Thursday Miscellany

CDC

Thursday Miscellany

David Ermer–ACA, CDC, COVID-19, HIPAA Privacy and Security Rules, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Today’s big news is that the ACA regulators (the Departments of Health and Human Services (“HHS”), Labor, and Treasury) finalized a lengthy pricing transparency rule for payers, including ERISA and FEHBP group health plans (see footnote 233). The related fact sheet explains

This final rule includes two approaches to make health care price information accessible to consumers and other stakeholders, allowing for easy comparison-shopping.

First, most non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items and services, including prescription drugs, through an internet-based self-service tool and in paper form upon request. For the first time, most consumers will be able to get real-time and accurate estimates of their cost-sharing liability for health care items and services from different providers in real time, allowing them to both understand how costs for covered health care items and services are determined by their plan, and also shop and compare health care costs before receiving care. An initial list of 500 shoppable services as determined by the Departments will be required to be available via the internet based self-service tool for plan years that begin on or after January 1, 2023. The remainder of all items and services will be required for these self-service tools for plan years that begin on or after January 1, 2024.

Second, most non-grandfathered group health plans or health insurance issuers offering non-grandfathered health insurance coverage in the individual and group markets will be required to make available to the public, including stakeholders such as consumers, researchers, employers, and third-party developers, three separate machine-readable files that include detailed pricing information.
The first file will show negotiated rates for all covered items and services between the plan or issuer and in-network providers.
The second file will show both the historical payments to, and billed charges from, out-of-network providers. Historical payments must have a minimum of twenty entries in order to protect consumer privacy.
And finally, the third file will detail the in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level.
Plans and issuers will display these data files in a standardized format and will provide monthly updates. This data will provide opportunities for detailed research studies, data analysis, and offer third party developers and innovators the ability to create private sector solutions to help drive additional price comparison and consumerism in the health care market. These files are required to be made public for plan years that begin on or after January 1, 2022.

The final rule also provides some medical loss ratio relief to compliant health insurance issuers as explained in the fact sheet. Here is AHIP’s reaction to the final rule.

Also today HHS issued an interim final rule with a comment period that “extends the compliance dates and timeframes necessary to meet certain requirements related to information blocking and Conditions and Maintenance of Certification (CoC/MoC) requirements. Released to the public on March 9, 2020, ONC’s Cures Act Final Rule established exceptions to the 21st Century Cures Act’s information blocking provision and adopted new health information technology (health IT) certification requirements to enhance patients’ smartphone access to their health information at no cost through the use of application programming interfaces (APIs).” The rule had been scheduled to take effect beginning next week.

Fierce Healthcare reports that “Regeneron’s anti-SARS-CoV-2 antibody cocktail has significantly reduced medical visits in ambulatory COVID-19 patients. The phase 2/3 clinical trial linked REGN-COV2 to a 57% decline in medical visits associated with COVID-19 in the 29 days after treatment.”

HealthPartners, a Minneapolis health insurer that participates in the FEHBP, offers a helpful, complete explanation of the benefits of wearing masks to prevent COVID-19. “At its core, wearing a mask is an act of kindness and neighborliness. It’s one of the simplest good deeds you can do these days, and a great way to be a force of positivity for the people in your life.”

Fierce Healthcare reports

The financial crisis for hospitals and physician practices caused by the COVID pandemic is a “clarion call” for the healthcare industry to move from a fee-for-service payment model to value, said Kevin Mahoney, chief executive officer of the University of Pennsylvania Health System (Penn Medicine).

“The hospital sector has taken a giant hit. We keep hearing about ‘the new normal.’ The lesson that we learned is that there is nothing new or normal about a pandemic, there’s just been an acceleration of trends,” Mahoney said during a recent virtual event hosted by the University of Pennsylvania. “It has laid bare how dependent hospitals are on commercially-insured, elective procedures, and without them, we don’t make money.”

The FEHBlog’s youngest son is a research coordinator for Penn Medicine. The FEHBlog seconds his boss’s sentiments.

The Surgeon General issued a timely

Call to Action to Control Hypertension (Call to Action) seeks to avert the negative health effects of hypertension by identifying evidence-based interventions that can be implemented, adapted, and expanded in diverse settings across the United States.

The Call to Action outlines three goals to improve hypertension control across the United States, and each goal is supported by strategies to achieve success:

Goal 1. Make hypertension control a national priority.
Goal 2. Ensure that the places where people live, learn, work, and play support hypertension control.
Goal 3. Optimize patient care for hypertension.

Following up on yesterday’s post about mandatory of coverage of COVID-19 vaccines with no member cost sharing once available, the FEHBlog wants to add that the same rule applies to Medicare. CMS “estimates the overall cost of providing the vaccine to every senior on Medicare would be around $2.6 billion, which would be covered by the federal government. CMS will also cover the vaccine for any uninsured individuals by using money from a $175 billion provider relief fund passed as part of the CARES Act.” It appears however that the vaccine would be administered through the Part D program. That would not be much help to FEHB plans as most FEHB members with primary Medicare coverage does not carry Medicare Part D.

Nextgov reports that

The Health and Human Services Department, the Cybersecurity and Infrastructure Security Agency and the FBI warn hospitals face an imminent threat from cybercriminals that encrypt and hold their data hostage—and some health care facilities are already dealing with the fallout.

The agencies collectively issued an advisory Wednesday detailing the tactics, techniques and procedures reportedly used against at least five hospitals already this week. The advisory includes recommendations for mitigating what observers are referring to as the most serious cyber threat the U.S. has seen to date, being perpetrated by an especially ruthless group of criminals.  

“CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers,” reads the advisory.

Friday Stats and More

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, SCOTUS–

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

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

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

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

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

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

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

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

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

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

Have a good weekend.

Midweek Update

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Telehealth, U.S. Healthcare–
Photo by Maria Teneva on Unsplash

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

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

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

In other good news Precision Vaccinations reports that

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

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

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

In other news —

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

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

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

Healthcare Dive lets us know that

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

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

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.

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.

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 20th through 37th weeks of this year (beginning May 14 and ending September 16; using Thursday as the first day of the week in order to facilitate this weekly update):

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

Because the FEHBlog does look at his charts which are intended to show trends, he realized that new deaths chart is flat because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (May 14 through September 16 (basically four months).

In other COVID-19 news:

  • The Wall Street Journal reports “

U.S. hospitals expect to be better prepared if a second wave of Covid-19 cases hits in coming months, doctors and administrators say, after gaining a better understanding how to triage patients, which drugs to use and what supplies are needed. When the new coronavirus first struck, beds filled up at record speed, ventilators were in short supply and proven treatments were scant. Since then, doctors say, they have developed a better understanding of who needs a ventilator and how quickly a patient can be discharged, and studies have pointed to a few drugs like the antiviral remdesivir and the steroid dexamethasone that can help

The FEHBlog heartily agrees that the country is better prepared but he believes that the Journal is assuming facts not in evidence when it speaks about a second wave because we really are still in the first wave.

  • Medscape offers an MD’s perspective on the leading COVID-19 vaccine candidates.
  • The Wall Street Journal reports that the Centers for Disease Control withdrew last month’s highly criticized advice that people who had contact with asymptomatic COVID-19 patients don’t need a COVID-19 test. “The Sept. 18 updated recommendation now says that close contacts of a person with a confirmed Covid-19 infection need a test even in the absence of symptoms. The changes were described as a clarification, rather than a revision, on the CDC website.”
  • Speaking of COVID-19 testing, Mercer Consulting offers advice on how to cover COVID-19 testing which Congress made unnecessarily complicated.

In other news,

  • Govexec.com reports that “House Democrats are preparing to vote [next week] on a six-week stopgap spending bill that would keep agencies open through Dec. 11, according to Democratic aide.” From reading the article, it looks like the continuing resolution which is not fully backed will be enacted thereby avoiding what would be the craziest government shutdown in American history.
  • Speaking of criticism, Fierce Healthcare reports that “the American Academy of Family Physicians, which represents about 135,000 physicians, said the recommendations miss the mark and skew toward virtual-only telehealth vendors and large medical systems with established telehealth infrastructure. The task force’s report doesn’t address the needs of independent practices that need guidance, support and payment advocacy, wrote Stephanie Quinn, AAFP senior vice president of advocacy, practice advancement and policy in a blog post Tuesday.” The most encouraging tele heath acceleration that the FEHBlog witnessed during the great hunker down is patients holding telehealth visits with their own doctors. That FEHBlog agrees with AAFP that this trend that should be strongly encouraged.
  • Healthcare Dive reports that “Privately insured patients pay 247% more at hospitals on average than Medicare patients for the same care, according to a new study by nonprofit think tank RAND. The study, based on 2018 data, shows the gap is increasing from 2017 and 2016, which saw disparities of 230% and 224%, respectively. If private payers had paid Medicare rates over the three-year study period, they would have saved $19.7 billion, RAND determined. The study could provide fodder for proponents of a government-run public option, a key tenet of Democratic presidential nominee Joe Biden’s healthcare agenda, which — like Medicare — would negotiate prices with hospitals and other providers.

Hey, Healthcare Dive, in contrast to health plans which do negotiate with healthcare providers Medicare imposes prices on providers. Government price fixing leads to disparities like this and it’s far from a good thing.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

The FEHBlog heard on a webinar today that the House of Representatives will be releasing their FY 2021 continuing resolution tomorrow. That resolution according to press reports will be acceptable to the Senate and the White House. The FEHBlog will keep an eye out.

In COVID-19 news

  • Fierce Pharma reports that “Moderna reached human testing for its COVID-19 vaccine candidate in record time, and now with its phase 3 trial moving right along, the company is expecting efficacy data in November—likely after Pfizer and BioNTech, but before everyone else.”
  • Fierce Healthcare reports that “CVS Health is planning to double the number of its drive-thru testing sites by mid-October, the healthcare giant announced on Thursday [September 17]. CVS intends to add more than 2,000 sites at its pharmacies in the next several weeks, bringing its total to more than 4,000 nationwide. The new locations will be opened in waves, beginning with 400 new sites opening on Friday. CVS currently offers testing in 33 states and the District of Columbia.”
  • Medscape reports that “Eli Lilly and Co said on Wednesday interim trial data showed its experimental monoclonal antibody treatment reduced the need for hospitalization and emergency room visits for patients with moderate COVID-19. The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. A Lilly spokeswoman said discussions with the U.S. Food and Drug Administration are expected to range from additional clinical trials to the possibility of an emergency use authorization.”

Progress. Also a Centers for Disease Control study has confirmed an earlier Wall Street Journal report that widespread flu immunization plus continued use of social measures to prevent the spread of COVID-19 , e.g., social distancing, mask wearing, etc, should lead to an easy flu season in the United States this winter.

In other news, Healthcare Dive provides health insurer CEO insights on 2021. “Though there’s significant uncertainty around the future of the insurance industry, many remarks can be summed up in a line from Cigna CEO David Cordani: ‘We feel bullish on 2021.’ And despite the major role of government in regulating healthcare, most officials seemed agnostic on the presidential election looming in less than two months.” That is certainly encouraging.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, HIPAA Privacy and Security Rules–
Photo by Patrick Fore on Unsplash

The Hill reports on the House leadership’s strategy for the COVID-19 relief bill.

Speaker Nancy Pelosi (D-Calif.) on Tuesday sought to heighten the pressure on Republicans to move a new round of coronavirus relief, announcing that the House will return to the Capitol next month to vote on another aid package if a bipartisan agreement is struck before the elections. * * *

House Majority Leader Steny Hoyer (D-Md.) acknowledged that most lawmakers will likely return to their districts when the scheduled session ends on Oct. 2, leaving party leaders seeking to hash out an agreement with the White House. If such a deal emerges, then members would be called back to Washington. In that sense, the dynamics would look very similar to those surrounding the long August recess, when the Capitol was virtually empty.

We must remember in this regard that the House can now vote virtually.

The House Problem Solvers Caucus which is truly bipartisan has offered its own COVID-19 relief proposal. The New York Times explains that

Lawmakers had acknowledged that the plan was unlikely to become law. But in unveiling it, the group sought to signal to Ms. Pelosi and the lead White House negotiators — Mark Meadows, the chief of staff, and Steven Mnuchin, the Treasury secretary — that there was ample common ground to be found in talks that have been dormant for weeks.

Health Payer Intelligencer reports that UnitedHealthcare has teamed up with Canopy Health to offer a concierge style health plan known as the California Doctors Plan to San Francisco area employers. “The payer projects that members will save up to 25 percent compared to other health plan premiums. Also, plan members will have no copay for primary care services and urgent care.” The FEHBlog enjoys reading about creative plan designs.

The HHS Agency for Healthcare Research and Quality has announced today that

the National Steering Committee for Patient Safety released Safer Together: A National Action Plan To Advance Patient Safety, which is the result of 2 years of work by 27 steering committee members who represent a diverse group of organizations and individuals, including healthcare systems, Federal agencies, provider associations, accrediting organizations, and patient advocates. Our goal was to provide healthcare system leaders with renewed momentum and clearer direction for reducing medical harm. Especially relevant during the COVID-19 pandemic, this national action plan and a companion implementation resource guide provide the latest implementation tactics, tools, and resources in a format that’s ready for immediate implementation. These important new resources are built on four foundational areas: culture, leadership, and governance; patient and family engagement; workforce safety; and learning systems.

This worthy initiative is certainly worth a gander.

In COVID-19 news

  • The National Institutes of Health have determined that substance use disorders (SUD) are linked to COVID-19 susceptibility.

By analyzing the non-identifiable electronic health records (EHR) of millions of patients in the United States, the team of investigators revealed that while individuals with an SUD constituted 10.3% of the total study population, they represented 15.6% of the COVID-19 cases. The analysis revealed that those with a recent SUD diagnosis on record were more likely than those without to develop COVID-19, an effect that was strongest for opioid use disorder, followed by tobacco use disorder. Individuals with an SUD diagnosis were also more likely to experience worse COVID-19 outcomes (hospitalization, death), than people without an SUD.

The Centers for Disease Control and Prevention (CDC) and the EU’s Joint Research Centre (JRC) will begin working with Siemens Healthineers to help standardize international antibody tests for COVID-19. This will include defining the proper concentrations of antibodies in the bloodstream—mapped to the novel coronavirus’s specific proteins—that could one day be used to establish the clinical threshold for a test to correctly determine whether a person is immune to the disease.

Finally, HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules announced four settlements with different healthcare provider organizations over allegations of their non-compliance with HIPAA Privacy Rule requirements to give individuals access to their own health records.

“Patients can’t take charge of their health care decisions, without timely access to their own medical information,” said OCR Director Roger Severino. “Today’s announcement is about empowering patients and holding health care providers accountable for failing to take their HIPAA obligations seriously enough,” Severino added.

How true.

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, OPM, Telehealth–
OPM Director Nominee John Gibbs (Senate video / Federal Times)

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for OPM Director nominee John Gibbs this afternoon. Here’s are links to Mr. Gibbs’ testimony and a Federal News Network article on the hearing. The Committee will vote on whether to advance Mr. Gibbs’ nomination to the full Senate at a business meeting scheduled for next Wednesday October 16.

The Senate Health Education Labor and Pensions Committee heard testimony today from the NIH Director Dr. Francis Collins and the U.S. Surgeon General Vice Admiral Jerome Adams on the topic of vaccines. U.S. News and World Report highlights an important segment of Dr. Collins’s appearance before the Committee.

AstraZeneca announced on Tuesday that its late-stage [COVID-19] vaccine study was being put on hold due to a “potentially unexplained illness” in one of the participants.

“With an abundance of caution at a time like this, you put a clinical hold, you investigate carefully to see if anybody else who received that vaccine, or any other vaccines, might have had a similar finding of a spinal cord problem,” Collins said.

Those who are concerned about the safety of the approval process should be reassured by the development, Collins said. “If it turns out that that is a real consequence of this vaccine and can be shown to be cause and effect then all the doses that are currently being manufactured for that will be thrown away because we do not want to issue something that is not safe,” Collins said. He added that the U.S. is investing in six vaccine candidates “because of the expectation that they won’t all work, although it would be lovely if they did.”

AstraZeneca was one of the nine drugmakers to pledge on Tuesday to uphold standards for science and safety in their pursuit of a coronavirus vaccine.

Healthcare Finance reports on America’s Health Insurance Plan comments on how health insurers can aid the COVID-19 vaccine distribution process. For example,

Insurers can use their member data to help identify which people meet the criteria to be eligible for the vaccine, according to the best available evidence. Outreach efforts must adhere to patient privacy requirements, AHIP said.

Insurers can coordinate across partners such as public health officials for data sharing regarding their members’ vaccine status, encouraging data to be shared with state or regional databases (Immunization Information Systems).

“Health insurance providers play an important role ensuring that people receive the vaccines that are recommended for them, and have experience conducting outreach to their members to inform them of the vaccines that are recommended for them and how they can get them,” AHIP said. This may include reminders to ensure they receive multiple doses of a vaccine when needed.”

The Health Affairs Blog experts offer five recommendations on how to better integrate telehealth with primary care.

RecommendationsRepresentative Open-Text Survey Responses
Harmonize the reimbursement criteria “Some insurance companies are paying less than in-person visits for telehealth visits from Day 1. Small practices, like usual, have been left to themselves for the most part.”“Primary care is extremely challenging with the constant change in protocols, the uncertainty and enormously confusing insurance schemes.”
Create billing codes or payment models for the additional work required to offer telehealth “Insurance companies not reimbursing telephone visits at a rate that supports the level of work done on a telephone visit.”“Elderly patients have no access or are unable to access virtual – more work, have to teach them how to take BP, some hard of hearing, etc.”“I am more stressed out doing telehealth, as we spend time to fix internet, video, and voice. There are calling issues, so it’s more time consuming.”
Provide coverage for at-home monitoring devices “I need blood pressure cuffs and glucometers covered by insurance for home monitoring.” “I will do tele health… provided patients have equipment.”“Patients lack thermometers, blood pressure cuffs, and pulse oximeters.”
Incentivize the development of and access to, patient- and provider-centered telehealth technology “Telehealth information technology platform is NOT user friendly.”“Difficult to properly diagnose with telehealth. Have been using photos from patients to supplement but still not really sufficient.”“Our patients are low-income with language barriers. Requiring third party interpreter by speaker phone takes extra time and reduces quality of care.”
Review, revise, and communicate telehealth malpractice policies  “I am not going to practice telehealth; it is not reliable and may increase malpractice cases.”“I’m very concerned about being sued for managing the patients over telehealth especially since many are requesting opioids.”“Malpractice premiums are a major barrier for telehealth.”

Source: Authors’ analyses of data from surveys administered to primary care providers in New York City from April to July 2020.

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth–

The U.S. Office of Personnel Management released its first of four Benefit Administration letters for the upcoming Federal Benefits Open Season which which will run from Monday, November 9, 2020 through Monday, December 14, 2020. Here are links to the BAL, a sample email to employees and a Venn diagram displaying the interlocking aspects of the health, dental, vision, and flexible benefits programs that participate in this Open Season. The FEHBlog expects that COVID-19 public health emergency will tamp down the traditional Open Season health fairs. It will be an interesting experiment to see whether this change impacts the volume of plan changes one way or the other.

In anticipation of FDA approval of COVID-19 vaccine(s), an expert panel formed by the National Academies of Science has issued for public comment draft recommendations for staging an equitable distribution of the vaccines according to a STAT News report. A public hearing on the draft recommendations is scheduled for tomorrow. This report then goes to the Centers for Disease Control which has an Advisory Committee on Immunization Practices. The staging offered in the recommendations makes sense to the FEHBlog, e.g., first responders first etc.

The Wall Street Journal reports that Americans should add strong ventiliation to the Covid-19 prevention toolbox along with mask, social distancing, etc.

After urging steps like handwashing, masking and social distancing, researchers say proper ventilation indoors should join the list of necessary measures. Health scientists and mechanical engineers have started issuing recommendations to schools and businesses that wish to reopen for how often indoor air needs to be replaced, as well as guidelines for the fans, filters and other equipment needed to meet the goals.

There’s a recently renovated office building near the FEHBlog’s offices in downtown DC that has a big outside sign stating that its ventilation services are tops and known to be anti-COVID. The FEHBlog will retry to remember to post a picture of the sign later this week.

Becker’s Health IT discusses a Centers for Medicare and Medicaid Services proposed rule issued yesterday. “The Medicare Coverage of Innovative Technology proposed rule would speed up the FDA approval process for Medicare coverage of new medical technologies. * * * Often referred to as the “valley of death,” for innovative medical tech products, the lag time between the FDA’s approval and Medicare establishing coverage prevents seniors from accessing these new technologies during the coverage determination process.” Ouch.

Speaking of innovation, Econtalk podcast host and economist Russ Roberts speaks this week with author Matt Ridley about his fascinating book titled “How Innovation Works.” Check it out.

In other news

  • EHR Intelligence reports “Following vote in the House of Representatives to remove the bill prohibiting the use of federal funds for the adoption of a national patient identifier (NPI), the Premier Healthcare Alliance and the Patient ID Coalition call on the US Senate to also lift the ban.” Good luck.
  • FYI, here’s a link to Treasury Secretary’s Steven Mnuchin’s testimony before the COVID-19 subcommittee of the House Oversight and Reform Committee. The federal employee press does not suggest that fireworks exploded at the hearing.
  • The Department of Health and Human Services announced today that “The Federal Communications Commission (FCC), HHS, and U.S. Department of Agriculture (USDA) today announced that they have signed a Memorandum of Understanding to work together on the Rural Telehealth Initiative, a joint effort to collaborate and share information to address health disparities, resolve service provider challenges, and promote broadband services and technology to rural areas in America.” Perhaps another silver lining in the COVID-19 cloud.
  • And then another. The HHS Agency for Healthcare Research and Quality explains that

There is evidence that people who receive longer-term treatment with medications for addiction treatment (MAT) have better outcomes. But, keeping people with OUD on MAT is challenging. Now, the COVID-19 pandemic may be making retention of patients in MAT even more difficult.

Fortunately, we can report some good news that should help us fight the opioids epidemic even as we try to maintain safe distance. It appears that people with OUD will stay in treatment when given support remotely as they do in person—a major benefit that appears to be emerging during the COVID pandemic.