Weekend update

Weekend update

Photo by Dane Deaner on Unsplash

The House of Representatives and the Senate remain on District / State work breaks this week. Of course the Congressional staff never rests. The Wall Street Journal reports that “House Speaker Nancy Pelosi (D., Calif.) on Sunday asked a top committee [the House Rules Committee] to look at moving forward on a $1 trillion bipartisan infrastructure bill along with the $3.5 trillion budget framework in an effort to balance the demands of her party’s ideological factions.” Fierce Healthcare identifies three major healthcare policy areas in the budget framework which healthcare lobbyists are watching carefully.

On the Delta variant front

  • The Wall Street Journal informs us that “Hospitalizations of Covid-19 patients in their 30s have hit a new record, U.S. government data show, a sign of the toll that the highly contagious Delta variant is taking among the unvaccinated.”
  • The message about the inportance of being vaccinated appears to be breaking through to the reluctant. Bloomberg tells us that “The U.S. reported almost 1 million Covid-19 vaccine doses on Saturday, the most for a single day since early July, reflecting a faster pace of inoculation as the delta variant spreads.” Nearly 60% of the vaccine eligible U.S. population (at least 12 years old) is fully vaccinated.

On the healthcare business front, Fierce Healthcare tells us that

UnitedHealth Group and Change Healthcare have entered into a timing agreement with the Department of Justice for their planned $8 billion merger.

In late March, DOJ made a second request for additional details and documentary information related to the merger. Under the timing agreement, which was reached on Aug. 7, UnitedHealth and Change agree to not “consummate” their merger before 120 days have passed since the two certified their compliance with the agency’s request.

The exception is if they receive written confirmation from DOJ that it has completed its investigation in that window, according to a Securities and Exchange Commission filing from Change Healthcare.

As we all know, timing is everything.

On the federal retirement front, Federal News Network reports

Federal retirements in July saw a big jump compared to last year, but the average processing time has swelled to nearly three months.

OPM received 8,922 retirement claims last month, compared to 6,819 claims in July 2020 — a 30.8% increase. Processed claims, meanwhile, only saw a 4.5% increase from 6,620 in July 2020 to 6,920 last month.

The latest numbers show that 2021 is generally seeing far more federal retirements than in 2020, when the pandemic reached its height. With the exception of January and February, every month this year has had year-over-year increases ranging from 10.8% to 47.2%.

Most notably, the 22% increase in federal retirements from June to July has led to a growing claims backlog. The inventory of claims ballooned from 24,999 in June to 27,001 in July, reversing the backlog’s downward trend after its peak in March.

Congress created two extremely complicated federal retirement programs. In the FEHBlog’s view, it’s up to those busy Congressional staffers to streamline the programs in order to facilitate automated claims processing.

Friday Stats and More

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 32nd week of this year (beginning April 2, 2020, and ending August 11, 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 same period (April 2, 2020, through August 11, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 11, 2021, which also uses Thursday as the first day of the week:

Here is a link to the Centers for Disease Control’s (“CDC”) latest weekly review for the COVID data tracker upon which the FEHBlog relies. The review is aptly titled: “Put on Your Masks and Thinking Caps.”

The American Hospital Association has released on You Tube a two minute long presentation on the value of COVID-19 vaccines. It’s called Eight Things to Know About the COVID-19 Vaccine. Its message should be widely distributed.

The Federal Times reports that Kaiser Permanente which is the third largest carrier in the FEHB Program announced a COVID-19 vaccine incentive for its FEHB plan membership today.

The CDC also issued 2021-22 Flu Season FAQs today. Among thing the FEHBlog learned that “All flu vaccines will be quadrivalent (four component), meaning designed to protect against four different flu viruses. For more information: Quadrivalent Influenza Vaccine | CDC.”

In an ironic twist, check out this quote from Fierce Healthcare

“The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,” said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.

“With mask mandates quickly returning and also acknowledging other trends we are observing within visit mix and volumes, we need to account for these other dynamics and a likely weaker cold and flu season due to these variant-related protective measures,” he said, also noting the company does not expect extra COVID-related demand.

“Consequently, we are adjusting down our visit forecast for the remainder of the year to account for these factors,” he said.

As the French say, “quelle domage”.

But seriously folks, Revcycle Intelligence informs us that

The percentage of telehealth claim lines has stabilized at about 5 percent of medical claim lines, indicating a new balance of virtual and in-person care.

The analysis conducted by FAIR Health as part of its Monthly Telehealth Regional Tracker included data representing the privately insured population, including Medicare Advantage, and excluded Medicare fee-for-service and Medicaid claims data.

The data revealed that the percentage telehealth claim lines increased slightly to 5 percent in May 2021, from 4.9 percent the previous month. The slight increase suggests a stabilization of telehealth utilization since telehealth claim lines had declined each month from February to April of this year.

And what’s more —

  • Healthcare Dive has a helpful wrap up article on the HIMSS conference. Take a look.
  • Federal News Network reports that the General Services Administration released federal employee travel per diems for the fiscal year beginning October 1, 2021. The combined per diems provide a cap of the federal contractor travel expenses that can be charged against an experience rated FEHB contract.
  • From Capitol Hill, Roll Call reports that nine centrist House Democrats have told Speaker Pelosi in writing that “We will not consider voting for a budget resolution until the bipartisan Infrastructure Investment and Jobs Act passes the House and is signed into law.” Roll Call adds that “Together, they’ve got more than enough support to stall the budget in the narrowly divided House where Democrats can lose no more than three members on party-line votes. No Republicans are expected to vote for the budget resolution, which is needed to begin the process on a $3.5 trillion reconciliation package chock full of Democratic priorities.”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Govexec reports that

The Veterans Affairs Department will more than triple the number of employees who must receive the vaccine, bringing the total to 360,000. VA originally required just its frontline health care staff—those hired under Title 38 of the U.S. Code—to be inoculated, which amounted to about 115,000 workers. 

The mandate will now include Title Five employees within the Veterans Health Administration—such as housekeepers, engineers and administrative staff—and health care providers such as psychologists, pharmacists, physical therapists, nursing assistants and others in “Hybrid Title 38” positions. 

“We’re now including most VHA employees and volunteers and contractors in the vaccine mandate because it remains the best way to keep veterans safe, especially as the Delta variant spreads across the country,” Secretary Denis McDonough said. “This pandemic is not over and VA must do everything in our power to protect veterans from COVID-19. With this expanded mandate, we can once again make—and keep—that fundamental promise.”

Employees impacted by the new mandate will have eight weeks to get the vaccine or prove they already have.

In the same vein, the Department of Health and Human Services (“HHS”) announced today that

[HHS] will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.

Staff at the Indian Health Service (IHS) and National Institutes of Health (NIH) who serve in federally-operated health care and clinical research facilities and interact with, or have the potential to come into contact with, patients will be required to receive the COVID-19 vaccine. This includes employees, contractors, trainees, and volunteers whose duties put them in contact or potential contact with patients at an HHS medical or clinical research facility.

Additionally, U.S. Surgeon General Dr. Vivek Murthy will immediately require members of the U.S. Public Health Service Commissioned Corps to be vaccinated against COVID-19 as part of medical readiness procedures to prepare for any potential deployment need as emergency responders

Those two mandates apply to about 20% of the federal workforce. In contrast, the general approach is a vaccine screening requirement — either attest to receiving the vaccine or wear a facemask and receive regular COVID-19 testing.

Furthermore, the Wall Street Journal reports that

The U.S. Food and Drug Administration authorized booster shots for certain people with weakened immune systems, likely the launch of broader efforts to better protect against evasive variants like Delta.

The agency on Thursday cleared giving a third dose of a messenger RNA Covid-19 vaccine from Pfizer Inc. PFE 2.01% and its partner BioNTech SE BNTX 4.13% or from Moderna Inc. MRNA 1.58% to immunocompromised people who had received a solid organ transplant or individuals who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

From the health equity front, the National Institutes of Health released a disturbing study on maternal mortality:

Racial and ethnic disparities in maternal mortality — deaths related to pregnancy or childbirth — in the United States may be larger than previously reported, suggests a study funded by the National Institutes of Health. By re-examining information on death certificates from 2016 and 2017, researchers found that the maternal mortality rate among non-Hispanic Black women was 3.5 times higher than among non-Hispanic white women. Previously, standard analyses had indicated a 2.5-times-higher death rate for Black women.

The new analysis also revealed that these disparities were concentrated among a few causes of death. Postpartum cardiomyopathy (disease of the heart muscle) and the blood pressure disorders preeclampsia and eclampsia were leading causes of maternal death for Black women, with mortality rates five times higher than those for white women. Pregnant and postpartum Black women were two to three times more likely than white women to die of hemorrhage (severe bleeding) or embolisms (blood vessel blockages).

The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and led by Marian MacDorman, Ph.D., of the Maryland Population Research Center at the University of Maryland. It appears in the American Journal of Public Health.

Healthcare Dive reports on HIMSS conference presentations on this important topic of achieving health equity.

Healthcare executives do say equity is a top priority for their organizations, with half of the CEOs surveyed by Deliotte early this year saying its among their top three organizational priorities this year, according to a recent report from the consultancy.

However, companies are at different stages of actually implementing equity and inclusion programs, with some reporting they’ve been focused on addressing disparities for years, and others just beginning to define what it means to their organization.

Of the 20 chief executives surveyed by Deliotte, 17 said they had a dedicated team or budget for health equity initiatives.

That top-level buy-in is important, but addressing health inequities needs to be a whole-enterprise mission, [Ronald] Copeland[, the chief equity, inclusion and diversity officer for integrated health giant Kaiser Permanente] said, integrated into every facet of payer and provider goals. One strategy to achieve this could be to make health equity a formal dimension of quality improvement, a policy that’s even recently been considered in federal payer programs under the Biden administration.

In other HIMSS conference news —

  • Fierce Healthcare informs about HIMSS conference discussion on rationalizing patient and provider experiences with multiple front end apps.
  • Healthcare Dive interviews Teladoc’s president of hospitals and health systems, Joe DeVivo about the state of the telehealth market and the company’s ambitions.

STAT News informed us today that 19,000 people attended the HIMSS conference in person and 5,000 attended virtually. 700 exhibitors attended. Both of those totals are about half of the normal in person attendance at HIMSS.

From the drug costs front, the White House released the President’s ideas on how to reduce prescription drug costs. The President leads off with encouraging Congress to allow CMS to negotiate Medicare Part D drug contracts. That change may save money for the federal government but it shift those savings to the commercial sector including the FEHB.

Also the HHS Inspector General released a report on opioid use among Medicare beneficiaries in 2020. “More than 43,000 Medicare Part D beneficiaries suffered an opioid overdose—from prescription opioids, illicit opioids, or both—in 2020.” The Inspector General also noticed a drop in prescriptions for opioid treatments which the OIG found concerning. “A May 2020 OIG data brief recommended that CMS educate Part D beneficiaries and providers about access to MAT drugs and naloxone. We continue to encourage CMS to take these steps. It is also critical for CMS to closely monitor the number of beneficiaries receiving MAT drugs and naloxone and take action, if needed. OIG is also committed to continuing our work on opioid use and access to treatment.”

In litigation news, the prescription benefit manager trade association, PCMA, has filed a lawsuit against HHS in the District of Columbia’s federal court challenging the legality of certain aspects of the payer transparency rule scheduled to start phasing in on January 1, 2022.

PCMA is not challenging the portions of the rule that direct plans to provide useful information directly to patients. But we are challenging the portions of the rule that do not meet those important objectives and will not produce information that patients and physicians can use.

These parts of the Trump administration’s transparency rule will drive prescription drug costs higher. By requiring disclosure of “historical” net prices, which are essentially current year net prescription drug prices, the rule will directly provide drug manufacturers access to their competitors’ negotiated rebates, discounts, and price concessions. This in turn will allow drug manufacturers to discount less deeply as they realize their price concessions went beyond those of competitors.

In addition, outside entities will not be able to develop reported information into a useful and understandable format for patients. Unlike health plans and PBMs, third-party application developers will not know patients’ existing insurance enrollment and eligibility or their current benefits and whether they have met a deductible or reached an out-of-pocket limit, and so the third-party applications are likely to cause widespread confusion among patients. Net prices are generally not useful information to patients because their deductible and coinsurance payments are calculated based on negotiated rates, not net prices.

PBMs and health plans already have real-time benefits tools for patients and prescribers, which they can use at the point of prescribing to check on cost-sharing for every patient based on their individual situation and health plan.

Coincidentally, the U.S. Chamber of Commerce has filed a substantially similar lawsuit in the federal court for the Eastern District of Texas. That case challenges the legality of the “historical net prices” provision and the “three machine readable tapes” provision of the HHS rule on the ground that they have no utility to consumers. Good luck.

Finally, the Census Bureau released a lot more 2020 census data today. The Wall Street Journal observes that “The nation’s population grew just 7.4% during the decade, the second slowest on record for a decennial census. Only the 1930s—the era of the Great Depression—saw slower growth.”

Midweek Update

Photo by Josh Mills on Unsplash

The American Hospital Association informs us that

The Senate early this morning approved on a party line vote a $3.5 trillion budget resolution, which included reconciliation instructions which will provide the majority party with the means to pass a comprehensive reconciliation package with just 51 votes in the Senate, rather than the usual 60-vote hurdle. The House will reconvene on Aug. 23 to consider the budget resolution. Once the resolution has passed both chambers, the House and Senate majorities can proceed with the reconciliation process, a resolution to which is expected in the fall. 

Bloomberg adds

Translating the budget framework into law will require Biden and Democratic congressional leaders keeping their party’s moderate and progressive wings marching together.

Just hours after passage of the budget blueprint, Senator Joe Manchin, a Democrat from West Virginia, said he couldn’t support a social spending bill with a $3.5 trillion price tag. Senator Kyrsten Sinema, an Arizona Democrat, has said the same. One Democratic objection is all it would take to scuttle the package in the Senate.

Time will tell but we are talking about $3.5 trillion on top of the $1 trillion infrastructure bill and multi-trillion COVID-19 relief bills that Congress has passed in the last 18 months. It appears that Congress is trying to disprove the adage that money can’t solve all problems.

One of the initiatives in the budget reconciliation package is to add dental, vision, and hearing coverage to Medicare. Kaiser Health News discusses the issue here.

From the Delta variant front

  • The Centers for Disease Control’s Advisory Committee on Immunization Practice released a helpful report on COVID-19 adverse side effects which it summarized as follows

What is already known about this topic?

Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.

What is added by this report?

On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination.

What are the implications for public health practice?

Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected. Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.

  • Forbes tells us that today “The Centers for Disease Control and Prevention encouraged anyone pregnant and breastfeeding to get vaccinated against coronavirus Wednesday, pointing to a growing amount of evidence that vaccines are safe and effective as new cases and hospitalizations linked to the virus surge across the country.” The Washington Post adds “Just 23 percent of pregnant women have received at least one shot of vaccine.”
  • Also from Forbes as schools begin to reopen “Vaccine rates among teenagers have remained lower than the U.S. population overall, with only 43% of 12- to 15-year-olds and 52.8% of 16- and 17-year-olds receiving at least a first dose as compared with 58.9% of the total population and 71.2% of adults.”
  • The Boston Globe discusses this teenage hesitancy issue — “The top reservation among parents of unvaccinated teens was the lack of information about the long-term effects of the shot, followed by concerns about side effects and fertility — despite conclusive evidence that the vaccine has no negative impacts on reproduction. Dr. Jill Kasper, a pediatrician at Cambridge Health Alliance, said she typically encounters ‘very little hesitancy’ from parents about routine adolescent vaccinations. That hasn’t been the case with COVID-19.”

The HHS Agency for Healthcare Quality and Research issued two noteworthy studies today. Here are the topline findings

  • #1 Overuse or low-value procedures may result in patient physical, psychological, or emotional harm. This study explored the association between eight low-value care procedures and length of stay (LOS) and cost. All eight procedures were associated with increased LOS and cost, particularly spinal fusion. Patients receiving low-value care may be exposed to increased risk of adverse events and hospital-acquired conditions.
  • #2 Medication administration errors made by parent or caregivers can result in medication errors at home. This systematic review found that 30% to 80% of pediatric patients experience a medication error at home, and that the risk increases based on characteristics of the caregiver and if a prescription contains more than two drugs.

Healthcare Dive informs us that

  • CVS Health said its Aetna unit will offer virtual primary care to self-funded employers nationwide in a move that underscores the growing popularity of telehealth services fueled by the COVID-19 public health emergency.
  • Using Teladoc Health’s physician-led care team model, the Aetna Virtual Primary Care service is intended to help strengthen the patient-doctor relationship and improve access to care, the vertically integrated company announced Tuesday. Members can receive health services remotely and in person.

Such support for primary care should be applauded.

In other healthcare news

  • STAT News reports that The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen [Adulhelm], citing insufficient evidence of “a robust and meaningful clinical benefit” and concerns about safety. In a notice issued by the agency, the VA said it will make exceptions for “highly selected patients” and listed several hurdles that must be cleared before the medicine will be covered, such as requiring it to be prescribed by providers who specialize in treating dementia and ensuring patients had recently received MRI brain scans. * * * ‘Its bad news for Biogen,’ said Ira Loss of Washington Analysis, which tracks legislative and regulatory issues affecting the pharmaceutical industry for investors, who noted several private insurers have either declined or delayed coverage for the drug. ‘The VA is a big buyer of medicines. And you don’t like this kind of publicity, that’s for sure.’”
  • Fierce Healthcare continues to report from the HIMSS conference in Las Vegas. “Health IT giant Epic launched a new customer story-sharing website that lets Epic users share insights, tips and creative ideas around using health IT to improve their organizations and patient care. The site, EpicShare.org, combines insights from industry leaders, quick tips on improving outcomes and performance, in-depth case studies as well as a “Hey Judy” column from Epic founder and CEO Judy Faulkner.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

The Senate passed a roughly $1 trillion infrastructure package with broad bipartisan support Tuesday, advancing a central piece of President Biden’s economic agenda that would amount to one of the most substantial federal investments in roads, bridges and rail in decades.

With 19 Republicans including Senate Minority Leader Mitch McConnell (R., Ky.) joining all 50 Democrats to pass the bill 69 to 30, the legislation sailed through the Senate. The bill will face a more complicated path in the House, where Democrats have yoked the fate of the infrastructure effort to the passage of a broad $3.5 trillion antipoverty and climate effort. 

Professor Katie Keith in the Health Affairs blog discusses the Administration’s health policy objectives in the budget reconciliation bill that the Senate is now taking up. “Vice President Harris emphasized the need for Congress to build on these [Affordable Care Act special enrollment period] coverage gains by 1) extending the American Rescue Plan Act subsidy enhancements; 2) closing the Medicaid coverage gap; 3) expanding Medicare to include dental, vision, and hearing coverage; and 4) lowering prescription drug costs.”

Becker’s Hospital review tells us how COVID-19 vaccination rates have changed in the states for the week ended August 9. The rates in 40 states lead by Mississippi (and the District of Columbia) are up and only 10 states are down.

STAT News informs us that

As the world amasses experience with Covid-19 vaccines, something we should have known from the start is coming into sharp focus.

Vaccines that are injected into arm muscles aren’t likely to be able to protect our nasal passages from marauding SARS-CoV-2 viruses for very long, even if they are doing a terrific job protecting lungs from the virus. If we want vaccines that protect our upper respiratory tracts, we may need products that are administered in the nose — intranasal vaccines.

Can they be made? Probably. Will they do what we want them to do, if they are made? Possibly. Is there still room for this type of next-generation product, given the record number of Covid vaccines that have already been put into use? Potentially. Will it be difficult to get them through development? Likely.

In this regard the National Institutes of Health reports on a successful animal study of a COVID-19 intranasal vaccine based on the Oxford / Astra Zeneca model. What’s more, “[a] clinical trial at the University of Oxford is now testing intranasal vaccination in human volunteers.”

Fierce Healthcare is running a daily HIMSS21 roundup from the conference being held in Las Vegas this week.

Reg Jones writes in FedWeek about FEHB coverage for adult children of federal employees and annuitants who are incapable of self support. This is a rather unique feature of the Program.

Finally the Wall Street Journal reports that

The U.S. Postal Service plans to charge more for packages shipped during the holidays, including those sent by individuals, to offset the rising cost of deliveries at the busiest time of the year.

The agency on Tuesday proposed adding surcharges on most packages shipped domestically between Oct. 3 and Dec. 26, saying the fees would apply to both commercial and retail customers. That means it won’t just be Amazon.com Inc.,Target Corp. TGT 0.63% and other big holiday shippers paying higher-than-normal rates; it will also cost more to ship a box of cookies to grandma.

The agency said the added fees, ranging from 25 cents for smaller packages to $5 for heavier items traveling longer distances, are in line with broader industry practices to charge more during the holiday season.

Monday Roundup

Photo by Sven Read on Unsplash

The Senate’s bipartisan infrastructure bill cleared a cloture vote last night. The Senate is expected to pass it by tomorrow. Roll Call reports on the $3.5 trillion “human infrastructure” related budget reconciliation bill that the Congressional Democrat leadership unveiled today.

In Delta variant news

  • Federal News Network informs us that “The Defense Department is taking actions to make COVID-19 vaccines mandatory for service members by mid-September, or once the vaccines gets licensure from the Food and Drug Administration, whichever comes first.”
  • The New York Times reports that long COVID is now afflicting children. “Studies estimate long Covid may affect between 10 percent and 30 percent of adults infected with the coronavirus. Estimates from the handful of studies of children so far range widely. At an April congressional hearing, Dr. Francis Collins, director of the National Institutes of Health, cited one study suggesting that between 11 percent and 15 percent of infected youths might ‘end up with this long-term consequence, which can be pretty devastating in terms of things like school performance.’” Quite troubling. All the more reason to accelerate vaccinations for children.
  • In this regard, the Wall Street Journal reports that “As the highly contagious Delta strain tears through the country, the trends thus far suggest vaccines can turn Covid-19 into a less dangerous, more manageable disease. “Vaccines definitely make a difference,” said David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.A Wall Street Journal analysis shows sharp geographic divides in vaccination and hospitalization levels, with every state that has an above-average vaccine rate showing below-average hospitalizations, including in well-vaccinated New England. In the South, meanwhile, fewer people are vaccinated on average and hospitalization rates are climbing faster.” Lesson hopefully learned.

From the second quarter financials report front, Fierce Healthcare tells us that “Kaiser Permanente reported $3 billion in net income for the second quarter of the year as membership in its health plan remains steady. The health system and insurer posted total operating revenues of $23.7 billion against total operating expenses of $23.3 billion. The revenue was slightly above the $22.1 billion it earned in the second quarter of 2020. Kaiser noted in its earnings statement Friday that favorable financial market conditions resulted in $3 billion in net income, compared with $4.5 billion for the second quarter of 2020.”

From the No Surprises Act front, a friend of the FEHBlog pointed out to him that a second NSA rule has been pending at the Office of Information and Regulatory Affairs (“OIRA”) for the past month:

AGENCY: HHS-CMS          RIN: 0938-AU61   Status: Pending Review
TITLE: Reporting Requirements Related To Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions (CMS-9907)
STAGE: Proposed Rule   ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/07/2021        LEGAL DEADLINE: Statutory

In other news —

  • Health Day tells about a severe blood shortage that is adversely affecting U.S. hospitals. “‘A blood shortage is when we have demand outpacing our supply,’ noted Paul Sullivan, senior vice president of donor services for the American Red Cross. ‘Usually it’s around some challenging period of the year. The beginning of summer, end-of-year holidays. And obviously we work hard to try to plan for those times.’ But this time is different, Sullivan said, with the COVID-19 pandemic and its fallout triggering a huge spike in hospital demands for blood. The result is a critical blood shortage that’s now seven weeks long and counting.” The article concludes “There’s more on the blood shortage and blood donations at the American Red Cross.”
  • In good news, Health Leaders Media reports that “The years-long effort to reduce unnecessary Cesarean section births in the United States is coming to fruition, an obstetrics expert says. Complications from C-sections such as hemorrhaging are widely considered to be a contributing factor to the country’s high maternal mortality rate. The federal Centers for Disease Control and Prevention have been monitoring maternal mortality since 1986. The number of pregnancy-related deaths has risen steadily since the monitoring effort began, from 7.2 deaths per 100,000 live births in 1987 to 18.0 deaths per 100,000 live births in 2014. “We are finally at the point where most hospitals are sharing their data and having conversations on an individual basis about C-section rates. We are having conversations about quality at labor and delivery units as well as about the quality of individual providers. It has taken more than a decade to get to this point,” says Amy VanBlaricom, MD, vice president of clinical operations for western states at Greenville, South Carolina-based Ob Hospitalist Group.”

Weekend update

Photo by Dane Deaner on Unsplash

The Senate remains in session for Committee and floor business while the House of Representatives remains on its District work break. Politico reports from the Senate floor that

The bipartisan infrastructure deal embraced by President Joe Biden and shaped by a gang of 10 senators is inching closer to clearing the chamber, with one more filibuster to clear on Sunday before the bill can pass later this week and land in the the House. * * *

[House Speaker] Pelosi and Senate Majority Leader] Schumer have devised a two-track process to enact as much of Biden’s domestic agenda as possible, pledging that the bipartisan infrastructure bill will only advance if it is married to the party-line legislation that will spend as much as $3.5 trillion on climate change action, paid leave policies and health care expansion. 

The Senate will immediately proceed to a budget setting up that massive bill on filibuster-proof ground after it completes its work on the bipartisan infrastructure bill. Schumer is also considering forcing votes on more elections legislation after Democrats’ sweeping overhaul plan failed in June.

From the Delta variant front

  • The CDC’s COVID Data Tracker informs us today that just over two thirds of Americans over age 12 and 90% of Americans over 65 have received at least one dose of a COVID-19 vaccine. The data tracker consistently has shown a 10% difference between one dose and fully vaccinated Americans which indicates to the FEHBlog that people follow through a get the second dose.
  • However, the Wall Street Journal reports about how neighbor deaths from unvaccinated neighbors has caused an Arkansas town to reconsider their reluctance to receive the COVID-19 vaccine. Another Journal article adds that “Top U.S. public-health officials on Sunday [August 8] voiced support for Covid-19 vaccination mandates imposed at the local level, while the head of a national teachers union also backed such a move in schools.”
  • Speaking of mandates, the FEHBlog found a link to the Safer Federal Workers Task Force FAQs on the Biden Administration’s vaccine screening program for federal employees, federal office visitors and on-site contractors that were released last Friday August 6. Interestingly, an FAQ indicates that

Q: Do agencies need to ask employees on maximum telework or remote workers about their vaccination status?

A: Yes, agencies should provide the Certification of Vaccination form to all employees, including employees on maximum telework and remote workers.

Healthcare Dive informs us about

  • Five intriguing panels at this week’s in-person HIMSS conference in Las Vegas.
  • A new survey conducted by Social Sciences Research Solutions for the Bipartisan Policy Center [that] concludes that telehealth is likely an ongoing viable option for consumers even after the COVID-19 pandemic winds down.
  • An overview of second quarter financial reports from health insurers.

The Biden Administration to its credit has proposed a rule rescinding the Trump Administration’s rule to establish a most favored nation pricing approach for Medicare Part B covered drugs.

Govexec reports on a recent Postal Service Board of Governors meeting attended by the three recently confirmed members whom President Biden had nominated. “The tenure of the U.S. Postal Service’s newest board members got off to a tense start on Friday as President Biden’s appointees voiced their displeasure with the agency’s direction and USPS’ leader stated he will still move forward with reforms.”

Friday Stats and More

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 31st week of this year (beginning April 2, 2020, and ending August 4, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 4, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 24, 2021, which also uses Thursday as the first day of the week:

While COVID-19 cases are soaring, the number of deaths remains stable thanks to the high vaccination rates for Americans over age 65. It is also encouraging that the number of administered vaccinations also is increasing.

In other Delta variant news:

  • Surprisingly, according to STAT News, “with nearly 20% of all U.S. Covid cases last week recorded in children, the American Academy of Pediatrics and 11 other organizations put out a consensus statement this week calling on providers conducting sports physicals to ask about children’s Covid vaccination status and to use it as an opportunity to administer a vaccine, if possible.”
  • Fierce Pharma tells us that “In a trial of nearly 480,000 healthcare workers in South Africa, Johnson & Johnson‘s one-dose vaccine helped prevent severe disease from the Delta variant, Bloomberg reports. The trial is the first piece of large-scale evidence that shows the shot works against the variant, the news service stated. In fact, Glenda Gray, one of the leaders of the work, said the vaccine may provide better protection against Delta than the Beta variant.”
  • MedPage Today reports that “Unvaccinated adults who were previously infected with COVID-19 were twice as likely to be reinfected as those previously infected but also fully vaccinated, researchers found. A case-control study in Kentucky found a more than two times higher risk of COVID-19 cases among unvaccinated adults with prior infection compared with their fully vaccinated counterparts (OR 2.34, 95% CI 1.58-3.47), reported Alyson Cavanaugh, PhD, of the CDC, and colleagues, writing in an early edition of the Morbidity and Mortality Weekly Report.
  • In related news Precision Vaccines tells us that “The World Health Organization (WHO) issued Influenza Update N° 399 on August 2, 2021, saying, ‘Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.'”

From the No Surprises Act (“NSA”) front, the FEHBlog discovered today that last Tuesday the tri-agencies and OPM submitted their second NSA interim final rule, which concerns the independent dispute resolution process, to OMB’s Office of Information and Regulatory Affairs for final review. OIRA already has two listening sessions concerning this rule making on its calendar. This indicates that the second interim final rule will be made public in early September, rather than on its October 1, 2021, due date.

From the federal employee front

  • Govexec brings us up to date on the development of the President’s mandatory vaccination program for federal employees. “The Safer Federal Workforce Task Force—a group President Biden created by executive order that is led by the White House, General Services Administration and Office of Management and Budget—confirmed in new guidance agencies would not initially ask for proof of vaccination, but they could follow up for documentation if they receive “a good faith allegation that strongly suggests” an employee lied on their attestation form. Those “certification of vaccination” forms will soon go out via email to all federal employees, with an Office of Management and Budget official saying that process will begin next week.  While agencies will initially rely on the honor system as it begins asking employees for their vaccination status, the administration made clear there could be consequences for lying.”
  • Govexec also discusses how Medicare Advantage plans are being integrated into FEHB plans. The trend started with HMOs and the APWU Health Plan picked it up for this year. Expect more plans to follow suit for 2022.  

In more news

  • Earlier this week, the FEHBlog noted a Reuters report that the Justice Department is preparing to file suit to block Optum’s acquisition of Change Healthcare. Fierce Healthcare reports today au contraire that “Change Healthcare President and CEO Neil de Crescenzo said Thursday he’s pleased with the company’s progress on regulatory review of its pending deal with Optum and is moving forward with plans for a successful integration. ‘We look forward to continuing to work diligently in coordination with UHG (UnitedHealth Group) to provide the necessary information requested by the DOJ (Department of Justice) and completing the transaction.'” Time will tell.
  • Medcity News informs us that “GoodRx struck a partnership with medication data giant Surescripts that would let healthcare providers access cash price information on medications. Arlington, Virginia-based Surescripts dominates the e-prescribing market, offering technology that routes clinicians’ electronic prescriptions directly to pharmacies. It’s owned by CVS Health and Express Scripts, and nearly 2 billion prescriptions were delivered through its software last year.”
  • mHealth Intelligence tells us that “While the pandemic prompted an unprecedented surge in telehealth to address healthcare needs, it also highlighted the gap between those who can access care and those who can’t. Now health systems, community health organizations, non-profits and philanthropic groups are moving to address those gaps with programs that use telehealth to extend care to those who can’t access or afford it. They’re fueling a surge in connected health charities and projects targeting the social determinants of health. Among those groups is Beam Up, an organization launched by telehealth company Beam Healthcare to address gaps in access to health food, quality education and healthcare services. Executives see a need for these services not only in other countries – a partnership with Tyto Care is equipping a handful of orphanages in Mexico with telemedicine technology – but in cities and rural regions across the United States.

Midweek Update

It turns out that OPM Director Kiran Ahuja held her first virtual press conference this morning.

  • The Federal Times discusses her conversation with reporters about implementing the President’s vaccination mandate and piloting an online retirement application for federal employees.
  • Federal News Network and FCW paint with broader brushes about Ms. Ahuja’s goals and challenges.

The FEHBlog noticed today that the OPM senior staff bios on its website provide a good picture of Director Ahuja’s team.

On the Delta variant front

  • Kaiser Health News makes a convincing economic agreement for receiving a COVID-19 vaccination.
  • The New York Times reports that “With a new surge of coronavirus infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people familiar with the effort said. President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.”

On the 2nd quarter financial reports front, Healthcare Dive reports that

Returning utilization of health services and higher-than-expected COVID-19 care costs drove CVS Health’s net income in the second quarter down 7% year over year to $2.8 billion, the healthcare behemoth reported Wednesday.

The payer business, which includes Aetna, reported a medical loss ratio of 84.1%, up significantly from 70.3% the same time last year. The hike in MLR, which was higher than both internal and analyst forecasts, is especially acute compared to the second quarter of 2020, which saw a severe dip in utilization as COVID-19 lockdowns and elective procedure restrictions kicked into gear.

However, CVS beat Wall Street expectations for both earnings and revenue, with topline of $72.6 billion, up 11% year over year, driven mostly by growth in government products. The Woonsocket, Rhode Island-based company raised its full-year guidance following the results.

In legal news, Business Insurance informs us that “The U.S. Department of Justice is weighing a possible lawsuit to block UnitedHealth Group’s (UNH.N) nearly $8 billion deal to acquire health care analytics and technology vendor Change Healthcare (CHNG.O), the Information reported on Tuesday.”

From the federal employee benefits front, Reg Jones tells us in FedWeek that “One valuable feature of the Federal Long Term Care Insurance Program is its more generous rules regarding coverage in retirement, as compared with the FEHB health insurance and FEGLI life insurance programs.” Of course, the greater flexibility may be explained by the facts that FEHB and FEGLI coverage are government funded while FLTCIP is fully member funded. Still it’s useful information.

In other mid-week news

  • The Center for Medicare and Medicaid Innovation released its 2020 report to Congress today.
  • STAT News tells us that “For all the explosive controversy over the approval of the first treatment for Alzheimer’s disease in nearly 20 years, hardly any patients have actually gotten it yet. The drug’s eye-popping, $56,000 annual price and questionable benefit to patients have been a shock to the bureaucracy that makes the health care system run — and that’s having a clear effect on uptake. Some analysts estimated last month that fewer than 100 patients were dosed in the first weeks after the therapy was approved, though availability will likely ramp up over the coming months.”
  • Health Payer Intelligence discusses “five ways payers have tackled mental, hehavioral Healthcare in 2021. As the coronavirus pandemic becomes more manageable and vaccination rates increase nationwide, payers are channeling funds into mental and behavioral healthcare programs.” That’s a sound focus of attention.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front

  • Govexec and FedWeek provide their respective updates on implementation of the Administration’s vaccine mandate. It’s not moving quickly.
  • Federal News Network informs us that “The Postal Service, as an independent agency, is setting its own rules on masks and vaccines apart from the rest of the federal workforce, but is seeing an uptick in employees who need to quarantine as the delta variant of COVID-19 presents new challenges for the agency.”
  • The Society for Human Resource Management offers advice on topics that should be covered in an employer’s COVID-19 vaccination policy.
  • Medscape gives us a report on a Delta variant “media briefing today sponsored by the Infectious Diseases Society of America.” “Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upwards of 80% or more, experts say. Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status * * *. Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations — and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.”

In the tidbits department

  • Healthcare Dive reports that “In what appears to be a break from the gloom physicians have felt over the past year due to the COVID-19 pandemic, independent medical practices “feel stronger, resilient, and positive about the future of their practice and the industry,” according to a new survey by Kareo.”
  • The Patient Centered Outcomes Research Institute tells us that “As the nation’s primary funder of patient-centered comparative clinical effectiveness research, PCORI examines the important questions that patients face and helps create an informed healthcare system. Congressional reauthorization in 2019 broadened this scope, giving PCORI the opportunity to chart a bold new direction as it looks at today’s health and healthcare challenges, including many exacerbated by the COVID 19 pandemic. To realize this opportunity fully, PCORI is crafting an ambitious strategic roadmap to guide future research funding and related initiatives.”
  • Fierce Healthcare informs us that “Consumer out-of-pocket spending on healthcare is set to hit an estimated $491.6 billion, or about $1,650 per person, in the U.S., according to a recent report. The number is a roughly 10% increase over last year’s total and is expected to maintain a continual annual growth rate of 9.9% for the next five years, according to healthcare market research group Kalorama Information. * * * Kalorama highlighted a handful of government, business and demographic trends that are expected to drive consumers’ out-of-pocket spending outward in a release summarizing the full report.”