Midweek Update

Midweek Update

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

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

Today according to the Wall Street Journal

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

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

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

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

In Biden Administration news, the American Hospital Association reports that

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

STAT News informs us

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

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

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

Monday Roundup

Photo by Sven Read on Unsplash

In a move hinted at in yesterday’s Weekend Update, the Office of Personnel Management today released government wide results from the 2020 Federal Employee Viewpoint Survey.

As shown in the 2020 OPM FEVS results, the federal workforce adapted quickly to the challenges presented by the pandemic. Together with their managers and policy makers, employees found creative solutions and leveraged workplace flexibilities – including the widespread adoption of telework — to continue to support their agency’s mission while balancing personal responsibilities. Results demonstrate that federal workers derive great satisfaction and meaning from successfully doing their jobs through even the most disruptive of circumstances.

Medscape reports on a recent Health Affairs reports on last year’s dip in healthcare services stemming from the great hunkering down.

Since last spring, utilization of healthcare services has largely rebounded, and [study coauthor Kevin] Callison [, PhD, assistant professor in the Department of Health Policy and Management at the Tulane School of Public Health and Tropical Medicine] speculated that involuntary delays in care have diminished greatly. He attributed that partly to improved treatment of COVID-19, the restored capacity of many healthcare facilities, and the expiration of orders to delay or cancel elective procedures. Also, he noted, people have become more comfortable with seeing physicians in person, which has partly explained the increase in ambulatory visits. Nevertheless, he added, “we’re not seeing a rebound above pre-pandemic levels to make up for that lost care.”

Healthcare Dive informs us that primary care “practices are financially stabilizing more than a year after the pandemic began. However, primary care practices are facing enormous challenges in the near term, including pent-up demand for medical and mental health services and a growing feeling of exhaustion among physicians.” Also those practice now are playing a much larger role in COVID-19 vaccination administration.

The Primary Care Collaborative surveyed more than 650 primary care physicians, nurse practitioners and pharmacists in 48 states, the District of Columbia and Guam. Altogether, nearly four out of 10 practices are administering the COVID-19 vaccines, “a marked increase” compared to just a few weeks prior, while 47% are partnering with local vaccination administration sites. “Primary care is now beginning to be leveraged to target the vaccine to hard-to-reach populations,” the survey’s authors concluded.

The International Foundation of Employee Benefits Plan discusses its “a webcast on legal considerations for employers regarding employee vaccinations.” Check it out.

Last week the FEHBlog called attention to National Prescription Drug Take Back Day, which was held on April 24. The Drug Enforcement Administration points out today that there are many convenient drug disposal sites open year round in our country.

Midweek update

Today was the second day of the OPM AHIP FEHB Carrier Conference. One of the sessions concerned COVID-19 vaccination outreach to socially disadvantaged communities. The FEHBlog learned that Kaiser Permanente, which is the third largest FEHB plan carrier, has released a COVID-19 vaccination equity tookit and that Geisinger, a Pennsylanvia based FEHB plan carrier, has produced a Neighborly website chock full of community resources. A speaker referenced this New York Times article on the following topic: “Half of American adults have received at least one shot of the coronavirus vaccine. Now comes the hard part: persuading the other half to get it.”

In COVID-19 vaccine news from outside the carrier conference

  • The Society for Human Resource Management reports that “To encourage more widespread vaccinations, President Joe Biden has announced a paid leave tax credit to employers that provide full pay for any employee who takes time off to get a COVID-19 vaccination. The tax credit is available to organizations with fewer than 500 employees, and it also provides full pay for employees who take time to recover from the vaccination. The credit covers up to $511 per day for each vaccinated employee, and is funded by the American Rescue Plan.” The FEHBlog will post the implementing IRS notice tomorrow.
  • Fierce Pharma reports that “AstraZeneca is still planning to apply for emergency use authorization of its shot in the U.S., a company spokesman confirmed. * * * If going down that road yields an endorsement from the U.S., it could help boost the damaged reputation of the shot. Much of the world, especially poorer nations, are in dire need of vaccines and global demand is expected to extend into the next few years at least. In addition, the shot has a key advantage over its mRNA rivals––its lower price, which makes it particularly attractive to developing nations.”
  • Govexec reports that “State Department Spokesperson Ned Price said on Tuesday that the department had delivered vaccines to all of its posts abroad, as of Sunday.“ and “The Defense Department said on Tuesday it expects to start receiving 390,000 vaccine doses weekly, which is up from an average of 155,500 per week. “[Eighty-three] percent of vaccines received by the Defense Department have been administered, exceeding the U.S. average of 78%, and more than 28% of our total force is now vaccinated,” Pentagon Press Secretary John Kirby said during a briefing on Monday. 

There was a lot of carrier conference discussion about expensive yet curative cell and gene therapies. The FEHBlog ran across this recent MIT report on that topic.

Also the FEHBlog was overjoyed to hear from an OPM speaker that with any luck laterthis decade OPM will begin providing carriers with HIPAA 820 standard transactions that will allow them to reconcile premiums to headcount. The FEHBlog has been advocating this logical step for quite a while.

In other healthcare news —

  • Healthcare Dive informs us about Elizabeth Fowler’s first public address since taking the reins of the CMS Center for Medicare and Medicaid Innovation earlier this year. “‘In my view, we’re at a really critical juncture in the path to value-based care,’ Fowler said at the National Association of Accountable Care Organizations’ spring conference on Tuesday, asking stakeholders for patience as CMMI reviews paused models and outlines a path forward.”
  • Saturday is the Drug Enforcement Administration’s spring edition of National Prescription Drug Take Back Day. “National Prescription Drug Take Back Day is a safe, convenient, and responsible way to dispose of unused or expired prescription drugs at locations in communities throughout the country. The October 2020 Take Back Day brought in 985,392 pounds (492.7 tons) of medication. This is the largest amount ever collected in the program’s ten years!” You can find your nearest collection site here.

Monday Roundup

Photo by Sven Read on Unsplash

Mondays have tended to be good news days for COVID-19 vaccines. As of today, over 50% of Americans over age 18 have received at least one dose of a COVID-19 vaccine.

Fierce Healthcare reports that

“CVS Pharmacy has begun stocking its virtual and in-store shelves nationwide with rapid tests for COVID-19—which can be purchased without a prescription and used by anyone regardless of whether or not they are showing symptoms—including three FDA-authorized diagnostics and sample collection kits produced by LabCorp, Ellume and Abbott.”

“Even as vaccines become more widely available, COVID-19 testing remains a critical tool to keep our communities safe,” Walgreens President John Standley said in a statement. Walgreens currently offers on-site testing at more than 5,500 of its pharmacies and plans to expand to 6,000 drive-thru sites by May, using Abbott’s ID NOW portable testing machines.

In addition, earlier this month CVS began offering COVID-19 antibody testing for $38 at 1,100 in-house clinics, using fingerstick blood samples to determine previous infections.

The U.S. Office of Personnel Management announced today that the agency

will allow [FSAFEDS] flexibilities permitted under the Consolidated Appropriations Act 2021 and the American Rescue Plan Act including allowing full carryover for a health care flexible spending account (HCFSA) and Limited Expense FSA (LEX FSA); extending the grace period for a dependent care flexible spending account (DCFSA); and permitting care for dependents through age 14 for 2020 and 2021 under a DCFSA. In addition, OPM is working with our FSAFEDS contractor, Health Equity, to offer a Special Enrollment/Election Period (SEP) in the near future.  This SEP will allow participants to increase or decrease their current elections for their DCFSA and/or their HCFSA.  In addition, the SEP will allow those who did not re-enroll for 2021 during Open Season in the Fall, the opportunity to enroll in a DCFSA and/or HCFSA for 2021.  Finally, OPM will allow DCFSA participants to increase their election during the Special Election Period to the new IRS maximum of $10,500 for 2021. 

All good news.

What’s more, the Wall Street Journal reported in its Saturday essay about the U.S. airline safety revolution.

Over the past 12 years, U.S. airlines have accomplished an astonishing feat: carrying more than eight billion passengers without a fatal crash.

Such numbers were once unimaginable, even among the most optimistic safety experts. But now, pilots for domestic carriers can expect to go through an entire career without experiencing a single engine malfunction or failure. Official statistics show that in recent years, the riskiest part of any airline trip in the U.S. is when aircraft wheels are on the ground, on runways or taxiways.

The achievements stem from a sweeping safety reassessment—a virtual revolution in thinking—sparked by a small band of senior federal regulators, top industry executives and pilots-union leaders after a series of high-profile fatal crashes in the mid-1990s. To combat common industry hazards, they teamed up to launch voluntary incident reporting programs with carriers sharing data and no punishment for airlines or aviators when mistakes were uncovered.

One wonders whether this successful strategy may be transferable to other pressing safety issues, such as patient safety. In this regard, a friend of the FEHBlog suggested check this Washington Post opinion piece written by a group of psychologists titled “We instinctively add on new features and fixes. Why don’t we subtract instead?
‘Less is more’ is a hard insight to act on, it turns out.” How true.

In other healthcare news —

  • The Kaiser Family Foundation informs us that

a relatively small number and share of drugs accounted for a disproportionate share of Medicare Part B and Part D prescription drug spending in 2019 (Figure 1).

— The 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition (7% of all Part D covered drugs) accounted for 60% of net total Part D spending.

— The top 50 drugs covered under Medicare Part B (8.5% of all Part B covered drugs) accounted for 80% of total Part B drug spending.

Some recent proposals to lower prescription drug prices have limited the number of drugs subject to price negotiation and international reference pricing. This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors. Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources . . . .

  • Employee Benefits News tells us

New research from Voya shows employees have a bias against HDHPs and the reason for that is as simple as marketing.

“One of the really interesting findings that we saw from the research about why there is that bias comes down to branding, pure and simple,” says Nate Black, vice president of consumer driven health for Voya Financial. “When we replaced the high deductible health plan name and called it something more generic, the share of people choosing high deductible health plans doubled. So just the name itself can have a really significant impact on how people think about what plan they should choose.”

Sixty-three percent of the people surveyed by Voya said they would choose the plan with the lowest deductible. As part of the study Voya designed an experiment asking participants to choose between a PPO and an HDHP. The experiment was set up in a way that the HDHP was always the optimal financial choice, despite this, 65% of those surveyed still chose the PPO plan.

Communicating the long term value of plans connected with health savings accounts is quite important.

  • Here’s a link to the CDC’s website on the Johnson & Johnson vaccine pause which explains

If you received the vaccine more than three weeks ago, the risk of developing a blood clot is likely very low at this time.

If you received the vaccine within the last three weeks, your risk of developing a blood clot is also very low and that risk will decrease over time.

Contact your healthcare provider and seek medical treatment urgently if you develop any of the following symptoms: severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin (petechiae), or new or easy bruising.

If you experience any adverse events after vaccination, report them to v-safe and the Vaccine Adverse Event Reporting System

The FEHBlog enrolled in v-safe after his first Pfizer vaccination and the CDC has continued to inobtrusively check in weekly. The FEHBlog is happy to help out.

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 15th week of this year (beginning April 2, 2020, and ending April 14, 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 greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through April 14, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through April 14, 2021 which also uses Thursday as the first day of the week:

It’s looking reasonably good. According to the CDC, as of today, 49.6% of the U.S. population over age 18, and 80.4% of the U.S. population over age 65, have had at least one dose of the vaccines. 31.1% of the over age 18 population and 64.6% of the over age 65 population are fully vaccinated. Over 200 million doses of the vaccines have been administered in the U.S.

The CDC has announced that “a virtual emergency meeting will be held to discuss Janssen (Johnson & Johnson) COVID-19 vaccine on [Friday] April 23, 2021, 11:00 a.m. to 5:00 p.m. ET” to discuss the ongoing FDA/CDC recommended pause in administration of that vaccine in the U.S. The Wall Street Journal reports that

Johnson & Johnson said Friday there wasn’t enough evidence to establish that the company’s Covid-19 vaccine causes the rare blood-clotting condition that prompted U.S. health officials this week to recommend a pause in its use.

The New England Journal of Medicine published online a letter from three J&J employees involved in vaccine development and epidemiology saying, “At this time, evidence is insufficient to establish a causal relationship between these events” and J&J’s vaccine.

And now for more —

  • Beckers ASC Review informs us that Optum “announced plans to add 10,000 physicians in 2021 earlier this year, and Wyatt Decker, CEO of OptumHealth, said Optum is on track to exceed that number [this week]. Optum now has 56,000 affiliated, contracted and employed physicians.” Wow.
  • The Food and Drug Administration announced its marketing approval for “Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. ‘Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,’ said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. ‘The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.’”
  • Fierce Healthcare reports that “Despite the challenges in 2020, physicians’ salaries have rebounded, along with hours working and with only a slight dip in patient volume, according to the Medscape Physician Compensation Report 2021. Based on responses from more than 18,000 U.S. physicians across 29 specialties, the survey—conducted Oct. 6, 2020, to Feb. 11, 2021—found that average salaries for primary care physicians held steady at $242,000 from $243,000 the previous year. Similarly, specialists’ average salaries dropped $2,000 to $344,000.”
  • Fierce Healthcare also reports

Ride-sharing company Lyft is letting patients schedule nonemergency medical transport (NEMT) on health organization’s dime with the launch of Lyft Pass for Healthcare. The latest healthcare offering falls in line with the initial Lyft Pass service launched in July 2020, which allows business organizations to monitor and cover the cost of employees’ transportation. Now, the company is extending those capabilities to healthcare organizations—commercial health plans as well as Medicare or Medicaid—and their members.

Through the app, users who need a ride to their medical appointments, vaccinations, prescription pickups or other destinations request a ride. This process is similar to ordering a pickup as a consumer, except that patients will need to select an in-app branded Lyft Pass provided via phone number, access code or a direct link. Healthcare organizations sponsoring the pass, meanwhile, are able to customize the program’s budgets, approved locations and scheduling windows. The organizations are able to monitor usage and manage spend while allowing members to be more autonomous with their NEMT scheduling.

Midweek Update

Bloomberg reports that

A Centers for Disease Control and Prevention panel ended discussion about the Johnson & Johnson vaccine without taking a vote, leaving it unclear how long the distribution of the shot will remain paused in the U.S. Some panel members advocated for a monthlong pause, while others were concerned about the effects of not having the J&J vaccine available, especially to the communities it was being targeted toward. As a result, distribution of the vaccine will remain halted at least until the panel meets next, perhaps in a week to 10 days.

The Wall Street Journal adds

The six cases [which resulted in the pause] exceed the background rate for the rare brain blood-clotting condition alone in women of this age group, said Tom Shimabukuro, a vaccine safety expert at the CDC who presented data on the cases. The illness the six women developed—cerebral venous sinus thrombosis, or CVST, combined with a low-platelet count—is even more rare, he said. 

The CDC issued an alert to healthcare providers Tuesday warning them to screen for the blood-clotting condition among patients who recently received the J&J vaccine and have severe headache or abdominal pain, shortness of breath, backache, leg swelling, new neurological symptoms or new or easy bruising. The condition requires a unique treatment, and healthcare providers shouldn’t give these patients the standard treatment, which involves using the anticoagulant heparin, the agency also warned. 

Notwithstanding yesterday’s supply disruption, 2.5 doses of the COVID-19 vaccines were administered yesterday according to the CDC. 47.6% of the U.S. population over age 18, and 79.6% of the U.S. population over age 65, have had at least one dose of the vaccines. 29.6% of the over age 18 population and 63% of the over 65 population are fully vaccinated.

On the artificial intelligence front, STAT News informs us that

Mayo Clinic [along with business partners] is forming a pair of companies to collect and analyze data from remote monitoring devices and diagnostic tools, a move that comes as part of a broader bid to harness patient data to deliver continuous care guided by artificial intelligence. The ultimate goal of the companies is to deliver more precise physiological information to patients and doctors around the clock, allowing them to make faster decisions to head off disease and deliver care without the usual morass of extra office visits and trips to the pharmacy.

Here’s hoping plus a link to the Mayo Clinic’s press release.

In other healthcare news, the Mayo Clinic also reminds us that “One in 5 Americans has a sexually transmitted infection,according to the Centers for Disease Control and Prevention (CDC). During Sexually Transmitted Diseases Awareness Week, April 12–17, the CDC encourages discussion, testing and help to remove the stigma surrounding sexually transmitted infections and diseases.”

The International Foundation of Employee Benefit Plans lets us know that

The number of organizations offering fertility benefits has increased over the past five years. According to the International Foundation of Employee Benefit Plans (Employee Benefits Survey: 2020 Results), 30% of U.S. organizations offer fertility benefits. Overall,

  • 24% cover fertility medications (8% covered in 2016, 14% in 2018)
  • 24% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018)
  • 14% cover visits with counselors (e.g., geneticists, surrogacy, etc.) (4% in 2016, 8% in 2018)
  • 12% cover genetic testing to determine infertility issues (up slightly from 11% in 2018)
  • 11% cover non-IVF fertility treatments (6% in 2016, 11% in 2018).

In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018 and even higher in 2020, with 10% reporting that they cover the benefit.

Fierce Healthcare reports

As growing numbers of specialty drugs come through the development pipeline, employers are finding new strategies to manage the associated costs, a new report from Willis Towers Watson shows. Katie Asch, senior director and U.S. consulting pharmacy practice lead at WTW, told Fierce Healthcare that two-thirds of new drug approvals are for specialty drug products. In addition, these products are gaining approval for additional indications, Asch said. * * *

The WTW analysis groups potential solutions in financial and clinical responses, with financial options focusing on costs directly and clinical solutions focusing on utilization. For instance, utilization management tools like prior authorization can ensure patients are taking drugs appropriately, while copay assistance programs can manage individual costs.

In addition, according to the report, employers are finding ways to deploy multiple solutions in tandem. The insurer may offer a stop-loss program that can work well in tandem with advanced strategies for chronic care management, for example. “We’re seeing plans focus a bit more attention there if they have already pulled all the levers,” she said.

The report also highlights some drug products that are expected to get the Food and Drug Administration’s OK in the coming months. Ponesimod, a therapy for multiple sclerosis, is expected to be approved around March 18 and would cost between $60,000 and $80,000 per year.

The Pause plus Tuesday Tidbits

Photo by Patrick Fore on Unsplash

Here is a link to the joint Food and Drug Administration / Centers for Disease Control statement on the recommended pause in administration of the Johnson and Johnson single dose COVID-19 vaccine that the agencies issued this morning. Becker’s Hospital Review reports that pharmacies and State governments administering the vaccine have implemented this recommendation.

Next steps —

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these [six] cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

STAT News adds

Experts applauded the decision as the right thing to do.

“The pause is a prudent step to take, because when very serious adverse events occur that are also very rare, what matters most is ‘very serious,’” said John Moore, an immunologist at Weill Cornell Medicine. “Not only are individual members of the public at some risk, but so is the wider confidence in the Covid-19 vaccines.”

“It’s a reasonable but unproven assumption that the J&J and AstraZeneca vaccine safety concerns are linked by being related to an immune response against an adenovirus component,” he said. “So, FDA and scientists need time to better understand what is going on, which means a pause is the right course of action.”

And now for the tidbits

  • Modern Healthcare reports that the House today joined the Senate in delaying otherwise required 2% cuts in Medicare payments for the remainder of 2021. The means that CMS will be giving the Medicare Administrative Contracts its approval to resume paying Medicare claims once the President signs the bill into law.
  • Healthcare Dive reports that “Salt Lake City-based Intermountain [which sponsors an FEHB HMO] is acquiring air ambulance company Classic Air Medical in a bid to better coordinate virtual and physical care for rural patients. Snapping up Classic, which operates aircraft in eight western states and has a significant overlap with Intermountain’s telehealth footprint, is meant to make it easier to transport high-need patients to the closest medical facility equipped for their needs, the nonprofit system said in a Monday statement.”
  • The Department of Health and Human Services “have published several new resources to help states, vaccination providers, and others leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them – to ensure accessibility.”
  • FedSmith explains “the Difference Between Postponed and Deferred FERS Retirement While postponed and deferred retirement sound similar, there are big differences for FERS federal employees who retire early with these options.” You only receive lifetime FEHB coverage in retirement with a postponed FERS retirement.
  • The trade association of prescription drug manufacturers Phrma has launched a new public relations campaign about its patient centered agenda while the Campaign for Sustainable Rx Prices “launched [its own] campaign Tuesday encouraging policymakers to act on campaign promises to hold Big Pharma accountable and lower prescription drug prices.” And so it goes.

Monday Roundup

Photo by Sven Read on Unsplash

Bloomberg reports that

The Covid-19 variant that’s become the dominant strain in the U.S isn’t as deadly as earlier research indicated, although it’s confirmed to be faster-spreading than other versions, according to a study.

Among 339 patients with the coronavirus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published Monday in the Lancet Infectious Diseases journal, compared with 38% of those who had non-B.1.1.7 infections.

“We’re not saying it’s nothing, but it’s not worse in terms of outcome in our study, in our setting,” said Eleni Nastouli, a co-author of the study and an associate professor at University College London. She noted that the study differed from some earlier research, looking at patients in hospitals, rather than in the community, and making precise identifications of variants with whole-genome sequencing.

Earlier data released by a U.K. advisory group and cited by the U.S. Centers for Disease Control and Prevention indicated that B.1.1.7 might be as much as a third more deadly than other variants of the virus. 

FLASH: Bloomberg reports Tuesday morning that

U.S. health officials recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine on concerns about rare and severe blood clotting side effects. A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said Tuesday in a joint statement. As of April 12, more than 6.8 million doses of the vaccine have been administered, the agencies said.

If you had to pause one of the vaccines this would be the week to pause the Johnson & Johnson vaccine due to the manufacturing / distribution problems. Fingers crossed for a short pause.

The Department of Health and Human Services today

marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. A new data brief shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months post-partum and disruptions in Medicaid coverage often lead to periods of uninsurance, delayed care, and less preventive care. The American Rescue Plan provides an easier pathway for states to extend Medicaid postpartum coverage from 60 days to 12 months.

Secretary Becerra also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. For the first time, applicants are required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

For more information on the fourth Black Maternal Health Week, check out the Black Mamas Matter Alliance’s website.

From the prescription drug front —

  • Cigna’s Evernorth unit, which includes the Express Scripts PBM, has released its 2020 Drug Trends report. The report’s by the numbers webpage is quite illuminating.
  • STAT News informs us that

Patrizia Cavazzoni has been named the permanent leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, the agency’s acting commissioner, Janet Woodcock, announced Monday morning. The position of CDER director is one of the most influential at the sprawling agency. Cavazzoni, who is in her late 50s, was handpicked by Woodcock to join the agency in 2018 and has been leading the drug center in an acting role since last spring. Cavazzoni is known as a problem-solver who has taken on some of the FDA’s most pressing problems, former top FDA officials told STAT last year.

From the healthcare technology front —

Healthcare Dive lets us know that

Microsoft is acquiring clinical documentation and artificial intelligence company Nuance Communications for $19.7 billion, two years after first inking an R&D partnership with the speech-to-text market leader. The Redmond, Washington-based tech giant said Monday it has entered into a definitive agreement to acquire Nuance for $56 a share — a hefty price tag, representing a 23% premium on the closing price on Friday. Nuance develops conversational artificial intelligence and cloud-based ambient clinical intelligence for doctor’s offices and hospitals.

Jingle bells to Nuance Communications. Healthcare AI is obviously a big deal.

  • Becker’s Hospital Review reports that “Google is in the early stages of a new project that aims to explore and develop a new consumer-facing health records tool for Android users, according to an April 9 STAT report. * * * The project could support the development of a medical records tool similar to Apple’s Health Records app, according to the report.”

Finally here’s an interesting smoking cessation twist from Healio:

A parental smoking intervention was effective and “inexpensive” to implement in pediatric primary care practices, with costs per quit that were comparable to other interventions, according to researchers. * * * “The impetus for screening parents for tobacco use in the pediatric setting is to protect children from exposure to secondhand smoke,” Douglas E. Levy, PhD, MPH, associate professor of medicine at Harvard Medical School and associate investigator at the Mongan Institute Health Policy Center at Massachusetts General Hospital, told Healio Primary Care. “Parents may be more receptive to smoking cessation messages when the recommendation comes from pediatric health care providers because the benefits are framed in terms of protecting their child’s health.”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Yesterday, the Office of Personnel Management issued its technical guidance supporting the call letter for 2022 benefit and rate proposals which are due by May 31, 2021. The guidance provides insight into the call letter’s priorities.

The FEHBlog’s priority is supporting the COVID-19 vaccination effort. STAT News reports that

Useful Covid-19 information isn’t reaching the Instagram generation [Z]. There’s almost no messaging specifically tailored to them from federal or state public health officials. There’s hardly anything official on Tik Tok. And even the limited efforts to reach them where they are — like Instagram’s links to its “Covid-19 information center”— aren’t working. * * * Numerous public health officials told STAT that the issue of growing vaccine reluctance among young people can be solved with a coordinated campaign of reliable, useful information that makes it both easy and enticing for young people to get vaccinated, even if they may not personally benefit much. Those same officials acknowledged, however, that much of the groundwork for messaging to young people is yet to be done.

Recognizing a problem is the first step toward solving it.

Govexec.com informs us that

FEMA has sent about 3,000 employees to vaccination sites and is fully running 30 mass vaccination centers. It declined to say how many volunteers it was seeking from other agencies. The emergency response agency is standing up community vaccination centers fully run and staffed by federal employees, providing funding and staffing to state-run sites and deploying mobile vaccination centers.

Thanks Feds.

The Centers for Medicare and Medicaid Services announced yesterday a proposed rule “that would update Medicare payment policies and rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for Fiscal Year (FY) 2022 and propose changes to the IPF Quality Reporting (IPFQR) Program. * * * Total estimated payments to IPFs are estimated to increase by 2.3% or $90 million in FY 2022 relative to IPF payments in FY 2021.  For FY 2022, CMS is proposing to update the IPF PPS payment rates by 2.1% based on the proposed IPF market basket update of 2.3%, less a 0.2 percentage point productivity adjustment.”

Fierce Healthcare alerts us that “Drugs for inflammatory autoimmune conditions account for a growing chunk of pharmacy spend, according to new data from Prime Therapeutics. The pharmacy benefit manager studied (PDF) data on its 15 million commercially insured members in 2019 and 2020 and found that fewer than 1% of members had an inflammatory autoimmune condition such as psoriasis, rheumatoid arthritis, ulcerative colitis or Crohn’s disease. However, drugs treating these conditions accounted for nearly 20% of drug spend in the medical and pharmacy benefit, Prime Therapeutics found.” Wow.

Healthcare Dive reports that

  • While urgent care centers do keep some lower-acuity patients from visiting costly emergency departments, their presence is not associated with a drop in total healthcare costs, according to a report in Health Affairs.
  • Using commercial claims and enrollment data from 2008 to 2019, researchers found an increase of 1,000 lower-acuity urgent care visits resulted in 27 fewer lower-acuity ER visits. The entry of a high-volume urgent care center into a ZIP code was associated with a 31% drop in emergency visits.
  • However, while ER trips were far more costly ($1,716 vs. $178), each $1,646 ER visit was offset by $6,327 more in urgent care costs because the number of urgent care visits per enrollee required to reduce one ER visit was 37.

Hmmm.

Health Payer Intelligence discusses a three ways for employers to fund their employee health benefit plans — insured, self-funded and an approach (with which the FEHBlog was not familiar) level funding.

In the level-funded model, the employer pays the insurer each month to cover expected healthcare expenditures, the Society for Human Resource Management (SHRM) website explains. The funds go towards claim payments, stop-loss insurance premiums, and administrative costs.

If this sounds familiar that is because this model borrows from both the fully-insured and self-insured models.

However, the distinction is that in a level-funded health plan, the insurer will return to the employer any funds that remain at the end of the year, if the volume of medical claims is not as high as anticipated. Alternatively, if the volume of medical claims exceeds the projected cost, employers will face a higher stop-loss insurance premium.

Although this is the general template for a level-funded plan, contracts may include various specifications, the SHRM site says. For example, some insurers may require that their company retain a certain percentage of the savings or that these funds roll over to be spent on medical claims in the subsequent year.

In this model, insurers—specifically larger insurers—may have cemented their level-funded plan offerings or they may work with employers to tailor the funding plan to fit the business’s needs.

Level-funded plans cater to smaller firms that want a self-insured health plan but may not be able to afford the high cost of medical claims and stop-loss insurance.

You do learn something new everyday.

Midweek update

Photo by Manasvita S on Unsplash

From Capitol Hill, STAT News reports that Senate leaders have reached an agreement to extend a Medicare pay bump for health care providers through 2021, a major lobbying win for hospitals.”

The Wall Street Journal reports two Senate confirmations in healthcare positions:

The Senate [today] confirmed Dr. Rachel Levine as assistant health secretary, making her the first openly transgender federal official approved by the Senate.

The vote was 52 to 48, largely along party lines, with GOP Sens. Lisa Murkowski of Alaska and Susan Collins of Maine joining all 50 Democrats.

The pediatrician and former Pennsylvania secretary of health helped steer the state’s response to Covid-19. She has also worked to increase awareness of equity issues that the LGBT community faces and is a professor of pediatrics and psychiatry at Penn State College of Medicine. 

and

Yesterday, the Senate approved Vivek Murthy, President Biden’s pick for surgeon general, by a 57-to-43 vote, marking his second stint in the post, which he held from 2014 through 2017. Dr. Murthy, who was co-chairman of Mr. Biden’s Covid-19 advisory board, has said he would use his position to provide science-based guidelines for ending the coronavirus pandemic.

From the COVID vaccine front, Medscape informs us that

White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

FLASH — The Washington Post reported at 10:30 pm Wednesday night that

An updated company analysis of the coronavirus vaccine developed by AstraZeneca and the University of Oxford showed that the two-shot regimen was robustly effective — 76 percent at preventing symptomatic illness — according to a news release from the drugmaker late Wednesday.

The finding, only slightly lower than results announced days earlier, underscores that the vaccine being widely used by many countries appears to be a powerful tool to help end the pandemic. No severe cases of illness were reported in study volunteers who received the vaccine. Among people 65 and older, the vaccine was 85 percent effective, the company reported.

Yesterday, the FEHBlog watched a Wall Street Journal interview with Mr. Slavitt as part of the WSJ’s Health Forum. The FEHBlog really enjoyed this WSJ video featuring reporter Joanna Stern with a COVID vaccine hunter from New Jersey. It’s certainly worth five and half minutes of your day.

HR Dive reports that

Employers should offer paid sick leave to employees with “signs and symptoms” following COVID-19 vaccination, according to guidance updated March 16 by the Centers for Disease Control and Prevention.

Employers should consider on-site vaccination programs if they have a large workforce with predictable schedules and enough space to run a clinic that meets social distancing requirements, CDC said. Employers that choose to offer vaccinations should record each offer and employees’ decisions. Employers should consider off-site vaccination if they are a small- or medium-sized organization lacking the resources to host a vaccination clinic, it said.

The agency also said that whether an employer may require COVID-19 vaccinations is a matter of state or other applicable law but noted that exemptions may apply: Medical exemptions for people who are at risk for an adverse reaction because of an allergy to one of the components used in the vaccine or a medical condition; and religious exemptions for people who reject being vaccinated because of their religious beliefs.

In healthcare business news, Fierce Healthcare lets us know that

Uber is ramping up its prescription delivery business by teaming up with software company ScriptDrop. The ride-share giant will be the default delivery service for ScriptDrop pharmacies in 37 states and will eventually expand to others.

ScriptDrop works with some of the top grocery chains, pharmacy chains and health systems in the U.S., including Albertsons, Jewel-Osco, Safeway and Vons. Through the tie-up with Uber, those pharmacies will be able to leverage the company’s technology to deliver more prescriptions to more customers.

From the report front, the FEHBlog noticed

Finally March 22 to 28, 2021, is National Drug and Alcohol Facts Week. “Held since 2010, NDAFW brings teens and scientific experts together to discuss the scientific facts about drugs, as well as their potential health effects on teen bodies and brains. ”