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.
Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 24th week of this year (beginning April 2, 2020, and ending June 16, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):
and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:
The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 16, 2021):
Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 16, 2021 (six months) which also uses Thursday as the first day of the week:
President Joe Biden urged unvaccinated Americans to get inoculated from coronavirus, warning that the highly transmissible delta variant of the virus could cause more deaths. “Even while we are making incredible progress [as reflected above], it remains a serious and deadly threat,” Biden said Friday during a White House event to celebrate 300 million doses of vaccine administered during the first 150 days of his administration.“The data is clear: If you are unvaccinated, you’re at risk of getting seriously ill, or dying, or spreading it.” A large swath of Americans — particularly in the politically conservative South — have declined shots despite warnings from health authorities that the virus remains a threat.”
in other COVID-19 news
Medscape informs us that “While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association (AHA)/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay. ‘We remain confident that the benefits of vaccination far exceed the very unusual risks,’ the leadership of the AHA/ASA said in a statement issued June 12. ‘The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,’ they point out. Late last week, the Centers for Disease Control and Prevention (CDC) alerted healthcare providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer–BioNTech or Moderna.
MedPage Today reports that “During the American Medical Association (AMA) House of Delegates annual meeting, members debated whether natural immunity or previous infection with SARS-CoV-2 was sufficient for the merit of immunity credentials.” The House of Delegate voted against treating natural immunity as equivalent to vaccination. “Multiple delegates pointed out that using natural immunity in lieu of vaccination would pit the AMA’s recommendations against those of the CDC.” Nevertheless as the Mayo Clinic points out, natural immunity helps us achieve some level of herd immunity. It needs to be considered with vaccinations for that purpose.
If you want more details on yesterday’s Affordable Care Act decision from the U.S. Supreme Court, check out Prof. Katie Keith’s post in the Health Affairs blog.
Beckers Hospital News lists seven Fortune 500 health insurers by membership. Health Payer Intelligence discusses the latest sustainability report from the company that tops this list, UnitedHealth Group.
On this Juneteenth holiday, Fierce Health tells us about how “healthcare executives call on President Biden to take ‘innovative, bold’ steps to tackle health equity using AI, big data.”
“It’s not a lack of data—we have so much data in this country now, in our healthcare systems and our EHRs and our patient registration systems,” Cole said. “The data is there but the analytics capability of that—what to do with that data—is something that we’re continuing to work on every day.”
Cole and John Lumpkin, M.D., president of the Blue Cross and Blue Shield of North Carolina Foundation, said both of their organizations have been reworking their collection and organization of race, ethnicity, gender identity and other related data tied to health inequity—a change that “should be a very simple thing to do” but requires an internal data system overhaul, Lumpkin said.
Still, executives said the finish line of those efforts is worthwhile. Incorporating SDOH data can yield substantial health and costs benefits at the individual and population levels, they said.
The Wall Street Journal reports on the rising fortunes of the country’s major pharmacy chains, CVS Health and Walgreens.
In health system merger news —
Healthcare Dive informs us that “Beaumont Health and Spectrum Health are looking to merge in a deal that would result in Michigan’s biggest health system with 22 hospitals and 64,000 employees across the state, with combined annual revenue of almost $13 billion. Executives of the two systems announced Thursday they have signed a letter of intent to explore creating a joint health system. The deal would include Spectrum’s Michigan-based health insurance plan, Priority Health, which has 1.2 million customers.”
Fierce Healthcare reports that “Southern health systems Ochsner Health and Rush Health Systems have announced plans for a merger they expect to be completed about halfway through 2022. The deal follows a 2019 strategic partnership between the two nonprofit providers and comes hot on the heels of Louisiana-based Ochsner’s merger with Lafayette General Health, which closed in October 2020 and grew the system to 35 hospitals. Rush, which has seven hospitals and more than 30 clinics in eastern Mississippi and western Alabama, will be rebranded as Ochsner Rush Health should the merger receive regulatory approval.”
Healthcare Dive also tells us that “Tenet, a major U.S. health system, has agreed to sell five hospitals in the Miami-Dade area for $1.1 billion to Steward Health Care System, a physician-owned hospital operator and health network. The deal also includes the hospitals’ associated physician practices. Dallas-based Steward has agreed to continue using Tenet’s revenue cycle management firm, Conifer Health Solutions, following the completion of the deal, which is expected to close in the third quarter. Further underscoring Tenet’s strategic focus, the sale will not include Tenet’s ambulatory surgery centers in Florida. Tenet will hold onto those assets as its ambulatory business becomes a bigger focus for the legacy hospital operator.”
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.’”
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.”
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.”
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.
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.”
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
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.
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.
Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 23rd week of this year (beginning April 2, 2020, and ending June 9, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):
and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:
The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 9, 2020):
Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 9, 2021, which also uses Thursday as the first day of the week:
All signs continue to look up. 50% of the American population over 12 years old is fully vaccinated per the CDC.
In COVID-19 news, the Food and Drug Administration announced the latest actions stemming from its ongoing investigation of the problematic Emergent Biosolutions Baltimore factory that had been manufacturing the Johnson & Johnson one dose COVID-19 vaccine:
[The FDA] is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management. * * *
The FDA has determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed.
Per Fierce Healthcare, the New York Times is reporting that the unsuitable batches total 60 million vaccine doses. Yikes.
Most employers “no longer need to take steps to protect their workers from COVID-19 exposure in any workplace, or well-defined portions of a workplace, where all employees are fully vaccinated,” the Occupational Safety and Health Administration said in guidance updated Thursday.
The agency also published an emergency temporary standard for U.S. healthcare employers. Employers included in the emergency temporary standard’s definition must develop and implement a plan to protect employees from COVID-19 in the workplace, and they must designate one or more workplace COVID-19 safety coordinators to implement and monitor their plans. The document also lays out requirements for patient screening and management, personal protective equipment and physical distancing, among other subjects.
OSHA’s updated guidance for all industries, meanwhile, encourages employers to grant paid time off for employees to get vaccinated. Employers also should implement physical distancing for unvaccinated and other at-risk workers in communal work areas, including limiting the number of such workers in one place at any given time.
In other healthcare news
Precision Vaccines informs us about an Avalere Heath study finding that non-COVID immunizations among adolescents and adults were significant down last year.
The American Medical Association discusses five ways healthcare must change for the post-pandemic world.
Cleveland Clinic, IBM, Aetna and Anthem have partnered to form a blockchain health firm, called Avaneer Health.
The Chicago-based healthcare company will aim to use blockchain capabilities to make healthcare more efficient and reduce administrative costs, according to a June 9 news release.
Five things to know:
Avaneer Health will be formed as a standalone business with significant investments from its founders: Aetna, Anthem, Cleveland Clinic, Health Care Service Corporation, IBM, The PNC Financial Services and Norfolk, Va.-based Sentara Healthcare.
Avaneer Health is a member-based open network supporting utilities developed for the healthcare industry. It is expected to improve healthcare by removing administrative barriers and alleviate inefficiencies in cross-party transactions that slow down care delivery.
The incoming CEO will be Stuart Hanson, former managing director and senior healthcare industry executive at JPMorgan Chase. He will take the helm in August.
The company will be built on blockchain technology to ensure privacy and reduce costs of data exchange.
Finally, the Biden Administration released its Spring 2021 semi-annual regulatory agenda.
The Unified Agenda provides uniform reporting of data on regulatory and deregulatory activities under development throughout the Federal Government, covering approximately 60 departments, agencies, and commissions. Each edition of the Unified Agenda includes regulatory agendas from all Federal entities that currently have regulations under development or review. Agencies of the United States Congress are not included. Fall editions of the Unified Agenda include The The Regulatory Plan, which presents agency statements of regulatory priorities and additional information about the most significant regulatory activities planned for the coming year.
The FEHBlog will be discussing the OPM agenda in next week’s posts.
In this week’s Econtalk podcast episode, the host Russ Roberts holds a conversation with author Ian Leslie about his book Conflicted. “Leslie argues that, far from being a negative thing, conflict is often the essential ingredient that helps us get to the right answer or best solution. Because some of our best thinking comes in collaboration with others, learning how to disagree civilly when our views conflict is the key to productive conversation in business and in marriage.” Outstanding.
Sobering news from the Wall Street Journal that “It took less than six months for the globe to record more than 1.88 million Covid-19 deaths this year, according to a Wall Street Journal analysis of data collected by Johns Hopkins University. The university’s count for 2021 edged just ahead of the 2020 death toll on Thursday. These numbers underscore how unevenly the pandemic spread around the globe, often hitting poorer nations later, but before they had access to the vaccines that have benefited Europe and the U.S. * * * Vastly different vaccination rates have sharpened the global divide. Only 2% of people in Africa and just over 6% in Asia have received at least one dose of vaccine, according to Our World in Data. That compares with 22% in South America, more than 40% in the European Union and more than half in the U.S. * * * World leaders are due to discuss their response to the pandemic when they gather in Cornwall, in southwestern England, on Friday.” David Leonhardt sheds light on the vaccinating the world in the New York Times. The bottom line is as he points out: “A rapid global vaccination program — combined with natural immunity in people who have already had Covid — could create the same virtuous cycle that’s underway in the U.S., Britain and other countries: A decline in cases feeds on itself, as there are fewer infected people able to spread the virus to others. And by prioritizing older people for shots, countries can cause deaths to decline even more sharply than cases.”
To that end, here in the U.S., Moderna “has requested an emergency use authorization (EUA) for its [two dose, mRNA] COVID-19 vaccine in adolescents [ages 12-17] with the U.S. Food and Drug Administration (FDA). Pfizer’s two dose, mRNA vaccine already is being administered to adolescents in this age group.
Johnson & Johnson announced that “the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months.” Absent this science based extension, large surplus of unused doses of this vaccine would have begun to expire later this month. The Wall Street Journal adds that the federal government continues to suspend shipments of new doses of the single dose vaccine, evidently to allow the surplus to deplete.
Fierce Healthcare reports on Kaiser Permanente’s efforts to boost the COVID-19 vaccination numbers. As of today, 64% of Americans over age 18 have received at least one dose and over 75% of Americans over age 65 are fully vaccinated.
In big healthcare legal news, a friend of the FEHBlog pointed out to him today that yesterday the Department of Health and Human Services submitted its interim final rule on No Surprise Billing Act implementation rule to the Office of Management and Budget’s Office of Information and Regulatory Affairs for final review before publication in the Federal Register.
Healthcare Dive informs us that “UnitedHealthcare, the biggest private payer in the U.S., is delaying a controversial policy that could retroactively deny emergency room bills it deems non-emergent — potentially saddling patients with costly medical bills — following intense backlash from patient advocates and hospital groups. ‘Based on feedback from our provider partners and discussions with medical societies, we have decided to delay the implementation of our emergency department policy until at least the end of the national public health emergency period,’ UnitedHealthcare tweeted on Thursday.
Health Payer Intelligence identifies four payers that have embraced value based contracting with healthcare providers in the first half of 2021.
STAT News reports on what’s ahead for Biogen’s new Alzheimer’s Disease drug. The article concludes “Despite the controversies, Mark Miller, the former executive director of the Medicare Payment Advisory Commission, thinks Aduhelm will be widely used and make billions for Biogen. Infusion centers used for cancer patients and others can accommodate Aduhelm patients, said Miller, now the executive vice president at the Arnold Ventures philanthropy. Doctors will make good money providing the drug. Most Medicare patients have supplemental coverage that will pick up the 20 percent copay. ‘There’s not a lot of friction here to say, “Don’t do this,’ he said.”
STAT News also tells us that “The treatment known as CAR-T, in which white blood cells are genetically modified to attack blood cancer, is one of the most exciting and expensive in medicine. But it has not been directly compared to standard treatments in a randomized trial — until now. Bristol Myers Squibb said Thursday that its CAR-T, Breyanzi, prevented the return of large B-cell lymphoma better than the standard of care treatment, which includes a chemotherapy regimen and a stem cell transplant, in which bone marrow cells are replaced to try to cure blood cancer. The news was released in a terse press release that does not include any details about how the therapy performed. But if the results hold up when published in a medical journal or presented at a medical meeting, they would represent a big step forward for CAR-T therapy.”
The American Medical Association offers a blueprint for controlling blood pressure.
NIH Director Dr. Francis Collins in his blog interviews U.S. Surgeon General Vivek Murthy on fighting the ongoing opioid epidemic.
In federal employment news, Federal News Network reports that
The Biden administration has lifted the 25% occupancy limit at federal buildings, though agencies must still jump through several hoops before bringing more employees back for in-person work.
The Office of Management and Budget, along with the Office of Personnel Management and General Services Administration, on Thursday issued detailed guidance on the administration’s approach for reopening agency offices during the pandemic — and offered a highly-anticipated glimpse at their approach for telework, remote work and other workforce flexibilities in a post-pandemic world.
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.
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