Thursday Miscellany

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

From the COVID-19 front

  • Fierce Healthcare reports that “The quick rollout of the COVID-19 vaccine in the U.S. saved an estimated 279,000 lives and prevented 1.25 million hospitalizations, a new study finds. The study, released Wednesday, warns, however, that surges of new cases due to the highly transmissible delta variant could reverse these gains. “Until a greater majority of Americans are vaccinated, many more people could still die from this virus,” said Alison Galvani, Ph.D., director of the Yale Center for Infectious Disease Modeling and Analysis, which conducted the study alongside the Commonwealth Fund.”
  • The Wall Street Journal reports that “Children are at extremely slim risk of dying from Covid-19, according to some of the most comprehensive studies to date, which indicate the threat might be even lower than previously thought. Some 99.995% of the 469,982 children in England who were infected during the year examined by researchers survived, one study found. In fact, there were fewer deaths among children due to the virus than initially suspected. Among the 61 child deaths linked to a positive Covid-19 test in England, 25 were actually caused by the illness, the study found.”
  • The Journal also informs us that “Pfizer Inc. will seek clearance from U.S. regulators in coming weeks to distribute a booster shot of its Covid-19 vaccine to heighten protection against infections as new virus strains rise.  The company said also it plans to start clinical trials in August of an updated version of its vaccine that would better protect against the Delta variant.” While the FEHBlog looks forward to lining up for the booster, Axios reports that “People who are fully vaccinated against the coronavirus do not need a booster shot at this time, the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement released Thursday evening.” Axios adds

One dose of the Pfizer-BioNTech or AstraZeneca coronavirus vaccine “barely” protects against the Delta variant of the virus, because of mutations the variant has developed, a new study published in the journal Nature Thursday found. 

But two doses of those vaccines generated a neutralizing response to the variant in 95% of people, highlighting the importance of full vaccination against COVID-19, Axios’ Jacob Knutson writes

  • Bloomberg discusses the idea of offering COVID-19 vaccines at Dollar General stores. “The researchers found that in the most vulnerable decile, the number of retail pharmacies that are eligible to provide vaccines through the Federal Retail Pharmacy Program is the lowest. But these vulnerable regions are also where Dollar General and other discount stores like it tend to cluster.” It’s worth a shot?

The National Institutes of Health released its annual joint report on cancer mortality. “The report shows a decrease in death rates for 11 of the 19 most common cancers among men, and for 14 of the 20 most common cancers among women, over the most recent period (2014-2018). Although declining trends in death rates accelerated for lung cancer and melanoma over this period, previous declining trends for colorectal and female breast cancer death rates slowed and those for prostate cancer leveled off. Death rates increased for a few cancers like brain and other nervous system and pancreas in both sexes, oral cavity and pharynx in males, and liver and uterus in females.” STAT News points out

Accelerating declines in lung cancer deaths may account for much of the overall progress seen in recent years, the authors of the report said. Over the past two decades, the death rate for lung cancer has declined even faster than the rate at which patients are diagnosed with the disease. And while part of the early success in preventing lung cancer can be attributed to the massive drop in smoking rates, the authors note the most recent downward trends seem to correspond with the approval of new treatments for non-small cell lung cancer that improved the likelihood of survival.

Death rates from melanoma also saw an accelerated decline in the past decade, despite a growing number of diagnoses. Like in lung cancer, authors point to the introduction of novel treatments around the same time as the turnaround on the death rate. New targeted and immune checkpoint inhibitors were approved by the Food and Drug Administration in 2011, one year before major declines in death rates were seen in women and two years before they were seen in men.

On the prescription drug front

  • The New York Times reports that “Under fire for approving a questionable drug for all Alzheimer’s patients, the Food and Drug Administration on Thursday greatly narrowed its previous recommendation and is now suggesting that only those with mild memory or thinking problems should receive it. The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million.”
  • GoodRX points out and discusses the fifteen most addictive prescription drugs and resource available to help the addicted. The National Institute on Drug Abuse has an outreach website for teenagers, for example.

In other healthcare news

Health Affairs blog bangs the drum for Congress to fund a universal patient identifier. For the reasons explained in the article, this step called for in the HIPAA statute of 1996 is long overdue.

Healthcare Dive reports that “Telehealth claim lines as a percentage of all medical claims dropped 13% in April, marking the third straight month of declines, according to new data from nonprofit Fair Health. The dip was greater than the drop of 5.1% in March, but not as large as the decrease of almost 16% in February. However, overall utilization remains significantly higher than pre-COVID-19 levels. The decline appears to be driven by a rebound in in-person services, researchers said. Mental health conditions bucked the trend, however, as the percentage of telehealth claim lines associated with mental conditions — the No. 1 telehealth diagnosis — continued to rise nationally and in every U.S. region.” The FEHBlog considers that to be good news because telehealth at least currently is best suited for mental health care and out of schedule healthcare situations.

In closing, the FEHBlog wants to emphasize an important aspect of last Thursday’s No Surprise Billing rule. As explained in the government’s model consumer notice for use by health plans,

When you get services from an in-network hospital or ambulatory surgical center, certain providers there may be out-of-network. In these cases, the most those providers may bill you is your plan’s in-network cost-sharing amount. This applies to emergency medicine, anesthesia, pathology, radiology, laboratory, neonatology, assistant surgeon, hospitalist, or intensivist services. These providers can’t balance bill you and may not ask you to give up your protections not to be balance billed.

If you get other services at these in-network facilities, out-of-network providers can’t balance bill you, unless you give written consent and give up your protections.”

The vast majority of surprise bills stem from out-of-network service provided by emergency rooms, air ambulance, and the types of providers listed above, all of whom are locked into using negotiation and baseball arbitration with the health plan. The only doctors who can approach the patient for a balancing billing waiver are the surgeon or oncologist in a non-emergency setting who meets with the patient well before the surgery. That makes sense.

This approach, however, will promote use of the independent dispute resolution system which the tri-agencies will unveil October 1. Three months is more than ample time for the FEHBlog’s fellow lawyer to prepare for this new business opportunity. Health plans should make sure that their out of network pricing negotiators are adequately staffed.

No Surprises Thursday

Photo by Josh Mills on Unsplash

The federal regulators, including the Office of Personnel Management, achieved their statutory deadline today for issuing the first round of No Surprises Act implementing rules. Here’s the regulators’ output, compliments of the Labor Department:

There is no doubt in the FEHBlog’s mind that the regulators did a fine job of making a silk purse out of sow’s ear / the poorly drafted statute. This rule will help carriers and providers meet the January 1, 2022, launch date. This law, if properly implemented, and signs are looking good now, will protect consumers from surprise medical bills, which was clearly Congress’s objective, but without creating an IT nightmare.

The regulators plan a second round of No Surprises Act rules for October 1, 2021. The second round will focus on the independent dispute resolution process.

From the COVID-19 front —

  • The New York Times reports that “The Johnson & Johnson coronavirus vaccine is effective against the highly contagious Delta variant, even eight months after inoculation, the company reported on Thursday — a finding that should reassure the 11 million Americans who have gotten the shot. The vaccine showed a small drop in potency against the variant, compared with its effectiveness against the original virus, the company said. But the vaccine was more effective against the Delta variant than the Beta variant, first identified in South Africa — the pattern also seen with mRNA vaccines.”
  • Medscape informs us that “The White House on Thursday announced it will send “strike teams” to 1000 counties where the COVID-19 Delta variant is spreading rapidly. The teams will be made up of health and logistics experts from several federal agencies and will conduct coronavirus testing, distribute medicines designed to fight the virus, and boost local and state efforts to increase vaccinations.”

In Thursday Miscellany —

  • GoodRx is tracking prescription drug manufacturer price changes which typically are made effecting January 1 and July 1.
  • The Centers for Medicare and Medicaid Services “is proposing actions that aim to close health equity gaps by providing Medicare patients battling End-Stage Renal Disease (ESRD) with greater access to care, through the ESRD Prospective Payment System (PPS) annual rulemaking. This proposed rule would update ESRD PPS payment rates, make changes to the ESRD Quality Incentive Program (QIP), and modify the ESRD Treatment Choices (ETC) Model.  The proposed changes to the ETC Model policies would aim to encourage dialysis providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model the agency’s first CMS Innovation Center model to directly address health equity.”
  • The Aetna Foundation and U.S. News and World Report released their 2021 healthiest U.S. communities rankings this week.

2021 Healthiest Communities- Top 10

*See the full rankings here

Top 10 Counties

  1. Los Alamos County, New Mexico
  2. Douglas County, Colorado
  3. Falls Church, Virginia
  4. Loudoun County, Virginia
  5. Broomfield County, Colorado
  6. San Miguel County, Colorado
  7. Pitkin County, Colorado
  8. Howard County, Maryland
  9. Morgan County, Utah
  10. Routt County, Colorado

2021 Key Measures

Top 5 Communities for Health Outcomes

  1. San Juan County, Washington
  2. Marin County, California
  3. Carver County, Minnesota
  4. Stevens County, Minnesota
  5. Hunterdon County, New Jersey

Top 5 Communities for Access to Health Care

  1. Olmsted County, Minnesota
  2. Montour County, Pennsylvania
  3. Suffolk County, Massachusetts
  4. Johnson County, Iowa
  5. Perry County, Kentucky

Top 5 Communities for Mental Health

  1. Honolulu County, Hawaii
  2. Pitkin County, Colorado
  3. Fairfax County, Virginia
  4. Santa Clara County, California
  5. San Mateo, California

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

In today’s Morning Rounds email, the American Medical Association informs us that

The New York Times (6/28, Mandavilli) reports a new study published in Nature has found the COVID-19 vaccines from Pfizer-BioNTech and Moderna “set off a persistent immune reaction in the body that may protect against the coronavirus for years, scientists reported on Monday.” Researchers gathered samples from the lymph nodes of 14 recruits at five different points following the first dose, finding “the number of memory cells that recognized the coronavirus had not declined” 15 weeks later. The Times adds, “The results suggest that a vast majority of vaccinated people will be protected over the long term.”

In a separate article, the New York Times (6/28, Mandavilli, Zimmer, Robbins) says the study adds to other research suggesting that “widely used vaccines will continue to protect people against the coronavirus for long periods, possibly for years, and can be adapted to fortify the immune system still further if needed.”

The Federal Times reports that GEHA, the second largest FEHB plan carrier, has launched a COVID-19 vaccination reward program for its members. Here is a link to GEHA’s website on this program.

As of today just about two thirds of Americans over age 18 have had at least one dose of a COVID-19 vaccination. Most importantly, approaching 90% of Americans over age 65, the cadre that suffered the most COVID-19 fatalities, has received at least one dose of the COVID-19 vaccine and 78% of that cadre are fully vaccinated. However, Bloomberg warns that

The gap between the most vaccinated and least vaccinated places in the U.S. has exploded in the past three months, and continues to widen despite efforts to convince more Americans to get a Covid shot. * * * In the least vaccinated group of counties, many of which are in the South and Central regions of the U.S., less than half as many people have gotten at least one Covid vaccine dose as in the most vaccinated counties in the cities and on the coasts. Those less vaccinated places are not catching up, either. The gap between more- and less-vaccinated counties is expanding, and the trailing counties are far below levels needed to halt future waves of infection

As the FEHBlog has pointed out previously, such herd immunity is built on both natural immunity and vaccination-created immunity. The FEHBlog encourages COVID-19 vaccination which has been miraculous. Nevertheless you cannot predict Delta variant devastation in certain areas of our country without considering natural immunity and the fact that most of elderly cadre is vaccinated. The FEHBlog also has confidence in the federal, state and county authorities as well as the Nation’s physicians to complete the vaccination campaign.

And now for Tuesday’s tidbits

  • The FEHBlog nearly fell off his chair when he read in Healthcare Dive that Nearly 70% of U.S. physicians are now employed by a hospital or a corporate entity, according to the latest report by Avalere for the Physicians Advocacy Institute, a coalition of state doctors’ groups. This is the first time the report included ownership by corporate entities outside of just hospitals. Hospitals and corporate entities, which include insurers or private equity groups, own nearly half of the physician practices in this country, according to the report released Tuesday that examines the two-year period from 2019 through 2020.  This longtime trend [really since the Affordable Care Act became law in 2010] was exacerbated during the COVID-19 pandemic, according to the report, which shows 48,400 physicians left private practice during the study period across all regions of the country.” The FEHBlog does not see this course reversing itself.
  • Buck consultants reminds FEHB plan carriers that the PCORI fee is due on August 2 this year because July 31 falls on a Saturday.
  • Medscape reports that “In the U.S. House [of Representatives], 20 Democrats and 10 Republicans have signed on as co-sponsors to the Protecting Seniors Through Immunization Act of 2021 (HR 1978), introduced in March by Rep. Ann Kuster (D-NH). The companion Senate measure (S 912) has the backing of two Democrats and two Republicans. This legislation would end copays in Medicare Part D plans for vaccines recommended for adults by the CDC’s Advisory Committee on Immunization Practices.” The FEHBlog, who is on Medicare, got hit for $400 in copayments to obtain two doses of the new ACIP recommended Shingles vaccine last year. Why it is taking over a decade for Medicare to align with the ACA on this point is beyond the FEHBlog’s understanding.
  • AHRQ’s Director Dr. David Meyers offers his perspective on getting telehealth properly integrated into our health care system.
  • The showstopper of this week will be the first interim final rule on implementation of the No Surprises Act which has a statutory deadline of Thursday July 1. The rule is expected to principally pertain to calculating the initial payments in the NSA scenarios. Hopefully the rule will provide more guidance than that. The rule has been pending approval from the Office of Management and Budget’s Office of Information and Regulatory Affairs since June 8. Since then OIRA has sponsored seven listening sessions with interested organizations. The last such listening session will be held tomorrow at 1 pm ET. Once the listening session is completed, a list of attendees and the meeting materials are posted on OIRA’s online calendar.

Monday Roundup

Photo by Sven Read on Unsplash

Bloomberg has released its latest COVID-19 resilience ranking.

Almost a year and a half into the pandemic, the best and worst places to be in the Covid-19 era are increasingly defined by one thing: normalization.

The biggest vaccination drive in history is enabling parts of the globe to abolish mask mandates, relax restrictions and dismantle border curbs, making the magnitude of reopening key to quality of life. Taming cases and deaths was once paramount, along with ensuring a robust health-care system. Now, the ability to essentially turn back the clock and return to pre-pandemic times is taking on an even greater significance.

Central to that is an economy’s openness to the world, and that’s why we’ve introduced a new element—Reopening Progress—to Bloomberg’s Covid Resilience Ranking. Two new metrics capture the ease of moving in and out of a place and how much air travel has recovered, alongside our 10 other measures tracking mortality rates to infection counts, freedom of movement to economic growth.

This pivot has ushered in dramatic changes to the ranks. The U.S. is now No. 1, with its fast and expansive vaccine rollout, dominated by the highly effective Messenger RNA shots, stemming what was once the world’s worst outbreak.

The U.S. Supreme Court today according to Fierce Healthcare

declined to hear an appeal of a lower court decision upholding the Department of Health and Human Services’ (HHS’) site-neutral payments policy.

The appeal was requested by the American Hospital Association (AHA) in February as part of a multiyear legal battle challenging HHS’ authority to bring Medicare payments to off-campus clinics in line with independent physician practices. The AHA’s bid was supported by a long list of other provider industry stakeholders.

By taking a pass on the case, the top court has now paved the way for HHS to move forward with the 2019 Outpatient Prospective Payment System rule—a policy the agency has said would have saved the Centers for Medicare & Medicaid Services roughly $800 million in payments to outpatient departments during 2020. * * *

HHS’ rule aims to remove payment disparities where hospital-affiliated clinics receive more Medicare reimbursement than physicians’ offices providing the same services. Researchers have suggested over the years that these disparities have played a part in provider consolidation.

Also today the Department of Health and Human Services released a third notice of Affordable Care Act Benefit and Payment Parameters as a proposed rule. Fierce Healthcare informs us that the proposed rule would set the ACA’s open season at an expanded November 1 through January 15 and also would allow exchanges to offer special enrollment periods for low income customers who may benefit from the American Rescue Plan’s expanded premium credits. Health Payer Intelligence discusses two impacts from the current ongoing special ACA open enrollment period which runs until August 15.

In other round up items

  • The ICD-10 Monitor tells us that the Centers for Disease Control released new ICD-10-CM codes for federal fiscal year 2022 which include 19 new social determinants of health codes in the “Z” chapter. Many of these new “Z” codes are attributable to the Gravity Project which is an HL7 FHIR accelerator organization.
  • The Wall Street Journal discusses what doctors want their patients to know about the new Alzheimer’s disease drug Aduhelm. For example, “The treatment would work over years, not weeks or months. Dr. [Paul] Aisen estimates that patients with mild cognitive impairment, which is often a precursor to dementia, might get an extra year or two before they start losing their ability to function independently.”
  • Fierce Healthcare reports that

Future demand for healthcare services will be relatively flat to declining, with little to no effect from the COVID-19 pandemic, according to a new forecast report.

At the same time, hospitals and health systems are facing increasing competition from consumer businesses such as Amazon and Walmart, retail behemoths that are rapidly expanding the supply of healthcare services.

The implications of softening demand and increasing supply suggest that pricing trends are ultimately unsustainable for healthcare providers, according to a new report from health system analytics company Trilliant Health.

The company’s analysis, based on 70 billion medical claims across 309 million patient visits, contradicts the commonly held belief that the demand for healthcare services nationwide is rising, according to Sanjula Jain, Ph.D., senior vice president of market strategy and chief research officer at Trilliant Health.

Time will tell.

Thursday Miscellany

U.S. Supreme Court building, Wash. DC

At long last, the U.S. Supreme Court issued its opinion today in the third case reaching the Court on the issue of the constitutionality of the Affordable Care Act (“ACA”). In an opinion written by Justice Breyer and joined by the Chief Justice and four other Justices, the Court ruled in short as follows:

As originally enacted in 2010, the Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage. The Act also imposed a monetary penalty, scaled according to in- come, upon individuals who failed to do so. In 2017, Con- gress effectively nullified the penalty by setting its amount at $0. See Tax Cuts and Jobs Act of 2017, Pub. L. 115–97, §11081, 131 Stat. 2092 (codified in 26 U. S. C. §5000A(c)).

Texas and 17 other States brought this lawsuit against the United States and federal officials. They were later joined by two individuals (Neill Hurley and John Nantz). The plaintiffs claim that without the penalty the Act’s minimum essential coverage requirement is unconstitutional. Specifically, they say neither the Commerce Clause nor the  Tax Clause (nor any other enumerated power) grants Congress the power to enact it. See U. S. Const., Art. I, §8. They also argue that the minimum essential coverage re- quirement is not severable from the rest of the Act. Hence, they believe the Act as a whole is invalid. * * *

[W]e conclude that the plaintiffs in this suit failed to show a concrete, particularized injury fairly traceable to the defendants’ conduct in enforcing the specific statutory provision they attack as unconstitutional. They have failed to show that they have standing to attack as unconstitutional the Act’s minimum essential coverage provision. Therefore, we reverse the Fifth Circuit’s judgment in respect to standing, vacate the judgment, and remand the case with instructions to dismiss.

Justice Thomas filed a concurring opinion, and Justice Alito, joined by Justice Gorsuch, filed a dissenting opinion. The FEHBlog confidently can state that he predicted this favorable outcome for the ACA. It always has been clear to the FEHBlog that the Supreme Court took the case to kill the lawsuit, not the law.

The Senate will take up Kiran Ahuja’s nomination to be OPM Director when it resumes floor business on Monday June 21. If Ms. Ahuja’s nomination is not confirmed next week, the Senate will be away from our Nation’s capital for two weeks for the Independence Day holiday.

Reg Jones’ latest column in FedWeek concerns federal employee survivor benefits in the case of a post-retirement marriage.

In federal employment news, Federal News Network reports that President Joe Biden signed the Juneteenth National Independence Day Act this afternoon, establishing June 19 as a federal holiday. Most federal employees will have tomorrow, June 18 off for observance as June 19 falls on a Saturday this year, the Office of Personnel Management said. * * * Nearly every state already recognizes Juneteenth as a holiday, but it now becomes the first federal holiday created since Martin Luther King Jr. Day was established in 1983.”

In COVID-19 news and this should come as no surprise, Medscape informs us that “More than half of unvaccinated Americans would prefer to get a COVID-19 vaccination at their doctors’ office, according to the results of a new national survey. * * * The preference to be vaccinated in a medical office was three to five times higher among unvaccinated Americans than were other strategies such as vaccinations at retail pharmacies or drug stores, community health centers, public health clinics, drive-up clinics, and large public vaccination sites.” As of today, 65% of Americans over age 18, and 87% of Americans over age 65, have had at least one dose of a COVID-19 vaccination.

In a burst of closing miscellany —

  • Kaiser Health News tells us that ” The pandemic-caused recession and a federal requirement that states keep Medicaid beneficiaries enrolled until the national emergency ends swelled the pool of people in the program by more than 9 million over the past year, according to a report released Thursday. The latest figures show Medicaid enrollment grew from 71.3 million in February 2020, when the pandemic was beginning in the U.S., to 80.5 million in January, according to a KFF analysis of federal data.”
  • Health Payer Intelligence informs us that “Medicare Advantage plans may better address racial care disparities than fee-for-service Medicare, according to the second in a series of reports that ATI Advisory has prepared for Better Medicare Alliance (BMA) in 2021. “With over 26.5 million beneficiaries enrolled in Medicare Advantage today, this report shows that minority beneficiaries are a driving force behind these enrollment gains; turning to Medicare Advantage to meet their health and social needs. When policymakers stand up for Medicare Advantage, they stand up for these seniors, too,” Allyson Y. Schwartz, president and chief executive officer of the Better Medicare Alliance, said in the press release. Around half of all Black Medicare beneficiaries and 53 percent of Latinx Medicare beneficiaries are in a Medicare Advantage plan, the report found. In contrast, only 34 percent of White beneficiaries and 31 percent of those who identified as “Other” races were enrolled in a Medicare Advantage plan.”
  • STAT News reports that “ovarian cancer, which kills about 15,000 Americans every year, has historically been one of the thornier cancers to treat. Only in the last few years has a new class of potent drugs, called PARP inhibitors, started to change that. But even with these promising new treatments, too often, tenacious tumors come roaring back. So there’s a need for yet newer drugs that can overcome any resistance the cancer evolves. According to research published Thursday, scientists might have found one. And it’s not actually a new drug at all. In fact, it’s been sitting, retired, in a drug library for decades. “While evaluating mechanisms of PARP inhibitor resistance over the last few years we came across this drug, novobiocin, which curiously enough, is an antibiotic,” said Alan D’Andrea, director of the Susan F. Smith Center for Women’s Cancers at the Dana-Farber Cancer Institute and co-author of the new study.” Encouraging.
  • “The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.  ‘Seasonal and perennial allergies affect millions of Americans every year, causing them to experience symptoms of nasal congestion, runny nose, sneezing and more,” said Theresa M. Michele, M.D., director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider.’”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

From the COVID-19 front

  • Sobering news from the Wall Street Journal that “It took less than six months for the globe to record more than 1.88 million Covid-19 deaths this year, according to a Wall Street Journal analysis of data collected by Johns Hopkins University. The university’s count for 2021 edged just ahead of the 2020 death toll on Thursday. These numbers underscore how unevenly the pandemic spread around the globe, often hitting poorer nations later, but before they had access to the vaccines that have benefited Europe and the U.S. * * * Vastly different vaccination rates have sharpened the global divide. Only 2% of people in Africa and just over 6% in Asia have received at least one dose of vaccine, according to Our World in Data. That compares with 22% in South America, more than 40% in the European Union and more than half in the U.S. * * * World leaders are due to discuss their response to the pandemic when they gather in Cornwall, in southwestern England, on Friday.” David Leonhardt sheds light on the vaccinating the world in the New York Times. The bottom line is as he points out: “A rapid global vaccination program — combined with natural immunity in people who have already had Covid — could create the same virtuous cycle that’s underway in the U.S., Britain and other countries: A decline in cases feeds on itself, as there are fewer infected people able to spread the virus to others. And by prioritizing older people for shots, countries can cause deaths to decline even more sharply than cases.”
  • To that end, here in the U.S., Moderna “has requested an emergency use authorization (EUA) for its [two dose, mRNA] COVID-19 vaccine in adolescents [ages 12-17] with the U.S. Food and Drug Administration (FDA). Pfizer’s two dose, mRNA vaccine already is being administered to adolescents in this age group.
  • Johnson & Johnson announced that “the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months.” Absent this science based extension, large surplus of unused doses of this vaccine would have begun to expire later this month.  The Wall Street Journal adds that the federal government continues to suspend shipments of new doses of the single dose vaccine, evidently to allow the surplus to deplete.
  • Fierce Healthcare reports on Kaiser Permanente’s efforts to boost the COVID-19 vaccination numbers. As of today, 64% of Americans over age 18 have received at least one dose and over 75% of Americans over age 65 are fully vaccinated.

In big healthcare legal news, a friend of the FEHBlog pointed out to him today that yesterday the Department of Health and Human Services submitted its interim final rule on No Surprise Billing Act implementation rule to the Office of Management and Budget’s Office of Information and Regulatory Affairs for final review before publication in the Federal Register.

AGENCY: HHS-CMS RIN: 0938-AU63Status: Pending Review
TITLE:Requirements Related to Surprise Billing; Part I (CMS-9909)
STAGE: Interim Final Rule ECONOMICALLY SIGNIFICANT: Yes 
RECEIVED DATE: 06/08/2021LEGAL DEADLINE: Statutory  

In other healthcare and healthcare business news:

  • Healthcare Dive informs us that “UnitedHealthcare, the biggest private payer in the U.S., is delaying a controversial policy that could retroactively deny emergency room bills it deems non-emergent — potentially saddling patients with costly medical bills — following intense backlash from patient advocates and hospital groups. ‘Based on feedback from our provider partners and discussions with medical societies, we have decided to delay the implementation of our emergency department policy until at least the end of the national public health emergency period,’ UnitedHealthcare tweeted on Thursday.
  • Health Payer Intelligence identifies four payers that have embraced value based contracting with healthcare providers in the first half of 2021.
  • STAT News reports on what’s ahead for Biogen’s new Alzheimer’s Disease drug. The article concludes “Despite the controversies, Mark Miller, the former executive director of the Medicare Payment Advisory Commission, thinks Aduhelm will be widely used and make billions for Biogen. Infusion centers used for cancer patients and others can accommodate Aduhelm patients, said Miller, now the executive vice president at the Arnold Ventures philanthropy. Doctors will make good money providing the drug. Most Medicare patients have supplemental coverage that will pick up the 20 percent copay. ‘There’s not a lot of friction here to say, “Don’t do this,’ he said.”
  • STAT News also tells us that “The treatment known as CAR-T, in which white blood cells are genetically modified to attack blood cancer, is one of the most exciting and expensive in medicine. But it has not been directly compared to standard treatments in a randomized trial — until now. Bristol Myers Squibb said Thursday that its CAR-T, Breyanzi, prevented the return of large B-cell lymphoma better than the standard of care treatment, which includes a chemotherapy regimen and a stem cell transplant, in which bone marrow cells are replaced to try to cure blood cancer. The news was released in a terse press release that does not include any details about how the therapy performed. But if the results hold up when published in a medical journal or presented at a medical meeting, they would represent a big step forward for CAR-T therapy.”
  • The American Medical Association offers a blueprint for controlling blood pressure.
  • NIH Director Dr. Francis Collins in his blog interviews U.S. Surgeon General Vivek Murthy on fighting the ongoing opioid epidemic.

In federal employment news, Federal News Network reports that

The Biden administration has lifted the 25% occupancy limit at federal buildings, though agencies must still jump through several hoops before bringing more employees back for in-person work.

The Office of Management and Budget, along with the Office of Personnel Management and General Services Administration, on Thursday issued detailed guidance on the administration’s approach for reopening agency offices during the pandemic — and offered a highly-anticipated glimpse at their approach for telework, remote work and other workforce flexibilities in a post-pandemic world.

Weekend update

The Senate will resume Committee work and floor voting this coming week while the House of Representatives will be limited to Committee business.

From the COVID-19 front

  • Bloomberg reports that “U.S. hospitalizations continue to fall, with 3.17% of beds occupied by Covid-19 patients on June 4, according to the U.S. Department of Health and Human Services. That percentage dropped from 3.67% on May 28 and is the lowest since March 14, 2020.”
  • The Advisory Board informs us its June 4, 2021, COVID-19 Roundup that “The World Health Organization (WHO) on Monday announced variants of the coronavirus will now be named after letters of the Greek alphabet, to simplify the variants’ names and avoid names that can be stigmatizing to a country. According to the new naming system, the variant B.1.1.7, which was first discovered in the United Kingdom, will now be called Alpha; the B.1.351 variant first discovered in South Africa will be called Beta; and the B.1.617.2 variant first discovered in India will be called Delta. Once all 24 letters of the Greek alphabet have been used, WHO said it will announce another naming system.”

Kaiser Health News tells us that

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The Department of Health and Human Services, last Friday, released

a new report that shows 31 million Americans have health coverage through the Affordable Care Act – a record.  The report also shows that there have been reductions in uninsurance rates in every state in the country since the law’s coverage expansions took effect. People served by the health Marketplaces and Medicaid expansion have reached record highs.  

The data shows those individuals currently enrolled in health coverage through the Health Insurance Marketplaces and Medicaid expansion under the ACA, including 11.3 million people enrolled in the ACA Marketplace plans as of February 2021 and 14.8 million newly-eligible people enrolled in Medicaid through the ACA’s expansion of eligibility to adults as of December 2020. 

In addition, there are one million people enrolled in the ACA’s Basic Health Program, and nearly four million previously-eligible adult Medicaid enrollees who gained coverage under expansion due to the ACA’s enhanced outreach, streamlined applications, and increased federal funding under the ACA. Today’s report shows the important role the ACA has played in providing coverage to millions of Americans nationwide.

The report also shows that between 2010 and 2016, the number of nonelderly uninsured adults decreased by 41 percent, falling from 48.2 million to 28.2 million. All 50 states and the District of Columbia have experienced reductions in their uninsured rates since the implementation of the ACA, with states that expanded Medicaid experiencing the largest reduction in their uninsured rate. California, Kentucky, New York, Oregon, Rhode Island, Washington, and West Virginia have reduced their uninsured rate by at least half from 2013 to 2019 through enrollment in Marketplace coverage and expansion of Medicaid to adult populations. To date, 37 states and the District of Columbia have expanded Medicaid to cover adults under the ACA. 

Healthcare Dive reports that

  • The nation’s largest commercial insurer is taking a closer look at whether visits to the emergency room by some of its members are necessary. Starting July 1, UnitedHealthcare will evaluate ER claims using a number of factors to determine if the visit was truly an emergency for its fully insured commercial members across many states, according to a provider bulletin
  • If UnitedHealthcare finds the visit was a non-emergency, the visit will be “subject to no coverage or limited coverage,” the provider alert states.
  • However, a statement provided to Healthcare Dive said the insurer will reimburse for non-emergency care according to the member’s benefit plan. In other words, the amount paid by UnitedHealthcare may be less if deemed a non-emergency.    

For what it’s worth, this plan designed to control healthcare resources makes sense to the FEHBlog.

Last week, the FEHBlog noted that OPM had a settled a lawsuit in the National Federation for the Blind alleged that the agency’s website was not adequately accessible to visually impaired FEHB members. To place the settlement in context, the FEHB calls attention to this NextGov article reporting that

Federal websites are not as accessible for those with disabilities as the law mandates they should be, according to a report released Thursday by the Information Technology and Innovation Foundation.

The report tested the 72 most popular federal websites and used a combination of automated tests and qualitative assessments to assess their compliance with Section 508 of the Rehabilitation Act. The law requires the General Services Administration to ensure federal websites are accessible to people with disabilities, including federal employees and the public.

According to the report, 30% of the most popular federal websites did not follow modern web accessibility standards on their homepages, and 48% failed a standard test on at least one of their three most popular web pages.

The report finds that

Overall, our assessments reveal a large amount of variation in how agencies are meeting Section 508 requirements. Some agencies that have a large footprint—such as the Internal Revenue Service, the Census Bureau, the Department of Defense, and the Department of Education’s office of Federal Student Aid—scored low in our accessibility test of their websites, indicating that people with disabilities may have difficulty accessing essential government services or information about these services online. * * *

Notably, the White House and the Centers for Disease Control and Prevention earned a perfect score in our accessibility test of all three of their pages, and also performed well in our qualitative assessment. The Biden administration has committed to adhering to WCAG 2.1 Level AA criteria on the White House website—a step above Section 508’s requirements, which use WCAG 2.0.19

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 22nd week of this year (beginning April 2, 2020, and ending June 2, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 2, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 2, 2021 which also uses Thursday as the first day of the week:

In this week’s COVID-19 update, the CDC advises

With summer upon us, many adolescents are looking forward to returning to activities they may have missed last summer, including travel, hanging out with friends, work, and summer campVaccinating adolescents is an important step toward stopping the spread of COVID-19. As of June 3, 2021, more than 5.9 million adolescents ages 12-17 years have received at least one dose of a COVID-19 vaccine. Fully vaccinated adolescents are at low risk of symptomatic or severe infection and are less likely to transmit COVID-19 to others. If you or someone you know is considering adolescent vaccination, talk with your pediatrician or healthcare provider about the benefits of vaccination. To find a vaccine provider near you, visit vaccines.gov.

In other new

  • The tri-agencies which administer the Affordable Care Act issued FAQ 46 today which reminds interested that the Biden Administration lowered the in-network out-of-pocket maximum limit for 2022 that the Trump Administration had proposed. As the FEHBlog reported in early May 2021, the maximum annual limitation on [in-network] cost sharing for the 2022 plan year will be $8,700 for self- only coverage, and $17,400 for other than self-only coverage.”
  • Fierce Pharma reports that “Friday brought news that the FDA has made Regeneron’s monoclonal antibody cocktail [to treat COVID-19] more user friendly, allowing it to be administered by subcutaneous injection in addition to its original administration form of intravenous infusion. The agency also approved a lower dose of the Regeneron drug, 1200 mg, allowing the company and officials to stretch available supply.”
  • The American Medical Association informs us about “Ochsner’s Connected MOM (Maternity Online Monitoring) initiative, which uses digital health tools to offer expectant mothers a convenient way to safely manage their pregnancy in collaboration with their physicians.” Oschner, of course, is a major health system serving New Orleans, LA, and environs.
  • HR Dive tells us about the types of incentives that employers are offering to encourage employees to get COVID-19 vaccinations. “Adam Sencenbaugh, partner at Haynes and Boone, said he has seen several creative forms of incentives from clients, ranging from paid time off to raffles. That mirrors reports of what other employers have done to incentivize vaccination, with ideas including direct payments and transportation provided to those receiving a vaccine. “We have yet to have a client ask us about a program that would be coercive in that respect,” Sencenbaugh added. “It’s been something that, if done appropriately, can even boost morale.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

Federal News Network provides the latest on the controversy over the Postal Service Health Benefits Program provisions in the Postal Reform Act (H.R. 3076 which has a Senate companion bill).

The new legislation requires current postal workers to enroll in Medicare Part A and B when they reach age 65. It gives current retirees the option of enrolling in Medicare, waiving the usual late enrollment penalties. Medicare will pick up initial hospital and prescription costs, and the Postal Service will become the secondary payer.

But current retirees who choose not to opt into Medicare will stay in the FEHBP.

While this arrangement is designed to save the Postal Service billions over the next decade, NARFE [ a prominent federal employee organization] worries it could raise premiums for federal employees and retirees still enrolled in the FEHBP. Those who are Medicare-eligible but choose not to enroll are some of the most expensive participants to insure.

The FEHBlog has a different outlook. First off, all federal annuitants, with exception of a naturally diminishing cadre of members who retired before 1984, have no cost Medicare Part A coverage. Most federal annuitants do join Part B. Income adjusted Part B premiums likely are the cause of newer annuitants tending to decline Part B coverage. In any event, Part A hospital expenses are weightier than Part B expenses. If a federal annuitant over 65 has declined Part B coverage and is enrolled in an FEHB fee for service plan, that Plan covers the annuitant’s expenses at Medicare rates which the FEHB Act, 5 U.S.C. Sec. 8904(b), obligates the provider to accept. That law has been in effect for nearly 30 years.

As the FEHBlog has mentioned on occasion, the enormous new savings opportunity that Postal reform will unleash lies in Part D prescription drug integration, not in Part B integration. In the 2003 Medicare Modernization Act that created Part D, Congress expressly permitted FEHB plans to integrate their benefits with Medicare Part D for annuitants over 65 (see 42 USC 1395w–132(b),(c)(3)). Integrated Part D programs known as EGWPs pay the Part D premium while reaping tremendous savings over going it alone. If OPM simply allowed all FEHB plans to exercise this option, FEHB premiums would be lower, and the Postal Service would not be militating for a separate program, in the FEHBlog’s considered opinion.

Healthcare Dive reports the Senate today confirmed the President’s nomination of Chiquita Brooks-LaSure to be Administrator of the Centers for Medicare and Medicaid Services by a 55-45 vote.

Brooks-LaSure has a long career in public policy, working in the Office of Management and Budget as a Medicaid analyst before moving on to serve as deputy director for policy at the Center for Consumer Information and Insurance Oversight during the Obama administration. She was also a director of coverage policy at HHS before transitioning to the private sector, working as a Medicare and Medicaid policy consultant for Manatt Health. With Tuesdays vote, Brooks-LaSure becomes the first Black woman to lead CMS.

The Senate has turned to considering an Assistant Attorney General nomination, and the FEHBlog hopes that Kiran Ahuja’s nomination to be OPM Director reaches the Senate floor soon thereafter for a confirmation vote.

From the COVID-19 front, Fierce Pharma informs us that

Teens across the U.S. started getting COVID-19 vaccines this month after Pfizer’s shot. With new data released Tuesday, Moderna’s shot could soon be available to kids, too.

In a phase 3 trial in kids ages 12 to 18, Moderna’s vaccine posted 100% efficacy after two doses. Investigators enrolled 3,700 participants and randomly assigned two-thirds to receive two doses of the Moderna vaccine. The remaining third received two doses of placebo.

Investigators recorded zero COVID-19 cases in the vaccinated group 14 days after the second dose, and four in the placebo group. They didn’t identify any new safety concerns.

The results set Moderna up for an FDA filing in the age group next month. Under that timeline, the vaccine could score an authorization in teens sometime this summer and play a role in a back-to-school vaccination push. * * *

Even younger children could be on their way to eligibility, too; Pfizer and Moderna are both running studies testing their vaccines in children as young as six months.

As of today, 50% of the U.S. population over age 18 is fully vaccinated against COVID-19, and public health experts opine in Medscape on why the jury is out on COVID-19 vaccination boosters.

And here are Tuesday’s Tidbits —

  • Medscape reports on how the COVID-19 pandemic has lead doctors to rethink low value care.
  • The Annals of Internal Medicine discusses on a study finding that “In clinician-owned practices, implementing a workflow to routinely screen, counsel, and connect patients to smoking cessation resources, or implementing a documentation change or a referral to a resource alone led to an improvement of at least 10 points in the smoking outcome with a moderate level of facilitation support. These patterns did not manifest in health- or hospital system–owned practices or in Federally Qualified Health Centers, however. The [blood pressure] BP outcome improved by at least 10 points among solo practices after medical assistants were trained to take an accurate BP. Among larger, clinician-owned practices, BP outcomes improved when practices implemented a second BP measurement when the first was elevated, and when staff learned where to document this information in the electronic health record. With 50 hours or more of facilitation, BP outcomes improved among larger and health- and hospital system–owned practices that implemented these operational changes.” Little things.
  • OPM released today a corrected version of Benefits Administration Letter No. 21-802, dated May 20, 2021, “which provides guidance on the OPM implementation of FSAFEDS Program flexibilities offered under the Consolidated Appropriations Act 2021 and accompanying law and guidance.”
  • MedPage Today posts a transcript of an interesting podcast in which “Vinay Prasad, MD, MPH, breaks down a new study that examined differences in breast cancer screenings before and during the COVID-19 pandemic overall, and among sociodemographic population groups.
  • The Internal Revenue Service released draft 2021 Forms 1095-B and 1095-C which health plans and employers respectively use to report individual health coverage information to the Service.
  • Healthcare Dive reports that “The finances of U.S. hospitals continue to improve as the coronavirus pandemic wanes, following months of steep losses last year, according to a new report from Kaufman Hall. In April, hospital margins, volumes and revenues were up across most performance metrics year to date and year over year, though they were down compared to March, the consultancy found. Researchers called the results ‘encouraging,’ but noted they were more indicative of a recovering industry following the record-low performance seen in the first two months of COVID-19 in 2020, rather than strong performance overall this year.”

Monday Roundup

Photo by Sven Read on Unsplash

Happy National Hospital Week.

Per a Food and Drug Administration press release,

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.

The CDC will take up the matter on Wednesday and assuming that CDC approval is given, then health plans will become obligated to cover the full cost of administering the vaccine to this new age group fifteen days later.

The Wall Street Journal adds FAQs:

Do we need to vaccinate children?

Yes, according to most infectious-disease experts. Children can and do get sick from Covid-19, though research shows they typically experience milder cases and are much less likely than adults and the elderly to be hospitalized or die from the virus. As of late March, more than 3.4 million children had been infected with Covid-19, according to the American Academy of Pediatrics, including nearly 14,000 hospitalizations and 279 deaths. The emergence of more-contagious variants, including the B.1.1.7 variant that was first identified in the U.K. and is now dominant in the U.S., appears to be sending younger patients to the hospital with a higher frequency, making vaccines in young adults and adolescents all the more urgent, some doctors and scientists say. In addition, scientists say children need to be vaccinated to achieve the communitywide, or herd, immunity that renders spread of the virus unlikely. “Vaccines give us the opportunity to really turn the tide on this pandemic, and children and teens really need to be a part of that strategy,” said Lisa Costello, a pediatrician and president of the West Virginia chapter of the American Academy of Pediatrics.

Monday continues to be a good day for COVID-19 vaccine news.

In other news —

  • Healthcare Dive reports that “Kaiser Permanente generated a profit of $2 billion in the first quarter of 2021, the integrated health system reported Friday, bouncing back from a staggering $1.1 billion loss in the first quarter of last year, largely tied to investment losses amid the stock market slide spurred by the COVID-19 pandemic.”
  • The Internal Revenue Service announced 2022 inflation adjustments for (a) minimum deductibles and maximum out of pocket cost sharing in high deductible health plans (“HDHP”) associated with health savings accounts {“HSA”) and (b) maximum health savings account contributions. The Journal of Accountancy explains

The annual limitation on deductions under Sec. 223(b)(2)(A) for an HSA with self-only coverage is $3,650, an increase of $50 over 2021; the corresponding amount for family coverage is $7,300, up $100 from 2021. Sec. 223(b)(3) allows an additional $1,000 annual contribution for individuals age 55 or older before the end of the tax year.

The high-deductible health plan (HDHP) that must accompany an HSA also has inflation adjustments, for its minimum plan deductible amount and its maximum annual out-of-pocket limitation. The deductible for 2022 must be at least $1,400 for self-only and $2,800 for family coverage, both the same as for 2021. The out-of-pocket maximums are $7,050 for self-only coverage and $14,100 for family coverage, increases of $50 and $100, respectively, from 2021.

  • The Department of Health and Human Services overruled the Trump Administration’s narrow interpretation of sex discrimination for purposes of the Affordable Care Act’s individual non-discrimination provision known as Section 1557. “Consistent with the Supreme Court’s decision in Bostock and Title IX, beginning today, [HHS’s Office for Civil Rights] will interpret and enforce Section 1557’s prohibition on discrimination on the basis of sex to include: (1) discrimination on the basis of sexual orientation; and (2) discrimination on the basis of gender identity. This interpretation will guide OCR in processing complaints and conducting investigations, but does not itself determine the outcome in any particular case or set of facts. In enforcing Section 1557, as stated above, OCR will comply with the Religious Freedom Restoration Act, 42 U.S.C. § 2000bb et seq., and all other legal requirements.
  • Federal News Network reports that “Few aspects of federal retirement seem to be trending down more than a year after the pandemic first hit the U.S. According to numbers released by the Office of Personnel Management, new claims, processed claims, processing times and the overall claims backlog were all higher in April 2021 than April 2020.” 
  • Fierce Healthcare informs us that “COVID-19 has only worsened social isolation, but [Blue Cross licensee] Anthem is addressing senior’s loneliness through a “wrap-around” program that encourages them to reach out. Through Member Connect, seniors are assigned a social care partner, who assists with connecting them to community services to address their social needs. They also have a phone pal, a volunteer Anthem associate who reaches out to them weekly. Many members (78%) said they either agreed or strongly agreed that participating in the program led to more meaningful connections with people. In addition, 66% said they are happy or very happy when taking into account all facets of their life in the past seven days.”