Thursday Miscellany

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Thursday Miscellany

David Ermer–Congress, COVID-19, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The Wall Street Journal reports that Senate minority leader Chuck Schumer and House Speaker Nancy Pelosi have expressed their support for the $980 million bi-partisan COVID-19 relief bill.

[Further] Senators said Thursday that they were trying to work out the details of a rough agreement the bipartisan group of nine senators and members of the Problem Solvers Caucus, a group of 50 centrist House lawmakers, had unveiled earlier this week.  * * * The bipartisan proposal, which would run through March 2021, includes $160 billion in state and local funding and would provide a short-term suspension of liability lawsuits related to Covid-19 at the state or federal level, giving states time to put in place their own protections. Lawmakers said the details of both contentious issues were being worked out before Monday [December 7], when the group hopes to release legislative text. * * * The bipartisan proposal also includes $288 billion for small-business relief, including for the Paycheck Protection Program, $16 billion for the distribution of a coronavirus vaccine, $82 billion for schools, $25 billion for rental assistance and $180 billion for additional unemployment insurance, including $300 a week through March, aides said. In addition, the plan would give $17 billion to airlines.

From the COVID-19 vaccine front

The co-leader of the US government’s Operation Warp Speed coronavirus vaccine initiative on Wednesday outlined the most ambitious timeline yet for vaccinating the most vulnerable Americans against COVID-19.

Moncef Slaoui, Warp Speed’s chief advisor, predicted that 100 million Americans would be immunized by the end of February.

Twenty million Americans should be vaccinated in December, followed by 30 million more in January and 50 million more in February, the former pharmaceutical executive said in a press briefing.

By then, “we will have potentially immunized 100 million people, which is really more or less the size of the significant at-risk population: the elderly, the healthcare workers, the first-line workers, people with comorbidities,” Slaoui said.

As of last year 255 million Americans were over age 18 which is the minimum age to receive the Pfizer – BioNTech and Moderna COVID-19 vaccines. (The total U.S. population is around 330 million currently.) Moderna has started a study of its COVID-19 vaccine on younger people aged 12 to 17.

  • CNN reports on the government’s plan to track COVID-19 immunizations and ensure that people who receive the first dose also get the second.
  • The New York Times offers an online tool to help you figure where is your place in line to receive the COVID-19 vaccine once they receive FDA emergency use authorization. Here’s the answer that the FEHBlog received:

Based on your risk profile, we believe you’re in line behind 118.5 million people across the United States. When it comes to Maryland, we think you’re behind 2.2 million others who are at higher risk in your state. And in Montgomery County, you’re behind 304,800 others.

In other COVID-19 news, Beckers Payer Issues reports that large health plans generally are tying their COVID-19 benefit flexibilities to the end date of the COVID-19 public health emergency which conforms to the FFCRA and CARES Act requirement. The current end date is January 21, but it is a safe bet that the Department of Health and Human Services extends that end date for another 90 days early next month.

There has been a lot of action at the Department of Health and Human Services (“HHS”):

  • Today, HHS “issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.” Principally, the amendment permits telehealth providers of care with prescription authority who are licensed in State A to prescribe COVID-19 testing and other COVID-19 counter measures for patients contacting them from State B. HHS initiated this change because “While many states have decided to permit healthcare personnel in other states to provide telehealth services to patients within their borders, not all states have done so.”
  • Also HHS “released an important HHS Action Plan and announced a partnership to reduce maternal deaths and disparities that put women at risk prior to, during, and following pregnancy. The U.S. Surgeon General Jerome M. Adams issued a complementary Call to Action to Improve Maternal Health outlining the critical roles everyone can play to improve maternal health.” Bravo.
  • Health Payer Intelligence explains that

CMS has introduced a new Medicare value-based contracting model that encourages greater care coordination and requires participants to take full risk for Medicare fee-for-service beneficiaries based on region.

The Geographic Direct Contracting Model uses outcomes-based payment models to address care quality, healthcare spending, care coordination, clinical management, and program integrity in targeted regions.

“Within each region, organizations with experience in risk-sharing arrangements and population health will partner with health care providers and community organizations to better coordinate care,” the press release explained.

Beneficiaries will not have to switch providers or payers. They will continue to have their Original Medicare benefits as well as their enhanced benefits and they may receive reduced cost-sharing for Medicare Part A and Part B, including Part B premium subsidies.

Finally Healthcare Dive explains that in HHS’s CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule 

CMS is eliminating the inpatient-only list that requires roughly 1,700 medical procedures to occur inside a hospital for Medicare members. The inpatient-only list will be completely phased out by 2024, according to the outpatient payment final rule released Wednesday. The hospital lobby balked at the change, contending the list is there to protect patients as the list of procedures can be complex and need hospital resources.

Ultimately, the list expands the options of where certain surgeries can be performed and may ultimately reduce out-of-pocket expenses for Medicare members as surgeries performed in an outpatient setting, such as an ambulatory surgery center, can be less costly, CMS said.

Also, the agency is moving forward with reimbursement cuts for 340B-acquired drugs, a hit to some hospitals. Meanwhile, the rule also loosens restrictions on some physician-owned facilities, also drawing ire from the hospital lobby.

Isn’t wild that in 2020 Medicare still requires 1700 surgeries to be performed on an inpatient basis. The FEHBlog hopes that the Biden Administration’s HHS continues the Trump Administration’s practice of re-evaluating and when appropriate long term practices that have outlived their value.

Midweek Update

David Ermer–AHRQ, Congress, COVID-19–

FYI this is the 3,001st FEHBlog column since 2006. My how time does fly.

The Wall Street Journal reports tonight that

Democratic leaders signaled Wednesday they were prepared to reduce their demands for the next round of coronavirus relief, fueling hopes that an agreement could be reached with Republicans by year’s end to boost struggling businesses and households.

Congressional leaders have been mired in disagreements for months. In a sign that the partisan standoff was easing, however, House Speaker Nancy Pelosi (D., Calif.) and Senate Minority Leader Chuck Schumer (D., N.Y.) said that a new, bipartisan $908 billion relief proposal released Tuesday should serve as the starting point for talks with GOP leaders and the White House. 

If a compromise is reached, those COVID-19 relief provisions would be included in the omnibus spending bill for the current federal fiscal year which must pass before December 12. The only alternative would be to pass a short term funding bill in order to punt the COVID-19 relief provisions into the next Congress which begins on January 3, 2021.

The Journal explains that “Few lawmakers want to linger in the Capitol beyond what is necessary. House Majority Leader Steny Hoyer (D., Md.) said Wednesday that congressional leaders hoped to finish up by the end of next week to give lawmakers time to quarantine before Christmas.” How 2020 is that?

The Centers for Disease Control released updated guidance today on COVID-19 quarantine periods (approaches to reducing the quarantine period for 14 to 10 days) and domestic holiday travel (don’t do it).

A friend of the FEHBlog shared this interesting Health and Human Services infographic on COVID-19 testing in our country.

This friend also pointed out this news about

A free online course developed by the Johns Hopkins Bloomberg School of Public Health on the basics of contact tracing has enrolled more than one million people over the past six months, teaching hundreds of thousands of individuals around the world how to deploy an epidemiological tool considered critical to slowing the spread of COVID-19.

The six-hour course, COVID-19 Contact Tracing, is hosted by Coursera and is open to anyone. Since its launch in May, it has attracted participants from every U.S. state and territory as well as more than 150 countries around the world. To date, more than 520,000 people have completed the course.

Pretty cool effort.

The Agency for Healthcare Quality and Research informs us about its partnership with Google to develop

a new online tool to help patients plan for medical visits. The new Google visit planning tool is built on the same evidence behind AHRQ’s QuestionBuilder app. It makes it easy for patients and those who care for them to privately list and prioritize their questions in preparation for a medical visit. When people use Google to search for a healthcare provider, they will have the option to create their own private visit plan.

Asking the right questions—and making sure you understand the answers—has always been at the heart of AHRQ’s “Questions Are the Answer” public education initiative. Launched in 2007 through a series of public service announcements with the Ad Council, the Questions Are the Answer message highlights the vital role patients and families play as part of their healthcare team.

That’s a helpful tidbit for health plans to share with their members.

Tuesday Tidbits

David Ermer–COVID-19 vaccine, Medicare, Telehealth–
Photo by Patrick Fore on Unsplash

From the COVID-19 vaccine front —

The first two vaccines against the novel coronavirus could be available to Americans before Christmas, Health Secretary Alex Azar said on Monday, after Moderna Inc became the second vaccine maker likely to receive U.S. emergency authorization. The Food and Drug Administration’s outside advisers will meet on Dec. 10 to consider authorizing Pfizer Inc’s COVID-19 vaccine. That vaccine could be approved and shipped within days, with Moderna’s following one week behind that, Azar said.

  • The Wall Street Journal reports on this afternoon’s CDC Advisory Committee on Immunization Practices (“ACIP”) meeting

The [ACIP] panel voted 13-1 in favor of giving the first [COVID-19] vaccines to about 21 million health-care workers and three million residents of long-term care facilities. 

Secretary of Health and Human Services Alex Azar has said federal officials will consider the committee’s recommendations, but that state governors may make final decisions about whom to vaccinate first with the doses that the federal government allocates to them based on their adult populations. He also has said he supports vaccinating vulnerable residents of nursing homes among the first groups.

States wouldn’t have to follow the CDC recommendations, but state and local authorities are expected to rely on them as guideposts for deciding who gets the vaccine first. States have until Friday to indicate to the federal government where they want their initial doses sent.

  • Becker’s Hospital Review informs us that “Any American who wants a COVID-19 vaccine will be able to get one by the end of June 2021, retired U.S. Army Lt. Gen. Paul Ostrowski, director of supply, production and distribution for Operation Warp Speed, said in an Nov. 30 interview with MSNBC. We will have over 300 million doses available to the American public, well before [June],”Mr. Ostrowski said.”

In other news, “Today the Centers for Medicare & Medicaid Services (CMS) released the annual [Medicare Part B] Physician Fee Schedule (PFS) final rule, prioritizing CMS’ investment in primary care and chronic disease management by increasing payments to physicians and other practitioners for the additional time they spend with patients, especially those with chronic conditions. The rule allows non-physician practitioners to provide the care they were trained and licensed to give, cutting red tape so healthcare professionals can practice at the top of their license and spend more time with patients instead of on unnecessary paperwork.” Here’s a link to the CMS fact sheet on the final rule.

The final rule is relevant to the FEHBP for two reasons — (1) a large cadre of Medicare prime annuitants is enrolled in the FEHBP and if any of them have not enrolled for Part B, fee for service plans use the Medicare PFS to pay their doctors and (2) the Medicare PFS is widely used to set payments for out-of-network providers because doctors are so familiar with the PFS. In that case, commercial health plans typically use a higher dollar modifier than Medicare which gives you an idea of how low the Medicare modifier is.

Finally, a friend of the FEHBlog called his attention to this FAIR Health analysis of the number telehealth claims which found that the number of telehealth claims jumped nearly 3000% from September 2019 to September 2020. Wow.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Wellness–
Photo by Sven Read on Unsplash

The FEHBlog should rename Monday’s column COVID-19 Vaccine Good News because for the fourth Monday in a row that news leads the FEHBlog.

Healthcare Dive reports that “Moderna on Monday released new study results showing the [messenger RNA based] coronavirus vaccine it developed with U.S. government scientists to be 94.1% effective at preventing COVID-19 in a large clinical trial, data the company will use to request emergency approval” from the Food and Drug Administration.

According to Moderna’s announcement

[P]rimary analysis was based on 196 cases [of COVID-19 within the test group of 30,000 individuals, half of whom received the vaccine and the other half of whom received a placebo]. 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 [vaccine] group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.

Healthcare Dive adds that

Moderna said it will submit on Monday [today] an application for emergency use authorization in the U.S. and for conditional marketing approval in Europe. The FDA will convene a panel of independent advisers to publicly review Moderna’s application, likely on Dec. 17. * * *

An authorization for either vaccine [Pfizer – BioNTech or Moderna] would kick off a mass immunization campaign in the U.S. But supplies of each shot will be extremely limited for months. Moderna expects to have just 20 million doses available in the U.S. this year, and between 500 million to 1 billion in 2021. [Two doses protect one person. The Wall Street Journal notes that Pfizer and BioNTech said they would deliver about 25 million doses by year’s end, potentially enough for about 12.5 million people in the U.S.]

A Centers for Disease Control and Prevention advisory committee will meet on Tuesday to vote on how vaccine doses will allocated. Healthcare workers on the front lines of the pandemic will likely be vaccinated first.

The Wall Street Journal expands on this last point:

Expected to be first in line: health workers treating coronavirus patients and in something of a surprise, nursing-home residents.

The Advisory Committee on Immunization Practices, the outside medical experts advising the U.S. Centers for Disease Control and Prevention, will vote on who should get the first doses, after discussing plans for distributing the shots and monitoring for potential side effects.

In other news

  • The FEHBlog overlooked the CDC’s Antibiotic Awareness Week which was held from November 18 – 24. Better late than never right. This is an important public health cause and the link provides useful resources.
  • The FEHBlog noticed a Health Payer Intelligence article about a health plan that “has reduced out-of-pocket healthcare spending by collectively giving members millions of dollars in rewards through their My Health Pays program.” The FEHBlog did a little investigative work and he discovered that the health plan in question participates in the ACA marketplace. It is crazy that individual health plans have no limits on wellness reward uses while group health plans generally must limit their wellness rewards to reimbursing medical services and supplies or Medicare premiums. Congress should level the playing field.

Weekend Update

David Ermer–ACA, Congress, COVID-19–

Congress returns to committee work and floor action this coming week for an expected two more weeks of the its lame duck session.

Top House and Senate appropriators on Tuesday [November 24] clinched a deal on a bipartisan set of funding levels, paving the way for a $1.4 trillion spending package to avert a government shutdown next month. The agreement on the funding allocations, confirmed by a House Democratic aide, establishes overall totals for 12 appropriations measures that will be rolled into one massive omnibus bill that would boost federal budgets for the rest of the fiscal year. Negotiators plan to keep the numbers — known as 302(b)s — under wraps until a bipartisan, bicameral omnibus is finalized, the aide said.

This means that Congress remains on track to pass an FY 2021 omnibus spending bill before the current continuing resolution funding the federal government expires on December 12.

Negotiations on another Covid-19 relief bill are at an impasse. Some measures may get attached to a spending package that must pass by Dec. 11 to avert a government shutdown. Another weekly boost to unemployment benefits would most likely be part of the mix, according to unemployment and policy experts.  The subsidy would probably fall between $250 and $600 a week and be retroactive to early September, they said.

  • The Wall Street Journal reports that “President Trump’s decision to defer payroll taxes until the end of the year is leaving challenges for lawmakers to manage after he leaves office in January, and they haven’t figured out what—if anything—to do. * * * [P]ayroll processor Paychex Inc. said take-up has been very low. The one big exception—which could create pressure for Congress to act—is the federal workforce, including many members of the military. Mr. Trump required executive-branch employees to participate. Lawmakers, particularly those from the Washington [D.C.] area, support legislation to let employees decide whether their taxes can be deferred. As the weeks tick by toward the year’s end, that becomes less feasible.

Late Wednesday, the Department of Health and Human Services released the proposed ACA Notice of Benefit and Payment Parameters for 2022. Of note, to community rated FEHB plan carriers HHS proposes to make the following changes to the medical loss ratio (“MLR”) calculation:

We propose to amend the MLR regulation to establish the definition of prescription drug rebates and other price concessions that issuers must deduct from incurred claims for medical loss ratio (MLR) reporting and rebate calculation purposes beginning with the 2022 MLR reporting year (MLR reports filed in 2023). We additionally propose to explicitly allow issuers the option to prepay a portion or all of the estimated MLR rebate for a given MLR reporting year in advance of the deadlines set forth in §§ 158.240(e) and 158.241(a)(2) and the filing of the MLR Annual Reporting Form. We also propose to establish a safe harbor allowing such issuers, under certain conditions, to defer the payment of any remaining rebates owed after prepayment until the following MLR reporting year beginning with the 2020 MLR reporting year (MLR reports filed in 2021). In addition, we propose to allow issuers to provide MLR rebates in the form of a premium credit prior to the date that the rules currently provide and beginning with the 2020 MLR reporting year (MLR reports filed in 2021). Lastly, we propose to clarify MLR reporting and rebate requirements for issuers that choose to offer temporary premium credits during a public health emergency declared by the Secretary of HHSfor future benefit years, beginning with the 2021 MLR reporting year (MLR reports filed in 2022). 

Of note to all FEHB plan carriers, HHS proposes to make the following changes to the out of pocket (“OOP”) cost sharing ceilings for in-network care:

The proposed 2022 maximum annual limitation on cost sharing is $9,100 for self-only coverage and $18,200 for other than self-only coverage. This represents an approximately 6.4 percent increase above the 2021 parameters of $8,550 for self-only coverage and $17,100 for other than self-only coverage. Similar to the proposal for the premium adjustment percentage index, for the 2023 benefit year and beyond, we propose to release the maximum annual limitation on cost sharing in guidance by January of the year preceding the applicable benefit year. 

For more details on the Notice check out Katie Keith’s columns on the Health Affairs Blog.

The Biden Administration’s HHS will finalize the Notice next year. HHS has a good deal of statutory discretion over the MLR calculation but very little discretion over (“OOP”) cost sharing ceiling calculations in the FEHBlog’s opinion.

The FEHBlog has learned that a two step process exists for approval a COVID-19 vaccine for individual and group health plan coverage.

  • First, as discussed in the FEHBlog, the FDA must give emergency use authorization to the vaccine. The relevant FDA advisory committee is meeting December 10 to consider the Pfizer – BioNTech vaccine. The Committee’s recommendation goes to the FDA Commissioner for final approval.
  • Once FDA approval has been given, the CDC’s relevant advisory committee the Advisory Committee on Immunization Practices (ACIP) must add its approval.
  • Fifteen days after ACIP approval is given, individual and group health plans, including FEHB plans will become obligated to cover the administration of the approved vaccine in and out of network without member cost sharing. That effective date will be in late December at the earliest. 
  • An emergency use authorization can only trigger plan health plan coverage of a vaccine during a related public health emergency. The current COVID-19 public health emergency period expires on January 20, 2021, unless as expected HHS extends that period for another 90 days before then,

Federal Employees Benefits Open Season Supplement

David Ermer–Federal employment benefits, OPM–

While the FEHBlog usually doesn’t post on Saturday, we are now half way through the Federal Benefits Open Season and several helpful articles on that topic have been published over the past week; so here you go.

  • Tammy Flanagan discusses in Govexec.com federal employee and annuitant options in the FEHBP and FEDVIP and federal employee options in FSAFeds program.
  • A couple of FEHBlog reminders on FSAFeds — the contribution caps on dependent and healthcare care flexible spending accounts for federal employees are the maximum permitted by federal law; healthcare FSA accountholders can tap their account before the funds have been deposited while dependent care FSA accountholders must wait until funds have been deposited before making permissible expenditures. The FEHBlog has noticed that OPM promptly updates their FSA plan when Congress or the Internal Revenue Service offers new flexibilities.
  • Walt Francis discusses FEHBP options and offers his quick picks in FEDWeek.
  • FedSmith analyzes FEHBP high deductible plans with health savings accounts and other consumer driven plans.

There are 17 days left in this Open Season.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 47th weeks of this year (beginning May 14 and ending November 25; 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 ending drop, which is found in every weekly chart, is not meaningful. The CDC’s Fluview was not updated today.

The FEHBlog has noted 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 same period (May 14 through November 25).

You will notice that FEHBlog has figured out how to more clearly present the two axes in these charts.

Although weekly new deaths continue to rise sharply, that weekly total remains below the heights reached in the Spring (shown below) even though the number of new cases in the fall (over 1 million last week) eclipse the number of new cases in the Spring (April 2 through May 13, always under 200,000 weekly):

The FEHBlog was happy to read in the Wall Street Journal that United Airlines has begun “operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.”

The FEHBlog plans a special Federal Benefits Open Season issue tomorrow. Stay tuned.

Happy Thanksgiving

David Ermer–ACA, U.S. Healthcare–

Even in this difficult year, we Americans can still enjoy our great holiday Thanksgiving. The Wall Street Journal discusses a study of how to cope with the COVID-19 great hunkering down — the results tie in with traditional Thanksgiving activities

“[M]usic [parades], exercise [touch football] and entertainment [NFL football and movies] were the most potent stress relievers for the greatest number of people. But of those three activities, music—singing, dancing, playing an instrument, or just listening to a favorite playlist—was the only one that led to a reduction of depression symptoms. A fifth of all the participants reported it as the most effective way to reduce their pandemic-induced blues. Music’s palliative effects were particularly potent for people who were highly sensitive to rewards.  * * * [Needless to say] Cooking, baking and eating also helped tamp down the blues. 

Health Payer Intelligence reports, and the FEHBlog could not agree more strongly that

Employers are gravitating toward integrated health care benefits to improve member engagement and patient experience as well as lower healthcare spending, according to a report commissioned by Anthem.

Integrated health care interweaves pharmacy, ancillary, supplemental health, and other benefits data into the employer’s health plan to facilitate smoother communication between employees’ providers.

Provider collaboration is key to this strategy. Three key methods for facilitating provider collaboration included connecting all providers through an [electronic medical record] EMR, establishing automatic reminders about extra dental cleanings, and sending health-related reminders to employees. Employers also leveraged AI and apps to connect employees to their benefits.

That’s a very interesting use of EMRs to help close gaps in care.

The Internal Revenue Service has announced that the Affordable Care Act’s Patient Centered Outcomes Research Institute (“PCORI”) fee “for policy years and plan years that end on or after October 1, 2020, and before October 1, 2021, is $2.66” per covered health plan life (/ bellybutton). The PCORI fee payment is due at the end of July. The adjusted fee is 12 cents higher than the fee paid in July 2020.

Tuesday Tidbits

David Ermer–COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the COVID-19 vaccination front —

  • It turns out that, according to Precision Vaccinations, the Food and Drug Administration’s “Advisory Committee on Immunization Practices (ACIP) held an out-of-schedule, emergency meeting to discuss various issues related to experimental COVID-19 vaccine candidates.” Rather than tackle the Pfizer / BioNTech vaccine emergency use authorization request the Committee primarily considered vaccination allocation issues. “During the ACIP’s Phase 1a proposed allocation plan, healthcare workers and those seniors living in Long-Term Care Facilities (LTCF), and those working for these facilities, would be the 1# priority group for vaccinations. As of November 6, 2020, LTCF residents and staff accounted for 6 percent of COVID-19 cases and 39 percent of related fatalities in the USA.”
  • STAT News adds that “Essential workers are likely to move ahead of adults 65 and older and people with high-risk medical conditions when the Centers for Disease Control and Prevention signs off on Covid-19 vaccine priority lists, coming after health care workers and people living in long-term care facilities, a meeting of an expert advisory panel made clear Monday. * * * Essential workers include people who work in meat packing plants and other food processing facilities, in municipal wastewater management operations, and in transport. It also includes police and firefighters and, in the current iteration of the ACIP’s plan, teachers. The CDC estimates there are roughly 87 million people in jobs designated as essential services.”
  • Fierce Healthcare reports that “The U.S. federal government aims to distribute 6.4 million doses of a COVID-19 vaccine to states 24 hours after it gets emergency approval, and officials are in the midst of dry runs to prepare for the shipments, officials said Tuesday. The White House’s Operation Warp Speed, a joint initiative between the departments of Health and Human Services (HHS) and Defense that aims to distribute the vaccine, gave an update to reporters Tuesday on the initial allocations of a vaccine. The update comes as emergency approval from the Food and Drug Administration (FDA) could come in the middle of December.”

MHealthIntelligence.com provides a helpful overview of the Stark, Anti-kickback Act changes rule.

According to Carrie Nixon, co-founder and managing partner of Nixon Gwilt Law, the  OIG’s Final Rule “gives healthcare providers and digital health companies more flexibility to enter into new business arrangements that incentivize care coordination and patient engagement as a means of improving outcomes and reducing the overall cost of care.”

“These new protections allow players in the digital health space – including Remote Patient Monitoring companies, telehealth companies, and healthcare predictive analytics platforms – to take on an unprecedented role in helping healthcare providers move the needle on patient outcomes and costs by providing in-kind and even monetary remuneration to these providers in the form of free or reduced cost items/services or shared savings arrangements,” she summarized in a recent article on her law firm’s website.

Deregulation is a very good thing. The FEHBlog prays that the Biden Administration does not back away from it.

The FEHBlog found OPM’s Fiscal Year 2020 Financial Report on its website today. Here’s a link.

Monday Roundup

David Ermer–COVID-19 testing, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Another Monday, another COVID-19 vaccine — the newest from Oxford University (UK) and Astrazeneca. The Times of London reports that

Oxford University scientists said this morning that they had created “a vaccine for the world” as trial results showed that their Covid-19 jab worked well enough to apply immediately for regulatory approval.

The vaccine involves two injections, administered at least a month apart, and the results suggest that using a lower first dose could boost efficacy to 90 per cent. However, that finding relied on limited data and may be amended.

Overall, a trial involving 24,000 people suggested that the vaccine was about 70 per cent effective.

It prevented severe disease and the need to be admitted to hospital, and there are promising early signs that it might also block transmission of the virus. No dangerous side-effects were reported, and the British medical regulator has begun to review safety and efficacy data.

Britain has ordered 100 million doses, and Astrazeneca, the drug company that is working with Oxford, said this morning that four million of those would be ready to be sent to care homes, GP clinics and other vaccination centres by the end of the year.

The Oxford vaccine can be stored in a normal fridge, making it easier to handle than Pfizer’s competing inoculation, which must be stored at about minus 70C. It is also considerably cheaper, costing a few pounds per dose. It is possible that the first doses could be administered before Christmas.

The FEHBlog heard on Fox Business this morning that a separate phase three trial for the Oxford vaccine is ongoing in our country. Oxford and Astrazeneca will present an emergency use authorization request to our Food and Drug Administration (“FDA”) based on that as yet uncompleted trial. The trial referenced in the Times of London article was conducted in the United Kingdom and Brazil. The FDA does not require that the phase three trials be conducted in the U.S. For example, the agency approved the Ebola vaccine based on a phase three trial conducted in Africa, but of course there’s no problem finding COVID-19 patients here.

Reuters reports that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet on December 10 to review the Pfizer / BioNTech emergency use application for its COVID-19 vaccine. The FDA is not bound by the Committee’s recommendation. Here is a link to the full FDA press release.

A friend of the FEHBlog recommended the 20 minute long Journal podcast interview with the founder of BioNTech Dr. Ugur Sahin. The FEHBlog found that podcast fascinating listening.

Govexec.com reports that “The departments of Defense and State, as well as the Veterans Affairs Department’s Veterans Health Administration, the Bureau of Prisons and Indian Health Service, will all receive a direct allocation of vaccines from the Centers for Disease Control and Prevention. The plan was spelled out in a COVID-19 Vaccination Program Interim Playbook, which was first reported by CNBC.” 

Following up on the major Health and Human Services rule makings on Fridays here are article with industry reaction:

  • As the FEHBlog expected, Fierce Healthcare reports that “A hurried final rule aimed at tying drug prices to those paid by foreign countries could lead to providers paying more for drugs than what they will get reimbursed by Medicare, according to several providers and experts.” It really makes you wonder why the American Medical Association’s House of Delegates conditionally endorsed adding a public option to the ACA marketplace earlier this month.
  • Fierce Healthcare further informs us that “CMS’ Stark, anti-kickback updates draw praise from hospitals, concern from physician groups.”
  • Health Payer Intelligence discusses the Medicare rule restricting the use of prescription drug rebates in Medicare Part D effective January 1, 2022. The FEHBlog cannot understand why if drug manufacturers want to end the rebate practices, it does not assure (with an enforcement mechanism) the health insurance industry and the government that the price reductions will balance out the lost rebates.