whites or blacks. We explored additional explanations for COVID-19 disparities, namely differences in job characteristics and how they interact with household composition. Blacks at high risk of severe illness were 1.6 times as likely as whites to live in households containing health-sector workers. Among Hispanic adults at high risk of severe illness, 64.5 percent lived in households with at least one worker who was unable to work at home, versus 56.5 percent among blacks and only 46.6 percent among whites.

FYI, HealthIT.gov reports that at the request of Congress the federal government “is investigating strategies to improve patient identity and matching. Stakeholder input and insight into existing challenges and promising innovations in patient identity and matching will inform [Office of the National Coordinator of Health Information’s] ONC’s report to Congress on technical and operational methods that improve patient identity and matching. We invite all stakeholders to submit comments to identity.onc@hhs.gov by September 18, 2020.”

Supreme Court journalist Amy Howe reports that the U.S. Supreme Court has announced its oral argument calendar for October 2020. The calendar does not include the ACA constitutionality case, Texas v. California. The FEHBlog is willing to bet the ranch that the Supreme Court will uphold the ACA’s constitutionality (although it may remove the individual mandate from the statute which is what Congress intended when it zeroed out the individual mandate penalty).

In other litigation news, the FEHBlog discovered today that on August 3, 2020, at 2 pm, the U.S. District Court for the District of Columbia will hear oral argument on the Whitman-Walker Clinic’s motion to preliminarily enjoin enforcement of the recent HHS revised ACA Section 1557 rule. Section 1557 is the ACA’s individual non-discrimination provision. The FEHBlog is keeping an eye on this case.

Regrettably , Federal News Network reports that OPM has decided not to award any Presidential Rank award this year due to the disruptions created by the COVID0-19 emergency. The FEHBlog was honored ten years ago to participate in judging these awards. The FEHBlog was and remains very impressed by the work of the federal employees wh0 are nominated for these awards. Hopefully the awards which also were suspended for 2013 will return next year.

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19 vaccine, Federal employment benefits, OPM, SCOTUS–

The Supreme Court wrapped up its October 2019 term today. Because it relates to the Affordable Care Act, the FEHBlog calls attention to the ever reliable and prodigious Katie Keith’s Health Affair’s blog post about yesterday’s Little Sisters of the Poor v. Pennsylvania decision. As Ms. Keith explains, this decision “was the third time in six years that the Supreme Court has ruled on the scope of the contraceptive mandate. This post recounts the history of the litigation, summarizes the decision, and discusses the impact of the ruling.” This decision has no impact on the FEHBP coverage of contraceptives. Enjoy your time off, Justices.

Also on the ACA front, Fierce Healthcare reports that

The Affordable Care Act’s insurance exchanges could add more than 1 million new members because of the COVID-19 pandemic.

The analysis released Thursday by Avalere attributes the spike to special enrollment due to massive job losses caused by COVID-19. The boost in customers could cause more insurers to return to a market they have left after financial losses over the past few years.

“With unemployment rates at or near 10% in almost all states, many consumers have been separated from their previous employer-sponsored plans,” the analysis said. “The economics of Medicaid eligibility in many states and the recent boost to unemployment assistance indicate that many are turning to the exchanges for coverage.”

On the COVID-19 vaccine development front,

At Fortune Brainstorm Health this week, there was lots of talk about the 200-plus efforts to find a COVID vaccine, and the extraordinary collaboration among companies and governments to get vaccines tested, manufactured and distributed—far faster than ever before. “We are taking what normally takes five to seven years, and doing it in five to seven months,” said Johnson & Johnson CEO Alex Gorsky. But Gorsky—whose company is one of the leaders in the vaccine race—also issued a strong warning to the group not to think of a vaccine as a silver bullet.

However, an effective vaccine certainly would be better than a poke in the eye with a sharp stick. Must everyone feel the need to dampen expectations?

  • In the same vein, Fierce Pharma discusses an internal CDC debate over what would be an effective COVID-19 vaccine.

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.

That’s a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

  • It’s worth noting that the smallpox eradication effort began in the 1790s and that pharma is on course for more than one vaccine concoction for COVID-19 which should lead to broader efficacy, right?

On the OPM front,

  • Federal News Network informs us OPM will be proposing to anoint greater Des Moine, IA as the latest metropolitan area in which federal employees will receive locality pay. Congrats Hawkeyes. “OPM will also propose an expansion of the existing Los Angeles/Long Beach, California, locality pay area to include Imperial County, California.” The changes if (when?) finalized would be effective January 1, 2021, and
  • Fedweek reports on a recent OPM Inspector General report on OPM’s federal employee retirement services. The Inspector General compliments OPM for its process improvements.

Weekend update

David Ermer–Congress, COVID-19 vaccine, SCOTUS–

The House of Representatives is engaged in Committee work this week. The Senate is on a State work period for the next two weeks. Meanwhile, according to Fierce Healthcare,

a collection of unions, business groups and policy institutes wrote to congressional leaders Wednesday asking for a provision on surprise medical bills to be included in the next coronavirus stimulus package. “We urge you to end surprise medical billing for all patients through the implementation of fair, market-based payments for out-of-network charges,” the letter said. The American Benefits Council, the AFL-CIO, the Business Group on Health and the American Health Policy Institute were among the groups that signed on to the letter.

That resolution is also the FEHBlog’s preference while provider groups often call for arbitration of some sort.

The U.S. Supreme Court has eight more cases to decide before its summer break. All of these cases were argued virtually in May 2020, and include one PPACA case involving the scope of the contraception mandate. Tomorrow is another decision day. This will be the first time in 24 years that the Supreme Court has released decisions in July. The most famous Supreme Court decision issued in July in the FEHBlog’s memory was the U.S. v. Nixon case decided July 24, 1974, which lead to the President’s resignation early the following month.

The Wall Street Journal brings us up to date on the state of COVID-19 vaccine development. Several candidates are headed into large scale final/phase 3 testing this month.

The U.S. federal government is planning to fund three 30,000-person trials starting this summer: Moderna Inc.’s vaccine starting this month, followed in August by a vaccine co-developed by University of Oxford and AstraZeneca PLC, and in September, a vaccine developed by Johnson & Johnson. Oxford’s vaccine recently began late-stage testing outside the U.S.

The scale is so large it means trials are effectively competing with each other for recruits. “One volunteer cannot be in two different studies. It’s a zero-sum game in that regard,” said Dr. Joseph Kim, chief executive of Inovio Pharmaceuticals Inc., which last week announced positive results in a small study and is preparing for a larger study. PRA Health Sciences Inc., which helps recruit trial patients, is mining busy Covid-19 testing locations, including public-health departments, testing labs and pharmacies, to find healthy volunteers, said Kent Thoelke, PRA’s chief scientific officer.

Fingers remain crossed.

On Friday, the FEHBlog suggested that readers check out last Monday’s Econtalk interview about healthcare reform. The discussion of Iora Health. Iora Health is a multi-state group practice which holds a Medicare Advantage plan contract and is looking to expand to employer groups. Their model is centered on the use of health coaches.

Weekend Update

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

The House and Senate will be conducting legislative and committee business this week preceding the Fourth of July holiday. Of note, on Tuesday at 10 am the Senate Health Education Labor and Pensions Committee will hold a hearing on ways to return to work and school safely following the great hunkering down.

The Supreme Court has thirteen more opinions to release before its summer break. The Court is expected to release opinions on Monday, Tuesday, and Wednesday this week, all at 10 am.

On the COVID-19 front —

  • Fierce Healthcare discusses how the Walgreen’s Pharmacy chain has leveraged its partnership with Microsoft and other technology companies to better respond to the COVID-19 emergency.
  • A few weeks ago, the Journal podcast offered a fascinating show on the Hertz bankruptcy. It’s worth a 17 minute long listen. The story highlights how a strong balance sheet helps companies weather storms like the COVID-19 emergency. Becker’s Hospital Review identifies 14 well known health systems in this favorable situation, including Kaiser Permanente. It’s not an exclusive list.
  • Healthcare Dive reports on the significant adverse financial impact that the COVID-19 emergency has had on primary care practices in the U.S. Surprisingly that article does not note that these practices have been eligible for Payroll Protection loans and federal grants. The government deserves credit for trying to soften the blow to this critical sector of our health care system. Tuesday June 30 is the deadline for applying for a PPP loan.

On the human nature front, the Wall Street Journal reports that COVID-19 first responders have been relaxing by playing a boardgame called Pandemic.

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.

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.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, Telehealth–

The Senate is engaged in legislative and committee business this week. Last week the Senate passed by unanimous consent a bill (S. 279) to amend the FEHB and FEGLI Acts for the purpose of extending coverage to employees of Indian tribal grant schools. This bill would close a gap created by the Affordable Care Act which generally extended coverage under these programs to Indian tribal employees. There are 128 tribal grant schools in the U.S.

The House of Representatives is engaged in committee business this week. That body is next scheduled to hold votes over the period June 30 through July 2.

The Supreme Court continues this week to release the remaining opinions from its October 2019 term. The Hill includes an article discussing the seven opinions that are expected to be politically controversial.

In other news Fierce Healthcare reports

  • “A top Department of Health and Human Services (HHS) official acknowledged [last week] that telehealth is here to stay after an explosion of use due to COVID-19 but hedged on whether new regulatory flexibility on reimbursement is going to stick around.” The permanent flexibility depends largely on Congress and state regulators, and
  • “OptumRx researchers are highlighting three more drug products that payers should be keeping an eye on in 2020″ — Roche’s Risdiplam, NS Pharma’s Viltolarsen, and Immunomedic’s Trodelvy.