Tuesday’s Tidbits

CDC

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare informs us

House Rep. Lloyd Doggett, D-Texas, introduced the Assuring Medicare’s Promise Act on Monday aimed at redirecting income tax revenue as a solution to Medicare’s hospital fund that will run out of money in 2028. * * *

The legislation aims to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. * * *

If the bill is implemented, Doggett expects Medicare Trust Fund solvency to be extended through 2040.

The legislation comes as Congress is taking a sharper eye at ways to shore up Medicare’s finances. The Senate, for instance, is eyeing closing similar loopholes for NIIT and would extend Medicare solvency for another three years, according to a CNN report.

Senate Democrats are working on a deal to give Medicare the power to negotiate lower drug prices, and the tax provisions could be included. 

From the Omicron and siblings front, we have mixed bag Covid news from the Wall Street Journal.

Covid-19 is circulating widely as the BA.5 Omicron subvariant elevates the risk of reinfections and rising case counts, spoiling chances for a summer reprieve from the pandemic across much of the U.S.

Covid-19 levels are high in a fifth of U.S. counties, according to the Centers for Disease Control and Prevention’s metric based on case and hospital data, a share that has been mostly rising since mid-April. BA.5 is estimated to represent nearly two in three recent U.S. cases that are averaging just more than 100,000 a day, CDC data show. The true number of infections may be roughly six times as high, some virus experts said, in part because so many people are using at-home tests that state health departments largely don’t track.  * * *

The pace of hospital admissions for Covid-19-positive patients has recently sped up, federal data indicate. The seven-day moving average for confirmed Covid-19 patients in hospitals has topped 34,000, federal data show, up from a low near 10,000 in April but far below January’s record peak topping 150,000.

Many of the hospitalizations are cases where patients test positive after being admitted for other reasons. Deaths are hovering around 300 to 350 a day, Dr. Jha said Tuesday. This is much closer to historic lows than highs, though he called the current level unacceptable.

The reduced threat is one reason a pandemic-fatigued populace is less likely to change behavior when cases are high, said Robert Wachter, chairman of the department of medicine at the University of California, San Francisco. * * * “Part of what motivated people to be super careful for a long time was the fear that I’m going to die of this thing,” Dr. Wachter said. “I think people have less fear of that, and that’s not inappropriate.”

From the U.S. healthcare business front

  • MedPage Today identifies the heavy hitters in Healthcare who topped the recently announced Fortune 500.
  • Insurance News Net reports that “Commercial health insurers suffered a 90% decrease in underwriting income last year as fewer people signed onto group health and instead moved into individual coverage on an exchange or a Medicaid program, and COVID care requirements far exceeded expectations. * * * Large, diversified carriers fared best, according to Antonietta Iachetta, AM Best senior financial analyst. “Smaller carriers with concentrations in the commercial business found themselves in an especially difficult position — more than half of insurers with capital and surplus under $50 million posted underwriting losses in 2021, the highest share of companies with losses for that group since 2012,” Iachetta said.”
  • Beckers Payer Issues reviews the history of Mark Cuban’s PBM Cost Plus Drug Co. to identity barriers to competing in that market.
  • Fierce Healthcare tells us, “Optum has quietly teamed with Red Ventures on a new joint venture focused on consumer health. The venture, called RVO Health, covers a mix of assets from both parties, including Optum’s Store and Perks and Red Ventures’ Healthline Media and Healthgrades. Virtual coaching platforms Real Appeal, Wellness Coaching and QuitForLife, news first reported by Axios. Through these elements, RVO includes a slew of consumer offerings, including doctor ratings through Healthgrades, medical information and communications from Healthline, Optum Perks’ prescription savings card and home delivery of health and wellness products through Optum Store.”

From the U.S. healthcare front

The American Hospital Association reports

After declining in recent years, antimicrobial-resistant infections starting during hospitalization grew 15% from 2019 to 2020, the Centers for Disease Control and Prevention reported today, based on limited data for 2020.

“During the pandemic, hospitals experienced personal protective equipment supply challenges, staffing shortages, and longer patient stays,” the agency notes. “Hospitals also treated sicker patients who required more frequent and longer use of medical devices like catheters and ventilators. The impact of the pandemic likely resulted in an increase of healthcare-associated, antimicrobial-resistant infections.”

More than 90% of U.S. hospitals in 2020 had an antibiotic stewardship program aligned with CDC’s Core Elements of Hospital Antibiotic Stewardship, CDC said. The AHA released an antibiotic stewardship toolkit in 2014 to help hospitals and health systems enhance their antimicrobial stewardship programs based on the CDC’s core elements, and in 2017 partnered with CDC on guidance to help small and critical access hospitals implement programs to improve antibiotic prescribing and use and reduce the threat of antibiotic-resistant infections. For more AHA resources to promote the appropriate use of medical resources, click here.

The CDC’s July 2022 Diabetes Insider called attention to its Diabetes and Your Skin website.

From the mental healthcare front, an expert contributor to HR Morning expresses his views on what employees want in mental health coverage from their employer-sponsored health plans.

From the artificial intelligence front, the Journal of AHIMA looks at the administrative cost savings potential of artificial intelligence.

Friday Stats and More

David Ermer–CDC, COVID-19, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week are the FEHBlog’s weekly charts of new Covid cases for 2022:

The CDC’s Weekly Review of its Covid Statistics observes “As of July 6, 2022, the current 7-day moving average of daily new cases (106,549) decreased 3.9% compared with the previous 7-day moving average (110,875).”

Here is the CDC’s weekly chart of new Covid hospital admissions

The CDC’s Weekly Review comments “The current 7-day daily average for June 29–July 5, 2022, was 5,080. This is a 3.1% increase from the prior 7-day average (4,930) from June 22–28, 2022.”

Here is the FEHBlog’s weekly chart of new Covid deaths for 2022

The CDC’s Weekly review observes “The current 7-day moving average of new deaths (273) has decreased 20.9% compared with the previous 7-day moving average (345).”

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in the 51st week of 2020 through the 27th week of 2022.

The CDC’s weekly review explains

Overall, about 260.3 million people, or 78.4% of the total U.S. population, have received at least one dose of vaccine. About 222.5 million people, or 67.0% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 106.6 million people have received a booster dose,** but 50.1% of the total booster-eligible population has not yet received a booster dose.

The American Hospital Association adds

The Food and Drug Administration today granted full approval of Pfizer’s COVID-19 vaccine for young teens, covering the age group spanning 12 to 15 years old. FDA said the vaccine, which has been administered in two-dose regimens to nearly 9 million Americans, earned full approval following its “rigorous analysis and evaluation of the safety and effectiveness data.” The approval does not apply to booster doses for that age group.

The CDC’s Weekly Review also provides the following Communities news:

As of July 7, 2022, there are 666 (20.7%) counties, districts, or territories with a high COVID-19 Community Level, 1,218 (37.8%) counties with a medium Community Level, and 1,331 (41.3%) counties with a low Community Level. Compared to last week, this represents an increase (+1.3 percentage points) in the number of high-level counties, an increase (+2.4 percentage points) in the number of medium-level counties, and a corresponding decrease (−3.7 percentage points) in the number of low-level counties. 49 out of 52 jurisdictions* had high- or medium-level counties this week. Rhode Island, New Hampshire, and Washington, D.C., are the only jurisdictions to have all counties at low Community Levels.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

From the Medicare front, Becker’s Hospital Review points out seven things to know about the CMS 2023 Medicare Part B physician payment rule issued yesterday. The lead item has grabbed the medical community’s attention.

The proposed physician fee schedule conversion factor for 2023 is $33.08, down from $34.61 in 2022. The proposal considers a statutory requirement that the conversion factor for 2023 remain flat as well, due to the expiration of the 3 percent increase in physician fee schedule reimbursement payments in 2022 that was required in the Protecting Medicare and American Farmers From Sequester Cuts Act.

For FEHB patients with primary Medicare Part B coverage, this reduction will amount to a cost shift from Medicare to FEHB if implemented by the final rule.

From the No Surprises Act front, Morning Consult offers the results of a survey finding that

One in 5 U.S. adults say they have received an unexpected medical bill this year, according to a new Morning Consult survey that underscores the prevalence of sticker shock in health care — even after federal efforts to combat it.”

The Morning Consult’s survey needs to be taken with a grain of salt because 22% of the surveyed adults are Medicare age (see Survey, p. 131), and the No Surprises Act does not apply to Medicare.

From the Rx coverage front, the PBM’s lobby PCMA compliments the Biden Administration for

taking real action to reduce prescription drug costs. Drug manufacturer pricing strategies that include patent thickets on certain brand drugs unfairly protect those drugs and biologics from generic and biosimilar competition.

The United States Patent and Trademark Office’s and the Food and Drug Administration’s enhanced review power for applications for drug patents that simply don’t deserve an intellectual property extension is a positive step toward eliminating patent thickets and bringing more competition to the marketplace.

That is thoughtful action by the PTO and FDA.

From the Dobbs front, the White House outlines an executive order the President plans to sign in response to the Supreme Court decision.

From the mental health front, Health Payer Intelligence discusses an initiative by “CVS Health and its payer arm, Aetna, [to]  expand its existing program with Psych Hub, advancing its efforts around adolescent suicide prevention.” Bravo.

From the artificial intelligence front, the Wall Street Journal reports “Using advanced analytics and AI, health insurers are building targeted medical advice for customers. Now comes the hard part: Getting them to respond. ‘There’s an art to that data communication,’ one doctor says.” Fascinating read.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Medicare, Rx coverage, U.S. Healthcare–

Happy National Postal Workers Day!

Using the CDC’s Covid Data Tracker and Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 26th week of 2022:

The CDC did not produce its weekly review of Covid statistics today as it’s the beginning of the July 4th holiday weekend. The CDC’s daily averages of new cases, new deaths and new hospitalization for the past week has been 109,944 cases, 316 deaths and 4,947 hospitalizations.

Beckers Hospital Review informs us

Temporary loss of smell emerged as a common indicator of COVID-19 early in the pandemic. Research into the cause and treatment of the condition, known as anosmia, is ongoing, though recent studies have brought us one step closer to answers. 

Two latest findings on COVID-19-related anosmia:

1. Loss of smell and taste is becoming less common as the virus evolves, according to researchers.

2. Smell and taste hasn’t fully returned for many people who contracted COVID-19 early in the pandemic, research shows. 

In retrospect, the FEHBlog is pleased that he continued theses charts from the last six months of 2021 into the first half of 2022 because doing so captured the three important surges. Now the FEHBlog has to decide what to do next Friday as the charts present a years worth of data.

Here is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (the 51st week of 2020) through this week, the 26th week of 2022.

It’s worth adding that the CDC is currenly providing weekly, not daily, vaccination stats. The CDC is now offering on a colorful, adjustable chart on “Primary Series Completion, Booster Dose Eligibility, and Booster Dose Receipt by Age, United States.

Medscape adds

COVID-19 vaccines protected against severe disease and death in people with overweight or obesity, a large English study found.

Compared with the unvaccinated, vaccinated individuals in each BMI group experienced significantly lower likelihood of COVID-related hospitalization starting at 2 weeks from their second dose, reported Carmen Piernas, PhD, of the University of Oxford, and colleagues:

* Underweight: OR 0.51 (95% CI 0.41-0.63)

* Normal weight: OR 0.34 (95% CI 0.32-0.36)

* Overweight: OR 0.32 (95% CI 0.30-0.34)

* Obesity: OR 0.32 (95% CI 0.30-0.34)

In other vaccine news, Medscape reports

A new study provides more evidence that influenza vaccination may help protect older adults against Alzheimer’s disease (AD).

In a large propensity-matched cohort of older adults, those who had received at least one influenza inoculation were 40% less likely than unvaccinated peers to develop AD over the course of 4 years.

“Influenza infection can cause serious health complications, particularly in adults 65 and older. Our study’s findings ― that vaccination against the flu virus may also reduce the risk of Alzheimer’s dementia for at least a few years ― adds to the already compelling reasons get the flu vaccine annually,” Avram Bukhbinder, MD, with McGovern Medical School at the UTHealth, Houston, Texas, told Medscape Medical News.

Sign me up.

Also from the public health front, Medscape tells us

About 80% of US adults have low to moderate cardiovascular (CV) health based on the American Heart Association (AHA) checklist for optimal heart health, which now includes healthy sleep as an essential component for heart health. With the addition of sleep, “Life’s Essential 8” replaces the AHA’s “Life’s Simple 7” checklist. * * *

The AHA Presidential Advisory — Life’s Essential 8: Updating and Enhancing the American Heart Association’s Construct on Cardiovascular Health — was published online June 29 in the journal Circulation.

A companion paper published simultaneously in Circulation reports the first study using Life’s Essential 8.

Overall, the results show that CV health of the US population is “suboptimal, and we see important differences across age and sociodemographic groups,” [Dr. Donald] Lloyd-Jones [chair of the department of preventive medicine at Northwestern University’s Feinberg School of Medicine in Chicago] said.

Medpage offers a detailed Q&A on monkeypox. Among them

Could monkeypox be spread easily from person to person, similar to COVID-19? 

“Monkeypox is certainly not COVID-19,” stressed [Capt. Agam] Rao [, MD, a medical officer at the U.S. Public Health Service at the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)]. Based on prior outbreaks and the current outbreak, monkeypox appears to spread through “direct close contact. So, intimate contact that might happen during sex, but also any other close contact that might occur — for example, if you live with someone who has monkeypox and you are sleeping on the same bedding and using the same towels.”

“It really is not something that you will just pass on to someone walking down the street,” she said.

While agency researchers are “keeping an open mind” about the possibility that the virus could be more easily transmitted, “at this time, there’s no indication that it would spread the way that COVID spread and spread to as many people, [and] at this time, the risk for the worldwide population … is low,” she added.

From the prior authorization front, Healthcare Dive reports

Aetna is no longer requiring prior authorization for cataract surgeries, a controversial policy the payer adopted a year ago, according to a new provider notice.

Aetna is also rolling back prior authorization requirements for video EEGs and home infusion for some drugs. It’s adding two new-to-market drugs to the precertification list.

The payer said in a statement that it came to its decision after analyzing real-time data from the year the requirement was in place. “Going forward, we will focus on retrospective reviews of procedures and providers where questions of medical necessity exist,” Aetna said.

From the Rx coverage front, Fierce Pharma offers an article on how payers are planning to avoid cost shocks associated with gene therapy.

Kelley Miller, senior director of managed markets for the specialty pharmacy Optum Frontier Therapies, said there are three major considerations for his team during coverage talks. One is the clinical landscape, while another is the “human” element of what the patients and their families are going through. Thirdly, the team looks at the “economic impact” of the treatment.

Once Miller’s team has that information, the “conversations should come fast and furious,” he said.

Despite the biopharma industry’s advances in gene therapies, ICER president Steven Pearson, M.D., M.Sc., said it’s still a “fairly dicey business proposition” for companies in this field, especially outside the U.S. He pointed to bluebird bio’s decision to pull beta thalassemia gene therapy Zynteglo from the European market last year.

From the U.S. healthcare front, Beckers Hospital Review reports

IBM Watson Health, in partnership with Fortune, has released its top 15 health systems, which they find set an example for health systems and hospitals across the nation. With its data, the report will continue to stand as a resource for these groups to improve their quality of care and efficiency. 

In its 14th year of publishing this study, IBM Watson Health found that the top 15 health systems had better survival rates, fewer patient complications, fewer healthcare-associated infections, better long-term outcomes, better 30-day mortality/revisitation rates and more. The study also found that patients revered the top 15 hospitals more than peer system hospitals. 

For 2022, Allina Health of Minneapolis, MN, sits on top of the large health systems division. Cone Health of Greensboro, NC, sits on top of the medium health systems division. Asante of Medford Oregon sits on top of the small health system division.

From the Medicare Advantage front, Health Payer Intelligence discusses AHIP’s statement on the Medicare Advantage program which places various attacks against the MA program in perspective.

In addition to defending prior authorizations and spotlighting certain facets of OIG reporting, AHIP also offered evidence for Medicare Advantage plans’ efficacy overall.

The health plans have been proven to excel on quality measures and on overall efficiency, surpassing original Medicare’s quality level. They also have to ascribe to certain network adequacy standards.

Medicare Advantage plans produce savings for the Medicare program and offer higher value for members and taxpayers. In particular, Medicare Advantage plans offer strong value to members who are lower-income and underserved.

Lastly, AHIP pointed out that these plans have bipartisan support.

Finally federal employee benefits consultant Tammy Flanagan follows the retirement process of a federal employee in a three-part article in Govexec.

Midweek update

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

From the Omicron and siblings front —

The Wall Street Journal reports

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

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

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

The American Hospital Administration informs us

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

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

Also, from the SDOH front, MedPage Today informs us

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

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

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

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

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

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

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

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

The American Hospital Association adds

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

From the Dobbs case front

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

In general, the guidance does two things:

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

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

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

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

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

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

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

Monday Roundup

David Ermer–CDC, Congress, COVID vaccine mandate, COVID-19, Medicare, OPM, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Federal News Network discusses the federal employee pay raise angles presented by the House financial service and general appropriations bill which cleared the House Appropriations Committee last Friday. Federal News Network indicates that the bill leaves the door open for the Senate to also accept the President’s proposed 2023 4.6% pay raise for federal employees and the military.

From the Dobbs case front, Govexec.com reports

President Joe Biden announced two actions immediately after the ruling: one directing the Department of Health and Human Services to safeguard access to contraception and medication abortion, and another protecting travel for medical appointments.

To those ends,

  • Govexec tells us that OPM today confirmed that its policy allowing federal employees to apply sick time to travel out of state remains in effect after the high court struck down Roe v. Wade, and
  • The Department of Health and Human Services (HHS) announced that a meeting was held today between Affordable Care Act regulators, including the HHS and Labor Department Secretaries, and health plan executives to emphasize the importance of full compliance with the ACA’s contraceptive coverage with no cost-sharing mandate when delivered in-network. The ACA regulators also issued a letter to health plans making the same point.

The FEHBlog ran across this NPR Shots article which explains that the Plan B or morning-after pill is considered a contraceptive and not an abortion drug. The Wall Street Journal informs us

Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.CVS Health Corp.,  Walmart Inc., and Rite Aid Corp. were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS and Rite Aid were limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.

From the Omicron and siblings and monkeypox front

  • Govexec reports on a U.S. Court of Appeals for the Fifth Circuit decision order rehearing a federal employee vaccine mandate case which upheld the mandate on lack of plaintiffs’ standing to challenge the mandate. The mandate nevertheless has remained on hold while the case winds it way through the appellate court.
  • USA Today reports on when and how to access the monkeypox vaccine.

From the Medicare front, HHS announced

a new model aimed at improving cancer care for Medicare patients and lowering health care costs. CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs.

From the reports and studies department —

  • The next issue of Health Affairs offers a bevy of articles on Type 2 diabetes and pre-diabetes which are available at this link.
  • The Congressional Budget Office has made available examples of the work performed by its Health Analysis Division.
  • HealthDay reports “More than 18 million Americans have now survived cancer, a new report shows. The American Cancer Society (ACS) and the U.S. National Cancer Institute collaborated on the report to estimate cancer prevalence and help public health officials better serve survivors.”
  • mHealth Intelligence calls our attention to a telehealth-oriented  Healthcare Experience Report: 2022 released by Zocdoc. The FEHBlog was pleased to read “Mental health continues to hold a place of dominance in telehealth. In May of 2020, 2021, and 2022, the percentage of mental health visits that occurred virtually was 74 percent, 85 percent, and 87 percent, respectively.” Hub and spoke telehealth, e.g, Teladoc, brings mental health care in-network thereby lowering benefit costs while improving access to care.

Weekend update

David Ermer–CDC, Congress, COVID-19, Electronic health records, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Capitol Hill —

The Senate is on a State work break for the next two weeks which encompasses Independence Day. The House of Representatives will be engaged in Committee business this week through Thursday. Then the House will be on District work break through the end of the following week.

The House Oversight and Reform Committee is holding a hearing tomorrow on an important topic: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.”

On Friday, the House Appropriations Committee approved

the fiscal year 2023 Financial Services and General Government bill on a 31 to 22 vote. * * *

The following amendments to the bill were adopted by the full Committee:

Rep. Quigley – The manager’s amendment makes technical and noncontroversial changes to the bill and report. The amendment was adopted by voice vote.

Rep. Stewart #3 – This amendment prohibits the government’s use of cloud computing platforms unless they prevent child exploitation images. The amendment was adopted by voice vote.

A summary of the bill is here. The text of the draft bill is here. The bill report, before the adoption of amendments in full Committee, is here. 

This bill includes FEHB and OPM funding.

It occurred to the FEHBlog over the weekend that on Friday he did not explain how the Supreme Court’s Dobbs decision overruling Roe v. Wade impacts the FEHB Program. The short answer in the FEHBlog’s opinion is that it has no impact.

Under the Hyde Amendment whose requirements have been applied to the FEHB via annual appropriations bills for decades, FEHB Program coverage of abortions is limited to abortions in cases of rape, incest, or endangerment of the mother’s life. Federal courts of appeals uniformly have held that the Hyde Amendment preempts more restrictive State abortion limitations. E.g., Planned Parenthood Affiliates v. Engler, 73 F.3d 654 (6th Cir. 1996) (citing precedential authorities).

From the Omicron and siblings front —

Nature reports

The BA.4 and BA.5 subvariants are spiking globally because they can spread faster than other circulating variants — mostly BA.2, which caused a surge in cases at the beginning of the year. But so far, the latest Omicron variants seem to be causing fewer deaths and hospitalizations than their older cousins — a sign that growing population immunity is tempering the immediate consequences of COVID-19 surges.

Nature explores what the rise of BA.4 and BA.5 means for the pandemic.

The FEHB agrees that the complete Nature article is worth reading.

The Wall Street Journal informs us

Pfizer Inc. and BioNTech SE vaccines modified to target the Omicron variant produced a significantly larger immune response than the companies’ currently available vaccine in a study, they said.

A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. * * *

The results, coming after Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggest possible benefit to modifying the shots to improve protection against an evolving virus.

The Journal adds that the Food and Drug Administration is considering whether to give emergency use authorization to the Omicron-oriented boosters for fall 2022. Based on the Nature article, it appears that Omicron will still be with us then.

Fortune identifies seven things doctors who treat long Covid want people to know.

From the Monkeypox front, Bloomberg Prognosis tells us

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern.

The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak.

“What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.”

NPR Shots expresses concern that U.S. testing program for this disease is inadequate.

For many of the [201] confirmed cases, health officials don’t know how the person caught the virus. Those infected haven’t traveled or come into contact with another infected person. That means the virus is spreading in some communities and cities, cryptically. 

“The fact that we can’t reconstruct the transmission chain means that we are likely missing a lot of links in that chain,” Jennifer Nuzzo, an epidemiologist at Brown University, says. “And that means that those infected people haven’t had the opportunity to receive medicines to help them recover faster and not develop severe symptoms. 

“But it also means that they’re possibly spreading the virus without knowledge of the fact that they’re infected,” she adds.

In other words: “We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University. “

NPR explains that the monkeypox testing process is much too cumbersome and the CDC hopes to have the process streamlined “sometime in July.”

Meanwhile, Precision Vaccines reports

New influenza vaccine effectiveness data presented at the U.S. CDC’s June 22, 2022 meeting of the Advisory Committee on Immunization Practices (ACIP) show flu shots worked better during 2021 – 2022 than initially reported.

Published on June 23, 2022, this ACIP data shows flu shots reduced the risk of influenza illness by about 35% among vaccinated people.

Data from October 4, 2021, through April 30, 2022, showed that flu vaccines reduced people’s risk of mild to moderate flu illness caused by H3N2 flu viruses—the most common flu viruses this season—by about one-third overall. * * *

Also, at the meeting, ACIP voted in favor of a preferential recommendation for certain flu vaccines over others for adults 65 years and older in the United States. 

The ACIP voted to preferentially recommend higher-dose flu vaccines (Fluzone High-Dose vaccine and Flublok recombinant vaccine) or adjuvanted flu vaccine (Fluad vaccine) over standard-dose unadjuvanted flu vaccines.

And if one of these vaccines is unavailable at the time of administration, people in this age group should get a standard-dose flu vaccine instead. 

From the health information technology front, Health Data Management calls out attention to the following

  • “In a [very sensible] letter to Department of Health and Human Services Secretary Xavier Becerra, several healthcare standards organizations are calling for streamlining and making more predictable the process for submitting attachments as well as modernizing existing rules to improve patient care and reduce burdens on clinicians.”
  • “New legal requirements for providers to give an estimated cost of patients’ medical services will be difficult to meet, particularly when multiple organizations are involved in a patient’s care, according to WEDI, the Workgroup on Electronic Data Interchange. Meeting the requirements of the No Surprises Act, which was included as part of a Consolidated Appropriations Act passed late in 2020, will be challenging because there is no standardized process to enable the exchange of cost information among facilities, WEDI notes.”
  • “While healthcare organizations see the prevailing trend of increasing patient consumerism, the ability to give patients opportunities to schedule their own appointments is lagging. Many organizations have adopted some capabilities for self-scheduling, according to new research from the Center for Connected Medicine (CCM), yet the use of these tools remains low [because] scheduling solutions lack the right algorithms and that organizations lack standardized scheduling templates across appointment types.”

In particular the second bullet strikes a chord with the FEHBlog as he has pointed out that Congress made a huge mistake by failing add the provider’s good faith estimate and the health plan’s advance explanation of benefits to the list of HIPAA standard transactions.

Happy First Day of Summer 2022

David Ermer–AHRQ, CDC, Congress, COVID-19, Electronic health records, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here. 

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Holiday Monday Roundup

David Ermer–CDC, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

Happy Juneteenth (observed)! Here are a few items that came to the FEHBlog’s attention today

From the Omicron and siblings front —

The New York Times informs us that “Despite Another Covid Surge, Deaths Stay Near Lows. Most Americans now carry some immune protection, experts said, whether from vaccines, infection or both.” Amen to that.

While the Food and Drug Administration has given emergency use authorization to Moderna’s vaccine for ages 6 to 17, the Centers for Disease Control has not yet ratified that decision so Pfizer’s vaccine remains the only vaccine available to that age group for now.

From the unusual viruses front, STAT News reports

When previously healthy little kids started showing up in hospitals with failing livers last fall and this spring, startled doctors and public health authorities didn’t know what was behind what they were seeing. They also didn’t know if what they were seeing was new. * * *

Now scientists at the Centers for Disease Control and Prevention have come up with some estimates for the normal rate of this condition, at least in the United States. Their findings, published earlier this week in the online journal Morbidity and Mortality Weekly Report, may come as a surprise.

Their research suggests there has not been an increase in cases of pediatric hepatitis of unknown origin, at least in the United States. Nor has there been a rise in the number of pediatric liver transplants, which a portion of these children have needed. Likewise, the rate of detections of infections caused by adenovirus 41 — a stomach bug virus that has been implicated as a potential trigger of these hepatitis cases — has not changed over time, the CDC scientists reported. * * *

With rates unchanged since before the Covid-19 pandemic, a theory espoused by scientists from Israel — that this is some sort of post-Covid condition — becomes harder to argue.

“It doesn’t mean that Covid still can’t have some collateral role with all of this. But I think these kind of data helps support that that’s probably not the cause,” explained veteran epidemiologist Michael Osterholm, who was not involved in the CDC work.

That’s encouraging news.

The Society for Human Resource Management tells us about its 2022 Employee Benefits Survey.

“Employer rankings of the importance of benefits shifted drastically in 2020 as they made pandemic-inspired adjustments, but these rankings have returned to an order like that seen pre-pandemic as businesses regain a semblance of normal operations,” said Daniel Stunes, senior researcher at SHRM.

Significantly, however, “all benefit types were rated by employers as more important to offer today than before the COVID-19 pandemic,” Stunes said, reflecting an increased appreciation for the role benefits play in fostering employee well-being and in attracting and keeping talent in a tight labor market.

Friday Stats and More

David Ermer–CDC, COVID-19, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 24th week of 2022:

While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.

Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:

New cases and deaths are both stable. MedPage Today adds

About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.

Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.

For more information, Science discusses clues to long Covid.

Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.

Over 100,000 people aged 12 and older have received at least one booster.

The Wall Street Journal adds.

Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *

The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.

The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.

The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.

From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports

Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.

From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.

From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.

From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.

From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.

Monday Roundup

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

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

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

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

What’s more, according to the Journal

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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