Friday Stats and More

ACA

Friday Stats and More

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

Based on the Centers for Disease Control (CDC) constantly improving COVID data tracker website, here are charts of new weekly COVID-19 cases and deaths using Thursday as the first day of the week. As you can see, new cases trended down last week. Per the CDC, “The current 7-day moving average of daily new cases (136,558) decreased 12.7% compared with the previous 7-day moving average (156,341).” Moreover, “The current 7-day moving average of new deaths (1,077) has decreased 11.3% compared with the previous 7-day moving average (1,214).”

Here are links to the COVID hospitalization statistics and the CDC’s weekly interpretation of its COVID data. Per the CDC, “The current 7-day daily average for September 1–September7, 2021, was 11,754 This is a 4.1% decrease from the prior 7-day average (12,251) from August 25–August 31, 2021.”

Here is chart of weekly COVID vaccines distributed and administered from the time administration began last December through the 36th week of this year (ending September 8, 2021):

New vaccinations have levelled out at a rate of roughly 5 million per week for the past two months. Per the CDC, “As of September 9, 2021, 92.6% of people ages 65 years or older have received at least one dose of vaccine and 82.2% are fully vaccinated. Over three-quarters (75.3%) of people ages 18 years or older have received at least one dose of vaccine and 64.5% are fully vaccinated. For people ages 12 years or older, 73.4% have received at least one dose of vaccine and 62.5% are fully vaccinated.”

The Food and Drug Administration today released this bulletin about the status of making available a COVID vaccine for young children.

The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. As outlined above, this process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months.

The New York Times reports

Federal health officials released new data showing that unvaccinated Americans are 11 times as likely as vaccinated people to die of Covid-19.

Three large studies, published on Friday by the Centers for Disease Control and Prevention, also highlighted the effectiveness of the shots at preventing infection and hospitalizations with the virus.

The research underscored a deep conviction among scientists that vaccine hesitancy and refusal have prolonged the pandemic. The administration’s new plan should stem the flood of infections and return the country to some semblance of normalcy in the long term, several experts said in interviews.

With respect to the President’s vaccination mandates, Gov Exec tells us that

The U.S. Postal Service is not committing to implementing any COVID-19 vaccine mandate—full or partial—for its workforce, with an agency spokesman saying officials will first need to see the fine print of new requirements President Biden has issued. 

Biden’s executive order mandating the vaccines for the federal workforce took a somewhat narrow definition of agencies that carved out USPS, which employs more than 640,000 people. The president on Thursday also announced the Labor Department would put forward a rule directing all employers with more than 100 workers to require their staff to either be vaccinated or submit to weekly COVID-19 testing. USPS said on Friday it was still determining whether the rule would apply to the agency.

From the No Surprises Act front, HHS has issued its proposed rule implementing the Consolidated Appropriations Act 2021 Division BB provisions on air ambulance reporting, health insurer / plan broker compensation reporting and HHS enforcement of the law. Here is a link to a fact sheet on the proposal. The public comment deadline is October 18.

HHS also announced today that its “Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.” The American Hospital Association was pleased with the news.

Federal News Network has interviewed many current and former federal employees about their memories of September 11, 2001. Check it out as the interviews include two OPM officials. Of course, never forget.

Midweek Update

David Ermer–ACA, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.

Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.

While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.

In other healthcare news

  • A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
  • The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
  • NCQA has made available a kidney health toolkit.
  • Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
  • Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.

Finally, the Wall Street Journal’s the Future of Everything series today discusses how

Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself. 

“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.

Friday Stats and More

David Ermer–ACA, COVID-19, COVID-19 vaccine, Government Contracting, U.S. Healthcare, Uncategorized–

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 33rd week of this year (beginning April 2, 2020, and ending August 18, 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 August 18, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 18, 2021, which also uses Thursday as the first day of the week:

Here’s a link to the CDC’s weekly interpretation of its COVID-19 statistics.

Politico reports that “More than one million Americans received a dose of Covid-19 vaccine on Thursday[August 19] , a benchmark the nation has not met in nearly seven weeks amid a resurgence of the coronavirus pandemic.”

HealthDay informs us that

Antibodies generated by COVID-19 vaccines are effective against the Delta variant and other coronavirus variants of concern, new research shows.

The findings may help explain why most vaccinated people have avoided the surge of Delta variant cases sweeping across the United States.

“In face of vaccination, Delta is relatively a wimpy virus,” said study co-author Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis.

Good to hear.

The Wall Street Journal tells us that

The Food and Drug Administration is expected next week to grant full approval of the Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE, according to people familiar with the planning, an action that could spur more vaccination requirements by employers and encourage more people who are hesitant to get vaccinated. * * *

Once fully approved, the vaccine would be eligible for off-label prescriptions, such as booster doses, according to the FDA. However, analysts said, the critical element for broad boosting is a recommendation from the Advisory Committee on Immunization Practices to the FDA, as physicians often follow ACIP recommendations.

With full approval, Pfizer would likely be permitted to market the vaccine to doctors, providers and the general public as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The Journal adds that

Of the three authorized vaccines in the U.S., only Pfizer has submitted all the required information to the FDA, according to the companies, and analysts expect it to be the first receive clearance. 

Moderna Inc., whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech, has said it is still completing rolling data submissions.Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

Fierce Healthcare reports that Janet Woodcock will not be nominated for a promotion from acting to permanent Food and Drug Commissioner due in large part to Aduhelm fallout.

From the regulatory front

  • After issuing a minimalist Affordable Care Act (“ACA”) FAQ 48 earlier this week, the ACA regulatory departments issued a blockbuster ACA FAQ 49 about payer transparency rule implementation and enforcement delays and answering many No Surprises Act (“NSA”) implementation issues left hanging by the first NSA interim final rule (“IFC”) released July 1.
  • OMB’s Office of Information and Regulatory Affairs (“OIRA”) has scheduled more meetings on the second No Surprises Act IFC which concerns the independent dispute resolution process. Those listening sessions now run late into next week. That means that the IFC won’t be released before the week of August 30 but that still would be about a month before the statutory deadline.
  • The American College of Emergency Physicians and Blue Cross each met with OIRA this past week. Here are links to their supporting letters. BCBSA OIRA IDR 8.17.21.pdf and ACEP EDPMA Pre-IDR Rulemaking Letter (8.10.21).pdf Common sense as expressed in the Blue Cross letter must prevail if the parties want to avoid having the second IFC also create major system changes.
  • The Society for Human Resource Management informs us that “covered employers [such as FEHB plan carriers] now have until Oct. 25 to file their 2019 and 2020 EEO-1 reports, according to a recent announcement from the U.S. Equal Employment Opportunity Commission (EEOC). Although the reporting deadline has been delayed several times during the COVID-19 pandemic, the agency said it will not authorize any more extensions.”

Weekend update

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

The House of Representatives is on a long District work break this month while the Senate has one more week of Committee business and floor voting before that body begins its State work break.

The Wall Street Journal reports from the Delta variant front

While the number of cases in the U.S. had climbed, the number of Americans getting vaccinated also surged, particularly in states like Louisiana, Arkansas and Mississippi, where the rates of vaccination were lower, the officials said. Roughly 60% of eligible Americans are fully vaccinated.

The Journal adds that

One recent vaccine recipient was Manny Cid, the 37-year-old mayor of Miami Lakes[, Florida]. He held off on getting a vaccine earlier in the pandemic because the virus seemed to affect mostly older people and he worked out daily and felt healthy, he said. Over time, his thinking changed as he saw young athletes and acquaintances suffer severe bouts of Covid-19. Then the Delta variant emerged, along with research showing people infected with it carry 1,000 times the viral material of people with the original strain. He decided to get a shot Monday.

“Seeing the impact of the Delta variant, attending funerals of people I highly respect, seeing more and more young people in bad shape…that’s really scary,” Mr. Cid said. “We’ve got to protect ourselves.”

In an interesting development, Health Payer Intelligence informs us that “Based on 75 individual [Affordable Care Act] marketplace rate filings, the coronavirus pandemic is not expected to meaningfully affect healthcare spending in 2022, a Peterson-Kaiser Family Foundation (KFF) Health System Tracker brief explained.”

The Centers for Disease Control reminds us that August is National Immunization Awareness Month. Hey health plans, “National Immunization Awareness Month (NIAM) is an annual observance held in August to highlight the importance of vaccination for people of all ages. Use these resources to assist you in communicating to healthcare professionals, parents, and patients about immunization during August and throughout the year.“

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, Medicare, OPM, U.S. Healthcare–

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 30th week of this year (beginning April 2, 2020, and ending July 28, 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 July 28, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 28, 2021, which also uses Thursday as the first day of the week:

Due to the Delta variant, new cases and hospitalizations are trending up while new deaths have remained low for two months.

Happily COVID-19 vaccinations are trending up again. As of today according to the CDC, 60% of the U.S. population over age 18 and 80% of those over age 65 are fully vaccinated. GEHA, the largest employee organization plan in the FEHB, announced that it has extended its COVID-19 vaccine incentive program to Labor Day, September 6.

The CDC defended its new masking policy for the vaccinated population by pointing to a case in which as reported by the Wall Street Journal

127 vaccinated people infected with the Delta variant during the outbreak appeared to carry as much virus as 84 unvaccinated or partially vaccinated people who became infected. The report referred to an outbreak in Barnstable County, Mass. Local officials there have said that at least 430 confirmed Covid-19 cases have been linked to one cluster following festivities over the July 4 weekend in Provincetown, on the tip of Cape Cod.

Among the 469 cases linked to the Barnstable outbreak in the CDC report, nearly 75% were fully vaccinated. For people with breakthrough infections, almost 80% had symptoms of cough, headache, sore throat or fever. Four were hospitalized and no deaths were reported, the CDC said. Infected people reported attending densely packed indoor events and outdoor events at bars, restaurants and houses.

Toward the conclusion of the article the journalist speaks with Dr. Ashish Jha, dean of the public-health school at Brown University.

Dr. Jha said he thinks this week’s guidance recommending masking in high-risk areas of the U.S. was reasonable, but also risked suggesting that vaccines aren’t effective against the Delta variant, which could discourage unvaccinated people from getting shots. We have the tools to address this variant, and they’re called vaccines,” Dr. Jha said.

The FEHBlog certainly would wear a mask at an indoor or outdoor super spreader event in a high risk area like the one where the FEHBlog is temporarily living, Travis County Texas. It’s worth noting this US Health Weather map which gauges the risk of catching a respiratory infection like COVID-19 or the flu in a particular US county. Ironically, my county of permanent residence, Montgomery County, Maryland, is low risk.

STAT News adds that the Food and Drug Administration is accelerating the process of reviewing Pfizer-Biotech’s application for full marketing approval of their COVID-19 vaccine. (Moderna also has made this filing.)

A typical review of an application like Pfizer’s takes 10 months. The agency granted Pfizer a “priority review” for its vaccine earlier this month, which signifies that staff will strive to finish the review of the application within six months. At the same time, he FDA has said it does not expect the process to take that long — a view echoed even by President Biden.

“My expectation …  is that sometime, maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval” Biden said last week when asked when the FDA would formally approve the Covid-19 vaccines, including the one developed by Pfizer and its partner BioNTech.

Jesse Goodman, who led the FDA’s biologics center from 2003 to 2009, said that the August-September time frame is “possible … if all goes smoothly.” He said the idea of a sprint is “reasonable,” so long the biologics center follows the normal chain of command for reviewing these applications.

In other news

  • Federal News Network tells us that “The House of Representatives on Thursday cleared a $600 billion package of seven spending bills, a small step forward in boosting civilian agency funding next year.The seven-bill “minibus” cleared the House Thursday afternoon by a 219 to 208 vote. The minibus is silent on federal pay for 2022, a silent endorsement of President Joe Biden’s proposed 2.7% raise for civilian employees. * * * The spending package also includes $42 million for the Office of Personnel Management over current levels and allows the agency to stand up an IT working capital fund.” The House is close to completing approval of the twelve appropriations bills. The Senate has not begun to vote on those bills and new federal fiscal year begins in two months, October 1.
  • The Congressional Budget Office released its financial analysis of the President’s budget proposal for the upcoming new federal fiscal year.
  • The ICD10 Monitor explains that yesterday the Centers for Medicare and Medicaid Services finalized four Medicare Part A payment rules which take effect on October 1 — skilled nursing facilities (SNFs), hospices,
  • inpatient rehabilitation facilities (IRFs), and inpatient psychiatric facilities (IPFs). The Monitor’s article summarizes each final rule.
  • The American Hospital Association offers a useful article on approaches to resolving COVID-19 vaccine hesitancy.
  • Fierce Healthcare informs us about insurer comments on the third 2022 Notice of Benefit and Payment Parameters, which proposed changes to the ACA marketplace.

Monday Roundup

David Ermer–ACA, CMS, COVID-19, COVID-19 vaccine, Medicare, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

David Leonhardt in the New York Times offered an encouraging article this morning:

When the Kaiser Family Foundation conducted a poll at the start of the year and asked American adults whether they planned to get vaccinated, 23 percent said no.

But a significant portion of that group — about one quarter of it — has since decided to receive a shot. The Kaiser pollsters recently followed up and asked these converts what led them to change their minds. The answers are important, because they offer insight into how the millions of still unvaccinated Americans might be persuaded to get shots, too.

What helps move people from vaccine skeptical to vaccinated? The Kaiser polls point to three main themes.

(The themes apply to both the 23 percent of people who said they would not get a shot, as well as to the 28 percent who described their attitude in January as “wait and see.” About half of the “wait and see” group has since gotten a shot.)

1. Seeing that millions of other Americans have been safely vaccinated. * * *

2. Hearing pro-vaccine messages from doctors, friends and relatives. * * * and

3. Learning that not being vaccinated will prevent people from doing some things.

That’s helpful information for the many vaccine advocates, among us.

Today was a busy day for regulatory action:

  • The Secretary of Health and Human Services renewed for another 90 day period the COVID-19 public health emergency. Earlier this month, the HHS Secretary issued a similar renewal for the Opioid public health emergency which of course predates the COVID-19 emergency. Here’s a link discussing the actions that the federal government can take in response to a public health emergency declaration.
  • The Affordable Care Act regulators issued implementation guidance FAQs part 47 today. As background, “on June 11, 2019, the U.S. Preventive Services Task Force released a recommendation with an “A” rating that clinicians offer [pre-exposure prophylaxis (PrEP)] with “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.” Accordingly, [as required by the ACA, non-grandfathered] plans and issuers must cover PrEP consistent with the USPSTF recommendation without cost sharing [when provided in-network] for plan years (in the individual market, policy years) beginning on or after one year from the issue date of the recommendation (in this case, plan or policy years beginning on or after June 30, 2020).” The FAQs concern the scope of the requisite no cost sharing coverage for this particular service. Affected plans and issuers are allowed sixty days to implement the guidance.
  • The Centers for Medicare and Medicaid Services “proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021.” Here is a link to the fact sheet on the proposal. Consistent with the President’s recent executive order on competition, the CMS rule making “proposes to set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500.  Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.” That should be attention getting if finalized. Also the rule making proposes to backtrack on Trump Administration CMS rules that would phase out inpatient only Medicare requirements for certain medical procedures. The former administration’s goal was to lower costs, but the current administration finds that the former administration did not follow all of the necessary patient safety procedural requirements when making this change.
  • Govexec reports that today “marks the deadline for agencies to submit their finalized return to office plans to the Office of Management and Budget. These plans, which are not intended to be public, will vary by agency.”

The American Hospital Association informs us that “The Centers for Medicare & Medicaid Services will host a national stakeholders call July 22 at 3:30 p.m. ET on the interim final rule, Surprise Billing Part 1, that implements aspects of the No Surprises Act that bans balance billing in certain out-of-network scenarios. The call-in number is 888-455-1397; the participant passcode is 8758359.” Thanks AHA and CMS.

Thursday Miscellany

David Ermer–ACA, COVID-19, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog realized today that he had neglected to provide this link to Prof. Katie Keith’s comprehensive Health Affairs Blog article on the first No Surprises Act interim final rule. AIS offers the following expert takes on that rule:

Industry experts’ perspectives:

Loren Adler, an associate director at the USC-Brookings Schaeffer Initiative for Health Policy, says that the QPA formula could lock in high rates for providers in some regions, particularly areas where there is a paucity of certain types of providers. He interprets the QPA calculation in the IFR as “a pretty provider-friendly definition.
Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, says that it’s important to remember the larger picture — the No Surprises Act could reduce physicians’ revenue in some cases. She says that it could exacerbate physician shortages in areas that pay lower rates than others as physicians move to more lucrative locations.
Going forward, it’s hard to say whether the law and IFR will have inflationary effects on health care prices overall, Adler says. “The biggest piece of that, the determinant, will be the arbitration process,” he adds. He’s waiting to see what happens when the law actually comes into effect and arbitrations begin to take place.

The FEHBlog hopes that this law will not encourage providers to leave health plan networks.

On the COVID-19 front

  • David Leonhardt in the New York Times informs us about “Hopeful News on Delta. The Delta variant is more contagious. It does not appear to be more severe.” “If a new variant is not actually more severe, it doesn’t present a greater threat to a typical person who contracts Covid. Vaccinated people would remain protected. For children too young to be vaccinated, serious Covid symptoms would still be exceedingly rare — rarer than many other everyday risks, like riding in a car — and still concentrated among children with other health problems.”
  • U.S. Surgeon General Dr. Vivek Murthy issued “the first Surgeon General’s Advisory of this Administration to warn the American public about the urgent threat of health misinformation. Health misinformation, including disinformation, have threatened the U.S. response to COVID-19 and continue to prevent Americans from getting vaccinated, prolonging the pandemic and putting lives at risk, and the advisory encourages technology and social media companies to take more responsibility to stop online spread of health misinformation.

On the Aduhelm front:

  • The Wall Street Journal reports that “A pair of large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month. The Cleveland Clinic and Mount Sinai Health System in New York said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.”
  • Healthcare Dive informs us that “On a morning call with investors [today], UnitedHealth leadership said they were waiting on more information before making a coverage decision regarding Aduhelm, Biogen’s expensive new drug for Alzheimer’s disease priced at an average cost of $56,000 per year.”
  • STAT News tells us that

Normally, if a drug gets FDA approval, that means it has some benefit to patients. But the FDA decided to greenlight Biogen’s controversial drug Aduhelm without that guarantee.

That decision leaves patients, clinicians, and insurance companies in the dark. Under by far the most pressure is Medicare [and FEHB is a close second because FEHB carriers are on the hook for Medicare eligible annuitants drug coverage (see Wednesday’s post)}, since most patients eligible for the pricey drug have insurance through the taxpayer-funded program. Officials with the program just this week started the process for figuring out how Medicare will cover the drug, which will take months.

Some experts and stakeholders, including the influential Alzheimer’s Association, have called on Medicare to activate a rarely used regulatory tool to get more data about how well the drug works. (The FDA has also said Biogen must study whether Aduhelm slows down patients’ cognitive decline, but the drug maker has said it doesn’t have to report its results for another nine years.)

The tool, called a Coverage with Evidence Development, would mean Medicare would only cover Aduhelm for patients who enroll in clinical studies. The process has the potential to create real-world data that could help patients, physicians, and payers navigate unprecedented and difficult decisions.

In miscellaneous news

  • Healthcare Dive reports that “UnitedHealth Group handily beat Wall Street expectations for earnings and revenue in the second quarter, reporting revenue up 15% year over year to $71.3 billion, leading the Minnesota-based healthcare behemoth to increase its full-year guidance following the results.”
  • The Department of Health and Human Services announced that “more than two million people have signed up for health coverage during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which opened on February 15, 2021 as the country grappled with the pandemic, and will conclude on the extended deadline August 15, 2021.” * * * “The report also shows that of the new and returning consumers who have selected a plan since April 1, 1.2 million consumers (34%) have selected a plan that costs $10 or less per month after the American Rescue Plan’s (ARP) premium reductions.” The President wants Congress to make permanent this two year long premium reduction program.
  • Fierce Healthcare adds that “Senate Democrats announced late Tuesday the framework for a $3.5 trillion infrastructure package that will expand Medicare to offer dental, hearing and vision benefits.”

Thursday Miscellany

David Ermer–ACA, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
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

David Ermer–ACA, COVID-19, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
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

David Ermer–ACA, AHRQ, Congress, COVID-19, COVID-19 vaccine, Medicare, Telehealth, U.S. Healthcare–
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.