Monday Roundup

Congress

Monday Roundup

David Ermer–Congress, COVID-19, Mental health care, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

The International Foundation of Employee Benefit Plans informs us that

The Department of Labor’s (DOL) Employee Benefits Security Administration along with the Office of Personnel Management, Internal Revenue Service, Department of the Treasury, Centers for Medicare & Medicaid Services, and Department of Health and Human Services (collectively, The Departments) issued an information collection related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage.​

In addition, the Departments and OPM are also seeking input about whether the requirements apply to Federal Employees Health Benefits carriers, including whether or not they are also health insurance issuers.

Here’s the FEHBlog’s input on that last point. Congress extended specific provisions of Division BB of the Consolidated Appropriations Act, 2021 to the FEHB Program when it created a new Section 8902(p) of the FEHB Act. Today’s notice concedes that Section 204 was not among those provisions in Section 8902(p). Regulations are intended to implement and interpret statutory law, and in the case of the FEHBP there is no statute to implement here. What’s more carriers already are obligated to report aggregated prescription benefit data to OPM. In other words, the regulatory field is occupied as far as the FEHB Program is concerned. The public comment deadline on this information collection notice is July 23, 2021.

The American Hospital Association gleefully reports

Nearly 100 bipartisan House members led by Reps. Thomas Suozzi, D-N.Y., and Brad Wenstrup, R-Ohio, urge the departments of Health and Human Services, Labor and the Treasury [in a June 17, 2021 letter] to ensure their rulemaking for the No Surprises Act reflects congressional intent for a balanced process to settle payment disputes between health plans and providers. The lawmakers also emphasized the need to provide sufficient time for public comments and evaluation through proposed notice and comment rulemaking. 

The FEHBlog wonders what caused Congress to fire this shot across the regulator’s bow. The statutory deadline for these rules is October 1, 2021, thereby creating an all too brief three month long implementation period for providers, payers, lawyers and arbitrators. This should be interesting.

To show that the FEHBlog is not entirely cranky as he writes this post, CVS Health announced today

Over the last year, Aetna, a CVS Health® company, has been implementing a comprehensive strategy to reduce suicide attempts 20 percent among Aetna members by the year 2025. With the right intervention and support, resources and management of suicidal thoughts, suicide is known to be preventable. In fact, 90 percent of people who die by suicide have a potentially treatable mental health condition.

This month, Aetna is launching its latest initiative — the development of a specialty provider network with a sole focus on suicide prevention in collaboration with Psych Hub, the world’s most comprehensive platform for mental health education. The joint effort will further arm Aetna practitioners with no-cost, evidence-based instruction, tools, and resources to identify and treat those at risk of suicide.

Well done and best of luck.

Also from the COVID-19 front Bloomberg informs us

After more than a year of obsessively tracking Covid-19 case numbers, epidemiologists are starting to shift focus to other measures as the next stage of the pandemic emerges.

With rich countries vaccinating growing proportions of their vulnerable populations, the link between infection numbers and deaths appears to be diminishing. Now, in some places the focus is on learning to live with the virus — and on the data that matter most to avoid fresh lockdowns.

“It’s possible we’ll get to a stage of only monitoring hospitalizations,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins University’s Coronavirus Resource Center, which has built one of the most comprehensive platforms to track the virus and its impact.

The Wall Street Journal provides an overview of the COVID-19 variant called Delta.

The latest data from The Centers for Disease Control and Prevention estimates the Delta variant makes up 9.9% of reported U.S. Covid-19 cases, while Alpha stands at 65.5%. * * *

Scientists are still studying the virus and their early conclusions aren’t definitive. But British scientists, who have probably done the most work on the variant, estimate it is from 40% to as much as 80% more infectious than the so-called Alpha variant, or B.1.1.7, which was first identified in England last year, is now prevalent in the U.S. and is itself more contagious than the version of the virus that emerged in China in 2019.

An analysis of more than 14,000 Delta cases by England’s public-health agency found a double dose of the shot developed by Pfizer Inc. and BioNTech SE reduces the risk of hospitalization after infection with Delta by 96%. Two doses of the vaccine developed by the University of Oxford and AstraZeneca reduce the risk by 92%, Public Health England said.

Very few of those hospitalized in the U.K. have been fully vaccinated, with the new cases mostly among younger people who aren’t yet vaccinated. There is no evidence that young adults and children are more at risk proportionately from this variant than other age groups, and the increased transmission mostly reflects the fact that they haven’t been immunized, scientists say.

In other news that caught the FEHBlog’s eye this Monday —

  • The FEHBlog enjoys following the healthcare efforts of business giants like Amazon, Apple, and Walmart. ZdNet reports on Microsoft’s new healthcare strategy.
  • Louisville KY television station WDRB tells us

Brentwood, Tenn.-based LifePoint Health [a large regional health system that owns over 80 hospitals] will acquire Louisville-based Kindred Healthcare LLC, a specialty hospital company, for undisclosed terms, according to a news release Monday. The deal is scheduled to close by the end of the year. The announcement comes weeks after Louisville-based Humana Inc. said it would absorb the remainder of the former Kindred’s home health and hospice business. In the news release, LifePoint said it plans to continue Kindred’s strategy of growing by establishing joint ventures and partnerships with hospitals. * * * LifePoint said it plans to invest $1.5 billion in its business following the deal.

At the time of wrapping up this post on Monday evening, the Senate had not yet taken up Kiran Ahuja’s nomination to be OPM Director. The FEHBlog will keep an eye on this matter. [Tuesday morning supplement — The Senate Press Gallery Calendar informs us that

The Senate on Tuesday morning at 11:45 am will hold two votes:

  1. Confirmation of the Fonzone nomination.
  2. Motion to invoke cloture on Kiran Ahuja to be Director of the Office of Personnel Management.

The Senate will recess following the cloture vote on the Ahuja nomination until 2:15 p.m. 

At 2:30 p.m. vote:

  1. Confirmation of the Ahuja nomination.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, SCOTUS, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

Happy Fathers’ Day and First Day of Summer.

Both Houses of Congress remain in session for Committee business and floor voting this week. Among the scheduled hearings for this week, the Senate Health Education Labor and Pensions Committee will hold a hearing on Tuesday morning to “examine vaccines, focusing on America’s shot at ending the COVID-19 pandemic.”

Speaking of which, Kaiser Health News reports on a June 10, 2021, FDA advisory committee meeting on pediatric COVID-19 vaccines. Here’s a link to the FDA’s briefing document.

Amy Howe who writes on the U.S. Supreme Court discusses the decisions that the Court is expected to issue over the remainder of this month and possibly early July. There are many interesting issues at stake but none of them relate to the FEHB Program.

STAT News offers an encouraging op-ed from two physicians who think that the pandemic has caused people to be more engaged with their healthcare. Hope springs eternal.

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Government Contracting, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate took no action on Kiran Ahuja’s nomination to be OPM Director today as Senators Booker and Peters remain out of pocket due to family illnesses.

On the hospital front —

  • The Advisory Board informs us about U.S. News and World Reports most recent rankings of children’s hospitals.
  • Axios reports that “Some of the hospitals with the highest revenue in the country also have some of the highest prices, charging an average of 10 times more than the actual cost of the care they deliver, according to new research by Johns Hopkins University provided exclusively to Axios.”

On the mental healthcare front, we have two articles on start- up companies from Katie Jennings in Forbes. One concerns Burlingame, Calif.-based Lyra Health and the other concerns “Lifestance Health Group, one of the nation’s largest outpatient mental health providers.” Check them out.

On the prescription drug front —

  • Healthcare Dive reports that “Anthem, one of the biggest U.S. payers, has joined an initiative to create low-cost generic drugs for hospital and retail pharmacies. The initiative CivicaScript, a subsidiary of hospital-owned nonprofit drugmaker Civica Rx, plans to initially develop and manufacture six to 10 common but pricey generic medicines that don’t have enough market competition to drive down cost, officials said Wednesday. The first generics could be available as early as 2022.”
  • Fierce Pharma informs us that “Antibody treatments have shown little success in helping COVID-19 patients with  severe disease. But a large [UK] study of hospitalized patients reveals that Regeneron’s antibody cocktail can reduce the chance of death in patients who haven’t produced their own antibody responses to the disease.”
  • STAT News interviews the Alzheimer Association’s CEO about the newly approved drug Aduhelm.

In miscellaneous news

  • The Wall Street Journal reports “Apple Inc. Chief Executive Tim Cook has said the company’s greatest contribution to mankind will be in health. So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction, according to people familiar with them and documents reviewed by The Wall Street Journal.”
  • Healthcare Dive tells us that “A University of Pennsylvania study that tracked Medicare claims for about 1.35 million beneficiaries who had joint replacement surgery found that hospitals participating in bundled payment programs spent less on the hip and knee joint procedures than hospitals receiving traditional fee-for-service payments. Spending, however, did not differ between hospitals that voluntarily joined bundling programs and those whose involvement was mandatory, according to the findings, which were published in a JAMA research letter. The results failed to validate assumptions that voluntary participants tend to achieve greater savings because they choose programs for the opportunity to reduce spending. The findings come as the head of the Center for Medicare and Medicaid Innovation, Elizabeth Fowler, suggested the agency would look to shift away from voluntary arrangements in favor of more mandatory models.”
  • Fierce Healthcare informs us that “The Centers for Disease Control and Prevention (CDC) released new interim guidance late Monday for healthcare providers treating patients with post-COVID conditions—an umbrella term the agency is using to capture a wide range of physical and mental health issues that sometimes persist four or more weeks after an individual’s COVID-19 infection. Sometimes referred to as “long COVID,” the conditions can present among COVID-19 patients regardless of whether they were symptomatic during their acute infection, the agency wrote in the guidance.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19 testing, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Senate Press Gallery informs us from today’s proceedings

12:22 p.m. Majority Leader Schumer announced that due to Senators Booker and Peters having family illnesses the cloture vote on the Ahuja nomination [to be OPM director] is delayed; and moved the Senate to a period of morning business.

It looks like the Majority Leader is concerned about a close vote. The FEHBlog will continue tracking and best wishes to the Booker and Peters families for speedy recoveries.

Federal Times reports that “Federal employees can enroll, re-enroll or change their flexible spending account coverage during the month of June, as the Office of Personnel Management announced June 14 that it authorized a special enrollment period as part of provisions outlined in the Consolidated Appropriations Act and the American Rescue Plan.”

The Federal Times adds

Because the Consolidated Appropriations Act authorized unlimited carryover of FSA funds for 2020 and 2021, feds that didn’t re-enroll in an FSA plan for 2021 but had remaining money left in their accounts in 2020 may wish to use the special enrollment period to reopen their accounts and gain access to those carried over funds.

The new flexibilities for the 2020 and 2021 plan years also allow enrollees with dependents who would have normally aged out of the program to continue to use those funds until the child is 14, rather than 13, and the government approved hand sanitizer and masks as FSA medical expenses.

In the tidbits department

  • STAT News informs us that “Amazon has made its FDA-cleared Covid-19 test available to consumers online, alongside a consumer diagnostics website where people can view their results. The consumer diagnostics website, AmazonDx.com, was previously only available to Amazon employees. As of Tuesday, however, it appears any customer can sign into the site using the same login information they use to access the shopping portion of the tech giant’s website.  Amazon received FDA authorization for the at-home test kit in May.”
  • Fierce Healthcare tells us that “A JAMA Internal Medicine study is the latest in a string of analyses revealing hospitals’ frequent noncompliance with a new federal mandate requiring them to post prices for medical services. Published Monday, the study found that, as of early March, 83 out of 100 randomly sampled hospitals were noncompliant with at least one of the major requirements of a new rule from the Centers for Medicare & Medicaid Services (CMS). This decreased slightly to 75 in a parallel review of the country’s 100 highest-revenue hospitals.
  • Healthcare Dive reports that “Humana is acquiring home-based services provider One Homecare Solutions from a private equity firm to beef up its at-home care offerings, as a growing number of payers foray into direct medical delivery. The acquisition of Miramar, Florida-based One Homecare, which does business as Onehome, follows Humana’s decision to snap up home health giant Kindred at Home for $5.7 billion and is meant to boost the insurer’s value-based home health strategy. Financial terms of the deal, expected to close in the second quarter of this year, were not disclosed.”
  • Healthcare Dive also reports that About half of physicians and even more patients said the U.S. healthcare system discriminates against people a great deal, a good amount or somewhat, according to a survey out Tuesday from the nonpartisan research group NORC at the University of Chicago. Patients’ trust in their primary doctor rises with age and income, though 12% of respondents said they have been discriminated against by a healthcare facility, and Black patients were twice as likely to report being discriminated against than White patients, the report found. But 81% of physicians gave their employers either an A or B grade for their efforts to address health equity, and said they’re optimistic their system will improve diversity and equity in the next five years.
  • Health Payer Intelligence discusses “six expectations employers have for provider care coordination Employers are looking for greater price transparency, reduced overtreatment, and improved patient experience, and overall better care coordination from their provider partners.”
  • The Wall Street Journal reports that “A national charity will for the first time buy medical debt, totaling $278 million, directly from hospitals, a push to speed financial relief to patients, many of whom shouldn’t have been billed at all under the hospitals’ financial-aid policies. RIP Medical Debt, which uses donations to wipe out unpaid medical bills, has reached a deal with nonprofit Ballad Health, a dominant hospital system in Tennessee and Virginia, to buy debt owed by 82,000 low-income patients. Many likely qualified for free care under Ballad’s policy but didn’t get it, executives at Ballad involved in the agreement said. The patients lacked applications, they said. RIP Medical Debt will abolish the total amount and is expected to notify households of the debt relief this month. Some bills are 10 years old.” Bravo.

In the OPM rule making agenda department, here are three more found in last Friday’s semi-annual regulatory agenda.

  • OPM is engaged in joint rule making with HHS to implement a provision of Consolidated Appropriations Act Division BB that Congress did not apply to the FEHB. “This joint rule with HHS would implement the prescription drug reporting requirements that apply to group health plans and health insurance issuers offering coverage in the group and individual markets under section 204 of the No Surprises Act.” OPM already has created aggregated pharmacy data reporting requirements for FEHB carriers.
  • OPM is engaged in joint rule making with HHS on the provider non-discrimination provision of the ACA Section 2706. While this law does apply to the FEHB, it’s unusual that OPM is teaming up with HHS to craft the rule.
  • OPM is engaged in a joint rule making with HHS on reporting requirements related to air ambulance and agent and broker services and HHS enforcement provisions under Division BB of the CAA 2021. OPM does need to create rules on air ambulance reporting related to the No Surprises Act.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, OPM, Rx coverage–
Thanks to Aaron Burden for sharing their work on Unsplash.

Happy Flag Day!

According to the U.S. Senate Press Gallery, sometime after 11:30 am tomorrow morning, the Senate will hold a cloture vote on Kiran Ahuja’s nomination to be OPM Director. If the cloture vote receives majority approval (assuming a quorum exists), then the Senate will vote to confirm Ms. Ahuja’s nomination sometime after 2:30 pm tomorrow.

From the COVID-19 front

  • MedPage Today reports that “While experience so far with COVID vaccines shows that some are associated with very rare, early side effects, experts say they have confidence about the long-term safety of these vaccines. That’s because past experience shows that severe side effects from vaccines most often appear within a time frame of about 6 weeks after vaccination, according to Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).”
  • Bloomberg reports that “Covid-19 vaccines from Pfizer Inc. and AstraZeneca Plc are highly effective after two doses at preventing hospitalization of those infected with the delta variant, underscoring the urgency in getting people fully protected, according to health authorities in England.” David Leonhardt adds in the New York Times that

The news about Covid-19 has been mostly positive in the U.S. over recent months. The vaccines continue to work well against every variant, and the number of Americans who have gotten a shot continues to rise.

But the U.S. still faces two problems. First, the pace of vaccinations has slowed, and a substantial share of Americans — close to one third — remains hesitant about getting a shot. These unvaccinated Americans will remain vulnerable to Covid outbreaks and to serious symptoms, or even death.

Second, the Delta variant — which appears to be both more contagious and more severe than earlier versions of the virus — is spreading rapidly within the U.S., after having first been identified in India. It now accounts for about 10 percent of cases, according to Dr. Scott Gottlieb, a former F.D.A. commissioner. * * *

“The Delta variant is by far the most contagious variant of this virus we have seen in the entire pandemic,” Dr. Ashish Jha saidyesterday. “The good news is the data suggests that, if you’ve been fully vaccinated, you remain protected, that the vaccines hold up.”

The clearest place to see this pattern is Britain, where the Delta variant has spread widely and where the vaccination rate is high. In Britain, there is “still no sign of increase in deaths, well after the strain has become dominant,” as Dr. Eric Topol of the Scripps Research Translational Institute noted.

Vaccine maker Novavax said Monday its shot was highly effective against COVID-19 and also protected against variants in a large, late-stage study in the US and Mexico.

The vaccine was about 90 percent effective overall and preliminary data showed it was safe, the company said.

While demand for COVID-19 shots in the US has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world.

That help is still months away, however. The company says it plans to seek authorization for the shots in the US, Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.

  • The Department Health and Human Services announced that it has “awarded $125 million to support 14 nonprofit private or public organizations to reach underserved communities in all 50 states plus the District of Columbia, Puerto Rico, Guam and the Freely Associated States to develop and support a community-based workforce that will engage in locally tailored efforts to build vaccine confidence and bolster COVID-19 vaccinations in underserved communities.”

Fierce Healthcare reports that

Following its acquisition of MDLive and the approval of new drugs in the market, Cigna’s Evernorth is expanding its care management program for weight loss.

The Weight Management Care Value program initially launched under Express Scripts as part of its slate of SafeGuardRx programs. Now, the company is harnessing the capabilities of other assets under its umbrella to broaden the program.

Members who enroll in the program will have access to new therapies like Novo Nordisk’s Wegovy, when clinically appropriate and prescribed by their doctor, as well as virtual care options provided by MDLive.

Here are two more OPM rule makings that were listed in OPM’s semi annual regulatory agenda that was released last Friday June 11

  • OPM has in store for us a new proposed rule on FEHB Enrollment and Changes in Enrollment “The Office of Personnel Management (OPM) proposes to amend title 5 part 890 of the Code of Federal Regulations governing the Federal Employees Health Benefits (FEHB) Program to allow OPM to make improvements and clarifications to the FEHB Program’s enrollment rules and processes, including centralizing certain health benefits enrollment functions. Currently, enrollment is administered by an enrollee’s employing agency or retirement system. This rule would allow OPM to leverage necessary IT functionality in order to conduct certain enrollment functions and collect information necessary to administer FEHB enrollments with greater efficiency and in alignment with the best practices of employer-sponsored insurance programs. In addition, OPM is proposing a process that would allow an employing office or OPM to decrease an individual’s enrollment type from self plus one or self and family to self only when there is only an enrollee and no family member.”
  • OPM plans to issue an interim final rule extending FEHB coverage to Tribal employees at 297 grant schools in accordance with the Consolidated Appropriations Act. This action suggests that the extension will take effect for the next Federal Benefits Open Season

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Michele Orallo on Unsplash

The House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week. The Senate’s Executive Calendar states that

Ordered, That at 5 p.m. on Monday, June 14, 2021, the Senate proceed to executive session to resume consideration of the nomination of Ketanji Brown Jackson, of the District of Columbia, to be United States Circuit Judge for the District of Columbia Circuit.

Ordered further, That at 5:30 p.m., all post-cloture time expire.

Ordered further, That following disposition of the Jackson nomination the cloture motions with respect to the nominations of Lina M. Khan, of New York, to be a Federal Trade Commissioner for the unexpired term of seven years from September 26, 2017 and Kiran Arjandas Ahuja, of Massachusetts, to be Director of the Office of Personnel Management for a term of four years, ripen.

Ordered further, That with respect to the motions to invoke cloture on Kahn and Ahuja nominations, the mandatory quorum calls required under Rule XXII be waived.

Ordered further, That if any of the nominations are confirmed, the motions to reconsider be considered made and laid upon the table and the President be immediately notified of the Senate’s actions. (Jun. 10, 2021.)

The FEHBlog will continue to keep an eye on Ms. Ahuja’s nomination.

Here’s a link to the Blue Cross FEP website for its COVID-19 vaccination incentive. FedSmith has a complete report on his experience with the new program.

Fierce Healthcare reports that

More than 96% of U.S. physicians have been fully vaccinated for COVID-19, with no significant difference in vaccination rates across regions, according to a new survey from the American Medical Association (AMA).

Of the physicians who are not yet vaccinated, an additional 45% do plan to get vaccinated, the AMA survey data (PDF) shows. The most common reason for not receiving the vaccine was that it was too new and has unknown long-term effects, according to physician responses.

The national AMA survey polled 300 physicians, including primary care doctors and specialists, between June 3-8. It’s the first survey to specifically collect data on practicing physicians’ COVID-19 vaccination rates, according to the AMA.

The survey results show an increase of more than 20% for physicians who have been fully vaccinated for COVID-19 compared to a May 2021 Medscape poll, AMA said.

“Practicing physicians across the country are leading by example, with an amazing uptake of the COVID-19 vaccines,” said AMA President Susan R. Bailey, M.D. in a statement.

In other encouraging news, the Wall Street Journal reports

The proportion of Covid-19 laboratory tests that are coming back positive is at the lowest recorded point since the pandemic took hold in the U.S., a sign of progress as the country moves ahead with reopening. * * *

The proportion of tests coming back positive has been consistently falling since April this year and is now at the lowest point since March 2020, the furthest back the Johns Hopkins data are available.

The low positivity rate [2%] is a signal that the drop in infections is really due to less disease in the country rather than because the U.S. is testing less for the virus, according to epidemiologists. It is another indication of how the U.S. is gaining ground against the Covid-19 pandemic, along with declining case counts, hospitalizations and deaths. 

“It’s a true reflection of a decrease in overall circulation in the U.S.,” said Anne Rimoin, an infectious-disease epidemiologist at the UCLA Fielding School of Public Health. “But we still do have pockets where we’re seeing transmission of the virus, and we need to be careful.”

NBC News adds that “There are only three Covid-19 patients at Sandra Atlas Bass Heart Hospital at North Shore University Hospital, on Long Island, New York — a far cry from when the hospital, which is part of Northwell Health, had as many as 600 patients during the peak of the pandemic. All three patients, who are in the intensive care unit, have one thing in common, said Dr. Hugh Cassiere, director of the hospital’s critical care services: They’re unvaccinated. The trend appears to be occurring at hospitals nationwide. “I haven’t had anyone that’s been fully vaccinated become critically ill,” said Dr. Josh Denson, a pulmonary medicine and critical care physician at Tulane University Medical Center in New Orleans.”

As the FEHBlog mentioned in Friday’s post, the federal government’s semi-annual regulatory agenda was posted on June 11. Over the course of this week, the FEHBlog will highlight the FEHB rule makings. Of note

OPM proposes to amend the Federal Employees Health Benefits Acquisition Regulation (FEHBAR) to update reporting requirements for health insurance carriers providing benefits through the Federal Employees Health Benefits (FEHB) Program. In the course of business, FEHB carriers collect pharmacy, enrollment, provider, person-specific medical and pharmacy claims, or in the case of managed care plans, encounter data related to enrollees and family members in order to provide healthcare coverage to those individuals. Under this proposed regulation, FEHB carriers would be required to submit this information to OPM, related to all benefits and services provided under the Program, on no less than an annual basis. This rule clarifies the requirements for FEHB carriers to furnish such reasonable reports, pursuant to 5 U.S.C. 8910, to better enable OPM, as a health oversight agency, to obtain the information necessary for proper administration of the FEHB Program.

View Rule (reginfo.gov) OPM first proposed to create an FEHB identifiable claims data warehouse in 2010. In 2015 OPM reported a massive data breach. Logically OPM should have backed off the idea of an FEHB identifiable claims data warehouse because that would be such an attractive target for hackers. It didn’t; OPM proposed an FEHB rule to create the identifiable claims data warehouse in September, 2019, and the rule making died at the Office of Management and Budget review stage three months later. OPM now has decided to take another bite at the apple; this time with an acquisition regulation.

OPM also has its own No Surprises Act rule making which includes the independent dispute resolution processes. 

This interim final rule with comment would implement additional protections against surprise medical bills under the No Surprises Act, including provisions related to the independent dispute resolution processes. 

New Section 8902(p) of the FEHB Act requires OPM to implement certain No Surprises Act provisions in the FEHB carrier contracts and to extend corollary obligations on healthcare providers by rule making. OPM states that this rule has a statutory deadline of October 1, 2021. HHS also is scheduled to release Part II of its No Surprises Act interim final rule making by the same date. The FEHBlog noted last week that Part I of that HHS rule making which has a statutory deadline of July 1, 2021, is pending OMB review.

Memorial Day Weekend update

David Ermer–CDC, Congress, Congress, COVID-19, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

Congress is on a State / district work break this coming week. The Supreme Court has over thirty cases to decide, including the latest Affordable Care Act constitutionality case, before adjourning for the summer in late June / early July.

The federal employee news organizations have highlighted portions of the President’s fiscal year 2022 budget proposal which was released last Friday.

  • The Federal Times reports that “President Joe Biden’s fiscal year 2022 budget anticipates a more than 50,000 full-time-equivalent employee increase to the federal payrolls next year, as part of concerted efforts to attract young and expert workers to federal service. * * * ‘The Federal workforce continues to become older on average. Almost 30 percent (635,397) of employees are older than 55, while 8.1 percent (176,805) of employees are younger than 30. By comparison, in the private sector, 23 percent of the workforce is younger than 30. Every single agency has fewer employees younger than 30 today than they had in 2010,’ the budget proposal’s analytical perspectives state.
  • Govexec informs us that “President Biden on Friday formally proposed an average 2.7% pay increase for federal civilian employees in 2022 as part of his fiscal 2022 budget proposal. * * * It was unclear Friday how Biden’s proposal would be divvied up between an across-the-board boost to basic pay and increases in locality pay. In recent years, pay raise provisions have included a 0.5% average increase in locality pay, although it was frozen at 2020 levels this year. * * * The proposal also marks a return to the principle of pay parity between the civilian and military workforce, as service members would also receive a 2.7% pay raise in 2022. 

Federal News Network offers three brief stories on the U.S. Postal Service

The Postal Service sent its first reduction in force notices to non-union management employees Friday [no indication of how many notices were sent out], and is planning to set higher prices on its mail products well above the rate of inflation [first class stamp would increase by 5% from 55 cents to 58 cents].

The Senate, meanwhile, voted [by unanimous consent] to confirm [Anton Hajjar] President Joe Biden’s third nominee to serve on the USPS Board of Governors. The board is now fully staffed for the first time since 2010, and will help the agency get its 10-year reform plan off the ground.

Thus the Senate has confirmed all three of the President’s Postal Governor nominees who shared a confirmation hearing with OPM Director Kiran Ahuja while Ms. Ahuja waits for a confirmation vote.

In healthcare news —

  • Bloomberg tells us that “The U.S. reported the lowest level of infection since the early days of the pandemic and welcomed back sports fans to stadiums. The Indianapolis 500 was run before 135,000 fans, the largest crowd for a sporting event since the pandemic began [but 1/3 of capacity].  * * * The world needs the cooperation of the Chinese government to trace the origins of Covid-19 and prevent future pandemic threats, two leading U.S. disease experts said Sunday.
  • NPR reports that “For children in particular, the risk of serious consequences from COVID-19 is the same magnitude as the risk they face from the flu, she says. But many parents seem more worried about the new and less familiar disease. * * * [E]xperts urge parents to try not to worry too much.
  • Because many FEHB plans provide hypertensive members with at home blood pressure monitor, the FEHBlog wants to share the American Medical Association’s views on what doctors wish their patients knew about home blood pressure measurement.

Finally, the FEHBlog’s eyes were drawn to the weekend Wall Street Journal’s Heard on the Street column which discusses the efforts of Walmart and Amazon to enter the healthcare business.

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And here are Tuesday’s Tidbits —

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

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.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, OPM, U.S. Healthcare–

Following up on yesterday’s post about the proposed Postal Service Health Benefits Program that Congress is considering, here is a link to the Senate Homeland Security and Governmental Affairs Committee’s press release on its companion bill to the House measure (HR 3706). The press release provides a link to the Senate bill for those interested.

The Office of Personnel Management issued a benefit administration letter to federal agencies “which provides guidance on the OPM implementation of FSAFEDS Program flexibilities offered under the Consolidated Appropriations Act 2021 and accompanying law and guidance.”

From the COVID-19 front, the American Hospital Association reports

FDA authorizes storing thawed Pfizer COVID-19 vaccine in refrigerator for up to 30 days before diluting. The Food and Drug Administration yesterday authorized storing thawed, undiluted vials of the Pfizer COVID-19 vaccine at refrigerator temperatures (35°F to 46°F) for up to 30 days after the company submitted data showing the vials can remain stable that long, up from the previously authorized five days. For details, see the updated fact sheet for health care providers administering the vaccine.
Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research, said the change should make it easier for vaccine providers such as doctors’ offices to administer the vaccine.
Once the thawed vials are diluted, providers must use them within six hours, a potential challenge for clinicians who lack sufficient demand for the vaccine during regular office visits.

That’s quite a conundrum. On the brighter side, Politico informs us

Emergent BioSolutions could resume manufacturing Johnson & Johnson’s Covid-19 vaccine within days, CEO Robert Kramer told a House [of Representatives] panel Wednesday. Restarting Emergent’s production of the J&J shot would revitalize efforts to get the single-dose vaccine to many Americans. The United States is currently relying entirely on vaccines from Pfizer and Moderna for its vaccination efforts; for the second straight week, the White House on Tuesday told state officials that the J&J vaccine was not available to order.

The American Medical Association adds that “The biggest impediment to getting more people fully vaccinated for COVID-19 is access, not vaccine hesitancy, according to Thomas R. Frieden, MD, MPH, former director of the Centers for Disease Control and Prevention during the Obama administration.” “We can make a lot of progress by making vaccination more convenient,” said Dr. Frieden, CEO of Resolve to Save Lives, an initiative to prevent epidemics and cardiovascular disease. “That’s really important. That means walk-in hours. That means easy locations, easy hours, supporting transportation and setting up pop-up sites outside of everywhere, from ballgames to bars to bowling alleys to shopping centers. We need to make it the default choice, basically, to get a vaccine.”

In healthcare business news,

  • Healthcare Dive lets us know that “Anthem and Epic on Wednesday announced a collaboration expanding bidirectional data exchange, in a bid to streamline administrative process like prior authorizations, a frequently cited pain point for providers, and give providers more real-time data on patient behaviors like medication adherence. The partnership will integrate Epic’s payer platform into Anthem’s operating system. The Indianapolis-based payer will also combine Epic’s information with other sources such as claims logs, health information exchanges and lab companies. Providers will also be notified of significant health events, such as when a patient is discharged, in an effort to improve follow-up care.” Awesome!
  • Fierce Healthcare reports that “While its joint venture with Amazon and Berkshire Hathaway, Haven, is no more, JPMorgan Chase is launching a new effort to address the cost and efficiency of employer-sponsored healthcare. Morgan Health will serve as a new business arm within the company that’s focused on these issues, the financial giant announced Thursday. Dan Mendelson will serve as CEO of Morgan Helth and report to Peter Scher, vice president of JPMorgan Chase. Mendelson is the founder and former CEO of Avalere Health.”

In healthcare news

  • The Associated Press informs us that “Screening and the HPV vaccine have led to drops in cervical cancers over the last two decades in the U.S., a new study finds, but the gains are offset by a rise in other tumors caused by the [HPV] virus. In the U.S., the HPV vaccine has been recommended since 2006 for girls at age 11 or 12, and since 2011 for boys the same age, and catch-up shots are recommended for anyone through age 26 who hasn’t been vaccinated. Experts agree it will take years to see the true impact because it can take decades for a chronic HPV infection to turn into cancer. What’s driving the HPV cancer trends is the youthful sexual behavior of baby boomers before the vaccine was out. The vaccine works best when given at younger ages before people are exposed to HPV through sexual activity, so it arrived too late for the boomers.
  • The Blue Cross Blue Shield Association reports that “Black women under the age of 24 are more likely to experience severe childbirth complications than white women over the age of 35 – an age group usually considered high risk, according to new data from the Blue Cross Blue Shield Association (BCBSA). Data shows the rates of childbirth complications have been increasing for women of color. In the last two years, the rate of Hispanic women with severe childbirth complications increased 19%. “There is an urgent maternal health crisis in our country,” said Kim Keck, president and CEO of BCBSA. “It is unconscionable that women of color face a greater risk of childbirth complications compared to white women. We must confront health disparities across the board to change the trajectory.” Amen to that.