Monday Roundup

Monday Roundup

The Wall Street Journal reports that

Two of the most advanced experimental coronavirus vaccines entered the pivotal phase of their studies on Monday, with the first subjects receiving doses of vaccines developed by Moderna Inc. and Pfizer Inc.

Researchers evaluating the vaccines plan to enroll 30,000 people in separate last-stage, or phase 3 trials, results of which will determine whether the vaccines protect against symptomatic Covid-19, and whether they should be cleared for widespread use.

Let’s go.

Also on the vaccine front, Healio informs us that the “Influenza vaccination was significantly associated with reduced risks for all-cause death, cardiovascular death, and death from acute myocardial infarction or stroke among adults with diabetes, according to an analysis of registry data.”

The FEHBlog recommends that you listen to, or read the transcript of, this week’s Econtalk podcast in which the host economist Russ Roberts discussed the COVID-19 emergency with Nissam Nicholas Taleb, who is a noted author on the topic of probability. Enlightening.

The American Hospital Association reminds us the July is Minority Mental Health Awareness month by offering a website full of resources. The FEHBlog attended an NCQA Digital Quality Summit breakout session track on racial and ethnic disparities in healthcare last week. Some of the health plan participants spoke up about the difficulty of identifying the racial and ethnic characteristics of their members. That is an important prerequisite to conducting investigations that will lead to solutions. It occurred to the FEHBlog that racial and ethnic characteristics could be added to the ICD-10 code set which would allow coders to spread this information via healthcare claims.

MedPage Today offers a variety of telehealth updates such as the following:

A program that integrated a dedicated team of 24/7 telemedicine clinicians with automated text message check-ins was able to monitor COVID-19 patients at home and quickly support those whose symptoms grew worse, a case study in NEJM Catalyst showed.

Outcomes from the first 3,000 patients invited to participate in the University of Pennsylvania Health System COVID Watch program showed that 83% of confirmed or suspected COVID-19 patients were managed by the automated program; only 17% escalated to needing clinical care, reported Anna Morgan, MD, MSc, of the Perelman School of Medicine at the University of Pennsylvania, and colleagues.

Finally, the Society for Human Resource Management summarizes recent U.S. Labor Department workplace guidance on COVID-19 issues.

Midweek update

There have been many ups and downs during the COVID-19 emergency. The one effort consistently making sure but steady progress is the COVID-19 vaccine development process. In today’s news from Fierce Healthcare

  • “AstraZeneca and the University of Oxford are set to share “positive news” on their COVID-19 vaccine soon, according to a leading U.K. journalist. The update, which could come as soon as tomorrow, may shed light on how the front-runner vaccine fared in early clinical trials.”
  • “Moderna and its partners in the federal government are just now gearing up for a late-stage COVID-19 vaccine trial set to launch later this month, but at the same time, the mRNA biotech is prepping a supply of doses for quick shipment if the shot gets an FDA go-ahead.”

In this regard, the FEHBlog has noted his addiction to the Econtalk podcast. This week the host Stanford economics professor Russ Roberts dropped this pearl of wisdom in the course of his conversation with a gaming company CEO:

It’s taken me a long time, Josh, but I’ve finally figured out that sometimes something that people are really excited about doesn’t happen. Driverless cars. Four years ago I thought , ‘By 2020 they’re going to be here for sure. AI [Artificial Intelligence], ‘Yeah, soon they won’t even–,’ you fill in the blank. A lot of these things turn out to be harder than they were thought to be. And of course, part of the reason for that is that the people who’ve spent the money to take the chances on it have an incentive to overstate the hype. It’s just part of the natural human experience.

And of course there are also the lawyers telling the entrepreneurs to tone it down. Hopefully the COVID-19 vaccine for which we are all excited will be a near term success. Knock on wood.

In telemedicine news —

  • The Health Affairs Blog features a detailed CMS Administrator Seema Verma article on the topic. She concludes “During these unprecedented times, telemedicine has proven to be a lifeline for health care providers and patients. The rapid adoption of telemedicine among providers and patients has shown that telehealth is here to stay. CMS remains committed to ensuring that the government supports innovation in telehealth that leverages modern technology to enhance patient experience, providing more accessible care.”
  • Health Payer Intelligence reports that

As payers lean more heavily on remote care, consumers stressed the need for greater convenience in care delivery and prefer to turn to telehealth and digital solutions, in part, as the answer, according to a recent CVS Health study. CVS Health fielded the survey in March 2020 and garnered 1,000 respondents. It drew particularly from twelve major cities and targeted African American and Hispanic participants. An additional survey covered 400 providers.

What a happy coincidence!

Finally, Healthcare Dive informs us about UnitedHealth Groups’s second quarter 2020 earnings report.

Payer arm UnitedHealthcare, the largest commercial health insurer in the U.S., brought in $49.1 million in revenue, up just 1% year over year. But its medical loss ratio, a marker of how much an insurer spends on patient care, plummeted to 70.2% in the quarter ended June 30, compared to 83.1% same time last year, due to temporary deferral of care amid the pandemic.

The question of course is when will the bounce back occur?

Tuesday Tidbits

Federal News Network reports that

House appropriators are silent on federal [employee] pay for now, increasing the likelihood that a planned 1% raise for civilian employees next year will advance as the president intended.

A draft budget bill for 2021, which the House Appropriations Subcommittee on Financial Services and General Government released Tuesday afternoon, makes no mention of a federal pay raise for General Schedule employees next year.

In their silence, House appropriators are essentially deferring to the proposal President Donald Trump offered earlier this year. In his budget request for 2021, the president recommended a 1% across-the-board federal pay raise for civilian employees next year, with no further locality pay adjustments. Military members are on track to receive a 3% pay raise next year.

The House bill also includes the three standard FEHBP appropriations clauses — a provision prohibiting the application of full Cost Accounting Standards coverage to FEHB plans (Sec. 611), a provision restricting abortion coverage (Sec. 611), and a provision mandating contraception coverage (Sec. 613).

Fortune Magazine discusses CMS Administrator Seema Verma’s comments on data accessibility and telemedicine at a Fortune conference today. Fierce Healthcare adds that “

CMS is eyeing ways to make expanding access to telehealth permanent, though the final word in overhauls to Medicare lies with Congress, Verma said. “It’s not a panacea; it’s not going to solve every problem,” she said. “Not everything is going to be able to be addressed by telehealth. But it’s a very powerful tool for medicine.”

Healthcare Dive provides us with background on the healthcare providers who received Payroll Protection Program loans from the federal government. In the FEHBlog’s book, the PPP is one of the best relief measures that Congress has dreamed up.

On the prescription benefit management front, Fierce Healthcare informs us that

Anthem’s pharmacy benefit manager IngenioRx will acquire ZipDrug, a data-driven pharmacy management company.

The acquisition expands IngenioRx’s offerings to include a platform that directs consumers to pharmacies with high-performing pharmacies and that offers home prescription delivery, the insurer announced (PDF) Monday.

IngenioRx will offer ZipDrug’s services both integrated into its broader PBM platform and as a standalone service, according to the announcement.

and that

Startup pharmacy benefit manager Capital Rx is teaming up with Walmart to bring greater transparency to specialty and mail-order prescriptions.

Capital Rx provides PBM services to employers and health plans through its “clearinghouse” model, in which they provide unit costs for drugs upfront to clients. The model is also designed to prevent “spread pricing,” in which a PBM charges a payer significantly more than a pharmacy’s price for a drug to reap profits.

Midweek update

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.

Monday Roundup

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

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

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.

Midweek update

NBC News reports that Wednesday evening, the Senate passed by unanimous consent a House passed bill to improve the Payment Protection Program that the CARES Act created to help small businesses with liquidity issues created by the great hunkering down.

UPI provides helpful context around the new Medicare program to control Medicare beneficiary out of pocket costs for insulin.

“Among commercially insured patients, high insulin prices do not necessarily translate to high out-of-pocket costs,” study co-author Dr. Amir Meiri, a research fellow with the Harvard Medical School Department of Population Medicine and a practicing internist, told UPI.

For these patients, “insulin out-of-pocket costs are generally lower than expected and declining, except among patients in high-deductible health plans with health savings accounts, who must pay for the full cost of medications — including insulin — until they reach their deductible,” Meiri said.

The time period for the study was 2007-16. Last year, the Internal Revenue Service pursuant to an executive order issued a ruling permitting coverage of insulin before the high deductible.

A friend of the FEHBlog called to his attention this 21st century, FDA approved digital stethoscope that could revolutionize care at home. Fierce Healthcare quotes Cambia Health’s chief medical officer who notes ““Telehealth as always been a benefit,” she said. “I think physicians now know that their patients want to use telehealth.”

Friday Stats and More

According to the CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, the number of COVID-19 deaths topped 100,000 this week. Due to greatly increased testing rate, the number of confirmed COVID-19 cases is now greatly outpacing the number of COVID-19 deaths. For example, over the past week the number of confirmed cases has increased by nearly 150,000 to 1,719,827 while the number of deaths increased by 7,561 to 101,711. The basic infection mortality rate (as calculated by the FEHBlog) has dropped over the past week. That is good news. Also check out Avik Roy’s Forbes column analyzing COVID-19 deaths.

In last Monday’s post, the FEHBlog gently ribbed OPM for not extending the 2021 benefit and rate submission deadline from Sunday May 31 to Monday June 1. To the delight of the FEHBlog and those FEHB carriers bumping up against the May 31 deadline, the FEHBlog learned today that OPM has granted this grace period. Muchos gracias.

Here’s a link to an interesting Healio report on patient deferral of wellness and chronic care visits to their primary care doctors during the great hunkering down. It is easy to register for Healio.

Results of a survey conducted by the Primary Care Collaborative and the Larry A. Green Center showed that 81% of 736 primary care clinicians reported that they have limited their wellness and chronic care visits, and 70% reported that the patients themselves postponed these visits.

The survey also revealed that preventive services are down among primary care practices, with just 5% reporting cancer screenings, 10% reporting adult vaccinations, 12% monitoring cancer survivors, 14% reporting childhood vaccinations and 25% screening for violence and neglect.

On a related note Healthcare Dive reports

  • Virtual care use grew 1.6 times since the summer of 2019, according to the Blue Cross Blue Shield Association’s COVID-19 National Pulse Survey. More than half of that growth has occurred since the onset of the COVID-19 crisis.
  • Generation Z (35%) uses telemedicine the most, with millennials (30%), Gen Xers (21%) and baby boomers (15%) behind them.
  • The pandemic has changed several behaviors, the survey found. Alcohol consumption is up 23%, and smoking, vaping and non-medical drug use rose by 19%, 15% and 13%, respectively.

Finally, Becker’s Hospital Review brings us up to date on a, HL7 / FHIR healthcare data sharing collaborative known as the Gravity Project “that aims to standardize medical data used to identify social determinants of health.” Cool.

Tuesday Tidbits

While the FEHBlog has been discussing the progress of convalescent plasma to treat COVID-19, its time to turn to the Gilead drug remdesivir Fierce Pharma discusses today a recently released peer reviewed study that shows that the drug works well with patients suffering from moderate severity COVID-19.

The 1,063-patient study showed remdesivir’s benefits appear greatest for hospitalized patients in the middle of the disease-severity spectrum. For those who required oxygen supplementation but were not mechanically ventilated, remdesivir cut the time to recovery by 47% compared with placebo. But remdesivir didn’t much help patients with mild or moderate disease, and outcomes for patients on invasive ventilation or extracorporeal membrane oxygenation were nearly the same in both arms of the study.

According to the article, studies are continuing on the efficacy of the drug for patients with mild severity COVID-19.

The Wall Street Journal reports today that physicians are concerned over fact that anti-anxiety and anti-depression prescriptions have spiked during the great hunkering down. “Many physicians have a low threshold for prescribing them. It’s very problematic,” says Bruce J. Schwartz, deputy chair and professor of psychiatry and behavioral sciences at Montefiore Medical Center in New York. “Many people do develop a dependency on these medications.” The article offers alternate approaches, and FEHB plans now usually offer coaching services to help with the problems.

Speaking of healthcare coaching programs, CNBC reports that the great hunkering down has been good for companies that provide coaching or telehealth / digital health programs.

The Centers for Medicare and Medicaid Services announced that their 2021 pilot program to lower insulin costs for Medicare beneficiaries is bearing fruit.

Based on CMS’s estimates, beneficiaries who use insulin and join a plan participating in the model could see average out-of-pocket savings of $446, or 66 percent, for their insulins, funded in part by manufacturers paying an estimated additional $250 million of discounts over the five years of the model. With a robust voluntary response from Part D sponsors, CMS anticipates beneficiaries will have Part D plan options in all 50 states, the District of Columbia, and Puerto Rico, through either a standalone prescription drug plan (PDP) or a Medicare Advantage plan with prescription drug coverage. Beneficiaries will be able to enroll during Medicare open enrollment, which is from October 15, 2020 through December 7, 2020, for Part D coverage that begins on January 1, 2021.

Well done. Hopefully the Medicare approach will be translatable to employer sponsored coverage like the FEHBP.