Tuesday Tidbits

Rx coverage

Tuesday Tidbits

David Ermer–ACA, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Patrick Fore on Unsplash

The Boston Globe reports today that

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday that as many as 20 million people could get coronavirus vaccinations around the end of the year.

He said that by that time there could be as many as 25 million doses of vaccine available from Pfizer and 15 million doses available from Moderna. The vaccination takes two shots so that would mean 20 million people could get protection.

He said it could happen by the end of December, or early January if the timeline slips a bit. “That’s what we’re anticipating and hoping,” he said in an interview at the 2020 STAT Summit.

The Wall Street Journal adds that

The strong early results for two leading Covid-19 vaccines have implications that go far beyond the current pandemic: They suggest the time has come for a gene-based technology that could provide new treatments for cancer, heart disease and other infectious diseases.

The [previously] unproven technology, named messenger RNA after the molecular couriers that deliver genetic instructions, has long eluded researchers. An mRNA vaccine has never been cleared by regulators. It is now the basis for Covid-19 vaccines from Moderna Inc.  and Pfizer Inc. and its partner BioNTech SE. * * *

The mRNA vaccines’ early success [with COVID-19] “gives us some encouragement for the technology for other vaccine targets in the future,” said Dr. Mark Mulligan, director of the Vaccine Center at NYU Langone Health. 

One of the advantages of mRNA vaccines, [Biotech co-founder] Dr. [Ugur] Sahin said, is that they can be quickly adjusted so vaccines can better respond to an eventual decline in immunity or virus mutations, which could render other vaccines less effective. Dr. Sahin said that regulator authorization [of the Pfizer and Moderna COVID-19 vaccines] could potentially lead to a “whole new category of medicines.”

Hope springs eternal.

Healthcare Dive informs us that “After years of speculation, Amazon finally announced Tuesday that it will sell and deliver prescription drugs on its online platform, Amazon Pharmacy.” Moreover —

Here’s a key distinction in how Amazon Pharmacy will operate: “Before checking out customers can compare their insurance co-pay, the price without insurance, or the available savings with the new Prime prescription savings benefit to choose their lowest price option,” Amazon said.

A previously vexing problem for patients was that sometimes prescription drugs would be cheaper using cash, or without using insurance coverage. But pharmacists were sometimes barred from alerting patients to the discrepancy due to “gag clauses.” In 2018, Congress passed a bill to ban gag clauses in certain plans.

Amazon Pharmacy shoppers will be able to input their insurance information and their clinicians will be able to send prescription information directly to the Amazon Pharmacy.

Speaking of market disruption, Plan Sponsor advises us about the growing popularity of “individual coverage health reimbursement arrangements (ICHRAs) to provide their workers with tax-preferred funds to pay for the cost of health insurance coverage that workers purchase in the individual market [/ the ACA marketplace].” This is the one major Trump Administration reform to the Affordable Care Act that did not attract opposition, in court or elsewhere, because it unquestionably strengthened the ACA marketplace.

On the healthcare studies front –

  • The National Library of Medicine informs us about the susbtantial patient safety benefits of including the patient’s photograph in the top line of their electronic health record when used at healthcare facilities, particularly emergency rooms
  • The National Institutes of Health announced $21 million of funding into research examining racial and ethnic disparities in pregnancy-related complications and deaths.

According to the Centers for Disease Control and Prevention, approximately 700 women die each year in the United States from pregnancy-related complications.

Research will include original, innovative, and multidisciplinary efforts to advance the understanding, prevention, and reduction of pregnancy-related complications and deaths among disproportionately affected women. This includes women from racial and ethnic minority groups, women with underprivileged socioeconomic status, and those living in underserved rural settings.

The racial disparities in pregnancy-related mortality are stark: respectively, African American and American Indian/Alaska Native women are 3.2 and 2.3 times more likely to die from pregnancy-related causes than are white women. In the case of African American women, the disparity increases with age. Black women under 20 are 1.5 times more likely to die from pregnancy-related causes than are white women in the same age group, but black women ages 30-34 are 4.3 times more likely to die from pregnancy-related causes than are white women ages 30-34. Approximately two thirds of pregnancy-related deaths are preventable, underscoring the need for more research to improve the maternal health outcomes for women before, during, and after delivery.

In addition to maternal deaths, over 25,000 women each year experience severe maternal morbidity(link is external) (SMM), requiring unexpected short- or long-term life-saving healthcare interventions. Like maternal mortality, SMM has a high rate of preventability. All racial and ethnic minority populations have higher rates of SMM than do white women.

Thursday Miscellany

David Ermer–COVID-19 vaccine, OPM, Rx coverage, SCOTUS–
Photo by Juliane Liebermann on Unsplash

OPM has posted an announcement about the beginning of the Federal Benefits Open Season which kicked off last Monday and the NIH Director Dr. Francis Collins offers guidance on how to celebrate the upcoming holidays with exposing yourself to COVID-19.

To illustrate that the Pfizer COVID-19 game in town vaccine is not the only game, Fierce Healthcare offers articles on two candidate which offer greater pre-administration stability, one by CureVac and the other by Johnson & Johnson.

Leaning on its years of experience, the drugmaker is well on its way to producing 1 billion doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, VP of strategic initiatives and COVID-19 vaccine supply chain at J&J’s Janssen unit, in an interview. 

J&J’s shot could have a storage and distribution edge over the likes of those from Pfizer and BioNTech, Lefebvre thinks. 

“In our plans, we will bring our product at -20° C into the J&J warehouses around the world,” he said.

J&J’s shot is expected to remain stable for up to two years at that temperature, about -4° Fahrenheit. Once it goes out to distributors and customers, it can be kept stable at 2 to 8° Celcius (a range of about 35.6° to 46.4° Fahrenheit) for up to three months, not much colder than your average refrigerator, Lefebvre said. 

As previously noted, the COVID vaccine manufacturers will seek emergency use authorization (“EUA”) from the Food and Drug Administration follow the completion of the phase III trial. Phrma, the drug manufacturer trade association, provides readers with an understanding of FDA EUA.

The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”

The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vaccines to prevent COVID-19 after issuing guidance on FDA’s recommendations for an EUA submission for a COVID-19 vaccine.­

The Department of Health and Human Services announced today its partnerships with chain and independent pharmacies to administer the COVID vaccines as the vaccines received EUA and are made available to the public under the government allocation plan, which kicks off with first responders.

In prescription drug benefit news,

  • Drug Channels is offering its “annual deep dive into employer-sponsored coverage for prescription drugs,” and
  • Good Rx unveils the 2021 changes in popular CVS Health and Express Script formularies.

Finally, the FEHBlog wants to call attention to Katie Keith’s excellent analysis of last Tuesday’s Supreme Court argument in the California v. Texas case. Although Ms. Keith does not project an outcome, the FEHBlog is comfortable stating that the Supreme Court will preserve the Affordable Care Act for the third time, except perhaps for the zeroed out individual shared responsibility provision, which already is a dead letter.

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.

Monday Roundup

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

Healthcare Dive reports that Utah-based “Intermountain Healthcare and South Dakota-based Sanford Health announced Monday that the two had signed a letter of intent to merge. Together the two will operate 70 hospitals — many of which will be located in rural communities across the country — and 435 clinics and insure 1.1 million people.” Intermountain participates in the FEHB under the name of its affiliate SelectHealth.

The Labor Department’s Employee Benefit Security Administration (“EBSA”) released its 2020 edition of its federal mental health and substance use disorder parity self compliance tool for health plans. The first edition was released in April 2018. What’s more on Thursday October 29 at 2 pm ET EBSA will hold a free compliance assistance webcast on this complicated law.

Here’s a link to OPM’s third quarter 2020 report on the development of its Master Enrollment Index for the FEHBP.

The Centers for Medicare and Medicaid Services posted information today about the ACA federal marketplace open enrollment period which begins on Saturday November 1 and ends on December 15, 2020.

Over the weekend, the FEHBlog read in the Wall Street Journal’s Numbers column about COVID-19 mortality predictions. The author explains that

Now, as many as 50 different research groups make predictions, but one of the most accurate assembles all of the individual models, calculates the median value and looks no more than four weeks into the future.

The ensemble forecast was founded by the Reich Lab at the University of Massachusetts, Amherst, in collaboration with the Centers for Disease Control and Prevention and is based in part on models previously developed to forecast influenza and other infectious diseases.

In the next four weeks, it predicts the total number of deaths attributed to the new coronavirus will surpass 240,000—adding roughly 17,000 deaths to the current tally.

Such projections help policy makers and health-care officials decide how to manage resources and implement or relax interventions intended to curb the spread of the disease.

On the brighter side —

  • The Wall Street Journal reports that

A Covid-19 vaccine being developed by the University of Oxford and AstraZeneca AZN 2.06% PLC showed a promising immune response and low levels of adverse reactions in the elderly and older adults, according to an interim analysis that the drugmaker said was encouraging.

The vaccine, now in late-stage human trials aimed at showing its efficacy and safety, is a front-runner in the global sprint for a shot to protect lives and jump-start economies hobbled by the pandemic. Trials in the U.K. could produce results before year-end, fueling hopes among scientists and government leaders that a vaccine might be available for high-risk groups here by early 2021.

  • Fierce Healthcare informs us that “CVS views its pharmacists as playing a key role in assuaging fears, CEO Larry Merlo said Friday. Merlo, speaking at an event hosted by The Washington Post, said that pharmacists “are among the most trusted professionals” in the industry and as such will be able to educate patients about the safety and efficacy of the vaccine.”
  • Fierce Healthcare also recognizes “ten women who have risen to the challenges posed by COVID, as well as played a role in positioning their respective companies to be where they are today.” For example, Anthem Blue Cross’ Liz Kwo M.D. is scaling digital products to improve outcomes. Bravo to all of the winners.

Friday Stats and More

David Ermer–COVID-19, HIPAA Privacy and Security Rules, Rx coverage, U.S. Healthcare, Uncategorized–

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 38th weeks of this year (beginning May 14 and ending September 23; 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:

For context take a look at this USA Today article on the three leading causes of death in the United States over the past 85 years (ending in 2018). COVID-19 will be taking over at least the spot for the third leading cause of death, which is currently held by accidental injuries.

In other news —

  • Forbes offers an update on Rite-Aid pharmacies and its prescription benefit manager. “Rite Aid said it will fully transition the PBM to Elixir in December and is “committed to becoming a dominant mid-market PBM, Rite Aid chief executive office Heyward Donigan said Thursday on the company’s second quarter earnings call.”
  • Benefits Pro (registration required) discusses the critical importance of educating employees about the advantages of health savings accounts. “Employers and financial advisors should discuss HSAs in the context of emergency savings and retirement planning, not just health care elections during annual enrollment.” The FEHBlog misses his ability to contribute to an HSA, an ability that he lost when he became Medicare eligible last year.
  • The Federal Times notes that Congress appears to be successfully convincing the Trump Administration to allow affected federal employees to opt out of the currently mandatory payroll tax deferral program. The article erroneously states that “The private sector does have the choice of whether to opt into the program, but feds and military members were automatically included.” Just like in the federal sector, it is the employer who makes the primary decision to participate in the payroll deferral program. It’s also the employer’s choice to allow employees to opt out of payroll deferral.
  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules took a big scalp today. “Premera Blue Cross (PBC) has agreed to pay $6.85 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over 10.4 million people. This resolution represents the second-largest payment to resolve a HIPAA investigation in OCR history. PBC operates in Washington and Alaska, and is the largest health plan in the Pacific Northwest, serving more than two million people.” The breach dates from the bad old days of 2014-15 when Anthem and OPM announced massive data breaches due to cyberattacker gaining deep access to company information systems.
  • ZDnet reports on recent cyberattack on an unidentified federal agency system. It’s worth reading because

[While] The name of the hacked federal agency, the date of the intrusion, or any details about the intruder, such as an industry codename or state affiliation, were not disclosed, CISA officially publish[ed] an in-depth incident response (IR) report detailing the intruder’s every step. The report, which ZDNet analyzed today, reveals how the intruder gained access to the federal agency’s internal networks through different channels, such as leveraging compromised credentials for Microsoft Office 365 (O365) accounts, domain administrator accounts, and credentials for the agency’s Pulse Secure VPN server.

Midweek Update

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage–
Photo by Manasvita S on Unsplash

Roll Call informs us that the House of Representatives pass the compromise Fiscal Year 2021 continuing resolution (H.R. 8337) by a wide margin. The bill heads onto the Senate which is expected also to pass the bill before the end of the current fiscal year next Wednesday September 30.

In COVID-19 news —

Johnson & Johnson (J&J) has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. * * * Unlike its rivals, J&J is evaluating the safety and efficacy of a single dose of a COVID-19 vaccine. If the one-dose regimen is successful, J&J could eliminate the logistical complexity and dropouts associated with trying to get people to return for a second shot. A one-shot regimen would also enable J&J to vaccinate 1 billion people each year. Few manufacturers of two-dose regimens can match that figure. * * *

In disclosing the start of the phase 3, J&J also called out the storage requirements of its vaccine. The candidate is expected to be stable for two years at -20°C and for upward of three months in the 2°C to 8°C range used to store many biologics. J&J said the candidate is “compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.” Pfizer’s mRNA vaccine must be kept at -70⁰C and be used within 24 hours of being thawed. Other COVID-19 vaccines have storage requirements more comparable to those of J&J’s shot.

Good news.

  • Fierce Healthcare reports that Walmart plans to use drones to deliver self-administered COVID-19 tests to single family homes within a one miles radius of one of their “pilot” stores. The recipient will need to mail the nasal sample to a lab. The gold standard will be self administered tests that can read out at home like a pregnancy test, but they are getting closer.

Fierce Healthcare also calls our attention to the fact that Optum’s latest quarterly drug pipeline report explains how health plans can prepare to cover “chimeric antigen receptor T-cell (CAR-T) therapies coming to market. CAR-T treatments for cancer are costly but are proliferating as they offer a potentially curative treatment for the disease. Through CAR-T therapy, a patient’s cells are modified in a lab and then reintroduced to the body to attack the cancer.”

The Health and Human Services Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, took another HIPAA business associate scalp today.

CHSPSC LLC, (“CHSPSC”) has agreed to pay $2,300,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to a breach affecting over six million people. CHSPSC provides a variety of business associate services, including IT and health information management, to hospitals and physician clinics indirectly owned by Community Health Systems, Inc., in Franklin, Tennessee.

Monday Roundup

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

Becker’s Health IT offers 20 bold health IT predictions for the next five years. Here are the FEHBlog’s favorites:

1. Joel Klein, MD. Senior Vice President and CIO of University of Maryland Medical System (Baltimore): I think at least half of all healthcare in America will be virtual within five years. There are two barriers:

• Payers. They might pay less but if they pay enough, it will be enough. If we can figure out how to solve emergency department visits with widespread, cost effective on-demand care, that will make a difference.
• ‘But I want to see my doctor.’ That might be true for some things, but the convenience factor (especially for tertiary care… especially for millennials…) once you really start doing it overwhelms most of the physical presence upsides.

Edward Lee, MD. CIO of The Permanente Federation (Oakland, Calif.): In five years, physicians will no longer need to manually document their notes into the EHR. Instead, artificial intelligence will capture all the pertinent information from the patient-physician encounter. This will enable physicians to spend quality time with their patients instead of worrying about writing their notes or placing orders in a computer system. Joy and meaning for physicians will increase, physician burnout will decrease, and above all, patient care will improve.

Michael Pfeffer, MD. Assistant Vice Chancellor and CIO of UCLA Health: Health IT will enable each patient to have a unified, interactive view of their health information regardless of place of care or type of clinical data (i.e. phenotypic, genomic, imaging). AI-based apps will help make sense of their data, taking into account social determinants of health and potential health disparities to improve health equity and health literacy. This intelligence will be paired with personal health preferences and data on health provider quality, access, pricing and satisfaction to help patients make truly informed decisions about their care.

Fierce Biotech reports that “Just under a week after it stopped its key phase 3 pandemic vaccine test [due to a safety concern], AstraZeneca and the University of Oxford have been given the green light to restart in the U.K.” What’s more

While AZ and Oxford have been highlighted as [COVID-19 vaccine] race leaders, so too have Pfizer and BioNTech, which said they now want to boost their phase 2/3 trial for one of their five mRNA vaccines, BNT162b2, from around 30,000 to 44,000.

Also over the weekend, the companies said they have asked the FDA for the extra participants in order to include a broader patient population and with plans to include adolescents as young as 16 and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C or hepatitis B infection to “provide additional safety and efficacy data.”

It said it’s on track to hit its original target of 30,000 patients this week; despite wanting more people, Pfizer said in a statement that it was still on course to deliver data by the end of next month.

CVS Health announced last week that in response to demand created by children returning to school, it has made “children age 12 years and older eligible for testing at the more than 2,000 test sites located at select CVS Pharmacy drive-thru testing locations, starting last Friday, September 11.”

In other news

  • The Washington Post reports that commuting in the Washington DC metropolitan area may not be back to normal until next summer.

Some 430 employers representing about 275,000 workers in the greater-Washington region — stretching from Baltimore to Richmond — participated in the survey conducted Aug. 10 to 28. Their responses offer a snapshot of what companies are thinking as they weigh resuming in-office operations.
A clear majority of Washington-area employers said they are adopting a phased approach to returning to the office, although many said they remain uncertain about the timing of that return. A third of the region’s employers said they don’t know whether they will have their workers back on site by next summer.

  • Govexec.com reports that “The Office of Personnel Management issued a proposed rule [today] that would enable federal agencies to appoint employees in STEM jobs, or positions on temporary or new projects or organizations, for a decade. OPM said the change would give agencies more flexibility when tackling long-term science, technology, engineering and mathematics projects and other non-permanent work. Current regulations require agencies to get special permission from OPM to keep any term employee on staff for longer than four years.” The public comment deadline is November 10, 2020.
  • The House Oversight and Reform subcommittee on government operations held a postal update hearing today. It turns out that the subcommittee’s objective was to be to call the Postmaster General’s qualifications into question. A bipartisan Postal Service Board of Governors selects the Postmaster General, rather than following the usual Presidential appointment followed by Senate confirmation route.

Midweek update

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

Section 1557 is the individual non-discrimination provision of the Affordable Care Act. In June 2020, the Department of Health and Human Services issued a final rule making numerous changes to the Obama Administration’s rule. Both rule makings sparked lawsuits challenging their legality.

Last time around, the lead case, Franciscan Alliance v. HHS, was filed in the Northern District of Texas. That case is still pending on appeal before the U.S. Court of Appeals for the Fifth Circuit.

This time around, the lead case, Whitman-Walker Clinic v. HHS, was filed in Washington, D.C. Roughly one month following oral argument in the case, U.S. District Judge James Boasberg this afternoon denied the plaintiffs’ motion for a preliminary injunction against enforcement of HHS’s revised Section 1557 rule with two exceptions:

  • The Court preliminarily enjoined the revised rule’s repeal of the sex discrimination definition found in the replaced Obama Administration rule. That definition afforded express protection to transgendered people.
  • The Court also preliminarily enjoined the revised rule’s religious organization exception to the law’s sex discrimination restrictions.

Here is a link to the lengthy yet illuminating opinion and the implementing order. The decision called to the FEHBlog’s attention another interesting civil rights provision of the ACA — Section 1554. This provision places limits on the HHS Secretary’s broad reaching regulatory powers under the ACA.

Judge Boasberg’s decision expands on the Brooklyn federal court decision issued August 17, 2020, that stayed enforcement of the sex discrimination definition repeal. While the federal government has not appealed the Brooklyn decision, the plaintiffs in the FEHBlog’s opinion are likely to appeal the denial of their preliminary injunction motion in the Whitman-Walker Clinic case. And so it goes.

The Centers for Medicare and Medicaid today released its final Medicare Part A inpatient prospective payment system rule for the government fiscal year beginning October 1, 2020.

The increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.9 percent. This reflects the projected hospital market basket update of 2.4 percent and a 0.0 percentage point productivity adjustment. This also reflects a +0.5 percentage point adjustment required by legislation.

Hospitals may be subject to other payment adjustments under the IPPS, including:

— Penalties for excess readmissions, which reflect an adjustment to a hospital’s performance relative to other hospitals with a similar proportion of patients who are dually eligible for Medicare and full-benefit Medicaid
— Penalty (1 percent) for worst-performing quartile under the Hospital-Acquired Condition Reduction Program
— Upward and downward adjustments under the Hospital Value-Based Purchasing Program

Medicare is one complicated program. Medicare is relevant to the FEHBP because the program impact the prices that FEHB plans pay for patient care and there is a large cadre of annuitant enrollees with Medicare Part A coverage.

In other healthcare related news —

  • Reuters reports that “President Donald Trump said on Tuesday he planned to meet with pharmaceutical companies this week regarding his so-called most- favored-nation executive order aimed at lowering drug prices paid by the U.S. federal government.”
  • STAT News reports that

A new analysis of several studies in which [inexpensive] steroid drugs were used to treat severely ill Covid-19 patients found the drugs significantly helped reduce patient deaths, bolstering earlier, preliminary evidence for the benefit of these medications. In multiple studies involving a total of 1,700 patients, a number of corticosteroids—anti-inflammatory drugs that can damp the effects of an overactive immune system—helped reduce deaths from Covid-19 by about a third, compared with patients who didn’t receive steroids, according to the analysis published Wednesday in the Journal of the American Medical Association.

  • HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, has created a consolidate website regarding HIPAA and Health Apps. The site includes links to generally helpful technical information on cloud computing and HIPAA and HIPAA and health IT. Check it out.

Monday Roundup

David Ermer–CDC, COVID-19, OPM, Rx coverage, Telehealth, U.S. Healthcare–

The Wall Street Journal provides a roundup on the status of the front runners in the race for a safe and effective COVID-19 vaccine. “Nine of these have advanced into Phase 3, which tests whether the dose that would be given to the public works safely.” The Phase 3 candidates fall into one of the following three vaccine approaches

Genetic-code vaccines deliver specific genetic instructions teaching the body’s cells to make a protein from the targeted virus, which in turn induces an immune response. One type incorporates a synthetic, engineered version of messenger RNA, or mRNA. These are molecules in the body that ferry DNA instructions for making immune-inducing proteins. Other gene-based vaccines use DNA itself.

A virus-based vaccine uses a killed or weakened form of the targeted virus to induce an immune response.

Viral vector vaccines use a modified virus different from the targeted virus to serve as a carrier of the vaccine teaching the body’s cells to make a protein from the targeted virus.

Candidates at the Phase 2 trial level are also using a protein-based approach that “incorporates a protein from the virus, or something resembling it, that will trigger an immune response.” The more, the merrier, right?

With respect to other COVID-19 ramifications:

  • Healthcare Dive discusses CDC surveys on the estimated 40% of Americans experienced a reduction in access to healthcare during the great hunkering down while Fierce Healthcare discusses how hospital systems are reacting to the drop.
  • The Healthcare Dive article also points out a “”separate CDC RANDS survey found that nearly 37% of people said their provider now offers a form of telehealth, compared to about 14% who said it was offered before the pandemic” while Health Payer Intelligence discusses what it takes to for health plans to build upon the uptick in virtual care.

In other healthcare news:

  • Fierce Healthcare reports on a new Aetna plan design for mid-sized and large employers in the Kansas City metropolitan area. “While the PPO plan will offer access to many regional providers, CVS’ HealthHubs and MinuteClinics are deeply embedded in the plan design, Aetna said.”
  • The Health Care Cost Institute released a study of its voluminous health plan claims data finding that “commercial [health plan] prices paid for the average professional service were 122% of what would have been paid under the Medicare Physician-Fee-Schedule.” The report looks at this comparison from several different angles.
  • Drug Channel analyzes GoodRx’s decision to make public stock offering. GoodRx offers prescription drug savings to consumers.

In follow up news:

  • Federal News Network reports on another National Finance Center announcement hitting the brakes on its earlier announced plan to implement the President’s August 8 executive order permitting employers to defer payroll taxes for certain employees as early as the first paycheck in September.
  • A Delaware Chancery Court judge, according to Fierce Healthcare, has decided that neither Anthem nor Cigna should receive damages as a result of the 2017 breakup of their planned merger. Hopefully that’s the end of this saga.