Weekend Update

CMS

Weekend Update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Dane Deaner on Unsplash

The U.S. House of Representative both will be engaged in committee work through Wednesday this week until Yom Kippur begins on Wednesday evening. The Senate also will be engaged in floor voting for the same period. Committee work principally will focus on the details of the $3.5 trillion budget reconciliation bill and a related Plan B measures including a stopgap extension of federal funding past September 30 and addressing the debt ceiling.

On the Delta variant front

The Wall Street Journal explains that epidemiologists no long think that COVID-19 can be eradicated. We have a good shot at the virus becoming endemic / a routine treatable illness.

When or even whether Covid-19 settles into that status depends on how many more people get vaccinated and how soon, said Adolfo Garcia-Sastre, director of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine at Mount Sinai in New York.

For Covid-19 to become mild, most people will need some immunity, which studies have shown reduces the severity of the disease. Infections provide some immunity, but at risk of severe illness, death and further spread of the virus, compared with vaccines. People could become vulnerable to SARS-CoV-2 if that immunity erodes or is weak, or if the virus mutates.

“The more people who are vaccinated, the less problems there are going to be,” Dr. Garcia-Sastre said.

The Journal’s Numbers columnist explains why COVID-19 vaccination boosters will be necessary.

“We’re fortunate with tetanus, diphtheria, measles and vaccinia,” Dr. [Mark] Slifka [from the Oregon Health & Science University] said. “We have identified what the threshold of protection is. You track antibody decline over time, and if you know the threshold of protection, you can calculate durability of protection. With Covid, we don’t know.”

Complicating things further, viruses and bacteria that mutate to escape the body’s immune response are harder to control.

Measles, mumps, rubella and chickenpox hardly mutate at all, but at least eight variants of SARS-CoV-2, the virus that causes Covid-19, have been found, according to the British Medical Journal.  

“It does make it more complicated for the vaccine to work,” Dr. Slifka said. “You’re chasing multiple targets over time. Flu also mutates. With flu, we’ve adjusted by making a new flu vaccine each year that as closely as possible matches the new strain of flu.”

The FDA’s Vaccines Advisory Committee meets on the topic of COVID-19 boosters this Friday September 17. The CDC’s Advisory Committee on Immunization Practices has scheduled a complementary meeting for September 29.

The FEHBlog ran across this interesting WebMD article titled “Monoclonal Antibodies vs. Vaccines vs. COVID-19: What to Know.” “‘As hospitalizations go up nationwide, we have a therapy here that can mitigate that,’ says William Fales, MD, medical director of the Michigan Department of Health and Human Services Division of EMS and Trauma. Getting monoclonal antibodies is one of ‘the best things you can do once you’re positive.’” However, the vaccine’s protection against COVID-19 has a much longer duration than this treatment. “There are two authorized uses for monoclonal antibodies: To treat or stop COVID-19’s progression in a high-risk person who tests positive, and to prevent COVID-19 in a high-risk person who’s been exposed.” The treatment is administered while hospitalized or while outpatient at an infusion center.

In RX news, Managed Healthcare Executive reports

The FDA has approved 30 biosimilars and 21 have been launched. But it won’t be till biosimilars for some of the more widely prescribed biologics are on the market before biosimilars really start to have a major impact on American healthcare and its cost, according to a top-ranking executive at OptumRx.

“We’re still a few years away from the point at which the most widely-utilized … products in the U.S. today will be available as biosimilars,” Savitha Vivian, senior vice president of clinical and formulary Services for OptumRx, said in an interview with Managed Healthcare Executive®. “And that’s really what we’re looking for, because that’s going to enable a more sizable and impactful bottom-line savings.”

Ms. Vivian expects Humira to hit the bio-similar market in 2023.

“Another significant biosimilar launch that is still two to three years away from one for Novo Nordisk’s insulin aspart injection (Novolog), a “highly utilized medication, especially in the outpatient setting,” noted Vivian.Biosimilars for Genentech’s Actemra (tocilizumab), a medication for rheumatoid arthritis and other forms of arthritis, and Stelara (ustekinumab), Janssen’s immunosuppressive drug for plaque psoriasis and psoriatic arthritis, are also two or three years away.”

Patient and provider comfort with biosimilars is still a “critical barrier” to the adoption of biosimilars, she said.

Switching therapies in patients who are stable on the biosimilar’s reference product to the biosimilar is not typically recommended, according to Vivian. “So from a clinical perspective, we need to be cautious in implementing strategies that force these types of switching.”Instead, she said, “what we really need is data showing that there’s really no additional risk from switching therapies in these hard-to-treat or hard-to-control chronic diseases. That’s going to really increase the confidence for prescribers to start using biosimilars in … those stable patients.”

Another barrier is a lack of interchangeability in biosimilars, with notable exception of Semglee (insulin glargine-yfgn), which was FDA-approved as biosimilar to, and interchangeable with Lantus (insulin glargine) this summer. In order to demonstrate interchangeability, studies must show there is no additional risk or reduced efficacy if a patient switches back and forth between the interchangeable biosimilar and the reference product.

Weekend update

David Ermer–CMS, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate remains on its State work break this week while the House of Representatives returns to vote on the Democrat $3.5 trillion budget blueprint and possibly the bipartisan $1 trillion infrastructure bill, both of which have cleared the Senate, among other measures. The Wall Street Journal reports

Dozens of liberal House Democrats have said they would not vote for the infrastructure bill until the broader budget package passes the Senate, in a bid to use their muscle to maintain pressure on centrist Democrats, some of whom have expressed concerns over the size and cost of a $3.5 trillion bill.

“Frankly, if we were to pass the bipartisan [infrastructure] bill first then we lose leverage,” said Rep. Ritchie Torres (D., N.Y.). If the nine centrist Democrats don’t budge, “it’s a recipe for gridlock because I can assure you that members like me have no intention of budging on our position,” Mr. Torres said. The centrist Democrats reiterated their position in a series of coordinated statements on Friday.

Mrs. Pelosi can lose no more than three Democrats on votes expected to be opposed by all Republicans. In an effort to appease the centrists, Mrs. Pelosi has scheduled a vote Monday night that would procedurally advance both the infrastructure bill and the budget framework. Centrists indicated that step was insufficient, since it wouldn’t pass the infrastructure bill. They worry that yoking the two bills together could result in months of delay before the broader $3.5 trillion budget package is ready for a vote.

This will be an interesting vote.

From the Delta variant front, Bloomberg reports that

The roll out of a third dose of Covid vaccine has sparked debate on ethical and political grounds, since a large swath of the human population is yet to receive any inoculation. But the case for boosters on scientific grounds is building.

The reason is delta. The most-infectious coronavirus variant to emerge so far is in a race with the human immune system, and there’s mounting evidence that delta is winning — at least initially. Fully vaccinated individuals infected with the variant have peak virus levels in the upper airways as high as those lacking immunity, a large study from the U.K. showed last week.

That suggests people with delta-induced breakthrough infections also may be capable of transmitting the virus, frustrating efforts to curb the Covid pandemic. Waning antibody levels in some highly vaccinated populations such as Israel have prompted calls to offer boosters to blunt fresh waves of hospitalizations. 

“The science is the boosters work, and they will definitely help,” said Shane Crotty, a virologist and professor at the La Jolla Institute for Immunology’s Center for Infectious Disease and Vaccine Research in California.

In fully vaccinated, healthy adults, booster shots from Moderna Inc. as well as Pfizer Inc. and its partner BioNTech SE cause antibodies to rebound to peak levels, if not well beyond, Crotty said in a Zoom interview Friday. Those antibodies are also likely to be more durable and adept at fighting a wider range of SARS-CoV-2 strains, he said. That’s especially helpful in fighting delta.

That’s important information.

From the physician compensation front, Fierce Healthcare informs us that

Physician pay barely increased in 2020, while productivity plummeted due to the pandemic, a new survey found. 

According to the latest AMGA medical group compensation and productivity survey, which reached nearly 400 medical groups representing more than 190,000 providers, increases in compensation were modest, while productivity impact was significant. 

“The trends we saw in this year’s survey were the obvious result of flat compensation combined with a decline in volume of services,” AMGA consulting president Fred Horton said in a press release. “Medical groups paid a steep price to retain their physician talent,” the statement went on, noting that the pandemic has emphasized the need for health providers to “reconsider their compensation plans so that they rely less on obligatory annual pay increases and more on incentivizing productivity that rewards valuable outcomes.” 

Transitioning to value-based compensation structures will create more resiliency against “future economic downturns,” he said.

The decline in productivity was driven by canceled elective procedures, diminishing access to health services for certain patients during the year and fear around seeking in-person care due to COVID-19, the group noted in its press release. 

Speaking of value-based compensation, a friend of the FEHBlog called his attention to this Atlantic magazine article about low value surgical care.

In 2017, the journal Plos One published a survey of 2,100 American doctors. Sixty-five percent of the respondents reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. What’s more, 70 percent of the responding doctors said that they believed profit was a driving factor. “The best way to lower health-care costs in America is to stop doing things we don’t need,” Marty Makary, a professor at Johns Hopkins School of Public Health and a co-author of the Plos One study, told me. Some medical institutions—Kaiser Permanente and the Mayo Clinic among them—no longer link physician pay to the quantity of procedures performed for this reason. * * *

In 2017, the journal Plos One published a survey of 2,100 American doctors. Sixty-five percent of the respondents reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. What’s more, 70 percent of the responding doctors said that they believed profit was a driving factor. “The best way to lower health-care costs in America is to stop doing things we don’t need,” Marty Makary, a professor at Johns Hopkins School of Public Health and a co-author of the Plos One study, told me. Some medical institutions—Kaiser Permanente and the Mayo Clinic among them—no longer link physician pay to the quantity of procedures performed for this reason.

The legal system acts as a final backstop. Most of the False Claims Act cases filed each year are health-care related, including cases concerning unnecessary surgeries. In 2020, the government recovered $2.2 billion in fraud and abuse via the False Claims Act, $1.8 billion of which was health-care related. Payouts for medical-malpractice claims in the U.S. hover around $4 billion each year. Although the law provides a route for the federal government to recoup costs, it cannot undo the procedures.

The Office of Management and Budget’s Office of Federal Procurement Policy sets policy for government contracts including the OPM contracts that create FEHB plans. Recently the President nominated Biniam Gebre to be OFPP Director, which is subject to Senate confirmation. Federal News Network interviewed former OFPP Directors about the President’s nomination. Check it out.

Midweek Update

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

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.

Monday Roundup

David Ermer–ACA, CMS, COVID-19, COVID-19 vaccine, Medicare, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

David Leonhardt in the New York Times offered an encouraging article this morning:

When the Kaiser Family Foundation conducted a poll at the start of the year and asked American adults whether they planned to get vaccinated, 23 percent said no.

But a significant portion of that group — about one quarter of it — has since decided to receive a shot. The Kaiser pollsters recently followed up and asked these converts what led them to change their minds. The answers are important, because they offer insight into how the millions of still unvaccinated Americans might be persuaded to get shots, too.

What helps move people from vaccine skeptical to vaccinated? The Kaiser polls point to three main themes.

(The themes apply to both the 23 percent of people who said they would not get a shot, as well as to the 28 percent who described their attitude in January as “wait and see.” About half of the “wait and see” group has since gotten a shot.)

1. Seeing that millions of other Americans have been safely vaccinated. * * *

2. Hearing pro-vaccine messages from doctors, friends and relatives. * * * and

3. Learning that not being vaccinated will prevent people from doing some things.

That’s helpful information for the many vaccine advocates, among us.

Today was a busy day for regulatory action:

  • The Secretary of Health and Human Services renewed for another 90 day period the COVID-19 public health emergency. Earlier this month, the HHS Secretary issued a similar renewal for the Opioid public health emergency which of course predates the COVID-19 emergency. Here’s a link discussing the actions that the federal government can take in response to a public health emergency declaration.
  • The Affordable Care Act regulators issued implementation guidance FAQs part 47 today. As background, “on June 11, 2019, the U.S. Preventive Services Task Force released a recommendation with an “A” rating that clinicians offer [pre-exposure prophylaxis (PrEP)] with “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.” Accordingly, [as required by the ACA, non-grandfathered] plans and issuers must cover PrEP consistent with the USPSTF recommendation without cost sharing [when provided in-network] for plan years (in the individual market, policy years) beginning on or after one year from the issue date of the recommendation (in this case, plan or policy years beginning on or after June 30, 2020).” The FAQs concern the scope of the requisite no cost sharing coverage for this particular service. Affected plans and issuers are allowed sixty days to implement the guidance.
  • The Centers for Medicare and Medicaid Services “proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021.” Here is a link to the fact sheet on the proposal. Consistent with the President’s recent executive order on competition, the CMS rule making “proposes to set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500.  Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.” That should be attention getting if finalized. Also the rule making proposes to backtrack on Trump Administration CMS rules that would phase out inpatient only Medicare requirements for certain medical procedures. The former administration’s goal was to lower costs, but the current administration finds that the former administration did not follow all of the necessary patient safety procedural requirements when making this change.
  • Govexec reports that today “marks the deadline for agencies to submit their finalized return to office plans to the Office of Management and Budget. These plans, which are not intended to be public, will vary by agency.”

The American Hospital Association informs us that “The Centers for Medicare & Medicaid Services will host a national stakeholders call July 22 at 3:30 p.m. ET on the interim final rule, Surprise Billing Part 1, that implements aspects of the No Surprises Act that bans balance billing in certain out-of-network scenarios. The call-in number is 888-455-1397; the participant passcode is 8758359.” Thanks AHA and CMS.

Tuesday Tidbits

David Ermer–CMS, COVID-19, Medicare, Mental health care–
Photo by Patrick Fore on Unsplash

Today, the FEHBlog virtually attended the NCQA Digital Quality Summit. A highlight was a VA healthcare speaker who pointed out the VA’s access to care website which is nifty. The site, for example, includes comprehensive comparisons of VA care versus outside care. The site should be useful to FEHB carriers because the FEHB Program covers a large cadre of veterans.

The Centers for Medicare Services released its proposed calendar year 2022 Medicare Part B physician payment rule. According to the fee schedule fact sheet

With the proposed budget neutrality adjustment to account for changes in RVUs (required by law), and expiration of the 3.75 percent payment increase provided for CY 2021 by the Consolidated Appropriations Act, 2021 (CAA), the proposed CY 2022 PFS conversion factor is $33.58, a decrease of $1.31 from the CY 2021 PFS conversion factor of $34.89. The PFS conversion factor reflects the statutory update of 0.00 percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from our proposed policies.

That would cause a cost shift to commercial carriers.

From the tidbit front —

  • The first interim final rule implementing the No Surprises Act was published in the Federal Register today. It turns out that the public comment deadline is Tuesday, September 7, 2021.
  • The NIH Director Dr. Francis Collins relates that

Many people, including me, have experienced a sense of gratitude and relief after receiving the new COVID-19 mRNA vaccines. But all of us are also wondering how long the vaccines will remain protective against SARS-CoV-2, the coronavirus responsible for COVID-19.

Earlier this year, clinical trials of the Moderna and Pfizer-BioNTech vaccines indicated that both immunizations appeared to protect for at least six months. Now, a study in the journal Nature provides some hopeful news that these mRNA vaccines may be protective even longer [1].

In the new study, researchers monitored key immune cells in the lymph nodes of a group of people who received both doses of the Pfizer-BioNTech mRNA vaccine. The work consistently found hallmarks of a strong, persistent immune response against SARS-CoV-2 that could be protective for years to come.

Though more research is needed, the findings add evidence that people who received mRNA COVID-19 vaccines may not need an additional “booster” shot for quite some time, unless SARS-CoV-2 evolves into new forms, or variants, that can evade this vaccine-induced immunity. That’s why it remains so critical that more Americans get vaccinated not only to protect themselves and their loved ones, but to help stop the virus’s spread in their communities and thereby reduce its ability to mutate.

  • In other NIH news, NIH researchers report a conundrum:

Medications to treat alcohol use disorder, although effective, are only being used to treat 1.6% of people with the disorder, according to a new study.

The findings show that medications for alcohol use disorder are rarely prescribed, even though approved drugs are available.

  • In an article that may be helpful for FEHB plans to share with members, the Centers for Disease Control discusses the causes for type 2 diabetes.
  • Health Payer Intelligence reports that employers are shifting the focus of their wellness programs from physical health to mental health. “Over nine in ten employers said that they were increasing their mental health and wellness programming in 2021, including pediatric mental health programs, according to a survey from Fidelity and Business Group on Health. Almost 75 percent reported that they were extending work-life balance support.and nearly 70 percent were expanding their paid leave policies.”

Monday Roundup

David Ermer–CMS, COVID-19 vaccine, Government Contracting, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the COVID-19 vaccine front

  • The New York Times reports that “The Food and Drug Administration warned on Monday that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome, another setback for a [one dose] vaccine that has largely been sidelined in the United States. Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision. The warning was attached to fact sheets about the vaccine for providers and patients.”
  • USA Today offers a success story on AHIP’s Vaccine Community Connectors program. “Most important, this effort helped the industry home in on one specific strategy to accelerate health equity: better access to health care data that incorporates the social determinants of health.” Speaking SDOH data, Health IT Analytics informs us about the use of SDOH data in researching and managing Alzheimer’s Disease.
  • The American Hospital Association reminded folks today to keep its Vaccine Communications Resources website in mind.

Fierce Healthcare reports that

“The Biden administration has started to investigate whether Medicare should cover the extremely pricey Alzheimer’s drug aducanumab. The Centers for Medicare & Medicaid Services announced Monday it is opening a National Coverage Determination (NCD) analysis on the drug that will cost patients $56,000 a year. Advocates and experts have called for the agency to move quickly to decide whether to cover the drug. “We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” said CMS Administrator Chiquita Brooks-LaSure, in a statement Monday. “That’s why our process will include opportunities to hear from many stakeholders.”

Earlier press reports on Aduhelm, as well as common sense, indicate that commercial health plans likely will follow CMS’s lead on coverage of that drug.

Healthcare Dive tells us that “Telehealth use overall has stabilized at levels 38 times higher than before the COVID-19 pandemic, ranging from 13% to 17% of visits across all specialties, according to new data from McKinsey released roughly a year since the first major spike in COVID-19 cases.” * * * On the provider side, 58% of physicians continue to view virtual care more favorably than before the pandemic, though that’s down slightly from September, when 64% of physicians were in support. As of April this year, 84% of doctors were offering telehealth, and 57% said they’d prefer to continue offering it. However, that’s largely dependent on reimbursement: 54% of doctors said they wouldn’t provide virtual care if it was paid at a 15% discount to physical services.”

HR Dive discusses the President’s July 9 executive order provision “taking aim at” non-compete agreements.

Biden’s order leaves some questions unanswered. It does not ban or impact any existing employment agreement, Chris Marquardt, partner at Alston & Bird, told HR Dive in an email. “Employers will need to wait and see what the Federal Trade Commission does in response to the Executive Order before thinking about its potential impact,” he said.

Among other reasons, intellectual property and trade secrets have been cited as cause for use of non-competes. But the agreements have been the subject of criticism for potentially driving down wages in certain industries and geographic areas.

Govexec.com offers an interesting take on how the July 9 executive order seeks to use Federal procurement and regulations to promote competition 

Weekend update

David Ermer–CMS, Congress, COVID-19, Rx coverage, Telehealth, U.S. Healthcare–

This coming week, the House of Representatives resumes Committee business and the Senate resumes both Committee business and floor voting. The Wall Street Journal adds that “After a two-week recess, senators return to Washington this week to determine the fate of much of President Biden’s roughly $4 trillion agenda. Senate Majority Leader Chuck Schumer (D., N.Y.) told Senate Democrats in a letter on Friday that he expects that the chamber will take up both a roughly $1 trillion infrastructure agreement and a resolution setting the parameters of a bill encompassing other Democratic priorities in the coming weeks.”

Returning to the President’s July 9, 2021, executive order on competition the accompanying Fact Sheet explains that with regard to healthcare:

BEGIN QUOTE

In the Order, the President:

  • Directs the Food and Drug Administration to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003.
  • Directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which provide low-cost options for patients.
  • Directs HHS to issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging. 
  • Encourages the FTC to ban “pay for delay” and similar agreements by rule.

Hearing Aids: Hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them. On average, they cost more than $5,000 per pair, and those costs are often not covered by health insurance. A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary. Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market. 
In 2017, Congress passed a bipartisan proposal to allow hearing aids to be sold over the counter. However, the Trump Administration Food and Drug Administration failed to issue the necessary rules that would actually allow hearing aids to be sold over the counter, leaving millions of Americans without low-cost options.

In the Order, the President:

  • Directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter. 

Hospitals: Hospital consolidation has left many areas, especially rural communities, without good options for convenient and affordable healthcare service. Thanks to unchecked mergers, the ten largest healthcare systems now control a quarter of the market. Since 2010, 139 rural hospitals have shuttered, including a high of 19 last year, in the middle of a healthcare crisis. Research shows that hospitals in consolidated markets charge far higher prices than hospitals in markets with several competitors.

In the Order, the President:

  • Underscores that hospital mergers can be harmful to patients and encourages the Justice Department and FTC to review and revise their merger guidelines to ensure patients are not harmed by such mergers.
  • Directs HHS to support existing hospital price transparency rules and to finish implementing bipartisan federal legislation to address surprise hospital billing.

Health Insurance: Consolidation in the health insurance industry has meant that many consumers have little choice when it comes to selecting insurers. And even when there is some choice, comparison shopping is hard because plans offered on the exchanges are complicated—with different services covered or different deductibles.

In the Order, the President:

  • Directs HHS to standardize plan options in the National Health Insurance Marketplace so people can comparison shop more easily.

END QUOTE

Roll Call and Healthcare Dive relate industry reaction to the order. The FEHBlog is not happy with drug importation from Canada directive because our population exceeds Canada’s by ten times. It’s a gimmic. Also the FEHBlog disagrees with standardizing plan designs which by definition inhibits competition. Also the objections to hospital and health insurer consolidation overlooks the fact that the Affordable Care Act largely has driven the consolidation, in the FEHBlog’s opinion.

The Health Affairs Blog discusses Centers for Medicare Services efforts to keep its Medicare Part B schedule current. The article explains

Currently, physician services in the US are priced by Medicare every January 1 in relative value units (RVUs). Every physician service is assigned a Medicare-allowed price in RVUs based on its work “intensity” defined by time, effort, skill, and stress relative to all other services. RVUs are converted to dollars via the Medicare “conversion factor,” which CMS sets annually. Total Medicare allowed payment for each service also includes RVUs for practice expenses and malpractice risk, which are theoretically unrelated to physician compensation.

Commercial insurers generally use the same RVU fee schedule as the basis for physician payments. Value-based payment models use Medicare valuations for calculating costs and payments.

In recent decades, technological advances have substantially expanded the number of procedural services, which are generally priced far above evaluation and management (E/M) services. As procedures are increasingly completed safely in less time, the RVU generation potential of procedurally oriented physician work has also grown. In contrast, the analogous expansion of therapeutic choices and medications that are at the core of E/M services have not been reflected by increased valuations. This has contributed to widened income gaps between proceduralists and non-proceduralists, leading to the lack of incentives for trainees to enter lower-reimbursed specialties, including primary care, endocrinology, oncology, rheumatology, and infectious diseases.

Federal News Network reports that

After a slower January and February, federal retirement seems to be picking back up in the first half of 2021 compared to 2020. June stats from the Office of Personnel Management for newly filed claims showed last month was higher than a year ago, when the pandemic was in full effect.

OPM received 7,264 new retirement claims last month compared to 6,555 new claims in June 2020 — a 10.8% increase. March, April and May each saw year-over-year increases ranging from 15.6%- 47.2%.

Processing them all is a different matter, as last month saw 6,884 claims processed compared to 7,300 processed in June 2020 — a 5.7% decrease. After peaking in March, the claims backlog has been moving downward, but at 24,999 last month is still 30.3% higher than a year ago and 92.3% higher than the steady state goal of 13,000 claims — nearly double.

From the COVID-19 front, Bloomberg informs us that “In the U.S., 334 million doses have been given so far. In the last week, an average of 506,771 doses per day were administered.” According to the CDC, 159.3 million Americans are fully vaccinated. The Wall Street Journal adds that “[While] millions of Americans have rolled up their sleeves to get vaccinated against Covid-19, one group is well behind: young adults.

Their reluctance is a significant part of why the U.S. missed the Biden administration’s goal of getting 70% of the adult population a first dose by July 4, and it is impeding efforts to develop the communitywide immunity sought to move past the pandemic and fend off Delta and other variants.

Now government health authorities are dialing up efforts encouraging 18- to 29-year-olds to get vaccinated.

Turning to the telehealth front,

  • The American Medical Association provides tips on how physicians can being warmth to the virtual visit.
  • Healio informs us that “New research suggests a letter may be all that it takes to lower the number of telehealth no-shows among older patients, even during a pandemic. * * * ‘The letter was a very simple reminder, stating ‘You have an upcoming telehealth visit with your doctor’ and included the date and a range of time that the provider would call, typically a 30-minute period,’ [researcher / physician Sarah] King said in the interview. * * * Overall, the researchers said their intervention was associated with a 33.1% drop in the telehealth no-show rate and an 8% drop in the no-show rate for in-person visits.”

Midweek Update

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

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

On the hospital front —

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

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

On the prescription drug front —

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

In miscellaneous news

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

Thursday Miscellany

David Ermer–ACA, CMS, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the COVID-19 front

  • Sobering news from the Wall Street Journal that “It took less than six months for the globe to record more than 1.88 million Covid-19 deaths this year, according to a Wall Street Journal analysis of data collected by Johns Hopkins University. The university’s count for 2021 edged just ahead of the 2020 death toll on Thursday. These numbers underscore how unevenly the pandemic spread around the globe, often hitting poorer nations later, but before they had access to the vaccines that have benefited Europe and the U.S. * * * Vastly different vaccination rates have sharpened the global divide. Only 2% of people in Africa and just over 6% in Asia have received at least one dose of vaccine, according to Our World in Data. That compares with 22% in South America, more than 40% in the European Union and more than half in the U.S. * * * World leaders are due to discuss their response to the pandemic when they gather in Cornwall, in southwestern England, on Friday.” David Leonhardt sheds light on the vaccinating the world in the New York Times. The bottom line is as he points out: “A rapid global vaccination program — combined with natural immunity in people who have already had Covid — could create the same virtuous cycle that’s underway in the U.S., Britain and other countries: A decline in cases feeds on itself, as there are fewer infected people able to spread the virus to others. And by prioritizing older people for shots, countries can cause deaths to decline even more sharply than cases.”
  • To that end, here in the U.S., Moderna “has requested an emergency use authorization (EUA) for its [two dose, mRNA] COVID-19 vaccine in adolescents [ages 12-17] with the U.S. Food and Drug Administration (FDA). Pfizer’s two dose, mRNA vaccine already is being administered to adolescents in this age group.
  • Johnson & Johnson announced that “the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months.” Absent this science based extension, large surplus of unused doses of this vaccine would have begun to expire later this month.  The Wall Street Journal adds that the federal government continues to suspend shipments of new doses of the single dose vaccine, evidently to allow the surplus to deplete.
  • Fierce Healthcare reports on Kaiser Permanente’s efforts to boost the COVID-19 vaccination numbers. As of today, 64% of Americans over age 18 have received at least one dose and over 75% of Americans over age 65 are fully vaccinated.

In big healthcare legal news, a friend of the FEHBlog pointed out to him today that yesterday the Department of Health and Human Services submitted its interim final rule on No Surprise Billing Act implementation rule to the Office of Management and Budget’s Office of Information and Regulatory Affairs for final review before publication in the Federal Register.

AGENCY: HHS-CMS RIN: 0938-AU63Status: Pending Review
TITLE:Requirements Related to Surprise Billing; Part I (CMS-9909)
STAGE: Interim Final Rule ECONOMICALLY SIGNIFICANT: Yes 
RECEIVED DATE: 06/08/2021LEGAL DEADLINE: Statutory  

In other healthcare and healthcare business news:

  • Healthcare Dive informs us that “UnitedHealthcare, the biggest private payer in the U.S., is delaying a controversial policy that could retroactively deny emergency room bills it deems non-emergent — potentially saddling patients with costly medical bills — following intense backlash from patient advocates and hospital groups. ‘Based on feedback from our provider partners and discussions with medical societies, we have decided to delay the implementation of our emergency department policy until at least the end of the national public health emergency period,’ UnitedHealthcare tweeted on Thursday.
  • Health Payer Intelligence identifies four payers that have embraced value based contracting with healthcare providers in the first half of 2021.
  • STAT News reports on what’s ahead for Biogen’s new Alzheimer’s Disease drug. The article concludes “Despite the controversies, Mark Miller, the former executive director of the Medicare Payment Advisory Commission, thinks Aduhelm will be widely used and make billions for Biogen. Infusion centers used for cancer patients and others can accommodate Aduhelm patients, said Miller, now the executive vice president at the Arnold Ventures philanthropy. Doctors will make good money providing the drug. Most Medicare patients have supplemental coverage that will pick up the 20 percent copay. ‘There’s not a lot of friction here to say, “Don’t do this,’ he said.”
  • STAT News also tells us that “The treatment known as CAR-T, in which white blood cells are genetically modified to attack blood cancer, is one of the most exciting and expensive in medicine. But it has not been directly compared to standard treatments in a randomized trial — until now. Bristol Myers Squibb said Thursday that its CAR-T, Breyanzi, prevented the return of large B-cell lymphoma better than the standard of care treatment, which includes a chemotherapy regimen and a stem cell transplant, in which bone marrow cells are replaced to try to cure blood cancer. The news was released in a terse press release that does not include any details about how the therapy performed. But if the results hold up when published in a medical journal or presented at a medical meeting, they would represent a big step forward for CAR-T therapy.”
  • The American Medical Association offers a blueprint for controlling blood pressure.
  • NIH Director Dr. Francis Collins in his blog interviews U.S. Surgeon General Vivek Murthy on fighting the ongoing opioid epidemic.

In federal employment news, Federal News Network reports that

The Biden administration has lifted the 25% occupancy limit at federal buildings, though agencies must still jump through several hoops before bringing more employees back for in-person work.

The Office of Management and Budget, along with the Office of Personnel Management and General Services Administration, on Thursday issued detailed guidance on the administration’s approach for reopening agency offices during the pandemic — and offered a highly-anticipated glimpse at their approach for telework, remote work and other workforce flexibilities in a post-pandemic world.

Memorial Day Update

David Ermer–CMS, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

On this second (and hopefully last) Memorial Day of the COVID-19 pandemic, let’s take a look at recent reports on the nation’s COVID-19 vaccination campaign —

  • The Wall Street Journal reports that while vaccination rates in the Southeastern states have been relatively low, COVID-19 transmission has been slowed in those states by a combination of vaccinations supplemented by people engaging in open air activities.

Health officials in warm-weather states have launched public-information campaigns to encourage residents to spend as much time outside as possible and are pushing for more vaccinations at outdoor sites such as state parks and minor league baseball parks, as a way of heading off another potential summer surge this year.

“Vaccination and people spending time outdoors are the two biggest factors” in why cases have been relatively low this spring, said Brannon Traxler, an epidemiologist who heads South Carolina’s public-health division.

Encouraging people to spend time outside is a high priority, but the even bigger priority is the focus on vaccination, Dr. Traxler said: “If we can get folks vaccinated, then the weather and where and how people congregate becomes less of a problem.”

  • The Centers for Disease Control reports on Patterns in COVID-19 Vaccination Coverage, by Social Vulnerability and Urbanicity from December 2020 through April 2021:

What is already known about this topic?

Counties with higher levels of social vulnerability have been disproportionately affected by COVID-19.

What is added by this report?

Disparities in county-level vaccination coverage by social vulnerability have increased as vaccine eligibility has expanded, especially in large fringe metropolitan (areas surrounding large cities, e.g., suburban) and nonmetropolitan counties. By May 1, 2021, vaccination coverage among adults was lower among those living in counties with lower socioeconomic status and with higher percentages of households with children, single parents, and persons with disabilities.

What are the implications for public health practice?

Outreach efforts, including expanding public health messaging tailored to local populations and increasing vaccination access, could help increase vaccination coverage in counties with high social vulnerability.

  • The San Francisco Chronicle reports that “Hope builds that COVID vaccine boosters won’t be needed for a year – or much long.” “’I expect we will have to be revaccinated eventually, but I don’t think it’s going to be in a year-or-two time frame,’ said Dr. Joel Ernst, an infectious disease expert at UCSF. ‘Obviously we don’t have a long period of observation, because we haven’t had the vaccines that long. But so far I’m reassured that the vaccine-induced immunity seems to be pretty durable.’”

In other news

  • Healthcare Dive informs us that “The Mayo Clinic reported turning a profit in the first quarter of the year, although its expenses rose significantly compared to the first quarter of 2020, which was mostly completed before the COVID-19 pandemic became a significant issue. * * * [M]ost patient volumes returned to pre-pandemic levels. Outpatient visits for the quarter matched 2019 numbers, while surgical volumes exceeded those of 2019, although inpatient days were down.”
  • Kaiser Health News tells us that “The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs.  Six states have passed laws to start such programs, and Florida, Colorado and New Mexico are the furthest along in plans to get federal approval.  The Biden administration said states still have several hurdles to get through, including a review by the Food and Drug Administration, and such efforts may face pressures from the Canadian government, which has warned its drug industry not to do anything that could cause drug shortages in that country.” Smart move by the Administration. Our country’s population dwarfs Canada’s.
  • The Wall Street Journal reports that “Genetically altered mosquitoes target deadly Dengue fever and ZikaIn pioneering test, insects with a gene primed to interrupt breeding are flying in the Florida Keys. Go get em. One pandemic is enough.