Tuesday Tidbits

Tuesday Tidbits

Following up on last Friday’s and Sunday’s posts on the President’s executive orders on drug pricing, here for greater perspective is a link to a Fierce Healthcare article offering the positions of the health insurance and PBM industry trade associations’ positions on the orders. Essential Hospitals lets us know that the text of the fourth international pricing index executive order has not yet been made public.

The Wall Street Journal reports that “Eastman Kodak Co. has won a $765 million government loan under the Defense Production Act, the first of its kind. The purpose: to help expedite domestic production of drugs that can treat a variety of medical conditions and loosen the U.S. reliance on foreign sources. * * * Kodak’s loan has terms similar to a commercial loan and must be repaid over 25 years, [Kodak CEO Jim] Continenza said. He said Kodak will produce “starter materials” and “active pharmaceutical ingredients” used to produce generic medicines. “We have a long, long history in chemical and advanced materials—well over 100 years,” Mr. Continenza said. He added that Kodak’s existing infrastructure allows the company “to get up and running quickly.”

On the COVID-19 front —

  • Federal News Network informs us that

About 4,000 federal employees have filed workers’ compensation claims with the Labor Department due to COVID-19. 60 people have filed death claims. Labor projects COVID-19 claims among federal employees may reach 6,000 in the coming weeks. The department’s inspector general says the division that handles federal employee claims is anticipating a strain in resources due to demand and social distancing mandates. It has alternative staffing plans if COVID-19 compensation claims continue to surge. Labor says it’s accepted over 1,600 federal employees claims so far. Over 2,300 are unadjudicated.

  • The Society for Human Resource Management brings us up to date on the Senate majority’s new $1 trillion COVID-19 relief bill, the HEALS Act.
  • The Center for Medicare and Medicaid Services released “an early snapshot of the impact of the coronavirus disease 2019 (COVID-19) pandemic on the Medicare population. The data shows that older Americans and those with chronic health conditions are at the highest risk for COVID-19 and confirms long-understood disparities in health outcomes for racial and ethnic minority groups and among low-income populations.” A large cadre of the Medicare population of course is also enrolled in the FEHBP so this data is worth a gander.
  • The National Institutes of Health announced the successful results of a double blind study of the Moderna / NIAID COVID-19 vaccine on non-human primates / rhesus macaques. As noted yesterday that vaccine entered phase 3 human trials this week.

In other news —

  • Becker’s Hospital Review identifies the highest ranking hospital in each State as found in U.S. News and World Report.
  • NPR discusses two new studies suggesting that the risk of Alzheimer’s disease can be reduced by taking flu and pneumonia vaccines.
  • HHS’s Office for Civil Rights (“OCR”) which enforces the HIPAA Privacy and Security Rules announced that “Lifespan Health System Affiliated Covered Entity, a non-profit health system based in Rhode Island, has agreed to pay $1,040,000 to the OCR and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to the theft of an unencrypted laptop [thereby evidently allowing access to protected health information on over 20,000 patients in 2017].

Midweek Update

A House of Representatives appropriations subcommittee approved by voice vote today the bill funding financial services and general government for the 2021 fiscal year. That bill encompasses OPM and the FEHBP. Yesterday’s FEHBlog post discussed the relevant substance of the bill considered today. The bill now moves onto full appropriations committee consideration.

Fierce Healthcare reports that “Healthcare leaders and health IT groups are calling on Congress to repeal a section of the law that prevents the U.S. Department of Health and Human Services (HHS) from working with the private sector to develop a nationwide patient identification strategy.” The advocates are pointing to the COVID-19 emergency as another reason for taking this sensible action. ” Amid the COVID-19 pandemic, contact tracing efforts are hampered without accurate demographic information that correctly identifies the right patient.”

Also, on the COVID-19 front, the National Institutes of Health (“NIH”) announced today that “The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.”

The Wall Street Journal reports that

Drugmaker Emergent Biosolutions Inc. plans to work with Mount Sinai Health System in New York City to test whether a drug derived from the blood plasma of recovered Covid-19 patients can prevent infections in doctors, nurses and military forces. The proposed study, which the partners announced Wednesday, would add to efforts evaluating the coronavirus-fighting potential of experimental drugs made from plasma donated by recovered patients. If the drug proves to work safely, it could help protect health-care workers and other people working in essential jobs who are at high risk of infection until a vaccine is ready and perhaps even after.

On the general U.S. healthcare front Healthcare Dive reports that

Walgreens on Wednesday announced plans to open up to 700 primary care clinics across the country over the next five years in partnership with medical services provider VillageMD, and “hundreds more” after that. As part of the agreement, Walgreens will invest $1 billion in equity and convertible debt in Chicago-based VillageMD over the next three years, including a $250 million equity investment Wednesday. VillageMD will use 80% of the funds to pay for opening the clinics, called Village Medical at Walgreens, and integrate digitally with Walgreens.

and that

Walmart will now sell health insurance policies directly to its customers, a spokesperson told Healthcare Dive, confirming speculation sparked by job postings from the retailer for Medicare sales managers and insurance agents, first reported by the Arkansas Democrat Gazette. Analysts with SVB Leerlink said the move underscores the attractiveness of this market and the likelihood of increased competition over time, while Walmart’s reach across U.S. consumers — including seniors — has the potential to drive up volume for Medicare plans.

What’s more, Health Payer Intelligence discusses why some health plans seek out seriously ill members to wit “By developing a greater understanding of seriously ill populations, payers and policymakers can more accurately target their population health management strategies.”

And a Forbes columnist criticizes government telehealth parity mandates. The column provides an interesting perspective on the telehealth craze. As the FEHBlog’s late grandmother frequently advised “moderation in all things.”

Last but not least, FedWeek explores the OPM Federal Employees Benefits Survey to understand why some federal employees don’t enroll in our beloved FEHBP.

the survey found that of those not enrolled [roughly 19% of the surveyed population], 90 percent are obtaining health care through some other program, most commonly through a spouse’s employment and most commonly through the military TRICARE program. “Less than one percent of respondents said that they are not enrolled in FEHB and do not have health insurance because they do not think there is a need,” OPM said.

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.

Monday Roundup

The FEHBlog has explained that OPM scores FEHB plans principally on certain HEDIS and CAHPS scores measured against where other health plans (generally not just FEHB plans) score. NCQA which manages HEDIS and CAHPS for health plan scoring purposes, released last Wednesday two years of specifications for HEDIS measures (the 2020 and 2021 measurement year “specs.”).

The happy result of this NCQA action is that beginning next year FEHB and other health plans subject to HEDIS will know the rules of the road five months before the measurement year begins rather than six months into the measurement year which has the the case right through this 2020 measurement year. Bravo NCQA.

Meanwhile Health Payer Intelligence reports on an America’s Health Insurance Plans commissioned study finding that “Nearly three-quarters of NCQA HEDIS quality measures will experience a negative impact from the coronavirus pandemic.” Marvelous. The article also suggests some ways that health plans can boost their HEDIS scores in these hard times.

Speaking of these hard times, three major healthcare provider associations (the American Hospital Association, the American Medical Associations, and the American Nurses Association) issued a letter today encouraging the public “to take the simple steps we know will help stop the spread of the virus: wearing a face mask, maintaining physical distancing, and washing hands.” That’s good advice for health plans to spread around too.

RevCycle Intelligence informs that the American Hospital Association and its fellow hospital groups are urging the Department of Health and Human Services to delay the January 1, 2021, effective date for the Administration’s hospital pricing transparency rule at least until the case challenging the rule works it way through the court system. At this point a federal district court has upheld the rule and the American Hospital Association has appealed that decision to the U.S. Court of Appeals for the D.C. Circuit. The article adds that

No response from CMS was available as of July 2. However, lawmakers are looking to make the price transparency rule law. Introduced by Senator Chuck Grassley (R-IA) on June 30th, the PRICE Transparency Act seeks to codify the hospital price transparency rule and a similar rule requiring payers to publicly share cost-sharing and in- and out-of-network provider rates.

In other 2021 news, the Centers for Medicare and Medicaid Services issued a proposed rule for pricing Medicare end stage renal disease coverage next year. “CMS is proposing that certain new and innovative equipment and supplies used for dialysis treatment of patients with ESRD in the home would qualify for an additional Medicare payment. These proposed changes would encourage the development of certain new and innovative home dialysis machines that would give beneficiaries more dialysis treatment options in the home that can improve their quality of life.”

Tuesday Tidbits

At today’s House Energy and Commerce Committee hearing on the COVID-19 emergency, Dr. Fauci, according to the Wall Street Journal, remarked that “he is ‘cautiously optimistic’ that a successful vaccine could be produced around the end of 2020. ‘I believe it will be when and not if,’ he said.” Amen to that. Here’s a link to today’s Senate Health Education Labor and Pension Committee’s hearing on the same topic.

The Labor Department’s Employee Benefit Security Administration issued a wide-ranging set of frequently asked questions on the health plan related provisions of the Families First Coronavirus Response Act and the CARES Act. Check it out.

Reuters reports on a sobering CMS study of the COVID-19 emergency on Medicare beneficiaries. ““The disparities in the data reflect longstanding challenges facing minority communities and low income older adults,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS).”

MedCity News informs us that “Clinical development will soon begin for an inhaled version of a [Gilead] antiviral drug {remdesivir} used to treat Covid-19 that is currently available only to hospitalized patients in intravenous form.” That’s a pro move.

Drug Channels offers its annual study of 2019 PBM drug spending reports.

The PBMs’ data highlight key trends about drug spending:
— For 2019, CVS and Express Scripts reported overall changes in drug spending that were in the low single digits. Prime reported mid-single-digit growth in overall drug spending.
— Spending growth on traditional drugs declined by mid-single digits for the third consecutive year. This decline came from deeper commercial rebates on brand-name drugs, ongoing deflation in generic drugs, and a small increase in the generic dispensing rates.
— The results for CVS and Express Scripts were comparable. For CVS Caremark’s commercial clients, net drug prices for traditional drugs declined by -6.3%, while utilization grew by 1.5%. For Express Scripts’ commercial clients, net drug prices for traditional drugs declined by -6.4%, while utilization grew by 1.4%.

In legal news

  • It was no surprise to learn from Politico that LGBTQ advocates already have brought a lawsuit against the Department of Health and Human Services (“HHS”) “over its rollback of LGBTQ patient protections, arguing that last week’s Supreme Court decision extending workplace legal protections to gay and transgender employees invalidates the new rules.” That should be a rollover win for the plaintiffs.
  • It was a pleasant surprise to learn that the U.S. District Court for the District of Columbia today ruled in favor of an HHS rule requiring hospital to disclose real prices, e.g, negotiated prices with health plans, for their services just like retail stores. The FEHBlog expects that this rule will lead to more and better (e.g., quality based) competition among hospitals. But first the decision will need to be affirmed by the Court of Appeals.

Tuesday Tidbits

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.

Thursday Miscellany

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.

Thursday Miscellany

Earlier this month, the National Center for Health Statistics released a report on 2019 births in our country. Here are some notable snippets from that report:

  • The provisional number of births for the United States in 2019 was 3,745,540, down 1% from the number in 2018 (3,791,712). This is the fifth year that the number of births has declined after the increase in 2014, down an average of 1% per year, and the lowest number of births since 1985.
  • The birth rate for teenagers in 2019 was 16.6 births per 1,000 females aged 15–19, down 5% from 2018 (17.4), reaching another record low for this age group. The rate has declined by 60% since 2007 (41.5), the most recent period of continued decline, and 73% since 1991, the most recent peak.
  • The low-risk cesarean delivery rate, or cesarean delivery among nulliparous (first birth), term (37 or more completed weeks based on the obstetric estimate), singleton (one fetus), vertex (head-first) births, also decreased to 25.6% of births in 2019 from 25.9% in 2018.
  • The percentage of infants born preterm (births at less than 37 completed weeks of gestation) fell 8% from 2007 (the most recent year for which national data are available based on the obstetric estimate of gestation) to 2014, but has risen 7% from 2014 (9.57%) to 2019.

Healthcare Dive reports that

The number of Medicare beneficiaries using telehealth skyrocketed in the early weeks of the pandemic as the Trump administration relaxed regulations to virtual care.

The looser regulations are only in place for the extent of the national public health emergency, but myriad groups have called on HHS to permanently relax the barriers. Top administration health officials have said they’re exploring the possibility.

Here’s hoping.

Health IT Security informs us about Verizon’s latest data breach investigations report.

For healthcare, there were 798 security incidents and 521 confirmed data breaches in 2019, compared to 304 incidents in the previous year. While miscellaneous insider errors, privilege misuse, and web applications were the leading causes 2018 healthcare data breaches, external threats outpaced insiders in this year’s report.

In fact, 51 percent of healthcare data breaches were caused by external actors, and insider-related breaches fell to 48 percent. Despite the slight increase in external-related breaches, healthcare does remain the leading industry for internal bad actors.

It’s not always a good thing to be in first place.

Let’s wrap it up with a story about responsible corporate citizenship. Becker’s Hospital CFO Report informs us that

CMS automatically sent out the first slice of federal funding under the Coronavirus Aid, Relief and Economic Security Act based on historical Medicare fee-for-service reimbursement. Now, several companies are returning the relief aid.

[Healthcare companies] Cigna, CVS Health, DaVita, Encompass and Walmart are among the companies sending back federal grants they received under the CARES Act, which are meant to reimburse healthcare providers for expenses or lost revenues tied to the COVID-19 pandemic, according to Business Insider. The companies are returning a total of nearly $574 million.

The common reason for returning these large amounts of money was aptly stated by CVS Health:

“We have made the decision to return the funds and forgo participation in subsequent disbursements,” CVS Health President and CEO Larry Merlo wrote in a May 19 letter to HHS Secretary Alex Azar. “In doing so, we hope to help HHS provide additional support to other providers who are facing significant financial challenges as a result of the pandemic.”

Bravo.

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.

Friday Stats and More

The CDC’s COVID-19 cases in the U.S. website, which the FEHBlog tracks, added age demographic information this week. The basic infection mortality rate stabilized then dropped slightly then stabilized again over the past two weeks. That has to be good news. The CDC’s weekly COVIDview supports the FEHBlog’s layman analysis.

MedPage Today offers an interesting story about the downswing of the illness from the perspective of New York City clinicians who have been on the front line.

The Centers for Medicare and Medicaid Services finalized today a subset of proposed Medicare Advantage and Part D changes that the agency proposed earlier this year. CMS is releasing the final rule in two installments so that Medicare Advantage and Part D plans are not overwhelmed. That’s considerate.

OPM released additional COVID-19 guidance for federal agencies today. The guidance concerns the Families First Coronavirus Response Act’s paid leave program for employees affected by COVID-19.