Monday Roundup

David Ermer

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

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.”

Midweek Update

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

This morning the Senate Homeland Security and Governmental Affairs Committee favorably reported the nomination of Craig E. Leen to be Inspector General, Office of Personnel Management “en bloc by voice vote.” The Committee also favorably reported the nomination of Russel Vought to be Director, Office of Management and Budget by a 7-4 roll call vote. Next step for these nominations — the Senate floor for confirmation votes presumably later this month.

Stat News reported on another COVID-19 treatment candidate. A Boston MA company Constant Therapeutics currently manufactures an enzyme therapy that may help COVID-19 patients. The article concludes

Constant’s task ahead is the blocking and tackling of running a clinical trial, something he believes the company is well-prepared for. “I’d love to say that a year from now there’s no need for this drug because we’re all immune, but that’s not going to happen,” [Constant’s CEO] said. “I think we can provide an enormous benefit to people and to the health care system if this drug works. And my gut says that it’s going to.”

These ongoing efforts to give doctors treatments for COVID-19 is our best bet along with public health efforts to bridge the gap to an effective vaccine, in the FEHBlog’s view.

The Wall Street Journal informs us that

In the Covid-19 pandemic, people with obesity are at higher risk for severe illness and death—adding new urgency to efforts to rethink the way doctors treat what has long been a public-health problem.

Instead of focusing only on diet and exercise, medical experts say, health-care providers need to shift to a multipronged strategy that includes new prescription weight-loss medications, behavioral therapy and possibly surgery. And to ensure the best results, they argue, this new approach should be overseen by clinicians specially trained in treating obesity. * * * The fast-emerging specialty of obesity medicine aims to close the education gap.

This is encouraging news. The Journal also reports about a study authored by

Lindsey Woodworth, an assistant professor in economics at the University of South Carolina. [Her study] first showed that when a new emergency room opens, crowding at nearby facilities instantly falls an average of 10%.

She then compared mortality rates at the older emergency departments before and after the change. She found that a 10% drop in patient volume leads to a 24% reduction in mortality rates in the first 30 days and a 17% reduction over six months.

Why can’t lower cost urgent care centers have the same effect?

Tuesday Tidbits

David Ermer–U.S. Healthcare–

Healthcare spending tidbits:

  • Fierce Healthcare reports on an AHIP sponsored study estimating COVID-19 spending by health plans through next year. The projected range is dramatic which illustrates that while we may be seeing the light at the end of the tunnel, we are still in the tunnel.
  • Beckers Hospital Review informs us “Emergency department volume fell 49 percent between January and April, with facilities in urban areas seeing the largest drop, according to an analysis from the Emergency Department Benchmarking Alliance.” Let’s hope that patient habits of addressing urgent care changed too.
  • Of the three spending tidbits the FEHBlog’s favorite is this Health Payer Intelligence article an about out of network spending study. “While overall out-of-network or potential surprise billing is slightly declining, out-of-network healthcare spending is on the rise for laboratory tests and hospitalists—particularly in pathology, a recent Health Affairs study found.” The article reminded me that before the great hunkering down Congress was expected to address surprise billing by the end of May. It’s now early June. Whoops.

In other tidbits —

  • Fierce Healthcare reports on a change of leadership at the American Medical Association. “Susan Bailey, M.D., the new president of the American Medical Association (AMA), called for physicians to advocate at the highest levels of government and insurance companies for support needed ‘to sustain private practice during a pandemic that threatens its very survival.'” Good luck Dr. Bailey.
  • Govexec.com discusses the pace of federal government office reopenings. The FEHBlog was more taken with this Wall Street Journal article on how larger employers are applying technology to reopen their offices safely.

Monday Roundup

David Ermer–ACA, Congress, Uncategorized–

It turns out the Senate Homeland Security and Governmental Affairs Committee will be considering the President’s nomination of Craig Leen to be OPM Inspector General at its June 10 business meeting which begins at 10 am ET. The FEHBlog expect him to receive Senate confirmation later this month.

On Friday June 5 the Centers for Medicare and Medicaid Services summarized all of the COVID-19 mandates applied and flexibilities offers to non-federal governmental health plans. It’s nevertheless a useful summary for FEHB plans too.

Today the Internal Revenue Service released the PCORI fee around for plan years beginning not earlier than October 1, 2019 or later than September 30, 2020. In other words this notice applies to the current FEHB contract / plan year which aligns with the calendar year. The amount is $2.54 per belly button up nine cents from last year. The payment deadline is July 31.

Finally, Health Payer Intelligence posted a hopeful story about cooperation between the State of Washington and a community health plan in a successful effort to improve the social determinants of health data available to the plan.

Organizations may find it overwhelming to tackle every social determinant of health at once, especially when they see how expansive the social services network can be. So [Jennifer] Polello], MHPA, PCMH-CCE, director of clinical data integration and social determinants of health at Community Health Plan of Washington] recommended beginning with one social determinant of health, maybe the most prevalent.

“Create workflows and workflow aids and education around just one social issue to start the ball rolling,” she said.

Regardless of the strategy employed, building this network of community resources to address social determinants of health is important now more than ever.

Well put.

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.

Friday Stats and More

David Ermer–Congress, COVID-19–

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 and deaths have taken a downward path

Week ending5/155/225/296/5
New Cases297,581159,546148,210142,829
New Deaths8956816075616353

The basic infection mortality rate (as calculated by the FEHBlog) continues to drop since its peak on May 15.

The Miami Herald features a fascinating article on disease super spreaders — both people and events.

“It’s not just that superspreading events are happening with SARS-CoV-2; they appear to be driving much of the pandemic,” The University of Hong Kong epidemiologists Dillon Adam and Benjamin Cowling wrote in the New York Times.

“This fact is alarming and reassuring at the same time … because it suggests a virus swift and efficient, and so seemingly unstoppable,” and “it also suggests a way to stop SARS-CoV-2 that is both less onerous and more effective than many of the strategies that have been pursued so far.”

”Forget about maintaining … sweeping measures designed to stem the virus’s spread in all forms. Just focus on stopping the superspreading,” the epidemiologists proposed in the newspaper.

In other words, restricting large gatherings could lower transmission rates, but in the U.S., it hasn’t been that easy.

It’s probably not easy anywhere, but it needs to be done in the FEHBlog’s humble opinion.

The International Foundation of Employee Benefit Plans offers a very thoughtful article on steps that health plans should take this year and next in response to the great hunkering down. For example, health plans should

  • Communicate the safety measures that have been put in place at hospitals and clinics. The Centers for Disease Control and Prevention have issued safety guidelines, including limiting visitors and screening patients and employees for the virus.
  • Communicate the importance of seeking urgent and preventive care. “We really want to encourage people to go and seek care that is needed when it is needed,” Baker said. “If we can just share the importance of preventive care from a high-level standpoint, without getting into the employees’ personal business, that may be something really beneficial in order to help manage plan costs,” she said.
  • Tweak wellness programs. Some employees may not have been able to qualify for wellness program incentives, so employers may want to change the guidelines to allow them to qualify.
  • Steps that plans take now could flatten the cost curve for the 2020 plan year. “Just a simple communication may be beneficial as things reopen,” [Dana] Baker [from the Mayo Clinic] said.

In closing, the Wall Street Journal reports that today’s surprisingly strong May employment report “boosted hopes that the economy has moved beyond the worst fallout from the pandemic and may recover more quickly than expected.” Also the President today signed the Payroll Protection Program flexibility act into law today. Here’s a summary of the new law.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Medicare–

Today the Centers for Medicare and Medicaid Services posted COVID-19 statistics from 88% of U.S. licensed nursing homes on its nursing home compare website. “These [nursing home] facilities reported over 95,000 confirmed COVID-19 cases and almost 32,000 deaths.” That is an extremely high case fatality rate and indeed the nursing home deaths represent roughly 30% of the total COVID-19 deaths in our country.

This statistic demonstrates the importance of not allowing people, particularly at risk people, to be placed in super spreader situations. The FEHBlog recalls from reading the Great Influenza book that the Spanish flu simply swept through crowded Army barracks and troopships in the fall of 1917 and 2018. The Wall Street Journal reports this evening that

The coronavirus pandemic dealt a crushing blow to nursing homes across the U.S., driving down their occupancy by nearly 100,000 residents between the end of 2019 and late May, according to new federal data. * * * The sharp decline in nursing home occupancy—about 10% of the nursing home population as of Dec. 31—reflects many factors including virus-related deaths, deaths from other causes and a steep drop in new admissions.

The silver lining in this particular COVID-19 cloud may be that the occupancy drop will allow the facilities to better socially distance the patients.

Healthcare Dive discusses how the complications associated with accepting federal grant money is discouraging “some” healthcare providers from accepting the grant money created by the CARES Act.

Of the five experts Healthcare Dive consulted, four said they had some provider clients opting to return the funds due to either a fear or unwillingness to accept the terms and conditions or worries over potential risks that come with accepting the money. “The lack of certainty has been a big pain point,” Mara McDermott, vice president of McDermott + Consulting told Healthcare Dive.

Perhaps a chunk of these opt-out provider pivoted to the Payroll Protection Program or one of the other general CARES Act offerings to small businesses.

Reuters reports that the Trump Administration “

has selected five companies, including Moderna Inc, AstraZeneca Plc and Pfizer Inc, as the most likely candidates to produce a vaccine for the novel coronavirus, the New York Times reported on Wednesday, citing senior officials. The other companies are Johnson & Johnson and Merck & Co Inc, according to the paper here The selected companies will get access to additional government funds, help in running clinical trials, and financial and logistical support, the paper reported.

The official White House announcement is expected later this month. The Wall Street Journal adds that

The U.S. government has reached a $1.2 billion deal with AstraZeneca to secure the supply of a potential coronavirus vaccine that could be ready as early as October. The government will bankroll a 30,000-person vaccine trial in the U.S. starting in the summer, plus the ramp-up of manufacturing capacity to make at least 300 million doses.