Catchup Sunday

Catchup Sunday

Happy Martin Luther King, Jr. Day weekend.

HHS issued several final rules on Thursday and Friday last week, none of which apply directly to the FEHBP:

  • The Centers for Medicare and Medicaid Services (CMS”) issued a final rule intended to streamline health plan prior authorization request to providers. America’s Health Insurance Plans, the health insurer trade association, was unimpressed. This rule applies to HHS’s own programs, e.g., Medicare, Medicaid, CHIP, the Qualified Health Plans in the ACA marketplace.
  • CMS also a final Calendar Year (CY) 2022 Medicare Advantage and Part D Rate Announcement, finalizing Medicare Advantage (MA) and Part D payment methodologies for CY 2022. Here’s a link to the fact sheet.
  • HHS also issued part of the final CY 2022 Notice of Benefit and Payments Parameters required by the Affordable Care Act. Katie Keith outlines the notice on the Health Affairs blog, noting

On January 14, 2021, the Centers for Medicare and Medicaid Services (CMS) released its final 2022 Notice of Benefit and Payment Parameters rule, joined in part by the Treasury Department. Historically, the “payment notice” adopts major changes for the next plan year in areas such as the exchanges and the risk adjustment program. Here, however, the final 2022 payment notice adopts only a subset of the policies considered in the proposed 2022 payment notice. This subset of policies includes the most controversial changes that had been included in the proposed rule. The final rule was accompanied by a fact sheet and a press release.

  • A friend of the FEHBlog called to his attention the fact that the Trump Administration HHS never published its proposed HIPAA privacy rule changes, announced December 10, 2020, in the Federal Register. (The HIPAA Privacy Rule does apply to the FEHBP.) What’s more the rule making cannot be found on the Federal Register’s latest public inspection list. The Biden Administration HHS will now have the opportunity to reconsider these “final actions” as well as what to do if anything with the proposed privacy rule changes.

The FEHBlog noticed that on January 7, 2021, the HHS Secretary extended the opioid crisis public health emergency another 90 days into April 2021.

Healthcare Dive informs us that

  • The Federal Trade Commission sent orders to six health insurance companies to obtain patient-level claims data for inpatient, outpatient, and physician services from 2015 to 2020, the agency said Thursday.
  • The FTC wants to figure out how hospitals’ acquisitions of physician practices has affected competition.  
  • The agency sent orders to some of the nation’s largest insurance companies, including UnitedHealthcare, Anthem, Aetna, Cigna, Florida Blue and Health Care Service Corporation.

Federal government personnel moves:

  • The Boston Globe reports that “President-elect Joe Biden on Friday nominated Eric Lander, a pioneer in the study of the human genome and the founding director of the Broad Institute of MIT and Harvard, to be his chief science adviser in a newly created Cabinet position. If confirmed by the Senate, Lander will be the first science adviser to serve in a presidential Cabinet * * *.
  • Medical Design and Resourcing reports that Food and Drug Administration (“FDA”) “veteran Dr. Janet Woodcock has been tapped as interim FDA commissioner by the Biden administration, according to published reports.” Dr. Woodcock currently serves as the FDA’s Director of the Center for Drug Evaluation and Research.
  • Bloomberg Law reports that Dr. “Francis S. Collins will stay on as NIH director under the Biden administration, making him one of the few biomedical agency directors to span three presidents.”
  • Govexec.com reports that “President-elect Joe Biden has named Jason Miller as his government management czar, tapping a former Obama administration economic adviser for the key role in setting the president’s management and federal workforce agenda. * * * Should Miller be confirmed by the Senate, he would serve under OMB Director-designate Neera Tanden if she is confirmed and replace Michael Rigas, who is serving in the OMB management role—and that of Office of Personnel Management director—in an acting capacity. The last Senate-confirmed official to hold the management position was Margaret Weichert, a Trump nominee who served concurrently as acting OPM director. Biden has yet to name a head of OPM.”
  • The Washington Post and the Partnership for Public Service offer a Biden Administration political appointee tracker.

As this is the FEHBlog, it is worth noting that Federal News Network has reported on the OPM’s Inspector General’s report on the impact of COVID-19 on the FEHBP. The OIG’s analysis was found in its September 2020 semi-annual report to Congress. Federal News Network queries “What about 2022, or future years for that matter, when FEHB enrollees flock back to their doctor’s offices again for those checkups and preventative procedures they’ve been putting off?”

Bear in mind that all health U.S. plans including FEHB plans experienced a V shaped drop in claims at the height of the great hunkering down last Spring. Many preventive tests are not required annually. The FEHBlog got his routine physical last summer by a combination of a holding a televisit with the doctor and giving blood etc. at the doctor’s office. Furthermore, prescription drug claims have held steady throughout the pandemic and flu cases remain “unusually low” during this winter. We will get through this together. When we reach the new normal, the healthcare sky will not fall in, at least in the FEHBlog’s view.

Friday Stats and More

Based on the CDC’s COVID Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through the second week of this year (beginning April 2, 2020 and January 13, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has 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 April 2, 2020 through January 13, 2021:

Finally here is a COVID-19 vaccinations chart for the past month which also uses Thursday as the first day of the week:

The CDC reports that as of today at 9 am roughly 10.6 million American have received one dose of either the Pfizer or Moderna vaccine and 1.6 million American have received both doses. 1.1 million doses of the vaccines were administered yesterday in total.

President-elect Biden announced additional members of his COVID-19 response team today, including

David Kessler, Chief Science Officer of COVID Response
David A. Kessler, M.D., who serves as a co-chair of the COVID-19 Task Force for President-elect Joe Biden, was the Commissioner of the Food and Drug Administration from 1990 to 1997, under Presidents George H. W. Bush and Bill Clinton. 

Per the American Hospital Association, this role will assume the responsibilities of the current head of Operation Warp Speed.” Beckers Hospital Review informed us on January 13 that “Moncef Slaoui, PhD, chief advisor of Operation Warp Speed, submitted his resignation at the request of President-elect Joe Biden’s team, although he’ll stay on for another month to oversee the transition to the new administration, CNBC reported Jan. 12. To close the loop NPR reports that the Biden Administration plans to retire the Operation Warp Speed moniker.

Also on the COVID-19 vaccine front, the Wall Street Journal reports tonight that

If manufacturing projections previously put forth by companies hold up, Mr. Biden’s pledge to administer 100 million doses of Covid-19 vaccines during the first 100 days of his presidency should be possible, according to manufacturing and supply chain experts. But efforts to significantly ramp up vaccines and curtail spread of the virus will depend on state partnerships and public buy-in for some public health measures. * * *

The success of the vaccination push rests in part on available supplies and the ability of a workforce to provide shots. Mr. Biden’s plan seeks to address both challenges through the expanded use of the Defense Production Act and a call for letting more people, including retired medical professionals, administer vaccines with training. He would also expand the use of pharmacies to provide vaccines.

The federally backed community vaccination centers would involve the Federal Emergency Management Agency, the National Guard and state and local teams. The administration would use federal resources and its emergency contracting authority to help launch the centers.

Monday Roundup

Photo by Sven Read on Unsplash

The Centers for Medicare and Medicaid Services has released a COVID-19 Vaccine Toolkit for health insurance issuers and Medicare Advantage plans. The toolkit’s purpose is as follows:

CMS is committed to ensuring that the private health insurance industry has the necessary tools to respond to the COVID-19 public health emergency (PHE). As safe and effective COVID- 19 vaccines become available, CMS issued this toolkit to help health insurance issuers and Medicare Advantage plans identify the issues that need to be considered and addressed in order to provide coverage and reimbursement for vaccine administration. Because COVID-19 vaccines will be federally purchased, this toolkit primarily focuses on vaccine administration. CMS remains available to provide technical assistance to issuers, Medicare Advantage plans, and other stakeholders. This toolkit:
• Provides a list of operational considerations for issuers and Medicare Advantage plans as they design their approach to promoting COVID-19 vaccinations and information on how issuers and Medicare Advantage plans can communicate with providers and enrollees on vaccinations and coverage;
• Outlines legislative and regulatory provisions applicable to issuers that ensure that enrollees can receive a COVID-19 vaccine in a convenient setting, with no out-of-pocket costs;
• Encourages issuers and Medicare Advantage plans to implement streamlined processes to quickly administer COVID-19 vaccine coverage; and • Describes how issuers and Medicare Advantage plans can maximize the number of their enrollees who get vaccinated once a COVID-19 vaccine becomes available

Meanwhile the Centers for Disease Control have released facts sheets on what to expect after you receive your first dose of COVID-19 vaccine and how to improve ventilation in your house during the great hunkering down.

Benefits Pro reports that the Equal Employment Opportunity Commission is poised to release proposed rules addressing the level of incentives employers may lawfully offer to encourage employee participation in wellness programs that require disclosure of medical information. “

Because the {Americans with Disabilities Act] ADA and [Genetic Information Non-Discrimination Act] GINA do not define “voluntary,” the NPRM proposes that in order to comply with the acts, employers may offer no more than a “de minimis” incentive to encourage participation in wellness programs. The exception would be for “wellness programs that are part of, or qualify as, group health plans and that require employees to satisfy a standard related to a health factor to receive a reward or avoid a penalty,” according to the proposed rule under the ADA.

Under the GINA regulation, the proposed rule makes an exception that would allow incentives for genetic information “when a wellness program offers an employee an incentive in return for his or her family member providing information about the family member’s manifestation of disease or disorder.”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

In the wake of the Democrat victories in the Georgia Senate elections, Katie Keith in the Health Affairs blog provides her insightful thoughts on what a Democratic Congress means for the Affordable Care Act.

The Robert Wood Johnson Foundation offers for our consideration five experts reflecting on the health equity implications of the COVID-19 public health emergency.

When Medicare pricing changes the healthcare industry takes notice.

  • The American Hospital Association reports today that ” The Centers for Medicare & Medicaid Services has recalculated the Medicare [Part B] Physician Fee Schedule payment rates and conversion factor for calendar year 2021 to reflect changes effective Dec. 27 under the Consolidated Appropriations Act. The new conversion factor is $34.89, which is 3.3% less than the CY 2020 conversion factor of $36.09 but more than the $32.26 conversion factor finalized in the PFS final rule, which would have represented a 10.2% net decrease in PFS payments for CY 2021. This change affects what FEHB plans pay for Medicare prime annuitants. Also where an annuitant over 65 does not pick up Medicare Part B, fee for service FEHB plans pay for doctors services using Medicare Part B payment rates.
  • Beckers Payer Issues reports that “A change in how Medicare pays laboratories for COVID-19 diagnostic tests took effect Jan. 1 * * * Medicare lowered the base payment for COVID-19 tests that use high-throughput technology to $75. Labs can get an additional $25 if they provide results in two days or less.” Medicare testing rates are sound benchmark for out-of-network COVID-19 labs which fail to comply with internet price post requirements.

The Centers for Disease Control yesterday issued an initial report concerning allergic reactions to the COVID-19 vaccines. Here’s the report’s summary:

What is already known about this topic?

Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination.

What is added by this report?

During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.

What are the implications for public health practice?

Locations administering COVID-19 vaccines should adhere to CDC guidance for use of COVID-19 vaccines, including screening recipients for contraindications and precautions, having the necessary supplies available to manage anaphylaxis, implementing the recommended postvaccination observation periods, and immediately treating suspected cases of anaphylaxis with intramuscular injection of epinephrine.

The Department of Health and Human Services announced today

a national plan to address the serious, preventable public health threat caused by viral hepatitis in the United States. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 sets national goals, objectives, and strategies to respond to viral hepatitis epidemics. Building on three prior National Viral Hepatitis Action Plans over the last 10 years, the Viral Hepatitis National Strategic Plan is the first to aim for elimination of viral hepatitis as a public health threat in the United States by 2030.  This plan serves as a roadmap for stakeholders at all levels and across many sectors, both public and private, to guide development of policies, initiatives, and actions for viral hepatitis prevention, screening, care, treatment, and cure.  

Federal News Network reports that

Federal payroll providers and agencies are beginning to detail exactly how and when federal employees and servicemembers will repay the Social Security taxes that were deferred from their paychecks during the last four months of 2020. The latest omnibus spending package, which the president signed into law last week, allows those subject to the president’s payroll tax deferral to repay the deferred taxes — worth 6.2% of their income — throughout the entire year of 2021, rather than the first four months of the year.

The article provides examples but generally the services are collecting in equal installments over the course of 2021.

Monday Roundup

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.

Happy National Rural Health Day

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.”

Monday Roundup

Photo by Sven Read on Unsplash

Perhaps at last we are beginning to see the light at the end of the COVID-19 tunnel. Pfizer announced positive initial results from the phase three trial of its two dose COVID-19 vaccine.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The Wall Street Journal explains (in part) that ‘

“When will the Pfizer vaccine be ready for [emergency use] authorization?

“It will be several more weeks at the earliest, because researchers and regulators still need to make sure the shot is safe. The U.S. Food and Drug Administration has said it wants to see two months’ worth of safety outcomes after vaccination for at least half of the people participating in any large, final-stage clinical trial before it considers authorizing a Covid-19 vaccine. The FDA says this will allow identification of any side effects, such as neurological or heart conditions, that weren’t apparent immediately after vaccination. So far, no serious safety issues have been found, Pfizer says. It expects the two months of safety data later this month, and can ask the FDA to authorize the vaccine soon thereafter. It isn’t yet clear how long the FDA will take to make a decision.

“When will people start getting vaccinated?

“Shots from Pfizer and BioNTech could start becoming available before the end of the year, as production has already begun, but initial supplies will be limited. Pfizer says it expects to produce up to 50 million doses globally in 2020—enough for 25 million people because the vaccine is given in two doses—and up to 1.3 billion doses in 2021. This means only the highest risk groups, such as front-line health care workers, could be inoculated this year. Many more doses would be needed to cover the U.S. and global population. Other Covid-19 vaccines in development will likely be needed for everyone to get vaccinated. Their makers have projected they could produce billions of doses next year if their vaccines are successful in clinical testing.”

The Centers for Disease Control released a study of hospital readmissions of COVID-19 patients from March through July 2021.

Among 126,137 unique patients with an index COVID-19 admission during March–July 2020, 15% died during the index hospitalization. Among the 106,543 (85%) surviving patients, 9% (9,504) were readmitted to the same hospital within 2 months of discharge through August 2020. More than a single readmission occurred among 1.6% of patients discharged after the index hospitalization.

The CDC also offered us guidance on avoiding COVID-19 during the Thanksgiving holidays.

The Centers for Medicare and Medicaid Services (“CMS”) released Affordable Care Act medical loss ratio rebate data from the latest health insurer reports for the three year period ending in 2019. The medical loss ratio data is broken out into three cohorts — individual insurance (minimum MLR 80%), small group insurance (minimum MLR 80%), and large group insurance (minimum MLR 85%). Each cohort then is further broken down state by state which no doubt increase the rebates. FEHB plan insurer rebates sensibly are paid to the the carrier’s contingency reserve, which is FEHB lingo for a premium stabilization fund.

Katie Keith in the Health Affairs blog offers her insights into tomorrow’s California v. Texas oral argument before the U.S. Supreme Court. C-SPAN will play the audio live on radio and the internet.

“The main issues to listen for are:

  • “Do the challengers—a coalition of states led by Texas and two individuals—have standing to challenge the ACA?
  • “Is the individual mandate, with a $0 penalty, unconstitutional?
  • “If the mandate is unconstitutional, is it severable from the rest of the ACA? If not, which other ACA provisions should be struck down alongside the mandate?”

Thursday Miscellany

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.

Friday Stats and More

Based on the Centers for Disease Control (CDC) Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 40th weeks of this year (beginning May 14 and ending October 7; 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:

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through October 7 (nearly five months).

Chris Conover recently wrote about your risk of dying from COVID-19 in the Forbes Apothecary. Three takeaways from the article:

  • Covid-19 has increased the risk of death for the average American by about 10 percent, but this increase in risk is much higher for seniors than children.
  • For seniors age 70 and older, getting Covid-19 is riskier than climbing Mt. Everest; in contrast, for those under age 20, the infection fatality risk is equivalent to driving a car for 7,500 miles.
  • Those under age 50 who get infected with the coronavirus lose less than one day of discounted quality-adjusted life expectancy; seniors age 70 or older lose nearly 90 days.

Today the CDC released the first weekly influenza update for this flu season in our country. The key update is brief: “Seasonal influenza activity in the United States remains low.” In contrast, the key update from this week’s COVID-19 update from the CDC is more nuanced:

Nationally, indicators that track COVID-19 activity continued to decline or remain stable (change of ≤0.1%). However, one region reported a slight increase in the percentage of specimens testing positive for SARS-CoV-2 and four regions reported slight increases in the percentage of visits for influenza-like illness (ILI). Mortality attributed to COVID-19 declined but remains above the epidemic threshold.

Today, the CDC also issued its National Action Plan for Combating Antibiotic Resistance 2020-2025, a worthy goal. “The U.S. Government will report annually on progress toward the objectives set in the Plan.”

In his Libertarian podcast this week, law professor Richard Epstein discussed why the Supreme Court will uphold the constitutionality of the Affordable Care Act in the California v. Texas case, which will be argued on November 10. The FEHBlog is buying what the good professor is selling. The discussion is in the first 10 minutes of the podcast which is less than 30 minutes overall.

The HHS Office for Civil Rights took its second scalp this week from a healthcare provider that allegedly failed to give patients HIPAA required access to their medical records, a big OCR priority. “NY Spine Medicine (NY Spine) has agreed to take corrective actions and pay $100,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access provision. NY Spine is a private medical practice specializing in neurology and pain management with offices in New York, NY, and Miami Beach, FL.”

Have a good weekend.

Midweek Update

Photo by Maria Teneva on Unsplash

The Blue Cross Blue Shield Association has a new president and CEO effective January 4, 2021 — Kim A. Keck. Ms. Keck, who will be the first woman to hold this position, is currently president and CEO of Blue Cross of Rhode Island. She worked for Aetna for 28 years. Of course, she succeeds Scott Serota. Congratulations, Ms. Keck.

Congratulations as well to the 2020 winners of the Nobel Prize in Chemistry, Emmanuelle Charpentier of the Max Planck Institute in Berlin and Jennifer Doudna of the University of California, Berkley, for their work in developing “genetic scissors” known as CRISPR-Cas9 “that can cut DNA at a precise location, allowing scientists to make specific changes to specific genes.” NPR explains that

“Once in a long time, an advance comes along that utterly transforms an entire field and does so very rapidly,” says Francis Collins, director of the National Institutes of Health, which has long supported Doudna’s research. “You cannot walk into a molecular biology laboratory today, working on virtually any organism, where CRISPR-Cas9 is not playing a role in the ability to understand how life works and how disease happens. It’s just that powerful.”

In other good news Precision Vaccinations reports that

The CDC researchers noted in the Morbidity and Mortality Weekly Report published on October 2, 2020, that during the 2019-20 flu season, 61.2 percent of surveyed pregnant women received the flu vaccine, which was 7.5 percentage points higher than the previous flu season. In addition, 56.6 percent of the women received the Tdap vaccine during pregnancy, and 40.3 percent received both vaccines. The percentage of women receiving both vaccines significantly increased from 35 percent just one year ago.

These increases were driven by increased vaccination coverage among Black and Hispanic women and those of other races reported the CDC. The CDC authors stated: “Racial disparities in vaccination coverage could decrease further with consistent provider offers or referrals for vaccination, in combination with culturally competent conversations with patients.” Specifically, this data found approximately 20 percent of pregnant women reported not receiving a provider recommendation for these vaccinations.

On the COVID-19 front, STAT News informs us that Eli Lilly reports good results with its synthetic antibody treatments for COVID-19. Lilly is seek emergency authorization use approval from the Food and Drug Administration as it continues to clinical trials on the treatments.

In other news —

The Department of Health and Human Services (“HHS”) announced today that

Surgeon General VADM Jerome M. Adams, M.D., M.P.H., issued a Call to Action urging Americans to recognize and address hypertension control as a national, public health priority. The Surgeon General’s Call to Action to Control Hypertension provides strategies for those on the frontlines of health care and public health to address this costly, dangerous and far too common chronic health condition.

According to Fierce Healthcare, Express Scripts has added new tools to its digital formulary that address “women’s health needs, tobacco cessation, muscle and joint pain, caregiver care and COVID-19 workplace support. The formulary’s goal is to assist employers and other plan sponsors in finding the digital health solutions that best fit their worker’s needs, and which have been vetted by experts at Express Scripts for key concerns like effectiveness, value, user experience and security.”

Healthcare Dive lets us know that

Doctors and consumers expect to use virtual care more often after COVID-19 than they did before, according to a new survey from telehealth vendor Amwell, hinting at the long-term potential of the virtual care model in healthcare. Prior to the pandemic, the majority of virtual visits were for on-demand urgent care. But this year, the volume of virtual specialty and scheduled visits outpaced urgent care, suggesting telehealth is becoming normalized across more fields and use cases. Only about 21% of consumers had a virtual visit for on-demand urgent care visit this year. By comparison, 54% had a scheduled visits with their primary care physician.

HHS’s Office for Civil Rights announced another HIPAA scalping of a healthcare provider that failed to provide individual access to their medical record, a top OCR priority at this time. “Dignity Health, doing business as St. Joseph’s Hospital and Medical Center (“SJHMC”), has agreed to take corrective actions and pay $160,000 to settle a potential violation of the HIPAA Privacy Rule’s right of access provision. SJHMC, based in Phoenix, Arizona, is a large, acute care hospital with several hospital-based clinics that provide a wide range of health, social, and support services.”