Thursday Miscellany

Federal employment benefits

Thursday Miscellany

David Ermer–ACA, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare–
U.S. Supreme Court building, Wash. DC

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

As originally enacted in 2010, the Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage.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

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

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

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

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

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

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

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

In a burst of closing miscellany —

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

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.

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, U.S. Healthcare–

Mark Gongloff in Bloomberg opinion lays out the global COVID-19 situation quite clearly

Former FDA chief Scott Gottlieb, a sensible observer throughout this disaster, tells Michael R. Strain he sees Covid-19 becoming like the flu, both in its seasonality and fatality rate. He figures Americans will be fully back to work and school by the fall and then face a new Covid wave in the winter. But with widespread vaccinations, it shouldn’t be worse than a bad flu season. Sounds kind of nice. 

But in the developing world, vaccinations are lagging badly, giving the disease too many chances to evolve. The scariness of India’s “delta” variant may be overhyped, but it seems both more transmissible and severe than others, writes Sam Fazeli. Vaccines are effective against it. But it could make Covid more tiger-like again for unvaccinated Americans and Brits, including young people.

So developed countries must get far more serious about vaccinating the rest of the world to stem further deaths, mutations and economic damage. President Joe Biden promising to give the world 500 million Pfizer doses is a great start, but it’s only a start. 

Former U.K. Prime Minister Gordon Brown writes this Friday’s G-7 meeting is a chance for countries to commit to more such concrete action and spending. The world’s biggest countries must pony up to the best of their ability, as they have with other emergencies. 

Also from the COVID-19 front

  • The Centers for Medicare and Medicaid Services announced today that

While many Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy, their physician’s office, or a mass vaccination site, some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination in these settings. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.

  • The Department of Health and Human Services announced that

The U.S. government will procure approximately 1.7 million courses of an investigational antiviral treatment, molnupiravir (MK-4482), for COVID-19 from Merck, pending emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).

Molnupiravir (MK-4482) is designed to induce viral genome copying errors to prevent the virus from replicating in the human body, and evidence to date from clinical trials in patients with COVID-19 suggests that molnupiravir may reduce replication of the SAR-CoV-2 virus.

This treatment is being evaluated in an ongoing Phase 3 trial for its potential to reduce the risk of hospitalization or death in non-hospitalized patients who have symptoms for five days or less and are at high risk for severe illness. The trial plans to enroll a total of 1,850 patients globally with final data expected in the fall of 2021.

  • FedSmith offers more details on Blue Cross Federal Employee Program (FEP)’s announcement that it will offer a $50 wellness incentive to FEP members over age 18 who are fully vaccinated against COVID-19. Notably, “FedSmith has been advised that eligible members who have already been vaccinated for COVID-19 can also take advantage of this program and receive the $50 on their MyBlue Wellness Card. These individuals will also have to submit evidence of their COVID-19 vaccination record.”

From the general healthcare front

  • PriceWaterhouseCoopers (PwC) released its Health Research Institute’s 2022 projection of medical cost trend.

PwC’s Health Research Institute (HRI) is projecting a 6.5% medical cost trend in 2022, slightly lower than the 7% medical cost trend in 2021 and slightly higher than it was between 2016 and 2020. Healthcare spending is expected to return to pre-pandemic baselines with some adjustments to account for the pandemic’s persistent effects.

HRI defines medical cost trend as the projected percentage increase in the cost to treat patients from one year to the next, assuming benefits remain the same. Typically, spending data from the prior year is used as an input in the projection. For 2021 and 2022, the medical cost trend is the projected percentage increase over the prior year’s spending, with the effects of the pandemic removed from the prior year’s spending.

  • Not surprisingly, the American Hospital Association sent a letter to UnitedHealthcare stating in pertinent part that

America’s hospitals and health systems are deeply concerned by UnitedHealthcare’s (UHC) recent policy announcement [recently mentioned in the FEHBlog] to allow for the retroactive denial of coverage for emergency-level care in facilities. This policy would put patients’ health and wellbeing in jeopardy, and we urge you to reverse the policy immediately.

The AHA contends that UHC’s policy violates the Affordable Care Act’s requirement that heath plans adjudicate emergency care claims using a prudent layperson standards. The FEHBlog expects that UHC has taken this legal requirement into account. The FEHBlog will continue to follow this matter.

  • mHealth Intelligence reports that “New research out of the University of California Davis finds that telehealth treatments for people with non-urgent mental health needs can be delivered via an asynchronous (store-and-forward) platform just as well as through an audio-visual platform.” This approach could make the delivery of mental healthcare more efficient.
  • According to a company press release, “Datavant, the leader in helping healthcare organizations securely connect their data, and Ciox Health, the leader in clinical data exchange, today announced that they have signed a definitive agreement to merge the two companies in a transaction valued at $7.0 billion. The combined entity, to be named Datavant, will be the nation’s largest health data ecosystem, enabling patients, providers, payers, health data analytics companies, patient-facing applications, government agencies, and life science companies to securely exchange their patient-level data. “The fragmentation of health data is one of the single greatest challenges facing the healthcare system today,” said Pete McCabe, CEO of Ciox Health. “Each of us has many dozens of interactions with the healthcare system over the course of our lives, and that information is retained in siloed databases across disparate institutions. Every informed patient decision and every major analytical question in healthcare requires the ability to pull that information from across the health data ecosystem while protecting patient privacy. We are thrilled to join forces with the Datavant team to connect health data to improve patient outcomes. Together we are well positioned to navigate the technical, operational, legal, and regulatory challenges to doing so, and are committed to acting as a neutral connectivity solution for our many customers and partners.”
  • The National Committee for Quality Assurance answers questions about the use of electronic clinical data in HEDIS reporting. For example,

Q: How does administrative reporting relate to ECDS reporting?

A: Administrative claims are considered a key data source for ECDS reporting if the data can also be made available to a member’s care team. It is one of the four major data categories for ECDS reporting. The ECDS reporting method expands the types of data permitted for HEDIS® reporting by allowing the use of structured data from electronic health records, health information exchanges and clinical registries, and case management systems in addition to administrative claims.

Q: Is NCQA going to phase out the hybrid method of data collection from HEDIS?

A: NCQA is actively assessing the appropriateness of removing the hybrid reporting method from select HEDIS measures as other data sources improve.

Tuesday’s Tidbits

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

The Blue Cross Blue Shield Association announced today that

the Blue Cross and Blue Shield (BCBS) Government-wide Service Benefit Plan, also known as the Federal Employee Program® (FEP®) announced it will launch a COVID-19 Vaccination Incentive Program starting Friday, June 11, 2021, to encourage members to get vaccinated against COVID-19 and help meet President Biden’s goal of having at least 70% of the U.S. adult population receive one or more vaccinations for COVID-19 by July 4, 2021.

Eligible members – those over the age of 18 with an FEP MyBlue® account – will receive $50 on their MyBlue Wellness Card when they provide official documentation of their COVID-19 vaccination record. Members can use these incentive funds to purchase qualified medical expenses. FEP is the first Federal Employees Health Benefit program to offer a vaccination incentive like this to its members.

In other COVID-19 news —

  • The Wall Street Journal reports that

Pfizer and partner BioNTech SE said Tuesday that they have begun testing their vaccine in children under 12 years old in a pivotal study. If the results prove positive, Pfizer said it would ask U.S. health regulators in September to expand use to some of the younger children.

Meantime, Moderna Chief Executive Stephane Bancel said results of testing Moderna’s vaccine in children as young as five years could become available by the fall, which if positive could lead to regulatory authorization of its use in the younger age group.

  • Dr. Marty Makary writes in a Journal op-ed that “The news about the U.S. Covid pandemic is even better than you’ve heard. Some 80% to 85% of American adults are immune to the virus: More than 64% have received at least one vaccine dose and, of those who haven’t, roughly half have natural immunity from prior infection. There’s ample scientific evidence that natural immunity is effective and durable, and public-health leaders should pay it heed.”

Hospitals, state health departments and the federal government are racing to decide how to use up millions of Johnson & Johnson’s vaccine doses that are set to expire this month.

The prospect of so many doses going to waste in the U.S. when developing nations are desperate for shots would add pressure on the Biden administration to share stockpiled vaccines. But there are few practical solutions to administering them quickly in the U.S. or distributing them in time to foreign countries, according to those involved in the vaccination drive.

The stockpile is, in part, an unintended consequence of the U.S.’s decision in April to temporarily suspend administration of J&J doses to assess a rare blood-clot risk. The pause forced states and providers to cancel large blocks of appointmentsthat were never rescheduled, leaving a surplus of supply, and in some areas increasing hesitancy over the J&J vaccine’s safety, according to industry officials. * * *

The issue of expiring doses is the latest setback for J&J’s Covid-19 vaccine effort. An accident at a contract manufacturer’s plant led to the contamination of material that could have yielded up to 15 million doses and led to a halt in production of the J&J vaccine there.

This serious Johnson & Johnson one dose COVID-19 vaccine distribution problem impairs efforts to vaccinate people like the unhoused who are unlikely to return for a second dose of the mRNA vaccine.

Following up on yesterday’s news about Food and Drug Administration of an Alzheimer’s Disease drug, the Wall Street Journal offers a medical specialist’s observations on this terrible disease. Also Fierce Healthcare informs us that Biogen has “unveiled collaborations with CVS Health, Cigna to boost access to its Alzheimer’s drug.”

The Washington Post informs us that

Senate Republicans are blocking a quick confirmation for President Biden’s nominee to lead the federal personnel agency, targeting her past emphasis on the concept of systemic racism known as “critical race theory” that has become a lightning rod for conservatives.

Republicans also are pushing back on Kiran Ahuja’s support for abortion rights at a time when a long-standing ban on federal funding for the procedure — known as the Hyde Amendment — has emerged as a renewed flash point for the right because of Biden’s support for overturning it.

The delay on Ahuja’s nomination is being led by Sen. Josh Hawley (R-Mo.), although several Republicans objected to a quick confirmation vote for her, according to senior Democratic and GOP officials. The move will force Senate Majority Leader Charles E. Schumer (D-N.Y.) to go through procedural hurdles on the Senate floor, rather than move quickly with a pro forma vote that is more common for nominees to lower-profile posts.

In the tidbits department —

The majority of the average healthcare premium dollar goes toward prescription drugs and outpatient and inpatient hospital costs, according to AHIP’s most recent research.

AHIP looked at 30 commercial health insurance providers’ financial statements between 2016 and 2018 to get the breakdown of how payers were spending members’ premiums. The data included spending by employer-provided coverage and coverage that individuals can purchase on the healthcare market.

The biggest chunk of the healthcare dollar went towards prescription drugs, with 21.5 cents dedicated to payments for outpatient prescription medications and prescription medications administered in a physician’s office or clinic.

Prescription drugs are closely followed by spending on outpatient hospital and inpatient hospital services, both around 19 cents while medical services come in at 12 cents.

  • Healthcare Dive informs us that yesterday “Apple unveiled new health features aimed at patient-doctor data exchange.” Moreover, “Apple is launching new mobility capabilities for its iPhone. Using information from its motion sensors, the phone can now collect data on someone’s balance, stability and coordination by measuring stride length and timing, and warn them they might be at risk for a harmful fall if they’re walking unsteadily. Usually, fall risk is assessed by a provider using a questionnaire and in-person exam.” The new features will be available on Apple devices in the fall of this year.
  • According to a Department of Health and Human Services press release, “The White House, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Food and Drug Administration (FDA) today released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report – PDF and its recommendations have been accepted by President Biden.”

“To secure the supply chain, the report’s recommendations center on four pillars:

  1. Boosting local production and fostering international cooperation;
  2. Promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
  3. Creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance, and
  4. Leveraging data to improve supply chain resilience.”

Tuesday’s Tidbits

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

Today is the deadline for submission of 2022 FEHB benefit and rate proposals to OPM. Also on the federal employment front, Federal News Network reports that

Agencies have until July 19 to submit employee and contractor reentry plans to the Office of Management and Budget, the Biden administration said Tuesday.

Agencies must finalize their plans for both reopening offices and setting post-reentry procedures and policies by that date, the Safer Federal Workforce Task Force, in collaboration with OMB, the Office of Personnel Management and the General Services Administration, said in an email.

Those final plans will build on draft reentry plans, which agencies are supposed to submit to OMB by June 18.

Agencies can, in phases, bring more employees and contractors back to their work sites after completing their final reentry plans, satisfying collective bargaining obligations and giving the workforce advanced notice, the task force said.

According to the CDC, over 50% of the total U.S. population has received at least one dose of a COVID-19 vaccine.

Also from the COVID-19 vaccination front

  • Moderna announced today that “it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.” Pfizer took the same FDA approval step with its mRNA COVID-19 vaccine a few weeks ago. This FDA approval process likely will take several months.
  • The Centers for Medicare and Medicaid Services released an informational bulletin on COVID-19 vaccinations for adolescents. While directed at the Medicaid program, the bulletin is filled with useful information for everyone. What’s more, the American Medical Association offers its view on what doctors wish parents knew about these vaccines.
  • The National Institutes of Health Director, Dr. Francis Collins, explains on this blog that “Studies confirm COVID-19 mRNA vaccines [are] safe, effective for pregnant women.” “Overall, both studies show that COVID-19 mRNA vaccines are safe and effective in pregnancy, with the potential to benefit both mother and baby. Pregnant women also are more likely than women who aren’t pregnant to become severely ill should they become infected with this devastating coronavirus. While pregnant women are urged to consult with their obstetrician about vaccination, growing evidence suggests that the best way for women during pregnancy or while breastfeeding to protect themselves and their families against COVID-19 is to roll up their sleeves and get either one of the mRNA vaccines now authorized for emergency use.”

MedPage Today in an op-ed adds that “policymakers should include natural immunity as determined by an accurate and reliable antibody test or the documentation of prior infection (previous positive PCR or antigen test), as evidence of immunity equal to that of vaccination. That immunity should be given the same societal status as vaccine-inducted immunity.” (FEHBlog supplement — At least at this early stage when it’s not clear whether a booster is required.) The CDC should give more attention to this cadre.

From the flu vaccine front, the National Institutes for Health announced that “A first-in-human, Phase 1 trial assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine designed to provide long-lasting protection against multiple flu virus strains has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland.” Wild.

In other good news, Health Payer Intelligence reports that “Member satisfaction has improved significantly among commercial health plans, JD Power’s 2021 commercial member health plan study found. “The past year has proven without a doubt that effective use of digital channels has the power to increase customer engagement, build trust and promote brand advocacy,” said James Beem, managing director of global healthcare intelligence at J.D. Power.“While many plans are showing tremendous progress by delivering for their members during a highly volatile and stressful period, they still have a long way to go when it comes to delivering consistently strong levels of customer engagement across all segments of their member populations.”

Regarding the President’s Fiscal Year 2022 Budget proposal

  • Govexec informs us that “President Biden ends trend of [federal employee] benefit-cutting budgets, but new Federal Workforce Initiatives are still being developed. Most of the workforce provisions outlined in the president’s first budget submission are vague references to policies that will be part of the forthcoming president’s management agenda.”
  • Becker’s Hospital Review offers seven takeaways on the budget proposal for healthcare executives.
  • Forbes Magazine predicts that President “Biden’s answer to the [looming] Medicare Trust Fund Insolvency is hidden In his Budget Proposal.” The answer, by the way, is to pay Medicare Part A from the general treasury like the other parts.

In other crystal ball articles

  • The Journal of AHIMA discusses how this health informatics organization is preparing for the post-pandemic world.
  • Healio predicts how primary care providers will use telehealth in the new normal. The answer is quite a bit. “Thirty-five percent of adults in the United States who were surveyed said they would consider leaving their primary care physician for qualified physicians providing on-demand telehealth services. This percentage was even higher — 50% — among Generation Z and millennials, according to the data. Older adults also expressed interest in telehealth services, with 48% of respondents aged 65 years and older reporting that they will likely continue to use telehealth after the COVID-19 pandemic.”

Midweek Update

David Ermer–COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–

The Wall Street Journal reports that

A monoclonal antibody drug to treat early Covid-19 infections has been authorized by the U.S. Food and Drug Administration, said Vir Biotechnology Inc.and GlaxoSmithKline PLC, makers of the drug.

The drug, called sotrovimab, is the third antibody medicine authorized to treat patients early in the course of disease who are at high risk of developing severe cases.

Vir and Glaxo said in March that a study of the drug had been stopped early because it was shown to be highly effective, reducing hospitalizations or death by 85%, compared with a placebo. * * *

It is unclear what near-term role the drug will play in the U.S., where new infections are falling and there remains a glut of unused antibody drugs made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.

Having a Plan B usually is a prudent step.

Speaking of prescription drugs, Healthcare Dive informs us that

  • “The Institute for Clinical and Economic Review, a nonprofit and frequent critic of drugmakers for excessively high drug prices, now plans to assess how health insurance policies harm patient access to care, the group announced Tuesday. This follows research by the group that argued cost-sharing should not be structured to shift healthcare costs to patients when they have no medically appropriate lower cost option.
  • “ICER’s review will not, however, look at whether cost-sharing should be reduced for drugs on which payers receive large rebates or whether payers should be asked to demonstrate how their policies on drug access save overall healthcare costs.
  • “Drugmakers have repeatedly tried to shift the blame for high out-of-pocket costs and limited access to drugs by pointing to the design of insurance plans. ICER’s review suggests a new emphasis by the group on examining the role insurers play alongside pharmaceutical companies in determining patient access and costs.”

Fedweek features Reg Jones’ latest missive on the relationship between federal employment benefits and life events. This report concerns the coverage of children under FEHB and FEGLI.

The FEHBlog has been tracking developments in the implementation of the No Surprises Act. In the course of doing so today, he found several letters from healthcare trade associations to federal regulators on this topic. Because it can be helpful to look over the fence, here are implementation comments from American Association of Orthopedic Surgeons, the American College of Radiology, the National Association of Free Standing Emergency Centers, the American Association of Medical Colleges, and the American College of Emergency Physicians. What’s more the Workgroup for Electronic Data has helpfully collected links to a bevy of expert analyses of the law. It’s a heavy lift.

In healthcare business news

  • Healthcare Dive tells us that “Hospital operator HCA Healthcare is linking up with Google Cloud on a new data analytics platform to support provider decision-making, the companies announced Wednesday. The deal between the 186-hospital system and the technology behemoth will build on HCA’s existing use of technology to streamline both clinical and non-clinical operations, and represents “significant investments” in the system’s mobile functions, the companies said. The goal is to give doctors and nurses workflow tools, analysis and alerts on their mobile devices for real-time updates on patients’ conditions, while also improving workflows such as supply chain, human resources and physical plant operations.”
  • Fierce Health reports that “The combined company of Grand Rounds Health and Doctor On Demand has expanded yet again to include a care concierge platform for the LGBTQ+ community. The virtual care companies announced Wednesday they signed a definitive agreement to acquire Included Health to improve health outcomes and address the health challenges facing communities including lesbian, gay and transgender patients as well as black, indigenous and people of color (BIPOC), the companies said in a press release.” Terms of the agreement were not disclosed

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.”

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.

Postal Reform Update and More

David Ermer–Congress, Federal employment benefits, U.S. Healthcare–

The Washington Post reports today that

A bipartisan group of senators [led by the Chair and Ranking Member of the Senate Homeland Security and Governmental Affairs Committee] introduced legislation Wednesday to lift significant financial burdens off the ailing U.S. Postal Service while tightening accountability requirements for mail delivery, a major stride for an agency that has tussled with its balance sheet and reputation for the better part of a year. The bill, identical to a version that has advanced in the House [H.R. 3706], would repeal $5 billion a year in mandatory retiree health-care expenses and require future postal retirees to enroll in Medicare[ via a Postal Service Health Benefits Program (“PSHBP’) within the FEHB Program]. Advocates say the measures would save the agency $30 billion over the next decade.

FedSmith recapitulates the key aspects of the PSHBP provisions in the House bill for us. FedSmith also helpfully shares NARFE’s comments on the House bill. However, FedSmith concludes that “What is not mentioned in the [House] bill, but a possibility that could impact the rest of the federal workforce is the possibility that this “reform” package could become just the first step in removing federal retirees from the FEHB.”

With all due respect to FedSmith, OPM, and presumably Congress, knows full well that removing retirees from the FEHB would discourage federal employees from opting for long term employment with the government. Currently, if a federal employee has at least five years of FEHB coverage preceding their civil service retirement, they carry FEHB coverage into retirement with the full government contribution.

FEHB coverage tops any Medicare supplement plan out there by a long shot. What’s more the dirty little secret of Medicare is that federal law does not prohibit Medicare supplement plans to impose pre-existing condition limitations on prospective members except when an individual becomes first eligible for Medicare. (Only four northeast states prohibit that practice.) For example, the FEHBlog lives in Maryland which allows Medicare supplement plans to impose pre-existing condition limitations. If the FEHBlog had picked a Medicare Advantage plan initially and later wanted to switch to traditional Medicare, his selection of Medicare supplement plans would be limited particularly he had encountered health problems.

In any event, annuitants with primary Medicare coverage are good FEHB risks who help control premiums for everyone. For those reasons, the FEHBlog does not foresee annuitants being removed from the FEHB. He would like to see OPM permit FEHB carriers to offer Medicare Part D prescription drug plan integration in their “traditional” plans because that Part D integration and not the Part A and B integration will generate the greatest savings for the PSHBP carriers. Congress already opened the door the FEHB integration with Medicare Part D In the Medicare Modernization Act of 2003 which created Part D.

Here are some other nuggets of interest:

  • Reg Jones continues his series on federal employee benefits in FedWeek. This week’s article concerns opportunities to enroll in or change coverage in federal employee benefit programs upon marriage.
  • The National Committee for Quality Assurance takes us on a trip along the road to health equity.
  • Healthcare Dive reports that “CommonSpirit Health and Essentia Health have called off a deal for Essentia to acquire 14 CommonSpirit facilities in North Dakota and Minnesota, the two Catholic systems announced Tuesday.”

Tuesday’s Tidbits

David Ermer–Congress, Federal employment benefits, HIPAA Privacy and Security Rules, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog had been wondering what was going on with the Postal Reform bill that includes a new Postal Service Health Benefits Program. It turns out that the House Oversight and Reform Committee plans to mark up the latest draft of that bill on Thursday morning. The FEHBlog plans to tune in for this meeting.

In health equity developments —

  • The Wall Street Journal reports that “Ride-sharing companies Uber Technologies Inc. and Lyft Inc. will make all rides to and from vaccination sites free until July 4 under a new partnership with the White House. * * * While the companies were already providing free or discounted rides in some circumstances, the rides will now be free to anyone in the U.S. who is going to a vaccination site to get the shot, and Lyft and Uber will promote the rides to and from tens of thousands of vaccination sites through their apps. The feature will launch in the next two weeks and run until July 4.”
  • Health Leaders Media informs us about Horizon Blue Cross’s ongoing efforts to advance health equity in New Jersey in cooperation with healthcare and community organizations as well as solid data.
  • The American Medical Association released a “strategic plan to embed racial justice and advance health equity.” “With the input of many both inside and outside of AMA, this strategic plan serves as a three-year roadmap to plant the initial seeds for action and accountability to embed racial justice and advance health equity for years to come.”

In regulatory developments –

  • Professor Katie Keith in the Health Affairs blog provides background on yesterday HHS decision to “interpret Section 1557 and Title IX, which prohibit discrimination on the basis of sex, to include discrimination on the basis of sexual orientation and gender identity.”
  • Fierce Healthcare reports that “The Centers for Medicare & Medicaid Services has sent its first wave of warning letters out to hospitals breaking federal rules requiring them to disclose payer-negotiated prices, a spokesperson for the agency confirmed.”
  • Healthcare Dives discusses healthcare organization comments to HHS’s Office for Civil Rights on its proposed rule that would make generally helpful adjustments to the HIPAA Privacy Rule, in the FEHBlog’s opinion.

Miscellaneous tidbits —

  • Reg Jones discusses the Federal Employees Group Life Insurance Program in FedWeek.
  • The Society for Human Resources Management writes about “Supporting Mental Health in the Post-Pandemic Workplace.”
  • Health Payer Intelligence discusses Blue Cross of North Carolina’s successful effort to consolidate member experience data from across the company to boost member satisfaction.