Today's News and Commentary

About the public’s health

ICYMI: U.S. FDA advisers overwhelmingly back authorizing Pfizer COVID-19 vaccine

Here is a summary on how the distribution will work.

Military-grade camera shows risks of airborne coronavirus spread: Superb video and expert commentary of spread patterns of breathing.

Probe: CDC official says she was ordered to delete email: “A senior manager with the Centers for Disease Control and Prevention told congressional investigators she was ordered to delete an email suggesting attempted political interference by the Trump administration in coronavirus reports to the public, according to a transcript released Thursday.” The information that was supposed to be changed dealt with pediatric transmission of SARS Co-V 2.

Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine: “Sanofi and GlaxoSmithKline’s COVID-19 vaccine has failed to trigger the desired immune response in people aged 50 years and older, forcing the partners to rethink the antigen formulation. The setback is expected to delay the availability of the vaccine from mid-2021 to near the end of next year.”

Study Finds Young People Quit or Reduced Vaping Habits During the Pandemic: Some good news from the pandemic: “A combination of stay-at-home orders and vape and smoke shop closures contributed to why many young adults and people under 21 years old quit or reduced vaping.
A national study looking at the e-cigarette habits among young adults and underage youth during the coronavirus disease 2019 (COVID-19) pandemic has found that 67.7% of e-cigarette users who changed their vaping habits during the pandemic had reduced their use or quit entirely.”

Many Black Americans, Republicans AND Women Aren’t Sure About Taking A COVID-19 Vaccine: The article provides a breakdown on attitudes by age, race, gender and political affiliation.

Flu vaccine distribution hits all-time high in the United States, CDC report says: “More doses of the influenza vaccine have been distributed in the United States this season than ever before, according to a new report from the Centers for Disease Control and Prevention. 
Roughly 188 million doses had been distributed as of Nov. 27, the CDC said in a weekly vaccination report updated Wednesday. That’s the most doses distributed in the country during a single flu season. 
At this point in the flu season last year, about 169.1 million doses had been distributed, the CDC says.”

Rising inequality of infant health in the U.S.: “Our results reveal that infant health inequality increased since 2010 across a variety of health measures at birth.”

About health insurance

COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing: Here is an updated FAQ statement from CMS.

Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage: “The Patient Protection and Affordable Care Act (ACA) provides that certain grandfathered group health plans and health insurance coverage that existed as of the law’s enactment are subject to some of the ACA’s requirements, such as the prohibition on preexisting condition exclusions, but are exempt from certain other requirements.”
This link is to the final rule with will be published 12/15/20. In the meantime, you can go here for a summary. Briefly, the rule first “clarifies that grandfathered group health coverage that is a high deductible health plan (HDHP) may increase fixed-amount cost-sharing requirements, such as deductibles, to the extent necessary to maintain its status as an HDHP without losing grandfather status. This change ensures that participants and beneficiaries enrolled in that coverage remain eligible to contribute to a health savings account. Second, the final rule provides an alternative method of measuring permitted increases in fixed-amount cost sharing that allows plans and issuers to better account for changes in the costs of health coverage over time.”

Affordable Care Act Approval Tied for High: “Americans' support for the 2010 Affordable Care Act, also known as Obamacare, has increased to a record-tying high of 55% after averaging 51% from 2017 through 2019. The act was less popular when President Barack Obama was in office, averaging 44% and never reaching 50%.” The variance is huge: Democrats favor by 94% and Republicans favor by 13%.

Moody's: Outlook stable for health insurers in 2021 despite COVID-19, policy pressures: “Moody's analysts expect the macroeconomic trends to be manageable for health plans next year, according to the report, with moderate earnings growth and telehealth and value-based care models helping to drive down cost pressures.
However, three key factors could turn that outlook negative, Moody's said: the pandemic, health policy changes or a worsened economic downturn. For example, insurers are likely to continue waiving costs for treatment and testing associated with COVID-19 through the middle of next year, if not longer.”

About hospitals and health systems

A look at the most expensive hospital construction projects in 2020: Considering the hit hospitals have taken this year, it is amazing that we see such major projects.

Fitch Ratings 2021 Outlook: U.S. Not-For-Profit Hospitals and Health Systems:”Fitch Ratings has changed its sector outlook to stable from negative for 2021, reflecting our expectation that results in 2021 will be consistent with the overall weak margins in 2020. Fitch believes that the acute care sector will remain pressured by the challenging operating environment in 2021, but not to a greater extent than in 2020. Fitch views it as unlikely that the sector will see significant government-mandated ‘stay-at-home’ orders, which should enable providers to continue serving non-COVID-19 patients (both elective and emergent) alongside a steady volume of COVID-19 patients. Traditional surgical and specialty care volume has not fully returned to 2019 levels, but some of the volume gaps may be filled by COVID-19 cases.”

About pharma

Abortion medication restrictions remain blocked during pandemic, judge rules: “U.S. District Judge Theodore D. Chuang in Maryland said the health risks have ‘only gotten worse’ since he first blocked restrictions in the summer in response to concerns about exposure to the coronavirus.
Requiring an in-person visit to a medical facility to obtain the drugs needed to induce abortion, Chuang said, is unduly burdensome.”

STATEMENT ON HRSA’S FINAL 340B ADMINISTRATIVE DISPUTE RESOLUTION RULE: “The Health Resources & Services Administration today released a final rule to implement an administrative dispute resolution process for the 340B drug pricing program. As Congress mandated in 2010, the process would establish a government panel to settle disagreements between covered entities and pharmaceutical manufacturers, such as a hospital’s claim that a drug company overcharged for 340B drugs.”

Rani Therapeutics nets $69M to transform injections into its easy-to-swallow 'robotic pill': “Rani Therapeutics has secured $69 million in new funding to move forward with the manufacturing and clinical testing of its “robotic pill”—a small, swallowable capsule that promises to shepherd more delicate drugs past the stomach before releasing them into the bloodstream.
The pill aims to make it easier for a patient to take therapies that typically require an injection or infusion, including treatments for diabetes, arthritis and other diseases.”

About healthcare IT

HHS proposes HIPAA changes: 7 things to know: “HHS' Office for Civil Rights released proposed modifications to the HIPAA Privacy Rule Dec. 10.
The Notice of Proposed Rulemaking is part of HHS' Regulatory Sprint to Coordinated Care initiative, which analyzes federal regulations that interfere with healthcare providers and health plans' efforts to better coordinate care for patients.
The proposed changes to the HIPAA Privacy Rule include strengthening individuals' access to their own health information, facilitating greater family and caregiver involvement in the care for individuals and access to their PHI during emergencies or health crises and reducing administrative burdens on HIPAA-covered providers and health plans.”