Thursday Miscellany

COVID-19

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.

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?

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.

Monday Roundup

David Ermer–CDC, COVID-19–

Let’s begin with a story that surprised as well as interested the FEHBlog. The Society for Human Resource Management reports that the U.S. Occupational Health and Safety Administration is requiring health plans, insurers, and other low hazard employers to report to OSHA “work-related coronavirus illnesses that result in a fatality or an employee’s in-patient hospitalization, an amputation or the loss of an eye.” Other employers have broader recording and reporting obligations.

A friend of the FEHBlog called to his attention this Newsweek interview with Dr. Anthony Fauci about whether we may encounter a second wave of COVID-19. While Dr. Fauci expects COVID-19 infections to continue at least through 2020, Dr. “Fauci says whether or not these ongoing new cases will become a wave will depend on whether ‘we prepare ourselves from now through June, July, August and September. We have four months to make sure we have in place the system, the test, the capability, the manpower to do the kind of identification, isolation and contact tracing as cases begin to reappear in the fall, because they will reappear.'”

STATNews also also features an interview with Dr. Fauci which focuses on vaccine development.

Today, prescription drug manufacturer Eli Lilly announced

[hospital] patients have been dosed in the world’s first study of a potential antibody treatment designed to fight COVID-19.

This investigational medicine, referred to as LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2, the virus that causes COVID-19.

The FEHBlog heard a discussion of the investigational new drug on television this morning. The Eli Lilly representative explained that this drug focuses on one antibody while convalescent plasma relies on an array of antibodies. The investigation. The Wall Street Journal explains that

Researchers at AbCellera Biologics Inc., a Canadian company that partnered with Lilly in March, and the U.S. National Institute of Allergy and Infectious Diseases identified an antibody with virus-fighting potential in a blood sample taken from one of the first U.S. patients who recovered from Covid-19.

Lilly’s scientists then essentially cloned the antibody to make the new therapy [which is administered intravenously]. Its goal is to block the virus from attaching to and entering human cells, thus neutralizing it.

This first random study uses hospitalized patients and if successful the next random study will use non-hospitalized patients. “Lilly said it is starting large-scale manufacturing of the therapy, so that if studies prove successful, it will have several hundred thousand doses available by the end of the year.” Let’s go.

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, OPM, Rx coverage, SCOTUS–

The House of Representatives and the Senate both will be in session on Capitol Hill this coming week, Of note from an FEHBP perspective is that Senate Homeland Security and Governmental Affairs Committee has scheduled a confirmation hearing for the President’s nominee for OPM Inspection General, Craig E. Leen, for Tuesday June 2 at 2:30 pm. Mr. Leen currently is Director of the Office of Federal Contract Compliance Programs (OFCCP) at the U.S. Department of Labor. The FEHBlog plans to tune in.

The Supreme Court heads into the home stretch of its October 2019 term tomorrow. The Court has 25 decisions left to issue before adjourning for the summer according to the Scotusblog.

OPM released more COVID-19 guidance last Friday. This guidance concerns preparedness for returning to OPM facilities.

Fierce Healthcare brings us up to date on COVID-19 testing at home options. The latest product receiving FDA approval is offered by Quest Diagnostics a/k/a Quest Labs.

The FEHBlog ran across on Twitter today this May 24 column from Reason senior editor Jacob Sillum.

According to the Centers for Disease Control and Prevention (CDC), the current “best estimate” for the fatality rate among Americans with COVID-19 symptoms is 0.4 percent. The CDC also estimates that 35 percent of people infected by the COVID-19 virus never develop symptoms. Those numbers imply that the virus kills less than 0.3 percent of people infected by it.

The FEHBlog also found this reassuring (at least to the FEHBlog) Science News article on COVID-19 mutations.

[C]oronavirus mutations are guaranteed to pop up over the coming months — and experts will continue to track them. “The data will tell us whether we need to worry, and in what way we need to worry,” [Louise] Moncla[, an evolutionary epidemiologist at the Fred Hutchinson Cancer Research Center in Seattle] says. “Everyone should take a deep breath and realize that this is exactly what we’ve always expected to happen, and we don’t necessarily need to be concerned.”