Midweek update

HIPAA Privacy and Security Rules

Midweek update

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, SDOH, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported. 

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.

The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.

What’s more, according to the Journal

A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.

The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.

An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.

From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us

** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.

** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.

** https://www.healthcaredive.com/news/regulators-unitedhealth-lhc-request-merger/625343/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-06-13%20Healthcare%20Dive%20%5Bissue:42394%5D&utm_term=Healthcare%20DiveIn a filing with the SEC on Friday, the companies said they have been complying with regulators and will continue to do so.

Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.

Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company. 

This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.

“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”

From the Rx coverage front, the Food and Drug Administration announced

the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.

From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced

issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *

The Guidance on How the HIPAA Rules Permit Health Plans and Covered Health Care Providers to Use Remote Communication Technologies for Audio-Only Telehealth may be found at: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Midweek update

David Ermer–COVID vaccine mandate, COVID-19, Electronic health records, HIPAA Privacy and Security Rules, Mental health care, No Surprises Act, U.S. Healthcare–

From the FEHB front, the Office of Personnel Management released the 2023 call letter for benefit and rate proposals and the related technical guidance letter.

OPM is to be congratulated for releasing the two letters simultaneously. Historically, OPM has released the call letter weeks or months before the technical guidance letter. As a result, carriers cannot start preparing their benefit and rate proposals, due May 31, until they receive both letters.

From the Omicron (and sibling) front, the American Medical Association informs us

The New York Times (3/15, Mandavilli) reports about “17 million Americans received the Johnson & Johnson Covid vaccine, only to be told later that it was the least protective of the options available in the United States.” However, “new data suggest that the vaccine is now preventing infections, hospitalizations and deaths at least as well as the Pfizer-BioNTech and Moderna vaccines.” The reasons are unclear, “and not all experts are convinced that the vaccine has vindicated itself.” Still, “the accumulating data nonetheless offer considerable reassurance to recipients of the vaccine and, if confirmed, have broad implications for its deployment in parts of the world.”

From the mental health care front, the American Hospital Association tells us

The Substance Abuse and Mental Health Services Administration yesterday released a toolkit to help health care providers and others prepare for the July 16 launch of 988, the new phone number for anyone experiencing suicidal thoughts or a mental health or substance use crisis to speak, text or chat with a trained crisis counselor. Authorized by the National Suicide Hotline Designation Act of 2020, the three-digit number will operate through the National Suicide Prevention Lifeline’s network of over 200 crisis centers.

“In the longer term, our vision is to build a robust crisis care response system across the country that links callers to community-based providers who can deliver a full range of crisis care services, if needed (like mobile crisis teams or stabilization centers),” SAMHSA notes.

To access the toolkit and other suicide prevention resources, visit SAMHSA’s new 988 website. 

From the U.S. healthcare front, Healthcare Dive reports

The long-term shift from hospital-based care toward more treatment delivered in the home and ambulatory centers picked up pace during the COVID-19 pandemic and is expected to continue to gain momentum, pressuring revenue growth and margins in the hospital sector, according to new research from Moody’s Investors Service.

Reimbursement changes, risk-sharing, investment in outpatient services including ambulatory surgery centers, advances in drugs and medical devices and greater use of at-home acute care services are among the forces driving the movement away from more expensive hospital inpatient care.

Medicare telehealth visits increased 63-fold during 2020, Moody’s said, citing HHS data. Although hospitals are reporting that telehealth use is receding as more patients return to in-person physician visits, it will likely remain above pre-COVID levels, the ratings agency said.

Kaiser Health News looks at the No Surprises Act from the patient’s perspective. It’s an important article because health plans should help their members keep the new law’s billing protections in perspective.

From the provider of the future front, mHealth Intelligence reports

Though a majority (63 percent) of clinicians worldwide expect most of their consultations to be remote within the next decade, 51 percent believe that telehealth will negatively impact their ability to demonstrate empathy with their patients, a new report revealed.

Developed by Elsevier Health and Ipsos, the Clinician of the Future report includes a quantitative survey, qualitative interviews, and roundtable discussions with nearly 3,000 practicing physicians and nurses worldwide. Of the total number of respondents, 434 were from the US. * * *

Empathy from physicians is becoming increasingly important for patients. A vast majority of clinicians (82 percent) surveyed said that soft skills like listening and displaying empathy have become more critical in the last decade. In the US, 76 percent of clinicians agreed with this statement.

Though the importance of soft skills has grown, the report notes that technical skills will be key in the future.

From the HIMSS Conference in Orlando, Florida, Healthcare Dive holds an interview concerning the FEHBlog leading interoperability innovation of 2022, TEFCA:

Healthcare Dive caught up with Mariann Yeager to talk TEFCA at the HIMSS annual healthcare conference in Orlando on Monday. Yeager is CEO of the Sequoia Project, a nonprofit that was selected in 2019 to serve as the recognized coordinating entity (RCE) charged with developing, updating and maintaining the common agreement and overseeing QHINs.

Yeager shared more details on the timeline of TEFCA implementation, why organizations should join the voluntary framework and how the Sequoia Project and the Office of the National Coordinator for Health IT are at the beginning of a long process of monitoring and modernizing a living document that, given uptake, could shape the future of health data exchange for decades into the future.

“We’re really proud of the work that we’ve done,” Yeager said.

Check out the full interview.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us that

Today, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened its final day of a scheduled meeting to discuss and vote on recommendations for booster doses of the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines, and to review data from the National Institutes of Health on mix-and-match booster doses.

The Committee unanimously voted (15-0) to approve the use of a single COVID-19 vaccine booster dose as follows:

1. Single booster dose of Moderna COVID-19 vaccine to be administered at least 6 months after completion of the primary series for individuals:

2. Single booster dose of the Janssen COVID-19 vaccine to be administered at least 2 months after completion of the primary regimen to individuals 18 years and older

3. Use of each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine

Data presented by Moderna showed a slow decline in neutralizing antibodies generated from the primary series over time.  Data from Janssen showed lower overall vaccine effectiveness compared to those who received an mRNA vaccine, and that evidence is not sufficient to determine if vaccine effectiveness is waning.

ACIP evaluated the benefits and risks of a booster dose for both the Moderna mRNA vaccine and for the Janssen vaccine.  The booster dose for the Moderna vaccine is half the dosage of the primary series shots, while those receiving a Janssen booster will receive the same dosage as the primary series.  CDC recommends that people receiving a booster dose receive the same vaccine as the primary series unless unavailable or another product is preferred.  Today’s vote created the pathway for heterologous booster doses for all vaccines, following FDA authorization yesterday.

The Committee also reviewed updates on the safety of all approved COVID-19 vaccines regarding incidences of myocarditis, pericarditis, and thrombocytopenia (TTS) and found no increased rates of these serious adverse events following additional booster doses of the vaccines. The data indicated that serious side effects for all vaccines are extremely rare. More research needs to be done on the safety of heterologous vaccine administration.

The final stop for these recommendations is the CDC Director Rochelle Walensky. The Wall Street Journal reports that Dr. Walensky approved the Committee’s recommendations this evening.

STAT News points out

When the [COVID] shots arrived late last year, the message from health officials was simple: Get vaccinated when you become eligible, and get whichever jab is offered to you. But with boosters becoming available for select groups of people, and a lower-dose shot for young children expected shortly, the campaign is moving from a simple set of instructions to more of a messy flow chart for people organizing and delivering the jabs. * * *

Sorting all this out will fall to pharmacies, immunization programs, pediatricians, and vaccine administrators, many already stretched thin, who will also have to track inventory and try to minimize waste. It will be a quick turnaround, as well: As soon as the CDC checks the final box for boosters with its recommendations, people will start demanding them.

Under ACA FAQ 50 issued October 4, 2021, health plans must immediately begin to cover administration of these boosters without member cost-sharing.

From the vaccine mandate front, Federal News Network reports that

A memo released by the Defense Department states that civilian [employees] will ultimately be fired from their jobs if they are not fully vaccinated. DoD wants all of its civilians to get the shot and go through the required waiting period for antibodies to flourish by Nov. 22.

DoD civilians who refuse to get the shot will go through “progressive enforcement actions,” the first of which is a five-day counseling and education period.

If an employee is still recalcitrant, they will be suspended without pay for less than 14 days. If the refusal continues, DoD will then terminate the employee for “failing to follow a direct order.”

The memo states that DoD will designate officials to handle the disciplinary process and “ensure consistent application of disciplinary measures.”

There are some exceptions to the rule. DoD will provide waivers to those who cannot get the vaccine due to medical conditions or for religious reasons. Further guidance will be available soon on the exceptions and DoD is currently not taking any action on exemption requests.

From the FEHB Open Season front, OPM made the following edit to its FEHB 2022 Significant Events chart:

StateFEHB CarrierPlan NameTerminatingOptions (endof 2021)TerminatingCodes (end of2021)Automatic EnrollmentOption and Codes for2022
IndianaHumana Health Plan,Inc.Humana Health Plan,Inc.HighLouisvilleMetropolitan areaMH1, MH3, MH2StandardLouisville Metropolitanarea – MH4, MH6, MH5
IndianaHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, IncHighA61, A63, A62BasicW61,W63,W62
KentuckyHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, Inc.HighA61, A63, A62Basic W61,W63,W62

From the federal employment benefits front, Reg Jones in Fedweek discusses death benefits available to surviving beneficiaries following a federal annuitant’s post-retirement death.

From the HLTH2.0 conference, Healthcare Dive provides more Amazon Health news and Fierce Healthcare discusses how to attract younger health plan members.

From the the Capitol Hill front, Healthcare IT News explains that why this may be the year that Congress finally restores funding for a HIPAA patient identification number. Fingers crossed.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports that on Tuesday the Senate Republicans refused to give unanimous consent to the Democrat effort to solve the debt ceiling issue without Republican support. Secretary of the Treasury Yellen advised Congress yesterday that she expects that current emergency measures used since August 1 to deal with the debt ceiling problem would soon be exhausted and “the government would be unable to pay all of its bills on time starting Oct. 18 unless Congress acts.” That of course is an unprecedented situation. The FEHBlog finds it interesting that the Congressional Democrat leadership has not lead with the bipartisan crafted continuing appropriation bill instead of the debt ceiling bill because the federal fiscal year ends on Thursday.

From the Delta variant front

  • The National Institutes of Health Director summarizes where we stand on the COVID-19 booster effort in his weekly blog post. The FEHBlog who has received two doses of the Pfizer vaccine over six months ago checked a major retail pharmacy chain site to see whether the booster is readily available and he found that it is which happily is a stark difference from last winters efforts to find the initial doses.
  • The Wall Street Journal reports that

Regulatory clearance of the Pfizer Inc. and BioNTech SE vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks.

The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September.

  • The Kaiser Family Foundation released an interesting survey on the current public response to COVID. As of today, according to the CDC, just over 75% of Americans eligible to receive the vaccine (ages 12 and older) have receive at least one dose.
  • Healthcare Dive adds that

As of Tuesday, hospitalizations in the U.S. are down 16% over the past two weeks, according to the 14-day average from data compiled by The New York Times.

The U.S. reached a turning point in this year’s summer surge earlier this month, according to the seven-day averages. The average hospitalizations reached a peak on Sept. 3, started to decline the next day and have been trending down ever since, according to data compiled by the Times.

In the tidbits department

  • The Department of Health and Human Services announced awarding “nearly $1 billion in American Rescue Plan funding to nearly 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. These awards will strengthen our primary health care infrastructure and advance health equity and health outcomes in medically underserved communities, including through projects that support COVID-19 testing, treatment, and vaccination. The awards were made through the Health Resources and Services Administration.”
  • Health Payer Intelligence discusses a Manatt Health report on episode based care.
  • HHS also announced “the appointment of Lisa J. Pino as Director of the Office for Civil Rights (“OCR”). OCR is the HHS agency which enforces the HIPAA Privacy and Security Rules among other things. As it is a small world, Ms. Pino previously was “Senior Counselor [at Homeland Security] and drove the 2015 U.S. cyber breach mitigation of 4 million federal personnel and 22 million surrogate profiles, the largest hack in federal history, by renegotiating 700 vendor procurements and establishing new cybersecurity regulatory protections.”

Midweek Update

David Ermer–ACA, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.

Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.

While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.

In other healthcare news

  • A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
  • The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
  • NCQA has made available a kidney health toolkit.
  • Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
  • Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.

Finally, the Wall Street Journal’s the Future of Everything series today discusses how

Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself. 

“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.

Tuesday’s Tidbits

David Ermer–Congress, Federal employment benefits, HIPAA Privacy and Security Rules, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog had been wondering what was going on with the Postal Reform bill that includes a new Postal Service Health Benefits Program. It turns out that the House Oversight and Reform Committee plans to mark up the latest draft of that bill on Thursday morning. The FEHBlog plans to tune in for this meeting.

In health equity developments —

  • The Wall Street Journal reports that “Ride-sharing companies Uber Technologies Inc. and Lyft Inc. will make all rides to and from vaccination sites free until July 4 under a new partnership with the White House. * * * While the companies were already providing free or discounted rides in some circumstances, the rides will now be free to anyone in the U.S. who is going to a vaccination site to get the shot, and Lyft and Uber will promote the rides to and from tens of thousands of vaccination sites through their apps. The feature will launch in the next two weeks and run until July 4.”
  • Health Leaders Media informs us about Horizon Blue Cross’s ongoing efforts to advance health equity in New Jersey in cooperation with healthcare and community organizations as well as solid data.
  • The American Medical Association released a “strategic plan to embed racial justice and advance health equity.” “With the input of many both inside and outside of AMA, this strategic plan serves as a three-year roadmap to plant the initial seeds for action and accountability to embed racial justice and advance health equity for years to come.”

In regulatory developments –

  • Professor Katie Keith in the Health Affairs blog provides background on yesterday HHS decision to “interpret Section 1557 and Title IX, which prohibit discrimination on the basis of sex, to include discrimination on the basis of sexual orientation and gender identity.”
  • Fierce Healthcare reports that “The Centers for Medicare & Medicaid Services has sent its first wave of warning letters out to hospitals breaking federal rules requiring them to disclose payer-negotiated prices, a spokesperson for the agency confirmed.”
  • Healthcare Dives discusses healthcare organization comments to HHS’s Office for Civil Rights on its proposed rule that would make generally helpful adjustments to the HIPAA Privacy Rule, in the FEHBlog’s opinion.

Miscellaneous tidbits —

  • Reg Jones discusses the Federal Employees Group Life Insurance Program in FedWeek.
  • The Society for Human Resources Management writes about “Supporting Mental Health in the Post-Pandemic Workplace.”
  • Health Payer Intelligence discusses Blue Cross of North Carolina’s successful effort to consolidate member experience data from across the company to boost member satisfaction.

Tuesday Tidbits

David Ermer–Congress, COVID-19, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

There are a boatload of tidbits today.

Roll Call reports that “The House [of Representatives] will vote to clear the $1.9 trillion pandemic relief package for President Joe Biden’s signature on Wednesday, Majority Leader Steny H. Hoyer told reporters.”

From the COVID-19 front

  • Fierce Pharma informs us that “Vaccine doses are fanning out around the globe, but officials worry that surging coronavirus variants could make the immunization push less effective. Thanks to a new lab study, Pfizer and BioNTech have some good news for them. “Pfizer and BioNTech’s mRNA shot [which the FEHBlog has received] appeared to work against three worrisome variants in a lab study, researchers from both companies and the University of Texas Medical Branch wrote in the New England Journal of Medicine. That includes the P.1 variant that arose in Brazil and has raised concerns about re-infections.”
  • Fierce Healthcare reports ” As the COVID-19 vaccine rollout continues, payers are gearing up to play a key role in easing vaccine fears and hesitancy. At Humana, for example, this has meant connecting with members at multiple touch points over the past year, and ensuring that vaccine education was not their first conversation with their health plan during the pandemic, Chief Medical Officer William Shrank, M.D., said. “I don’t think any of our members see this as our first outreach,” Shrank said.” But bear in mind health plans better late than never.
  • The Society for Human Resource Management discusses how employers can take steps now to reduce pandemic fatigue in their employees.

From the general healthcare front —

  • The Wall Street Journal informs us that “A federal medical panel is calling for a significant expansion of CT scanning for smokers to detect lung cancer, citing studies that found the imaging studies can save more lives than previously known. The U.S. Preventive Services Task Force is advising people ages 50 to 80 to get the screening if they have smoked on average a pack of cigarettes daily for 20 years, and who currently smoke or have quit within the past 15 years. The panel’s previous recommendation, in 2013, recommended people get screened between ages 55 and 80, and have smoked the equivalent of a pack of cigarettes a day for 30 years, and currently smoke or have quit within the past 15 years.” The USPSTF recommendation will result in FEHB coverage of the CT scan for FEHBP members in the expanded group without member cost sharing in 2023.
  • Health Affairs helpfully reports “Bundled payment has shown promise in reducing medical spending while maintaining quality. However, its impact among commercially insured populations has not been well studied. We examined the impacts on episode cost and patient cost sharing of a program that applies bundled payments for orthopedic and surgical procedures in a commercially insured population. The program we studied negotiates preferred prices for selected providers that cover the procedure and all related care within a thirty-day period after the procedure and waives cost sharing for patients who receive care from these providers. After implementation, episode prices for three selected surgical procedures declined by $4,229, a 10.7 percent relative reduction. Employers captured approximately 85 percent of the savings, or $3,582 per episode (a 9.5 percent relative decrease), and patient cost-sharing payments decreased by $498 per episode (a 27.7 percent relative decrease).” Interesting.
  • Health Payer Intelligence discusses how payers can take action against racial and ethnic healthcare disparities. Because “the payer industry’s core function is to pay for medical care, insurers can play a key role in overturning local care disparities through their payment strategies, offering funds to organizations that reduce disparities, and by spending locally in a way that is conscious of systemic inequities by purchasing from black and minority-owned businesses,” [Kedar] Mate [president and chief executive officer at the Institute for Healthcare Improvement (IHI), president of the IHI Lucian Leape Institute, and a member of the faculty at Weill Cornell Medical College] said.

From the healthcare industry front

  • Forbes informs us that “In the largest advertising blitz ever undertaken by the health insurance lobby, America’s Health Insurance Plans will spend at least $10 million on a national education campaign to show how health plans are ‘are working together to deliver affordable and accessible care and coverage.’”
  • Fierce Healthcare explains that “If there was one key word to come out of Cigna’s investor day on Monday [March 8], it would be “growth.” The insurer spotlighted its ambitions to expand across its enterprise, from its insurance plans to pharmacy to digital tools, at the virtual event for investors Monday morning. CEO David Cordani said that its growth plans “fuel our purpose.”
  • Fierce Healthcare also reports that “COVID-19 accelerated a number of trends already brewing in the healthcare industry, and that’s not likely to change this year, according to a new report from CVS Health. The healthcare giant released its annual Health Trends Report on Tuesday [March 9], and the analysis projects several industry trends that are likely to define 2021 in healthcare, ranging from technology to behavioral health to affordability. “We are facing a challenging time, but also one of great hope and promise,” CVS CEO Karen Lynch said in the report. “As the pandemic eventually passes, its lessons will serve to make our health system more agile and more responsive to the needs of consumers.”
  • Drug Channels lists that fifteen largest U.S. pharmacy chains in terms of market share and revenue. CVS Health leads the pack.

From the regulatory front, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced today “a 45-day extension of the public comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on December 10, 2020, and it was published in the Federal Register on January 21, 2021.  The 45-day extension moves the current deadline for the public to submit comments from March 22, 2021, to May 6, 2021. The notice of extension of the comment period is available at https://public-inspection.federalregister.gov/2021-05021.pdf – PDF.” The FEHBlog is pleased that the Biden Administration is giving serious consideration to this proposed rule.

Cybersecurity Saturday

David Ermer–Cybersecurity, HIPAA Privacy and Security Rules–
Photo by Christine Sandu on Unsplash

The Wall Street Journal reports today that

Investigators probing a massive hack of the U.S. government and businesses say they have found concrete evidence the suspected Russian espionage operation went far beyond the compromise of the small software vendor publicly linked to the attack.

Close to a third of the victims didn’t run the SolarWinds Corp. software initially considered the main avenue of attack for the hackers, according to investigators and the government agency digging into the incident. The revelation is fueling concern that the episode exploited vulnerabilities in business software used daily by millions. * * *

The attackers “gained access to their targets in a variety of ways. This adversary has been creative,” said Mr. Wales, whose agency, part of the U.S. Department of Homeland Security, is coordinating the government response. “It is absolutely correct that this campaign should not be thought of as the SolarWinds campaign.”

That is chilling news. What should be done?

In that regard, Fortune seeks to untangle the U.S. cybersecurity “mess” for us. The article explains

Restructuring [the U.S. cybersecurity] system is core to the work of the Cyberspace Solarium Commission, a task force commissioned by Congress to help reform U.S. cybersecurity. “Our focus [is] on making the market more effective at driving good behavior,” says commissioner Suzanne Spaulding, a senior adviser for cybersecurity and counterterrorism at the Center for Strategic and International Studies. “If the market isn’t performing the way it should, why isn’t it?” 

The commission spent the past year drawing up a wide-ranging list of recommendations, and in January, 26 of them became law as part of the 2021 National Defense Authorization Act. The NDAA creates a White House–level Office of the National Cyber Director and grants new private-sector threat-response powers to the federal Cybersecurity and Infrastructure Security Agency—significant changes that commission members hope will prompt closer collaboration between government and industry on security standards. “A lot of the recommendations, some of us have been making for years,” says Cilluffo, who’s also a commissioner. “But the political will was not where it needed to be. Now, we don’t need any reminders.”

Solarium’s mandate has been extended for at least another year, and its next round of advocacy and recommendations will focus more squarely on the private sector. The goal: creating better incentives for building secure software and sharing intelligence about cyberthreats.

On the personnel front, GovConWire reported last week that

Sources said Biden is likely to name [Jen] Easterly to the newly created role of national cyber director at the White House to help guide the current administration’s cybersecurity strategy and oversee digital security efforts of agencies.

Easterly is head of resilience at Morgan Stanley and previously served as deputy director for counterterrorism at the National Security Agency between 2011 and 2013. She served in the National Security Council as special assistant to the president and senior director for counterterrorism during the Obama administration.

Healthcare Dive also noted that “The Biden administration hired Chris DeRusha as federal CISO, tasking him with coordinating cybersecurity policy across federal agencies. DeRusha previously served as the top cybersecurity officer for the Biden presidential campaign.”

Cyber Scoop adds with respect to the ongoing investigation that

[L]awmakers are demanding answers from the National Security Agency about another troubling supply chain breach that was disclosed five years ago.

A group of lawmakers led by Sen. Ron Wyden, D-Ore., is asking the NSAwhat steps it took to secure defense networks following a years-old breach of software made by Juniper Networks, a major provider of firewall devices for the federal government.

Juniper revealed its incident in December 2015, saying that hackers had slipped unauthorized code into the firm’s software that could allow access to firewalls and the ability to decrypt virtual private network connections. Despite repeated inquiries from Capitol Hill— and concern in the Pentagon about the potential exposure of its contractors to the hack — there has been no public U.S. government assessment of who carried out the hack, and what data was accessed.

Lawmakers are now hoping that, by cracking open the Juniper cold case, the government can learn from that incident before another big breach of a government vendor provides attackers with a foothold into U.S. networks.