Monday Roundup

Medicare

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.”

Tuesday Tidbits

David Ermer–CMS, COVID-19, Medicare, Mental health care–
Photo by Patrick Fore on Unsplash

Today, the FEHBlog virtually attended the NCQA Digital Quality Summit. A highlight was a VA healthcare speaker who pointed out the VA’s access to care website which is nifty. The site, for example, includes comprehensive comparisons of VA care versus outside care. The site should be useful to FEHB carriers because the FEHB Program covers a large cadre of veterans.

The Centers for Medicare Services released its proposed calendar year 2022 Medicare Part B physician payment rule. According to the fee schedule fact sheet

With the proposed budget neutrality adjustment to account for changes in RVUs (required by law), and expiration of the 3.75 percent payment increase provided for CY 2021 by the Consolidated Appropriations Act, 2021 (CAA), the proposed CY 2022 PFS conversion factor is $33.58, a decrease of $1.31 from the CY 2021 PFS conversion factor of $34.89. The PFS conversion factor reflects the statutory update of 0.00 percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from our proposed policies.

That would cause a cost shift to commercial carriers.

From the tidbit front —

  • The first interim final rule implementing the No Surprises Act was published in the Federal Register today. It turns out that the public comment deadline is Tuesday, September 7, 2021.
  • The NIH Director Dr. Francis Collins relates that

Many people, including me, have experienced a sense of gratitude and relief after receiving the new COVID-19 mRNA vaccines. But all of us are also wondering how long the vaccines will remain protective against SARS-CoV-2, the coronavirus responsible for COVID-19.

Earlier this year, clinical trials of the Moderna and Pfizer-BioNTech vaccines indicated that both immunizations appeared to protect for at least six months. Now, a study in the journal Nature provides some hopeful news that these mRNA vaccines may be protective even longer [1].

In the new study, researchers monitored key immune cells in the lymph nodes of a group of people who received both doses of the Pfizer-BioNTech mRNA vaccine. The work consistently found hallmarks of a strong, persistent immune response against SARS-CoV-2 that could be protective for years to come.

Though more research is needed, the findings add evidence that people who received mRNA COVID-19 vaccines may not need an additional “booster” shot for quite some time, unless SARS-CoV-2 evolves into new forms, or variants, that can evade this vaccine-induced immunity. That’s why it remains so critical that more Americans get vaccinated not only to protect themselves and their loved ones, but to help stop the virus’s spread in their communities and thereby reduce its ability to mutate.

  • In other NIH news, NIH researchers report a conundrum:

Medications to treat alcohol use disorder, although effective, are only being used to treat 1.6% of people with the disorder, according to a new study.

The findings show that medications for alcohol use disorder are rarely prescribed, even though approved drugs are available.

  • In an article that may be helpful for FEHB plans to share with members, the Centers for Disease Control discusses the causes for type 2 diabetes.
  • Health Payer Intelligence reports that employers are shifting the focus of their wellness programs from physical health to mental health. “Over nine in ten employers said that they were increasing their mental health and wellness programming in 2021, including pediatric mental health programs, according to a survey from Fidelity and Business Group on Health. Almost 75 percent reported that they were extending work-life balance support.and nearly 70 percent were expanding their paid leave policies.”

Tuesday’s Tidbits

David Ermer–COVID-19, Medicare, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the COVID-19 front

  • The Hill informs us that “President Biden on Tuesday pleaded with Americans to get vaccinated against COVID-19 as the White House signaled a shift toward grassroots tactics to reach those who have yet to get a shot.” Here is a link to the President’s full remarks.
  • NPR Shots offers a daily look at each state’s progress in vaccinating its residents.

From the hospital pricing transparency front —

  • The Wall Street Journal explains how it has been analyzing the pricing data that federal law required hospitals to make publicly available on January 1, 2021. “The Journal reviewed hospital pricing disclosures collected by Turquoise Health Co., a startup that has been gathering the data from hospital websites since the regulations went into effect.” The Turquoise Health website is worth a gander.
  • NPR Shots also analyzed the newly available hospital pricing data. “While it’s still an unanswered question about whether price transparency will lead to overall lower prices, KHN took a dive into the initial trove of data to see what it reveals. Here are five takeaways from the newly public data and tips for how you might be able to use it to your benefit: 1) As expected prices are all over the map; 2. Patients can look up information but the info is incomplete; 3. Third party firms like Turquoise Health are trying to make searching prices simpler and cash in; 4. Consumers can use the data to negotiate with hospitals when paying cash, and 5. Hospitals are not fully on board currently.

In the tidbits department —

  • Today, the Centers for Medicare and Medicaid Services announced Dr. Meena Seshamani, M.D., Ph.D. [formerly with MedStar Health] as Deputy Administrator and Director of Center for Medicare. She started her work today.
  • Fierce Healthcare reports “The United Health Foundation, the philanthropic arm of the UnitedHealth Group, released its America’s Health Rankings Health Disparities Report last week, and the healthcare giant found a number of disparities worsened in the 2017 to 2019 time frame. While the data come from before the pandemic, experts say they offer a baseline that can be used to address critical public health needs. For example, adults who did not graduate high school had a rate of frequent mental distress that was 123% higher than people with a college degree. Females had a 70% higher rate of depression than males, according to the report.”
  • NPR Shots discusses how an “obesity drug’s [Wegovy] promise now hinges on insurance coverage.”

In clinical trials, weekly injections of semaglutide — or Wegovy, as it’s been branded — helped people drop an average of 15% of their body weight. That’s an average of about 34 pounds over 16 months, before their weight plateaued, a far greater weight loss, obesity specialists say, than achieved with other drugs on the market. At least as important, Wegovy raised none of the alarm bells with the FDA or obesity doctors that it might trigger serious side effects of the sort some people experienced by taking fen-phen or other previous medical treatments for obesity.

But with a price tag for Wegovy of $1,000 to $1,500 a month, a big question remains: Will insurers cover its significant cost for the millions who might benefit? * * *

Insurance coverage, it turns out, is a giant question — not just with Wegovy but with obesity drugs in general. Some private insurers do include some prescription obesity drugs in the list of medicines they’ll cover; it’s too early to tell whether Wegovy will make those lists. Many doctors and patients are optimistic, because it is a higher dose of an existing diabetes medication called Ozempic, which insurers often cover.

A few select state Medicaid programs will cover medications that treat obesity in some circumstances. But, significantly, Medicare does not cover obesity drugs — and many private insurers typically follow Medicare’s lead.

Yet the demand for a good treatment is there, says Dr. Fatima Cody Stanford, a leading obesity researcher at Harvard. She was not involved in conducting the Wegovy clinical trial but closely followed it. “I’m excited about it,” she says, because of the dramatic weight loss.

The drug acts on the brain so people eat less and store less of what they eat. That helps address the excess weight as well as helping with related diseases of the liver or heart, for example.

  • The FEHBlog enjoys book recommendations and so he lapped up STAT’s list of “the 36 best books and podcasts on health and science to check out this summer. Among them, this one particularly caught the FEHBlog’s attention as he has enjoyed reading this author’s output and the topic is intriguing: “The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race” By Walter Issacson I recommend it because this captivating book provided clear and accessible explanations of the scientific discovery of CRISPR-Cas9 and its remarkable power as a gene editing tool, interwoven with the complex human stories of Jennifer Doudna and her relationships with the many other accomplished scientists who brought it all together.— Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases”

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.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The Food and Drug Administration (“FDA”) announced today that the agency has “approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. 

“Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”

The Wall Street Journal adds

Biogen priced the newly approved drug higher than analysts expected. The company said it would charge about $56,000 a year per patient.

A preliminary analysis conducted by the Institute for Clinical and Economic Review, a nonprofit research and advisory group, said the drug could be cost-effective at a per-patient price of $2,500 to $8,300 a year.

Alzheimer’s is a progressive degenerative disease that slowly robs people of their memory and the ability to care for themselves.

About six million people suffer from Alzheimer’s in the U.S. Of those, as many as 1.4 million could be eligible to take Aduhelm, according to estimates by Cigna.

What’s more, according to the Journal,

Cigna will likely cover the drug for people who match the patients studied in Biogen’s clinical trials—those with early-stage Alzheimer’s and amyloid buildup in their brains—said Steve Miller, Cigna’s chief clinical officer.

Most Alzheimer’s patients are covered by Medicare, and their out-of-pocket costs could be significant, depending on their coverage, because of so-called coinsurance payments that require patients to cover a percentage of certain health costs, Dr. Miller said.

“The out-of-pocket testing costs could be a real barrier for those patients who lack the financial means,” said Dr. Miller.

Cigna estimates that patients with traditional Medicare insurance could be on the hook for more than $10,000 a year in coinsurance and copayments for the drug and amyloid testing, Dr. Miller said. Additional costs for people with supplemental Medigap insurance or commercial coverage through Medicare Advantage could reach up to $4,000 annually.

Dr. Miller said patients may be eligible for financial assistance to cover the extra costs through nonprofit foundations, which are often funded by drugmakers.

Healthcare Dive offers a comprehensive article about the new drug that is not behind a paywall.

From the COVID-19 front

  • David Leonhardt in the New York Times reports on his takeaways from Britain’s recent, modest rise in new COVID-19 cases:

One, vaccines are still the most effective way, by far, to defeat this terrible pandemic. Nothing matters more than the speed at which shots go into arms — in Britain, in the U.S. and especially in poorer countries, where vaccination rates are still low.

Two, behavior restrictions can still play a role in the interim. If hospitalizations or deaths in Britain rise over the next two weeks, there will be a strong argument for pushing back the full reopening of activities. And that has obvious implications for the U.S., too. Restricting indoor activities for unvaccinated people is particularly important.

Three, caseloads are no longer as important a measure as they used to be. Before the vaccines were available, more cases inevitably meant more hospitalizations and deaths. Now, the connection is more uncertain. As a recent Times story put it, paraphrasing British scientists, “upticks in new infections are tolerable so long as the vast majority do not lead to serious illness or death.”

  • The Society for Human Resource Management discusses stepped-up employer efforts to encourage COVID-19 vaccinations and reduce employee tensions over COVID-19 masks and vaccination in the workplace.
  • Medscape offers suggestions for healthcare providers and possible health plans on how to target COVID-19 vaccine hesitancy.
  • The Massachusetts Institute of Technology’s Pandemic Technology Project reports on best community practices in closing COVID-19 vaccination gaps.

From the OPM front

  • Govexec informs us that OPM “on Monday moved to finalize new regulations making it easier for federal agencies to bring back former employees at a higher salary than when they left government. Currently, federal agencies have the authority to rehire former federal workers outside the competitive hiring process, but they can only offer them positions at the same pay grade they held before they left federal service. Under a final rule set to be published in the Federal Register Tuesday, effective July 8, agencies will be able to use that process to rehire former federal workers at higher salaries than when they left government, accounting for the experience and skills they gained through education and the private sector.”
  • Federal News Network informs us that “Federal retirement activity slowed across the board last month, from new claims to backlogged cases and even the time it takes to process them. The latest numbers from the Office of Personnel Management showed that 7,684 new claims were filed in May compared to 9,414 in April — an 18.4% decrease month over month but a 15.6% increase from the same time a year ago. The number of claims processed also dropped to 8,451 in May versus 11,396. That’s a 25.8% decline month other month, although April was unusually high for processed claims when compared to historical monthly totals. May’s processed claims were about even year over year. The retirement backlog decreased from 25,386 claims in April to 24,619 claims in May, but that represented a 35.4% increase from May 2020. In January of this year, the backlog, which has not met it’s goal of 13,000 claims for more than a year and a half, peaked at 26,968 claims and has slowly inched back down.” It’s the FEHBlog’s understanding that OPM’s issues stem from an unnecessarily complex federal retirement system that only Congress can fix.

In other news

  • Beckers Hospital Review reports that “Walmart Health’s primary care medical group has filed paperwork to expand virtual care in 16 more states, Insider reported June 7.”
  • Healthcare Dive informs us that even before the new information blocking rule’s effective date, “the majority of hospitals have allowed patients to view and download their health information via their own patient portal [in recent year] . However, hospitals allowing patients to use third-party apps to see their data increased sharply from 2018 to 2019, according to a new report from the federal agency that regulates U.S. health IT.”

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

President Biden today announced a strategy for sharing “at least 80 million U.S. [COVID 19] vaccine doses globally by the end of June.

On the U.S. COVID-19 vaccination front

  • David Leonhardt reports in the New York Times that

When the C.D.C. reversed its Covid-19 guidelines last month and said that vaccinated Americans rarely needed to wear masks, it caused both anxiety and uncertainty.

Many people worried that the change would cause unvaccinated people to shed their masks and create a surge of new cases. On the flip side, a more optimistic outcome also seemed possible: that the potential to live mostly mask-free would inspire some vaccine-hesitant Americans to get their shots.

Almost three weeks after the change, we can begin to get some answers by looking at the data. So far, it suggests that the optimists were better prognosticators than the pessimists.

  • HR Dive informs us that “Vaccine mandates are not a consideration for 83% of employers responding to law firm Fisher Phillips’ recent pulse survey. That figure is up from January, when the firm recorded 64% of respondents saying they would not impose a vaccine requirement. At that time, 27% of employers said they had yet to decide if they would mandate vaccinations. “Most employers — 75% — said they are encouraging workers to get their vaccines, the May 25 survey results revealed.”

Fortune Magazine released its Fortune 500 and sitting in the top 10 are four healthcare companies (CVS Health (4), United Health Group (5), McKesson (7) and AmerisourceBergen (8). For the second year in a row the top two companies are Walmart and Amazon, both of which are attempting to break into the healthcare market.

In his latest FedWeek column, Reg Jones discusses continuing FEHB coverage of unmarried children of enrollees beyond age 26 provided the child is incapable of self-support. “The term “incapable of self support” generally means that the child earns less than the equivalent of GS-5, step 1 [$30,414 in 2021]. However, this is not a hard and fast rule. In making a decision, consideration is given to the child’s earnings and condition or prognosis.”

From the Centers for Medicare and Medicaid Services front:

  • Kaiser Health News reports that expanding health insurance coverage is the top priority of the newly installed CMS Administrator, Chiquita Brooks-Lasure.
  • Healthcare Dive tells us that Elizabeth Fowler, head of the Center for Medicare and Medicaid Innovation, said that CMMI’s ongoing strategy review has resulted in more conscious choices in where it should invest, which includes pivoting away from voluntary models. “Voluntary models are subject to risk selection, which has a negative impact on the ability to generate system-level savings. Providers that aren’t generating the extra revenue tend to exit the program, and those that are tend to stay,” Fowler, now on her third month at the job, said at a Health Affairs briefing. “So we are exploring more mandatory models.”
  • Fierce Healthcare informs us that Congress wants CMMI to be more transparent in its spending. A bipartisan letter “said CMMI’s authorizing statute, which was part of the Affordable Care Act, calls for the center to gather input from interested parties. However, this requirement has often been shunted aside by the center and rarely observed.”

Medcity News reports that the Labor Department’s top health benefits law enforcement priority is compliance with the federal mental health parity law.

To uphold the law and ensure parity in coverage, the labor department has two strategies in place, [Secretary of Labor] Walsh said.

The department’s Employee Benefits Security Administration agency has created a task force that focuses on enforcement of the act, he said. The task force is reviewing its inventory of case files, looking to identify potential violations and send out requests to payers for data on parity analyses, which they are required to maintain to show their compliance with the law.

Further, the Department of Labor, along with other government agencies involved in this work such as the Department of Health and Human Services and Internal Revenue Service, is providing regular reports to Congress on their findings and enforcement actions, Walsh said. This can help inform legislation on insurance coverage moving forward.

Govexec provides the latest Postal Service news, including a confirmed report that the FBI is investigating Postmaster General DeJoy “for allegations that he illegally pressured employees at his former company to donate to Republican candidates while promising to later reimburse them through bonuses.”

The Wall Street Journal reports today that

A drug sold by AstraZeneca PLC and Merck & Co. reduced the recurrence of breast cancer in women with an early but aggressive form of the disease, a long-running [blinded] international study found. The finding, which on Thursday was published online by the New England Journal of Medicine and released at a major cancer-research meeting, marked the latest advance in cancer treatments targeting the genetic traits of tumors. It could expand the arsenal of weapons against a hereditary form of breast cancer. The result also helps validate the pharmaceutical industry’s investment in a pricey new class of drugs that target cancer cells, known as PARP inhibitors.  * * *

PARP inhibitors work by blocking cancer cells from relying on a survival tactic: the ability to repair their own DNA after their DNA is damaged naturally or by other drug treatments. This, in turn, contributes to cancer-cell death.

Health regulators have approved these types of drugs in recent years to treat ovarian, breast, prostate and pancreatic cancers. The drugs have been found to be particularly useful against cancers associated with harmful mutations in genes known as BRCA1 and BRCA2. Women with these hereditary mutations have a higher risk of developing breast cancer, and often at a younger age than is typical. The BRCA mutations account for about 5% of the estimated 281,000 cases of breast cancer diagnosed annually in the U.S.

Weekend update

David Ermer–Congress, Medicare, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives will be conducting Committee business this week and is not expected to resume floor voting until June 14. The Senate will be conducting Committee business and floor voting this week. Tomorrow the Senate will begin the voting process for confirmed President Biden’s nominee for Centers for Medicare and Medicaid Services Administrator, Chiquita Brooks-LaSure.

The Supreme Court will hold another opinion day tomorrow which may be the occasion for the release of the California v. Texas Affordable Care Act constitutionality decision. Lexology discusses the fallout from the Surpreme Court’s December 2020 opinion in Rutledge v. PCMA narrowing the scope of ERISA preemption with respect to prescription benefit manager law. State legislatures have jumped on the opportunity created by the Rutledge opinion.

In 2021 alone, at least eight states have enacted some sort of PBM reform legislation, including Alabama, Arizona, Arkansas, Mississippi, New York, North Dakota, West Virginia and Wisconsin. PBM reform regulation has passed both the state house and senate in Texas and is on its way to the governor. These bills run the gamut of regulating the PBM industry, from prohibiting PBMs from charging pharmacies fees during and after the claims adjudication process, prohibiting PBMs from reimbursing their own affiliated pharmacies at a higher level than independent pharmacies to banning PBM discrimination against pharmacies participating in the Federal 340B medication discount program. This trend is likely to continue with almost 100 bills introduced across 39 states similarly aimed at regulating the PBM industry

Cost curve up. ERISA decisions like this one impact FEHB preemption because courts have interpreted the two preemption laws as generally analogous in scope.

In other news and opinions:

  • Medpage Today offers an op-ed about the importance of primary care. The FEHBlog agrees that “Patients need support for mental and physical health all in one place” and accordingly health plans should encourage the use of primary care.
  • Fierce Healthcare reports that “There was a significant increase in pharmacy fraud and abuse under the pandemic, analysts at OptumRx say. The pharmacy benefit manager giant recovered $300 million in fraud, waste and abuse spend in 2020 and documented the largest ever increase in fraudulent claims, which were up 300% compared to 2019. In addition, Optum’s investigative audits led to an increase of 135% in fraud recoveries last year from 2019. The average audit recovery per case was also 70% higher in 2020 than in 2019, Optum found. Optum found the fraudulent behavior concentrated among independent pharmacies and rarely found similar activity among retail chains, [Optum analysts] said. Due to the findings, the PBM axed 112 pharmacies from its network.
  • Kaiser Health News informs us that “Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down. The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services. At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals. The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs. But that rarely happened. Instead, these emergency rooms — not physically connected to hospitals — generally set up in affluent suburban communities, often near hospitals that compete with the free-standing ERs’ owners. And they largely treated patients who did not need emergency care, but still billed them and their insurers at expensive ER rates, several studies have found.” Good luck Colorado as this approach also may reduce surprise billing issues.

Midweek Update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, OPM, Rx coverage, Telehealth–

Tomorrow morning the House Oversight and Reform Committee will mark up its bipartisan Postal Reform Act (H.R. 3076) and the Postal Improvement Act (HR 3077). H.R. 3076 would eliminate the Postal Service’s unique obligation to pre-fund the cost of FEHB coverage for its annuitants. It also would create a subprogram with the FEHB for postal service employees and annuitants that would be fully integrated with Medicare Parts A (hospital), B (professional services) and D (prescription drugs) for annuitants over age 65.

Existing FEHB plans largely receive the financial benefit of Medicare Parts A and B integration, but OPM does not permit FEHB plans to offer Medicare Part D integration known as EGWPs. The FEHBlog expects H.R. 3076’s mandatory use of Part D EGWPs in the subprogram will unleash a gusher of new benefit savings for subprogram plans. Fingers crossed that successful adoption of Part D EGWPs in this subprogram leads OPM to allow carriers to add them in existing FEHB too. However, as currently drafted, the subprogram would launch on January 1, 2023, which is aggressive timing in the FEHBlog’s view.

Today according to the Wall Street Journal

The Centers for Disease Control and Prevention recommended that 12- to 15-year-olds receive the Covid-19 vaccine from Pfizer Inc. and BioNTech SE, expanding the nation’s vaccination campaign. 

The CDC took the step after its vaccination advisory panel voted to recommend the shot at a meeting Wednesday after reviewing clinical trial data and other relevant information. The vote by the Advisory Committee on Immunization Practices, or ACIP, was 14-0, with one voting member recusing. * * *

Covid-19 cases are rising in adolescents, and as older Americans have gotten vaccinated, adolescents make up an increasing proportion of the overall U.S. case count, Sara Oliver, a CDC medical officer, said. Adolescents accounted for 9% of reported cases in April, a larger proportion than cases involving people 65 years and older as more adults have been vaccinated, she said.

According to the CARES Act of 2020, health plans, including FEHB plans, must begin to cover the Pfizer vaccine without member cost sharing for this age group no later than fifteen days from today, May 27, 2021. According to the Journal, “Pfizer anticipates asking the FDA in September to authorize its vaccine’s use in children 2 to 11 years old should ongoing studies prove positive. The company said It plans to make a similar request for children 6 months to 2 years of age in the fourth quarter.”

In Biden Administration news, the American Hospital Association reports that

Health and Human Services Secretary Xavier Becerra today swore in Andrea Palm as deputy secretary. Confirmed by the Senate yesterday, Palm previously served as secretary-designee of Wisconsin’s Department of Health Services and in several leadership roles at HHS during the Obama-Biden administration.  
“My focus will be on improving the lives and livelihoods of the American people: tackling the COVID-19 pandemic, efficiently and equitably distributing vaccines, expanding access to affordable health care, addressing the epidemic of substance use disorders, and improving mental health care,” she said. 
Biden’s nominee to serve as Centers for Medicare and Medicaid Services administrator, Chiquita Brooks-LaSure, today moved one-step closer to confirmation with the Senate voting 51-48 to discharge the nomination. The Senate could hold a final vote on her confirmation next week.  

STAT News informs us

  • “Telehealth companies, flush with cash after the Covid-19 pandemic spiked both demand and investment, are now embarking on massive lobbying efforts to secure their interests on Capitol Hill. The goal is clear: Lawmakers are weighing whether to permanently loosen regulations that were temporarily eased during the pandemic. Among other changes, providers have been allowed to practice in states where they are not licensed, and Medicare has been permitted to pay providers the same for virtual visits as in-person ones. Lobbyists for the rapidly growing industry are determined to keep those changes intact.” Watch for this result the big infrastructure bill.
  • Amazon’s objectives for its nascent pharmacy business are straightforward: “better selection, better convenience, and better prices,” according to TJ Parker, the vice president of pharmacy at the company.“ It really is the Amazon playbook,” he said during a Wednesday panel at STAT’s Health Tech Summit. * * * “Customers really want more Amazon and less pharmacy and so our work from here is to make pharmacy truly as seamless to us as amazon.com [is] for other categories,” Parker said. Among Amazon’s latest offerings: a new price-comparison tool for medications, which launched Tuesday. Now, when someone searches for a prescription drug on Amazon, Amazon Pharmacy’s price for a drug is listed alongside the cost for Prime members at other pharmacies like CVS, Walgreens, Walmart, and Costco.” Watch out GoodRx.

On a related note, the Drug Channels blog assesses how Cigna’s growing pharmacy platform expands its channel power.

Last week, Cigna released its earnings for the first quarter of 2021. I was struck by how quickly Cigna’s Express Scripts PBM business has increased revenues and prescriptions from its retail pharmacy network. Our second chart below highlights this growth. The businesses in Cigna’s Evernorth segment—especially Express Scripts, Ascent Health Services, and InsideRx—are already providing rebate negotiation, network management, and/or a sourcing platform for Prime Therapeutics, Kroger, Humana, GoodRx, and Amazon.”

Midweek Update

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Mark Tegethoff on Unsplash

Govexec reports that at the Senate Homeland Security and Governmental Affairs Committee’s business meeting today, the Committee advanced to the Senate floor the nominations of Kiran Ahuja to be OPM Director along party lines and the three nominations of Postal Service Governors with bipartisan margins. The FEHBlog expects these nominations to be brought to the Senate floor next month.

From the COVID-19 front:

  • The Wall Street Journal informs us that “Vaccines appear to be starting to curb new Covid-19 infections in the U.S., a breakthrough that could help people return to more normal activities as infection worries fade, public-health officials say. By Tuesday, 37.3% of U.S. adults were fully vaccinated against Covid-19, with about 2.7 million shots each day. * * * With the U.S. recently averaging at least 50,000 new daily cases, the pandemic is far from over. But the U.S. is nearing a nationwide benchmark of having 40% of adults fully vaccinated, which many public-health experts call an important threshold where vaccinations gain an upper hand over the coronavirus, based on the experience from further-along nations such as Israel.”
  • Today the Centers for Disease Control released a report on the mRNA vaccines. Here are the highlights which support the Journal’s report particularly as over 2/3s of Americans over age 65 are fully vaccinated.

Clinical trials suggest high efficacy for COVID-19 vaccines, but evaluation of vaccine effectiveness against severe outcomes in real-world settings and in populations at high risk, including older adults, is needed.

What is added by this report?

In a multistate network of U.S. hospitals during January–March 2021, receipt of Pfizer-BioNTech or Moderna COVID-19 vaccines was 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged ≥65 years.

What are the implications for public health practice?

SARS-CoV-2 vaccines significantly reduce the risk for COVID-19–associated hospitalization in older adults and, in turn, might lead to commensurate reductions in post-COVID conditions and deaths.

  • The Wall Street Journal also reports that “Covid-19 tests for people to use to get quick results at home are finally becoming available to buy at pharmacies and retailers. Yet an obstacle might stand in the way of regular use: cost. * * * The U.S. Food and Drug Administration recently cleared over-the-counter sales of two of these rapid at-home screening tests, one from Abbott Laboratories and another from Quidel Corp. 

Major pharmacies recently said they plan to sell a two-pack of Abbott’s test for nearly $24, while Walmart says it will charge just under $20. The price for Quidel’s test hasn’t been released, though Quidel has indicated it will be less than $30 for a pair.

“Twenty-five dollars for a Covid test, I think most people would pay that once. But would they pay it every week or every two weeks?” says Zoe McLaren, a health economist and an associate professor in the School of Public Policy at the University of Maryland, Baltimore County. “It’s not designed to be a one-time cost.”

Dr. McLaren and medical-testing experts expressed hope that prices would drop if more companies get clearance to sell paper-strip tests. * * * Public-health authorities say they are glad to see the tests in stores, and the tests will be valuable tools for checking symptoms or for specific occasions, such as traveling or visiting relatives.

From the Medicare front

  • The Centers for Medicare and Medicaid Services released yesterday a proposed fiscal year 2022 Medicare Part A inpatient prospective payment system rule. “The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.8 percent. This reflects the projected hospital market basket update of 2.5 percent reduced by a 0.2 percentage point productivity adjustment and increased by a 0.5 percentage point adjustment required by legislation.”
  • Healthcare Dive provides its perspective on the proposal which evidently was well received by the hospital industry. “[T]he American Hospital Association applaud[ed] the provision that removes the requirement that hospitals report privately negotiated rates with Medicare Advantage payers on Medicare cost reports and another that repeals market-based weight methodology for determining payments.”

On the FEHB front

  • FedSmith advises that “Federal employees facing a future with children aging out of TRICARE should consider enrolling in an FEHB policy. This is because FEHB plans provide coverage for children in the family option up to age 26. Additionally, the family FEHB premium for the employee, spouse, and children may be less than the cost of the TYA option for one individual. FEHB employees who are eligible for TRICARE and interested in having their children covered in an FEHB plan have to enroll during Open Season. Federal employees with TRICARE also need to enroll in a plan at least a year ahead of retirement for the FEHB plan to be continue in retirement.” Interesting.

On the artificial intelligence front, Forbes lists its top 50 AI companies to watch. Enjoy.