Monday Roundup

U.S. Healthcare

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.

Friday Stats and More

David Ermer–COVID-19, Electronic health records, Medicare, Rx coverage, U.S. Healthcare–

Based on the CDC’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 46th weeks of this year (beginning May 14 and ending November 18, roughly six months; using Thursday as the first day of the week in order to facilitate this weekly update):

The upward surge in COVID-19 cases is reflected the CDC’s latest overall weekly hospitalization rate chart for COVID-19 (disregards the dip at the right side of the chart):

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 six month long period (May 14 through November 18) (the dip at the tail of this chart is accurate information).

Meanwhile the CDC’s weekly flu surveillance report continues to inform us that “Seasonal influenza activity in the United States remains lower than usual for this time of year.” Better one epidemic than two.

On the bright side, according to the Wall Street Journal, Pfizer and BioNTech did file an emergency use authorization request for their COVID-19 vaccine today.

Now it will be up to the U.S. Food and Drug Administration to decide whether the two-shot vaccine works safely enough to roll out to millions of people.

It is unclear how long the agency will take to review the vaccine, which Pfizer and BioNTech just days earlier said was 95% effective and well-tolerated in a 44,000-subject trial.

Given the urgency, the FDA is expected to move quickly. The timing of the filing is in line with industry and government officials’ projections for authorization and distribution to begin next month. Pfizer said the filing could allow for distribution to begin the middle to end of December.

The Health and Human Services Department (“HHS”) released a string of final rules today affecting Medicare prescription drug plans and both hurting and helping the finances of doctors participating in Medicare and certain other federal health programs (but thankfully not the FEHBP). As the saying goes, he who lives by the sword can die the sword.

  • HHS issued a final rule generally barring the use of prescription drug rebates in the Medicare Part D program effective January 1, 2022.
  • HHS issued another final rule that implements, effective January 1, 2021, a pilot program”, known as the Most Favored Nation (MFN) Model, [that] will test [for seven years] an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries.”
  • Finally. HHS issued a final rule which loosens up on self-referral a/k/a Stark Act rules that inhibit the entrepreneurial spirit of doctors participating in Medicare. The purposes of the change is to facilitate value based pricing and coordinated care. Doctors should like this one but the FEHBlog wonders whether the AMA will think that it goes far enough.

Of course, we also will have to wait to see the incoming Biden Administration’s reaction to these rules.

Healthcare Dive discusses conflicting viewpoints on AHIP’s position which the FEHBlog shares that the COVID-19 relief law Wild West approach to health plan coverage of out-of-network COVID-19 leads to price gouging. Only Congress can fix this problem.

Speaking of Congress, Govexex.com reports that

Congressional leaders have voiced early speculation in recent days that lawmakers will be able to set line-by-line funding levels for agencies throughout government before the end of the year without the need for another stopgap measure. 

Top negotiators in the House and Senate met on Thursday to discuss a potential compromise for the rest of fiscal 2021 appropriations. On Friday, House Speaker Nancy Pelosi, D-Calif., was the most recent leader to cautiously express optimism that Congress can pass a full-year, omnibus spending bill before the current continuing resolution expires Dec. 11. 

“The anticipation was that it was really about the omnibus,” Pelosi said of the meeting. “You have to remember, we have to have an omnibus bill. We must keep government open.” She added it was a “very important responsibility” during the lame duck session of the 116th Congress. “We don’t want another continuing resolution. I don’t think they do either.”

Finally, the FEHBlog was impressed by Humana CEO Bruce Broussard’s call for health system interoperability without further delay. Mr. Broussard is Board Chair of America’s Health Insurance Plans for 2021. Here’s a snippet.

Change requires reforming the incentive structure to encourage and require vendors to create and sell systems that can talk to each other. Health care systems, hospitals, and physician practices — guided or encouraged by the market and the federal government — should choose interoperable systems. Public and private payers should implement value-based payment models that reward the purchase and use of interoperable systems. It’s also up to the federal government to implement and enforce standards for EHR vendors that promote interoperability while simultaneously strengthening the protection of personal health information.

If industry and government don’t lead the charge to make America’s health care system interoperable, consumers will bear the challenge of piecing together their own health data across the system — a dangerous prospect that could hinder patient care in the midst of a global pandemic. The free flow of protected data across the health care system ensures that treatment decisions are informed safely and effectively by the most current information available and tailored to the individual. A clinician with complete information at her fingertips can easily see the full picture and manage her patient’s care from the hospital to the pharmacy to long-term follow-up care.

This pandemic will eventually end. But the need for interoperability will remain urgent as we seek long-term solutions to bring down costs, improve care delivery, and increase efficiency in our health care system.

There’s no time like the present.

Happy National Rural Health Day

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

It is National Rural Health Day which HHS’s Health Resources and Services Administration is proud to celebrate.

The Defense Department reports on yesterday’s Operation Warp Speed press conference. The Wall Street Journal adds that

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines. “When you see vaccines start to equal or exceed demand is when you’ll see it out of the pharmacies,” said Ms. Whicker.

According to Endpoint News, “BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday [/ tomorrow].

The Wall Street Journal further reports on the COVID-19 front that

U.S. hospitals say they are facing the pandemic’s largest surge armed with treatment improvements that allow them to save lives, care for more patients and accelerate the recovery of coronavirus sufferers.

HCA Healthcare Inc., one of the nation’s largest hospital chains with 186 hospitals, has more intensive-care capacity as the sickest patients recover more quickly. At the Mayo Clinic’s hospital in Rochester, Minn., coronavirus patients now stay a median of five days, half as long as in March. The time Covid-19 patients spend at Advocate Aurora Health’s 26 Midwestern hospitals has fallen 25% on average since May.

The shift could be a result of several factors and more study is needed, said doctors and researchers. But the results are consistent with anecdotal reports from doctors saying that new tools and a better understanding of how Covid-19 attacks the body are helping to improve medical outcomes.

Also HHS announced today launching

a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

The Centers for Disease Control and the American Medical Association, the American Hospital Association and the American Nursing Association are encouraging Americans to curb holiday travel and scale back holiday gatherings due to the recent surge in COVID-19 cases. That’s a useful message for health plans circulate to members and employees.

Following up on this week’s launch of Amazon’s online Pharmacy, the Drug Channels blog comments that

This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks. Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter. For now, Amazon is choosing to join the drug channel, not fundamentally change it.

Healthcare Dive lets us in other expert insights on this development.

In other prescription drug coverage news, the Wall Street Journal reports this evening that

The Trump administration is planning on Friday [/ tomorrow] to roll out two final rules aimed at lowering drug prices—one curbing rebates paid to middlemen in Medicare and another pegging the prices of certain prescription drugs in the U.S. to their prices in other developed countries, according to a person familiar with the planning. The plans, slated to be announced in the White House Rose Garden, have been a signature pledge of President Trump’s since his 2016 election campaign. Both rules are expected to be final, meaning they have completed the required public comment period and can take effect immediately.

“Immediately” in this setting would not prevent the incoming Biden Administration from putting the brakes on the iniative without trouble, in the FEHBlog’s opinion.

In other news —

  • According to a press release, “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association (BCBSA) to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.” Helpful.
  • According to Fierce Healthcare, “While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service. The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report. Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.”

Happy Veterans Day

David Ermer–COVID-19, OPM, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Fedweek reminds us that “With just about a third of federal employees having also served in [the U.S. military], today is an especially important day in our community. Thanks for your service.

Healthcare Dive cumulates its reporting on health insurer third quarter 2020 financial results.

In the third quarter, insurers saw a slight dampening from the record-high profits [which of course are constrained by the ACA MLR and OPM’s even stricter FEHB MLR] recorded in the previous quarter as medical utilization rebounded to about 95% of normal volumes for most major payers.

They warned, however, that tailwinds may not last as people seek previously deferred care in the fourth quarter and into next year. Another widespread halting of elective procedures is unlikely as providers have learned more about safely carrying out routine care despite COVID-19 surges.

But novel coronavirus case rates and hospitalizations have reached record levels nationwide this week and it’s unclear how safe people will feel returning to hospitals and doctor’s offices for non-emergent treatments.

Good point.

The Wall Street Journal warns that

Hospitals across the nation face an even bigger capacity problem from the resurgent spread of Covid-19 than they did during the virus’s earlier surges this year, pandemic preparedness experts said, as the number of U.S. hospitalizations reached a new high.

The number of hospitalized Covid-19 patients Tuesday reached 61,964, according to the Covid Tracking Project, passing the prior record of nearly 60,000 in April as the virus surged in the northeast. Hospitalizations hit a nearly identical peak again in late July, as the pandemic’s grip spread across the South and West.

Epidemiologists said the record is likely to be swiftly replaced by another as Covid-19 cases soar nationally. “We already know this is going to go far north,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Fierce Healthcare adds that

Health IT giant Epic has rolled out a new tool for hospitals that helps predict patients’ likelihood of testing positive for COVID-19. The COVID-19 risk prediction model was designed by Cleveland Clinic researchers and was developed and tested using clinical data from more than 11,000 patients. The model uses information from patients’ comprehensive health records combined with patient-entered information in Epic’s patient-facing app, MyChart, to show an individual’s likelihood of testing positive for COVID-19.

Finally on the FEHBP front, FEDWeek reports that

OPM has issued guidance on removing ineligible family members from coverage under the FEHB program, stressing that under its rules, either an employing agency, OPM or an FEHB carrier may “request proof of family member eligibility from an employee at any time for existing enrollments.”

In a pair of similar messages to agencies and to carriers, OPM set the process for requesting proof of family member’s eligibility for existing enrollments, what documents may be used as proof, what actions can be taken based on the response, and the process for reconsidering a decision to remove someone from coverage. Carriers are to inform employing offices in order to avoid duplicate requests for verification, it added, and carriers are to be “judicious in exercising this authority.”

Honestly, it is the employer’s responsibility to police its eligibility rolls. Around five years ago, OPM added a provision to the FEHBP standard contract requiring carriers to pay the freight for an OPM contractor to audit eligibility rolls for ineligible family members. However, OPM has not implemented this clause to date.

Tuesday Tidbits

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

The FEHBlog spent two hours this morning listening to the oral argument in the latest Affordable Care Act (“ACA”) constitutionality case to reach the U.S. Supreme Court, California v. Texas (No. 19-840). This activity resulted in the FEHBlog learning a new word hortatory and receiving confirmation that his hunch is correct, to wit, There is no chance that the Supreme Court will disrupt the ACA status quo as a result of this case. Indeed the Supreme Court clearly took the case to preserve, not disrupt, the status quo. If you are interested, Amy Howe from the SCOTUSblog has written a legal analysis of the oral argument.

Following up on yesterday’s good news about Pfizer’s COVID-19 vaccine, the Wall Street Journal informs us that

In Kalamazoo, Mich., Pfizer has turned a stretch of land the size of a football field into a staging ground outfitted with 350 large freezers, ready to take delivery of millions of doses of Covid-19 vaccine before they can be shipped around the world.

To make sure its Covid-19 vaccine doses arrive at hospitals and clinics frozen and potent, Pfizer created its own container to ship them.
The temperature-controlled container can store between 1,000 and 5,000 doses for 10 days at minus 70 degrees Celsius before requiring re-icing.

From that site, and another in Puurs, Belgium, the pharmaceutical giant said it wants to deliver up to 100 million doses this year and another 1.3 billion in 2021.

One person needs two doses of the vaccine in order to be protected, again assuming that the phase III study of the vaccine remains on its currently successful course.

The Journal further reports that

U.S. health officials on Monday authorized use of the first treatment for people with earlier-stage Covid-19 who aren’t hospitalized, filling a gap in treatment.

The U.S. Food and Drug Administration said Eli Lilly LLY 2.97% & Co.’s antibody drug should be used for patients ages 12 and up with mild to moderate Covid-19, based on a study showing it helped improve symptoms and kept many patients out of the hospital.

The drug is named bamlanivimab [and it is infused into the patient]. Lilly said it will begin shipping the drug immediately to AmerisourceBergen Corp. ABC 3.59% , a national drug distributor, to distribute it as directed by a federal allocation program [which is described in this HHS announcement issued today].

The Journal also discusses ongoing U.S. problems with COVID-19 testing

The U.S. is running more Covid-19 tests each day than at any other point during the pandemic, but the increased testing doesn’t fully explain recent case surges across the nation, data show. Altogether, testing data suggest Covid-19 diagnostic tests are still severely underused in the U.S. And inconsistencies in data collection and reporting systems are hampering efforts to understand and contain the virus’s spread as the holidays approach, public health and testing executives say.

Because the FEHBP covers a large cadre of senior citizens, it is worth pointing out this AHRQ funded report finding that

Healthcare costs for seniors who needed emergency services after a fall averaged $26,143 in the year following the event, according to an AHRQ-funded study published in The Journal of the American Geriatrics Society. Those costs significantly exceeded the average $8,642 in healthcare costs in the year prior to the event

In civil service news,

Federal employees would not receive an across-the-board increase in pay next year under provisions outlined in a series of fiscal year 2021 funding bills released by the Senate Appropriations Committee Nov. 10. Unlike FY2021 funding passed in the House earlier this year — which simply did not include any provision addressing federal pay — the Senate bill actively sets 2021 pay levels at the same rate as 2020. That difference would override any planned pay increase out of the White House, which was set at 1 percent in President Donald Trump’s February budget proposal.

The Senate is pushing through these measures in order to create a baseline for negotiating an omnibus continuing resolution with the House, which has completed its appropriations bills work, before the current continuing resolution expires on December 11.

  • Federal News Network reports on the Biden Administration’s transition team. Of note,

Kiran Ahuja, a former chief of staff at the agency, will lead the OPM team. Ahuja served at OPM during the aftermath of the agency’s cybersecurity breaches. Prior to her OPM service, she led the Obama administration’s White House Initiative on Asian Americans and Pacific Islanders. Today, she’s the CEO of Philanthropy Northwest, a non-profit organization. The rest of the team is filled with OPM alums who served at the agency as senior advisors during the Obama administration.

Weekend Update

David Ermer–Congress, COVID-19, OPM, SCOTUS, U.S. Healthcare–

The House and the Senate are resuming some Committee work this coming week. The Senate may be conducting floor votes but the House will not resume floor voting until next week. Wednesday November 11 is a federal holiday for Veterans’ Day.

Tuesday morning will feature the oral argument in the latest Affordable Care Act constitutionality case, California v. Texas (No. 19-840). The argument will proceed as follows beginning at 10 am:

  • 30 minutes for California, et al.,
  • 10 minutes for the U.S. House of Representatives,
  • 20 minutes for the Solicitor General, and
  • 20 minutes for Texas, et al. 

Of course, the FEHBlog will be listening to the oral argument and he will report his observations on Tuesday. The FEHBlog enjoys the live audio version of the Supreme Court’s oral arguments because the Justices ask questions in order of seniority following the Chief Justice. If you want to listen in too, here’s a link to C-SPAN website which will send you a reminder if you share your email address.

The Centers for Medicare and Medicaid Services did fix their broken link to the 2021 Medicare premium and cost-sharing changes fact sheet over the weekend. Here’s an active link for your information.

Of course, the Federal Benefits Open Season begins tomorrow and runs through December 14. Good luck to all.

Kaiser Permanente released its third quarter 2020 financial results last Friday.

“Although the pandemic continues to have an impact on Kaiser Permanente, during the third quarter we safely resumed in-person preventive and elective care, started to address the backlog of deferred procedures that were put on hold due to COVID-19, and continued to leverage and grow virtual care for members’ safety and convenience,” said executive vice president and chief financial officer Kathy Lancaster.

NPR Shots offers a useful overview of COVID-19 cases and deaths similar to the CDC and it offers a preview of the Biden Administration’s approach to the pandemic.

On Monday, I will name a group of leading scientists and experts as transition advisers to help take the Biden-Harris COVID plan and convert it into an action blueprint that starts on Jan. 20, 2021,” Mr Biden said last night in a public address.

A Biden spokesperson told NBC’s Meet The Press Sunday that the coronavirus task force will be led by former Surgeon General Dr. Vivek Murthy and Dr. David Kessler, who led the Food and Drug Administration during the 1990s.

“We have to function as one nation. That means having a national plan,” Dr. Murthy, a key adviser to the Biden campaign, told NPR recently.

Friday Stats and More

David Ermer–COVID-19, Medicare, Rx coverage, U.S. Healthcare–

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 44th weeks of this year (beginning May 14 and ending November 4; 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 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 4).

On the flip side, also according to the CDC, “seasonal influenza activity in the United States remains low.”

Fierce Biotech discusses the progress of a Humanigen investigation new drug called lenzilumab which is undergoing a phase 3 trial.

If the trial succeeds, lenzilumab could emerge as part of the arsenal for treating some of the sickest COVID-19 patients. Lenzilumab may stop cytokine storms, the severe hyperimmune responses that drive organ damage in some COVID-19 patients. Currently, physicians treat such severe patients with steroids and Gilead’s remdesivir, but there remains a need for more efficacious therapies. 

The chances of anti-SARS-CoV-2 antibodies meeting that need have diminished in recent weeks as prospects in development at Eli Lilly and Regeneron have failed in severe COVID-19 patients. Efforts to use existing drugs, notably anti-IL-6 antibodies such as Sanofi’s Kevzara, to stop cytokine storms in COVID-19 patients have also failed. 

In other investigational drug news, the Boston Globe reports that

Biogen Inc.’s experimental Alzheimer’s disease therapy [mentioned in the FEHBlog earlier this week] failed to gain support from a panel of US Food and Drug Administration advisers on Friday, putting the drug at a crossroads as the agency weighs approval.

The outside experts voted 8 to 1, with 2 undecided, that data from a single clinical trial with positive results was insufficient to show Biogen’s drug works. The vote contradicts a report FDA reviewers prepared ahead of the meeting that supported the efficacy of the drug, called aducanumab, though there was dissent in the agency. * * *

The advisory committee’s recommendations aren’t binding. The FDA often calls on panels of experts, including researchers, medical professionals and patient representatives, when it is considering whether to approve a new drug. Wall Street analysts said the FDA seemed set on viewing the drug positively.

“This will be a test for the FDA on what happens when the FDA is on one extreme and the panel is seemingly on the other, with science and evidence or the lack thereof being at the core of discussion,” Mizuho analyst Salim Syed said in an email to Bloomberg News.

At long last (given the fact that the Medicare Open Season stated on October 15), the Centers for Medicare and Medicaid Services this afternoon announced Medicare Part B premiums and Parts A and B cost sharing changes for 2021:

  • The standard monthly premium for Medicare Part B enrollees will be $148.50 in 2021, an increase of $3.90 from $144.60 in 2020.  The fact sheet that would show income adjusted premiums for high earners was unavailable online this evening. Check again here on Sunday.
  • The Medicare Part A inpatient deductible that beneficiaries will pay when admitted to the hospital is $1,484 in 2021, an increase of $76 from $1,408 in 2020. 
  • The annual deductible for Medicare Part B beneficiaries is $203 in 2021, an increase of $5 from $198 in 2020.

CVS Health not only announced third quarter earnings today; it also disclosed that its current CEO Larry Merlo is retiring and Karen Lynch, who currently heads the Aetna business unit, will replace him. Congratulations to both of them. Healthcare Dive adds

CVS’ medical loss ratio was 84%. That’s compared to just 70.3% in the second quarter as consumers deferred non-essential care amid COVID-19.

CVS has now administered more than 6 million COVID-19 diagnostic tests across 4,000 testing sites, representing 70% of all testing done in retail settings, Merlo said.

Health Payer Intelligence discusses how “Blue Cross and Blue Shield of Illinois (BCBSIL) has partnered with hospitals across the state in a new program that seeks to pursue health equity by focusing on mitigating health disparities for racial and ethnic minorities.” Well done.

Midweek Update

David Ermer–OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

The Acting OPM Director Michael Rigas and the Secretary of Health and Human Services Alex Azar have issued a memorandum and resource document encouraging federal employees to get their flu vaccination. According to the memo –

“By getting an annual flu vaccine, employees can reduce the spread of flu and reduce stress on the healthcare system, as well as keep our entire federal workforce – and country – healthier and stronger during COVID-19. For these reasons, the U.S. Department of Health and Human Services and Office of Personnel Management urge every federal employee to do their part to fight flu and get vaccinated and to encourage family members, friends, and coworkers to as well.

“It is also a good time to make sure you, and others close to you, are up-to-date on other recommended vaccinations, so ask your health care provider about other vaccines you need. All vaccines recommended by the Centers for Disease Control and Prevention, such as flu vaccines, are covered at no cost to Federal Employees Health Benefits (FEHB) plan members. Most FEHB plans also cover vaccines at pharmacies and retail stores, in addition to doctor’s offices and clinics, with no co-pays when in-network.”

CNBC reports that prescription drug manufacturer Biogen is drawing stock market attention due to positive Food and Drug Administration staff reaction to the study results of its Alzheimers Disease treatment aducanumab. “Patients [in a study] receiving the highest dose of aducanumab experienced a significant reduction in the progression of cognitive and functional impairments.”

The Cambridge, Massachusetts-based company’s drug targets a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease. A panel of outside experts is expected to meet Friday to recommend the drug’s approval to the FDA. The FDA’s final decision on Biogen’s drug is expected by March 2021.

Health Payer Intelligence discusses a study on Medicare spending for beneficiaries with diabetes 2 and multiple chronic diseases. A takeaway from the study is that

Medicare spending among beneficiaries 65 years and older with type 2 diabetes is greatly affected by the presence of multiple chronic conditions. The presence of multiple chronic conditions increases the odds of any payments being made for services, as well as the mean spending in multiple service categories. However, patient characteristics, especially race, are also associated with variation in total spending for services.

Minority beneficiaries have lower odds of any spending, possibly due to not seeking care, but when services are provided, spending is higher, on average, compared with White beneficiaries.

Total spending for minority beneficiaries with multiple chronic conditions is higher compared with their White counterparts with the same combinations of disease.

Health systems, insurance systems, and the public health infrastructure can use these results to inform outreach programs and policy initiatives to make preventive care more accessible for racial and ethnic minorities.

As further evidence of American medical ingenuity, Healthcare Dive reports that

A new study in JAMA Network Open provides a potential roadmap to hospitals that may be leery to shut down elective surgical procedures while trying to deal with a spike in coronavirus patients. The key is the use of predictive modeling in developing a clinical decision support tool. Although such tools are abundant in healthcare, few are used to determine how likely a patient is to use certain hospital resources.

According to the study, such a tool is able to separate out elective surgical cases based on length of hospital stay, intensive care length of stay, whether or not a ventilator is required and discharge to a skilled nursing facility. A patient’s age is the biggest factor in most of those determinations, followed by the number of previous inpatient and outpatient visits made by those patients.

“This work shows the importance of a learning healthcare environment in surgical care, using quantitative modeling to guide decision-making,” the study concluded. Along the same lines, Banner Health in Arizona has been using artificial intelligence to continue performing elective procedures during the pandemic.

Tuesday Tidbits

David Ermer–ACA, COVID-19, Mental health care, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Happy Election Day!

The FEHBlog enjoyed reading this American Medical Association article about the five things that doctors should tell their patients about the COVID-19 vaccines currently under development. This could be good information for health plans to share with their members.

Fierce Healthcare reports that

Nearly half the nation’s hospitals, many of which are still wrestling with the financial fallout of the unexpected coronavirus, will get lower payments for all Medicare patients because of their history of readmitting patients, federal records show.

The penalties are the ninth annual round of the Hospital Readmissions Reduction Program created as part of the Affordable Care Act’s broader effort to improve quality and lower costs. The latest penalties are calculated using each hospital case history between July 2016 and June 2019, so the flood of coronavirus patients who have swamped hospitals this year were not included.

The number and severity of penalties were comparable to those of recent years, although the number of hospitals receiving the maximum penalty of 3% dropped from 56 to 39.

Beckers Hospital Review provides a list of those 39 hospitals here.

Healthcare Dive informs us that

Humana bested Wall Street expectations as it gained more members during the third quarter, generated higher revenue and beat earnings estimates, according to its quarterly results released Tuesday morning.

The payer’s medical utilization continued to trend slightly below pre-COVID levels during the third quarter, though still well above the severe dip in March and April. The lower levels of utilization were partially offset by higher COVID-19 testing and treatment costs as cases began to tick back up.

Executives warned during Tuesday’s call with investors that they expect a loss in the fourth quarter due to a number of issues, including COVID-19 testing and treatment and rebounding utilization.

It’s the last bullet that caught the FEHBlog’s attention.

Finally, Kaiser Health News offers a nice story about seniors forming friendship pods to ward off the loneliness of the great hunkering down.

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Today’s big news is that the ACA regulators (the Departments of Health and Human Services (“HHS”), Labor, and Treasury) finalized a lengthy pricing transparency rule for payers, including ERISA and FEHBP group health plans (see footnote 233). The related fact sheet explains

This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping.

First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. For the first time, most consumers will be able to get real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024.

Second, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information.
The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers.
The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy.
And finally, the third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level.
Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022.

The final rule also provides some medical loss ratio relief to compliant health insurance issuers as explained in the fact sheet. Here is AHIP’s reaction to the final rule.

Also today HHS issued an interim final rule with a comment period that “extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements. Released to the public on March 9, 2020, ONC’s Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health information technology (health IT) certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs).” The rule had been scheduled to take effect beginning next week.

Fierce Healthcare reports that “Regeneron’s anti-SARS-CoV-2 antibody cocktail has significantly reduced medical visits in ambulatory COVID-19 patients. The phase 2/3 clinical trial linked REGN-COV2 to a 57% decline in medical visits associated with COVID-19 in the 29 days after treatment.”

HealthPartners, a Minneapolis health insurer that participates in the FEHBP, offers a helpful, complete explanation of the benefits of wearing masks to prevent COVID-19. “At its core, wearing a mask is an act of kindness and neighborliness. It’s one of the simplest good deeds you can do these days, and a great way to be a force of positivity for the people in your life.”

Fierce Healthcare reports

The financial crisis for hospitals and physician practices caused by the COVID pandemic is a “clarion call” for the healthcare industry to move from a fee-for-service payment model to value, said Kevin Mahoney, chief executive officer of the University of Pennsylvania Health System (Penn Medicine).

“The hospital sector has taken a giant hit. We keep hearing about ‘the new normal.’ The lesson that we learned is that there is nothing new or normal about a pandemic, there’s just been an acceleration of trends,” Mahoney said during a recent virtual event hosted by the University of Pennsylvania. “It has laid bare how dependent hospitals are on commercially-insured, elective procedures, and without them, we don’t make money.”

The FEHBlog’s youngest son is a research coordinator for Penn Medicine. The FEHBlog seconds his boss’s sentiments.

The Surgeon General issued a timely

Call to Action to Control Hypertension (Call to Action) seeks to avert the negative health effects of hypertension by identifying evidence-based interventions that can be implemented, adapted, and expanded in diverse settings across the United States.

The Call to Action outlines three goals to improve hypertension control across the United States, and each goal is supported by strategies to achieve success:

Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension.

Following up on yesterday’s post about mandatory of coverage of COVID-19 vaccines with no member cost sharing once available, the FEHBlog wants to add that the same rule applies to Medicare. CMS “estimates the overall cost of providing the vaccine to every senior on Medicare would be around $2.6 billion, which would be covered by the federal government. CMS will also cover the vaccine for any uninsured individuals by using money from a $175 billion provider relief fund passed as part of the CARES Act.” It appears however that the vaccine would be administered through the Part D program. That would not be much help to FEHB plans as most FEHB members with primary Medicare coverage does not carry Medicare Part D.

Nextgov reports that

The Health and Human Services Department, the Cybersecurity and Infrastructure Security Agency and the FBI warn hospitals face an imminent threat from cybercriminals that encrypt and hold their data hostage—and some health care facilities are already dealing with the fallout.

The agencies collectively issued an advisory Wednesday detailing the tactics, techniques and procedures reportedly used against at least five hospitals already this week. The advisory includes recommendations for mitigating what observers are referring to as the most serious cyber threat the U.S. has seen to date, being perpetrated by an especially ruthless group of criminals.  

“CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers,” reads the advisory.