Happy New Fiscal Year

David Ermer

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

Happy New Fiscal Year

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM–

Today, October 1, 2020, is the beginning of the new 2021 federal fiscal year and the fourth calendar quarter of 2020. Federal News Network reports that the President signed the compromise continuing resolution into law at 1 am this morning. The federal government is now funded through December 11, 2020.

The Washington Post reminds us that

Most federal employees [became] eligible Thursday [October 1] for paid parental leave, a benefit valued at about $1 billion a year and one of the most significant expansions of their benefits since the creation of unpaid parental leave more than 25 years ago. The new entitlement will allow employees to take paid time off for part or all of 12 weeks over a 12-month period, effective with births, adoptions or foster placements that occur Thursday and after. Previously, employees could take 12 weeks of unpaid time available under the Family and Medical Leave Act.

On the COVID-19 front —

  • The Wall Street Journal provides operational background on the current Phase III COVID-19 vaccine trials.
  • The Department of Health and Human Services announced an agreement with the Rockefeller Foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools. The partnership establishes a pilot program with select cities and states in The Rockefeller Foundation’s Testing Solutions Group (TSG), a network of public officials devoted to rapidly scaling COVID-19 testing, tracing, and tracking in their communities.”
  • STAT News discusses the somber connection between diabetes and COVID-19.

Data from the U.S. Centers for Disease Control and Prevention show more than three-quarters of people who died from Covid-19 had at least one preexisting condition. Overall, diabetes was noted as an underlying condition for approximately 4 in 10 patients. Among people younger than 65 who died from the infection, about half had diabetes.

[Moreover,] Juliana Chan, director of the Hong Kong Institute of Diabetes and Obesity, said the pandemic has intertwined with and exposed two other widespread problems: diabetes and disparities triggered by social determinants of health.

“What we are seeing is nothing new, but it is really just on a massive and global scale,” she said in an interview. “I hope that there is something positive out of this, that people understand that we are hit by three epidemics.”

  • The U.S. Department of Labor issued additional FAQs “regarding the need to report employees’ in-patient hospitalizations and fatalities resulting from work-related cases of the coronavirus.”

Because October is National Cybersecurity Awareness Month, the FEHBlog wishes to point out this Health IT Security report that

From October 2019 to July 2020, Microsoft data shows hackers have rapidly improved the sophistication and increased the frequency of cyberattacks. And when it comes to incident response engagements, ransomware attacks were the most common cause. The report follows reports that the Universal Health Services health system is currently recovering from what appears to be one of the biggest ransomware attacks in recent history. Further, nearly a dozen healthcare entities in the past month have either faced similar incidents or saw their data leaked online by ransomware threat actors.

Midweek Update

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

Late this afternoon, the Senate approved the compromise FY 2021 continuing resolution (H.R. 8337) by a vote of 84-10. The President is expect to sign the bill into law tonight. The bill provides continued funding for the federal government through December 11. Congress will hold a lame duck session following the national election on November 3 to consider next steps on FY 2021 appropriations.

This bill includes two provisions relevant to the FEHBP:

  • Section 2401 caps any increase to the Medicare Part B premium at 25% of what it otherwise would be for 2021. Presumably this cap only applies to the basic Part B premium and not to the increased premiums paid by high earners. In any event it should help encourage annuitants to join or stay enrolled in Part B. CMS should be announcing Medicare Part B and other traditional Medicare cost sharing amounts later in October.
  • Section 138 allows OPM, “which is still grappling with its own funding shortfall after the governmentwide security clearance business transferred to the Defense Department last year, to tap into the trust funds it oversees to keep its own operations going.” How would this impact the FEHBP? Section 8909 of the FEHB Act imposes a 4% surcharge on net to carrier premiums. 75% of that surcharge is deposited in a contingency reserve for the carrier which acts like a premium stabilization fund. The remaining 25% of that surcharge is available to cover OPM costs of FEHB administration to the extent appropriated by Congress. Congress typically appropriates only 1/4 of the administration fund to OPM and the balance per Section 8909 is deposited into the FEHB plan contingency reserves based on enrollment. It appears to the FEHBlog that this new law has given OPM the authority to tap into that surplus that otherwise would have been available to the FEHBP carriers. This is not the only such trust fund available to OPM.

The Wall Street Journal and the Hill report that the House Speaker Nancy Pelosi and the Secretary of the Treasury Steven Mnuchin will continue to discuss a compromise fourth COVID-19 relief bill tomorrow. The two leaders met today for 90 minutes and they hope for more progress tomorrow.

On the COVID-19 front —

  • The U.S. National Science Foundation discusses how it has been funding small businesses in the fight to control COVID-19. “Startups nationwide responded with creativity and a diversity of experiences to create innovative technology solutions in the COVID-19 crisis,” said Andrea Belz, director for the Division of Industrial Innovation and Partnerships. “NSF-funded solutions have the potential to make a significant impact in the fight against COVID and future pandemic threats.” That’s encouraging.
  • Forbes reports on a deal between startup tech company doc.ai and major health and Blue Cross licensee Anthem. “One of the products that Anthem is offering its members through doc.ai is called Passport, which helps employees safely return to in-person work during the Covid-19 pandemic. An employer decides on the parameters and each morning the employee answers a self-assessment that determines whether or not the app generates a unique barcode to enter the office building. But the key here is that the protected health information is never sent to the employer—it stays on the employee’s phone—and all the employer sees is whether the QR code was issued. De Brouwer likens it to “soft contact tracing,” where privacy comes first. The data is never uploaded to a server, but stays on the mobile device.” Also encouraging
  • In not so encouraging but understandable news, MedPage Today reports that “Overall frequency of alcohol consumption among adults ages 30-80 increased 14% versus 2019, with increases of 17% for women, reported Michael Pollard, PhD, of RAND Corporation in Santa Monica, California, which administers the survey, and colleagues. * * * ‘Health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,’ Pollard and co-authors wrote.”

On the healthcare fraud front, the HHS Inspector General announced today

The Department of Health and Human Services (“HHS”) Office of Inspector General, along with our state and federal law enforcement partners, participated in a health care fraud takedown in September 2020. More than 345 defendants in 51 judicial districts were charged with participating in health care fraud schemes involving more than $6 billion in alleged losses to federal health care programs. Since 2016, HHS-OIG has seen a significant increase in “telefraud”: scams that leverage aggressive marketing and so-called telehealth services. The conspirators include telemedicine company executives, medical practitioners, marketers, and business owners who scammed hundreds of thousands of unsuspecting patients in their homes.

Wow.

In miscellaneous news —

  • HHS created a Hospital Price Transparency website today three months before the final rule takes effect on January 1, 2021.
  • HHS also announced today “five cooperative agreements to health information exchange organizations (HIEs) to help support state and local public health agencies in their efforts to respond to public health emergencies, including disasters and pandemics such as COVID-19.” These HIEs provide a vital framework for sharing health information.
  • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the Multi-State Information Sharing & Analysis Center (MS-ISAC) have released a joint Ransomware Guide that details practices that organizations should continuously engage in to help manage the risk posed by ransomware and other cyber threats. The in-depth guide provides actionable best practices for ransomware prevention as well as a ransomware response checklist that can serve as a ransomware-specific addendum to organization cyber incident response plans.” Check it out.
  • Health Payer Intelligence helpfully reports on a surprise billing study published in the American Journal of Managed Care which finds that

More than 10% of health plan spending is attributable to ancillary and emergency services that commonly surprise-bill. Reducing payment for these services by 15% would reduce premiums by 1.6% ($67 per member per year), and reducing average payment to 150% of traditional Medicare rates—the high end of payments to other specialists—would reduce premiums by 5.1% ($212 per member per year). These savings would reduce aggregate premiums for the nation’s commercially insured population by approximately $12 billion and $38 billion, respectively.

The study is based on claims data from major health insurers housed in the Healthcare Cost Institute.

Tuesday Tidbits

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

Today the Senate invoked cloture on the compromise FY 2021 continuing resolution (HR 8337) by an 82 to 6 vote. The Senate now is in a position to pass the legislation and send it to the President for signature before the end of this federal government fiscal year, tomorrow September 30.

The Wall Street Journal reports that House Speaker Nancy Pelosi and Treasury Secretary Stephen Mnuchin have resumed discussing a compromise COVID-19 relief bill. Their discussions will continue tomorrow.

Healthcare consulting company WillisTowersWatson released a new white paper about the impact of the COVID-19 public health emergency on healthcare spending in the U.S.

Health care plan sponsors may see an unprecedented decrease in year-over-year medical costs in 2020, as system capacity shifts and fear of contracting COVID-19 in medical settings drives a significant volume of foregone and deferred care. Significant uncertainties remain however, including the course of the pandemic, the availability of effective vaccines and treatments, and changes in the health care delivery system that could impact future health care costs.

Willis Towers Watson has evaluated a set of potential future care utilization scenarios contemplating a variety of patterns of infection and care return. Across our scenarios, 2021 costs to employer plans are expected to be slightly higher (0.5% to 5.0%) than the non-pandemic baseline projection. Nevertheless, when 2020 and 2021 are combined, all scenarios show cost reductions (–2.8% to –3.8%) relative to the non-pandemic baseline. The baseline comparison from which these estimates were developed reflects projected costs for 2020 and 2021 assuming the pandemic never occurred. Employers should consider these scenarios as they budget for and measure the performance of their health care plans in the upcoming year.

Speaking of COVID-19 vaccines, the National Institutes of Health today announced that based on a separate Phase I study, the COVID-19 vaccine being jointly developed by Moderna and NIH had a positive impact on 40 older adult volunteers. This vaccine currently is in the Phase III study with a younger cohort. The separate Phase I study found that “Overall, the researchers found that “the investigational vaccine was well-tolerated in this older age group. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups.” NIH is proposing that the Phase III study be expanded to include a senior cohort.

In other tidbits

  • Beckers Hospital Review reports on “13 things to know about Aetna, Anthem, Cigna, Humana and UnitedHealthcare’s virtual care strategies.” The article reminds the FEHBlog that the current end date for the federal government’s COVID-19 public health emergency technically is October 23. In all likelihood HHS will extend the deadline for another ninety days to Inauguration Day.
  • Healthcare Dive reports that “HHS has sent the Office of Management and Budget an interim final rule, called Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency, received on Sept. 17. ONC declined to comment on the rule. But the title implies it will extend dates identified in the sweeping information blocking provisions — notably, the looming November compliance deadline for providers — and dates for the Conditions and Maintenance of Certification provisions requiring EHR platforms to be interoperable.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, SCOTUS, Telehealth–
Photo by Sven Read on Unsplash

In COVID-19 vaccine news —

  • The American Hospital Association has a COVID-19 vaccine resources and information website.
  • PharmaManufacturing is reporting that ” Pfizer’s CEO recently stated that the company could be ready to submit data from a late-stage trial of its coronavirus vaccine by the end of October — but experts are urging the company to slow its roll. According to Bloomberg Law, more than 60 bioethicists and researchers have penned a letter asking Pfizer to delay data reporting until November.” Why not let the Food and Drug Administration do its job?

In COVID-19 rapid testing news, HHS announced today a detailed “national distribution plan for the Abbott BinaxNOW Ag Card rapid test to assist Governors’ efforts to continue to safely reopen their states. BinaxNOW is a unique testing option to provide support to K-12 teachers and students, higher education, critical infrastructure, first responders, and other priorities as governors deem fit. The BinaxNOW rapid test – the only U.S. Food and Drug Administration-authorized antigen rapid point-of-care test that does not require an instrument – is easy to use, will produce COVID-19 test results in 15 minutes, and costs $5. * * * The Federal government purchased these Abbott BinaxNOW diagnostic tests on August 27, 2020, to ensure equitable distribution of the first 150 million units – one day after an Emergency Use Authorization (EUA) was issued by the FDA to ensure they would be expeditiously distributed to vulnerable populations as quickly as possible.

In other news —

  • The Centers for Disease Control reported today about COVID-19 trends among school age children in our country. “Since March, 277,285 COVID-19 cases in children have been reported [out of seven million in total]. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years.”
  • Healio reports on the multiple uses of telehealth beyond acute primary care. “[T]elehealth has been routinely incorporated in specialties such as psychiatry and asthma/allergy care, even prior to the COVID-19 era [‘PC”]. * * * Further, telemedicine allows for triage of patients with COVID-19 symptoms without requiring face-to-face visits to help direct next steps for testing and treatment. Telehealth can be effectively incorporated into oncology care — provided thoughtful and appropriate measures are taken.”
  • There has been a lot of press about the nomination of Judge Amy Coney Barrett to the Supreme Court following the sad occasion of Justice Ruth Bader Ginsburg’s death. It is quite likely that Judge Barrett will be sitting on the Supreme Court when the California v. Texas case is argued on November 10. Speculation is rife about this development and it is truly unfortunate that the Trump Administration is now siding with the States opposing the law’s constitutionality in the California v. Texas case. In the FEHBlog’s opinion, the position against the law’s constitutionality is a weak cup of tea. The FEHBlog is confident that the Supreme Court opted to hear the case to end this litigation in favor of the ACA’s general constitutionality. Congress obviously did not intend to render the ACA unconstitutional by zeroing out the individual mandate. The American Prospect observes

The whole legal argument [against the ACA’s constitutionality] depends on the fact that Republicans used reconciliation to pass the 2017 tax bill through the Senate with a simple majority. Due to the restrictions around reconciliation, Republicans couldn’t technically repeal the mandate in total, instead just lowering the penalty to nothing. The case effectively goes away if Congress either adds back in a penalty (even of just one cent), or just officially repeals the mandate, thereby severing it from the whole health care law.

Trying to bring back a penalty is a terrible option. The mandate is deeply unpopular, and it would be easy for Senate Republicans to oppose that move. What’s more, in the months since the mandate penalty went away, we’ve learned that it wasn’t as necessary to making the Obamacare system work as Democrats insisted in 2009 and 2010. Fully repealing the individual mandate, on the other hand, is an easy fight to win, as well as good policy. It is generally bad to have unenforced laws on the books.

Congress should take this action now by enacting an individual mandate repeal just as it repealed other ACA taxes in 2019. This is not to suggest that Congressional action is the only step that could save the law. But it would short circuit this craziness.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 testing, Electronic health records, OPM, U.S. Healthcare–

The FEHBlog is back inside the Beltway after a relaxing week on the Jersey Shore.

Both Houses of Congress will be conducting legislative and committee work this week following Yom Kippur which occurs from sundown tonight until sundown tomorrow. The Senate must pass the compromise continuing resolution funding the federal government through December 11 no later than Wednesday September 30.

On September 30, the Senate Homeland Security and Governmental Affairs Committee will take up the nomination of Chad Wolf to be Secretary of Homeland Security. The Committee continues to defer action of the nomination of John Gibbs to be OPM Director.

Before long OPM will be publicizing the 2021 FEHBP government contribution. The September 1, 2020, OPM Benefit Administration Letter states that OPM will be taking this action in “early October” and early October starts this Thursday October 1. Thanks to Google Alerts, the FEHBlog ran across this Janesville (Wisc.) Gazette article reporting that an FEHB plan called MercyCare with only 80 enrollees understandably will be leaving the FEHB Program at the end of this year.

While driving back from New Jersey the FEHBlog was musing about the uptick in COVID-19 cases. This musing reminded him to provide a link to this lengthy Wall Street Journal article published earlier this month about the “really diabolical” COVID-19 virus. WSJ articles on COVID-19 usually are accessible outside the paper’s paywall.

Taken on its own terms, SARS-CoV-2 is the infectious disease success of the past 100 years.

Almost unmatched in the annals of emerging human contagions, it has parlayed a few chance infections into a pandemic of around 27 million confirmed cases so far.

Doctors long expected the advent of such a virus, but even so, the shrewdness of the coronavirus caught many by surprise, and goes a long way to explaining how the world has struggled to contain it ever since.

“We underestimated it,” said Peter Piot , the head of the London School of Hygiene & Tropical Medicine and a co-discoverer of Ebola, who fell victim to the coronavirus himself in March.

In any event, looking forward, Healthline offers an update on the state of rapid COVID-19 testing.

In other news

  • Fierce Healthcare reports on UnitedHealthcare’s vision for a path forward on health reform. The study highlights the following policy priorities: 1. Universal coverage, 2. Improving affordability, 3. Enhancing the health experience, and 4. Boosting health outcomes.
  • Fierce Healthcare also provides insights into last week’s final rule creating a process for importing less expensive drugs from Canada. “HHS didn’t comment on whether Canada was on board with any re-importation proposals. The country has vociferously opposed national re-importation measures because of concerns it would dwindle their own drug supplies.” Time will tell. The FEHBlog is not a fan of this sort of drug importation.
  • Healthcare Dive reports that “Microsoft’s video platform, Teams, is integrating directly with electronic health records software to permit clinicians to launch telehealth visits from the EHR.” Microsoft’s first integration deal is with the largest EHR vendor Epic. This will facilitate direct telehealth visits between primary care providers and the patients.
  • Health Payer Intelligence discusses payer strategies for offering home healthcare / remote monitoring to members.

Friday Stats and More

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

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 38th weeks of this year (beginning May 14 and ending September 23; using Thursday as the first day of the week in order to facilitate this weekly update):

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

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

In other news —

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

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

Thursday Miscellany

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

The Wall Street Journal reports today that the Blue Cross Blue Shield Association (BCBSA) has reached with class plaintiffs’ counsel a tentative settlement agreement in a employer and individual consumer class action alleging anti-trust law violations among Blue Cross licensees that was filed in 2012. The settlement which includes $2.7 billion in payments and BCBSA operational changes intended to increase competition among Blue Cross licensees. The agreement is pending approval by the Blue Cross licensees and an Alabama federal court judge.

BCBSA also is facing a similar class action brought by a class of healthcare providers. The Journal report indicates that this case is headed to litigation. If you can’t access the Journal article due to its paywall (which is worth the investment in the FEHBlog’s humble opinion), Becker’s Hospital Review summarizes the settlement here.

Somewhat ironically, according to this Health Payer Intelligence report, the House of Representatives earlier this week passed a bill to repeal a law passed in 1945 that exempts health insurers from certain federal anti-competitive regulations.

The President issued an executive order today discussing his healthcare strategy and warning Congress that Health and Human Services will act to end healthcare surprise billing if Congress fails to pass its own surprise billing law by the end of the year. HHS issued a press release about the following agency actions taken today to implement the President’s strategy:

  • Issued a final rule from the Food and Drug Administration to open the first-ever pathway for states to use to safely import prescription drugs to lower patients drug costs.
  • Solicited private-sector proposals, as called for in the President’s July executive order, on allowing Americans to get lower-cost FDA-approved drugs and insulins from American pharmacies via importation and reimportation.
  • Released the 2021 Medicare Advantage and Medicare Part D Premium landscape, showing that average 2021 premiums for Medicare Advantage plans are expected to decline 34.2 percent from 2017 while plan choice, benefits, and enrollment continue to increase, and that Part D premiums will be down 12 percent from 2017, with over 1,600 drug plans offering insulin at no more than $35 per month.
  • Issued a notice of proposed rulemaking from the Health Resources and Services Administration to pass on steep discounts at community health centers on insulin and epinephrine to Americans who are uninsured or have high cost-sharing, including the nearly 3 million health center patients with diabetes.

The Society for Human Resource Management compares the Presidential candidate’s health plan coverage proposals here.

Last month the FEHBlog noted that GoodRx, the prescription drug discounter, was planning an initial public offering. Fierce Healthcare reports that

GoodRx raised $1.1 billion in its initial public offering after pricing its deal well above its expected price range. The GoodRx IPO began trading Wednesday at $46 per share, 39% above its $33 per share offering price. GoodRx stock rose above $49 per share in early afternoon action, Investors.com reported. That boosted the consumer healthcare technology firm’s market cap to about $12.7 billion.

Whoa Nelly.

Midweek Update

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

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

In COVID-19 news —

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

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

Good news.

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

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

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

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

Tuesday Tidbits

David Ermer–Uncategorized–
Photo by Patrick Fore on Unsplash

The Hill reports that

House Democrats reached a deal with Republicans on legislation to avert a government shutdown after rekindling talks over disputed farm assistance, with a vote planned as soon as Tuesday night [/ tonight]. Speaker Nancy Pelosi (D-Calif.) said in a statement that Democrats had reached an agreement to add nearly $8 billion in nutrition assistance for low-income children and families in exchange for “accountability” in assistance for farmers sought by the Trump administration.

Yippee. Duly predicted by the FEHBlog.

The Wall Street Journal reports‘ that

U.S. health regulators have drafted guidelines that would require a Covid-19 vaccine to meet rigorous standards to gain clearance for use, according to people familiar with the matter. Among the proposed requirements is that a coronavirus shot reduce the rate of infections by 50% compared with placebo, which the regulators have already required for a regular approval of any Covid-19 vaccines. The Food and Drug Administration (FDA) submitted the draft plan for review last week to Secretary of Health and Human Services Alex Azar, according to the people. The White House Office of Management and Budget is also reviewing the plan, the people said.

Rigorous. Good. People are more likely to trust vaccines that have been subjected to rigorous standards. A

Speaking of the FDA, that agency today “announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.” Good move.

The Centers for Medicare and Medicaid Services announced today “that it will expand the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. The model has saved Medicare about $650 million over four years while preserving quality of care and access to essential services. * * * [Today’s] Second Interim Evaluation Report * * * found that the model reduced RSNAT service use by 63% and RSNAT expenditures by 72% among beneficiaries with end stage renal disease and/or severe pressure ulcers during the first four years of the model. This decrease in RSNAT service expenditures, in turn, caused a total decrease of Medicare fee-for-service (FFS) expenditures of 2% (about $650 million over four years). The report did not find evidence that the model adversely affected quality of care.” It’s good news that CMS has found a way to reduce the cost of this service which is important to Medicare beneficiaries,

Monday Roundup

David Ermer–CDC, Congress, HIPAA Privacy and Security Rules–

Photo by Sven Read on Unsplash

The House of Representatives Rules Committee issued a rule today on the FY 2021 continuing resolution (H.R. 8913) by a 7-3 vote. The House is expected to vote on the bill soon. Nothing is certain in this world but the FEHBlog considers this CR to be on track to become law.

Katie Keith writes in the Health Affairs Blog on the impact of Justice Ruth Bader Ginsburg’s death on the California v. Texas case (No. 19-840) raising the constitutionality of the Affordable Care Act (“ACA”) That case is scheduled for oral argument on November 10 one week after the national election. The FEHBlog expects the Supreme Court to preserve the ACA no matter who wins the Presidential election because the Texas case challenging the law is weak. The proof is in the pudding as the preexisting condition free ACA marketplace has kept running without the individual mandate, just like the FEHBP.

The Centers for Disease Control last week issued its 2019 U.S. maps of adult obesity prevalence. Here are the CDC’s obesity tidbits which should be useful for FEHB plans which cover the nation in particular:

  • 6 states had an obesity prevalence of 35 percent or higher among non-Hispanic White adults.
  • 15 states had an obesity prevalence of 35 percent or higher among Hispanic adults.
  • 34 states and the District of Columbia had an obesity prevalence of 35 percent or higher among non-Hispanic Black adults.
  • Obesity decreased by level of education. Adults without a high school degree or equivalent had the highest self-reported obesity (36.2%), followed by high school graduates (34.3%), adults with some college (32.8%) and college graduates (25.0%).
  • Young adults were half as likely to have obesity as middle-aged adults. Adults aged 18-24 years had the lowest self-reported obesity (18.9%) compared to adults aged 45-54 years who had the highest prevalence (37.6%).
  • All states and territories had more than 20% of adults with obesity.
  • 20% to less than 25% of adults had obesity in 1 state (Colorado) and the District of Columbia.
  • 25% to less than 30% of adults had obesity in 13 states.
  • 30% to less than 35% of adults had obesity in 23 states, Guam, and Puerto Rico.
  • 35% or more adults had obesity in 12 states (Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia).
  • The Midwest (33.9%) and South (33.3%) had the highest prevalence of obesity, followed by the Northeast (29.0%), and the West (27.4%).

The Health and Human Services Office for Civil Rights announced today that the “Athens [Georgia] Orthopedic Clinic PA (“Athens Orthopedic”) has agreed to pay $1,500,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy and Security Rules.” Athens Orthopedic which serves 138,000 patients annually settled allegations of widespread system violations of those rules.