Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, No Surprises Act, Telehealth–

From Capitol Hill, Healthcare Dive reports

A group of 375 organizations sent a letter to the Senate on Tuesday urging lawmakers to act to pass legislation extending COVID-19-era telehealth flexibilities for another two years.

The letter was led by health IT and telehealth lobbies, but also joined by a number of health systems including Ascension and Cleveland Clinic, physician groups including the American Medical Association, tech companies including Amazon and Google and large employers including Walmart.

Without action, the policies — which threw open the doors to telehealth and led to skyrocketing utilization in the early days of the pandemic — will expire 151 days after the end of the COVID-19 public health emergency.

Health Payer Intelligence adds that according to a recently conducted survey on consumers enrolled in employer-sponsored health plans commissioned by AHIP:

First, most consumers across the political spectrum agreed that providers should not be permitted to charge unnecessary administrative fees and medical services mark-ups. Nearly eight out of ten respondents said that they supported this statement (78 percent), with three-quarters or more in each political party reporting this response.

Second, there was also strong bipartisan support for protections against hospital monopolies. Over three-quarters of consumers supported preventing hospitals from consolidation, mergers, and acquisitions that involved bringing other medical practices into one hospital system (76 percent). Consumers also indicated support for protections against site-based cost increases (75 percent).

Respondents wanted more transparency about healthcare deals. Slightly more than seven in ten consumers supported improving transparency around private-equity firms’ healthcare acquisitions.

Third, the researchers also found bipartisan alignment around telehealth. Slightly more than two-thirds of respondents agreed that the government should eliminate regulatory barriers to telehealth utilization (67 percent).

“Consumers value choice and flexibility in how they access health care. Telehealth proved to be an essential resource for consumers throughout the COVID-19 pandemic and should continue to play a role in the future of health care,” the survey stated.

To provide context, Beckers Hospital CFO Report informs us

HHS is set to extend the COVID-19 public health emergency [PHE] by its standing deadline of Oct. 13. 

HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days’ notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days’ notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.

If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023. * * *

For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.

In No Surprises Act news yesterday, the NSA regulators issued a request for information (RFI) from stakeholders and the general public. The RFI concerns the law’s requirement that health plans provide an advance explanation of benefits (AEOB) in response to a good faith estimate (GFE) of healthcare costs requested by the patient to their healthcare provider. The provider would submit the GFE request to the health plan. HIPAA governs many similar claims transactions involving providers and payers. Surprisingly, Congress did not add these claim transactions to HIPAA, which would have made perfect sense. The FEHBlog does not understand why the regulators have not asked Congress to take this necessary step. At first glance, the contemplated process strikes the FEHBlog as unnecessarily complicated if the object is to avoid patient surprises. Nevertheless, at least the regulators are seeking public input.

From the Omicron and siblings front, the National Institutes of Health announced

A research team funded by the National Institutes of Health has shown that commercially available rapid antigen tests can detect past and present variants of concern and has identified potential mutations that may impact test performance in the future. As new variants of the SARS-CoV-2 virus continue to emerge, concerns have been raised about the performance of rapid antigen tests.

The team, which was funded by NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, developed a method to evaluate how mutations to SARS-CoV-2 can affect recognition by antibodies used in rapid antigen tests. Since most rapid antigen tests detect the SARS-CoV-2 nucleocapsid protein, or N protein, the team directly measured how mutations to the N protein impacted diagnostic antibodies’ ability to recognize their target.

“Rapid antigen tests remain an important COVID-19 mitigation tool, and it is essential to ensure that these tests can detect the SARS-CoV-2 virus as it continues to evolve,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for the RADx Tech program at the NIH. “Considering the endless cycle of new variants, the data from this study will be useful for years to come.”

From the healthcare technology front, Fierce Healthcare informs us

[Cigna’s] Evernorth is expanding its digital health formulary yet again, adding five new solutions to the platform.

The formulary will now include Big Health’s Sleepio for insomnia and the tech company’s Daylight tool for anxiety. In addition, Evernorth said it will expand inclusion of Quit Genius’ tools to its platforms for alcohol use disorder and opioid use disorder.

Lastly, Evernorth will now include HealthBeacon’s Injectable Care Management System for inflammatory conditions, which is meant to assist patients in managing injectable medications. Glen Stettin, M.D., chief innovation officer at Evernorth, told Fierce Healthcare that all of the new tools fit key concerns for employers and plan sponsors, such as mental health and high-cost inflammatory conditions.

“Our clients care about areas where either lots of people need help and treatment or where they’re spending lots of money,” Stettin said.

From the federal employee benefits front, benefits expert Tammy Flanagan writing in Govexec discusses how federal employees should time their retirement.

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found. 

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
 
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found. 

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Monday Roundup

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare, Wellness–

From Capitol Hill, Govexec informs us that

Congress is looking to fund federal agencies at their current spending levels through mid-December, with momentum growing for a 10-week stopgap bill to avoid a government shutdown on Oct. 1. 

Lawmakers must clear several hurdles before voting on a continuing resolution to kick off fiscal 2023, but they could act as soon as this week. Senate Majority Leader Chuck Schumer, D-N.Y., said last week he would work with Republicans to “avoid even a hint of a shutdown,” though several disagreements remain. Negotiations appear to have settled on a CR that would fund agencies through approximately Dec. 16, but lawmakers have yet to determine exactly which provisions will be added to it. 

From the federal appointment front, STAT News reports

President Joe Biden on Monday appointed longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health.

Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized. The president officially launched the agency in March with $1 billion in initial funding allotted by Congress, but the search for its inaugural director has taken months.

Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.

Good luck, Dr. Wegryzn.

From the omicron and siblings front

The American Hospital Association tells us

Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal government continues to purchase and distribute them, the Centers for Medicare & Medicaid Services announced today.

The Centers for Disease Control and Prevention this month recommended Pfizer’s updated COVID-19 vaccine booster for Americans aged 12 and older and Moderna’s updated COVID-19 vaccine booster for Americans aged 18 and older at least two months after completing a primary COVID-19 vaccine series or booster. Authorized by the Food and Drug Administration, the updated boosters are bivalent, meaning they help protect against the most recently circulating omicron variants as well as the original virus strain.

Americans can find local sites administering the new COVID-19 vaccine booster here. For more on provider requirements and payment, visit the CDC COVID-19 Vaccination Program and CMS toolkit.

The Wall Street Journal reports

Illness caused by Covid-19 shrank the U.S. labor force by around 500,000 people, a hit that is likely to continue if the virus continues to sicken workers at current rates, according to a new study released Monday.

Millions of people left the labor force—the number of people working or looking for work—during the pandemic for various reasons, including retirement, lack of child care and fear of Covid. The total size of the labor force reached 164.7 million people in August, exceeding the February 2020 prepandemic level for the first time. The labor force would have 500,000 more members if not for the people sickened by Covid, according to the study’s authors, economists Gopi Shah Goda of Stanford University and Evan J. Soltas, at the Massachusetts Institute of Technology.

“If we stay where we are with Covid infection rates going forward, we expect that 500,000-person loss to persist until either exposure goes down or severity goes down,” said Mr. Soltas. That assumes that some of those previously sickened eventually return to work.

The authors “provide the most credible evidence to date about labor-market impacts for a large set of workers,” said Aaron Sojourner, an economist at the W.E. Upjohn Institute for Employment Research, who wasn’t involved in the study.

From the U.S. healthcare business front —

Healthcare Dive relates

Escalating costs for labor, drugs, supplies and equipment are adding to the long-term pressures facing rural hospitals, raising the risk of more closures that could jeopardize patient access to care, the American Hospital Association warned in a new report. 

Many hospitals were already in difficult financial positions before the COVID-19 pandemic began, due to challenges including low patient volume and reimbursement, geographic isolation, staffing shortages and aging infrastructure, the AHA said. From 2010 through 2021, 136 rural hospitals closed, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. In 2020, when the pandemic hit, a record 19 rural hospitals closed.

The public health emergency put additional pressure on margins and patient volumes. “While rural hospitals were partially buoyed by the Provider Relief Fund and other sources of COVID-19 assistance that limited closures in 2021, the financial outlook for many rural hospitals moving forward is precarious,” the AHA said.

Revcycle Intelligence reports

Private equity acquisition of physician practices in dermatology, gastroenterology, and ophthalmology was associated with increased healthcare spending and utilization, according to a study published in JAMA Health Forum. * * *

Following a private equity acquisition, physician practices saw consistent growth in spending during the next eight quarters. Acquired practices saw a mean increase of $71 in charges per claim or a 20.2 percent increase. In addition, practices saw an increase of $23 in the allowed amount per claim—an 11 percent increase.

Patient utilization of healthcare services grew as well after practices underwent acquisitions.

Across the eight post-acquisition quarters, the mean number of unique patients increased by 25.8 percent. This increase was mainly driven by more new patient visits, which rose by 37.9 percent. The number of encounters grew by 16.3 percent and the number of evaluation and management (E/M) visits increased by 37.1 percent.

The increase in patient visits may reflect changes in management and practice operations or overutilization of profitable services and low-value care, the study suggested. This could lead to higher healthcare spending without corresponding benefits.

Additionally, researchers said the growing number of visits was consistent with private equity firms’ common strategy to maximize revenue through a fee-for-service delivery system.

Ruh roh on both counts.

Healthcare Finance adds

Quality can go a long way in determining if a consumer is willing to pay more for their healthcare, as indicated by new survey responses published by revenue cycle company AKASA.

Out of more than 2,000 respondents, the survey found that 57% would pay more for a higher quality of care. Out of all categories in the survey, care quality was the only area in which a majority said they would be willing to pay more.

Forty-seven percent said they would pay more for the ability to work with the care team of their choice. Forty-one percent said they would pay more for the ability to work with hospitals of their choice, while the same percentage said they’d pony up more cash for better location proximity or convenience.

In public health news, the American Hospital Association celebrates the fact that

The United Network for Organ Sharing, which serves as the nation’s transplant system under contract with the federal government, Friday reported its millionth U.S. organ transplant. UNOS and the Organ Donation and Transplantation Alliance credited the organ donation and transplantation community, including transplant hospitals, with making the historic milestone possible. The first successful transplant took place at Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston in 1954.

UNOS and the Alliance encourage the transplant community to join Living It Forward, a national initiative to commemorate the achievement and accelerate the path forward to the next million transplants. They also encourage members of the public to register as organ donors, noting that each donor can save up to eight lives and help up to 75 people through tissue donation. Over 100,000 people remain on the transplant waitlist.

From the Rx coverage front, BioPharma Dive tells us that

The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.

Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotyktu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.

Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.

“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.

In wellness news, Healio informs us that

Widespread adoption of simple lifestyle changes, including switching to a well-known eating plan, could reduce risk for CV events and death for millions of adults with stage 1 hypertension, researchers reported.

“Millions of working-age people are walking around with elevated BP, which is symptomless but is also a leading preventable cause of disability and death,” Kendra D. Sims, PhD, MPH, a postdoctoral fellow at the University of California, San Francisco (UCSF) School of Medicine who presented the findings at the American Heart Association Hypertension Scientific Sessions, told Healio. “Our study found that 27,000 CVD events and 2,800 deaths could be prevented during the next 10 years if people with elevated BP follow through with recommended lifestyle changes. We would then save $1.6 billion in associated health care costs. The largest benefit comes from eating more fruits and vegetables and less salt, as outlined in the Dietary Approaches to Stop Hypertension (DASH) diet.

Weekend Update

David Ermer–Congress, COVID-19, Mental health care, SDOH–

The House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week.

From the Omicron and siblings front —

Bloomberg Prognosis offers an interesting observation from Katrine Wallace, an epidemiologist at the University of Illinois at Chicago,

“For some viruses, where there is better mucosal immunity in the nose (via past infection or vaccines), people can fight off pathogens and develop an immune response without ever feeling ‘sick.’” In other words, for certain infections, your immune system might get revved up by recognizing a virus, and then swiftly fight it off. 

“However, Covid-19 is not a virus that we have developed lasting mucosal immunity for, either through vaccines or via previous infections,” says Wallace.

This is the whole rationale for the development of the new Covid shots that are inhaled instead of injected, she says. The nose and mouth are where Covid first enters the body, so the vaccine antibodies elicited by those types of vaccines give people a more immediate line of defense. 

The Wall Street Journal provides details on nagging Covid death levels:

Roughly 85% of people who died from Covid-19 through mid-August this summer were 65 or older, a Wall Street Journal analysis of death-certificate data show. The rate is similar to 2020 peaks, before vaccines were available. Deaths trended younger for much of last year.

Covid-19 is on pace to be the third-leading cause of death for the third straight year, said Dr. Robert Anderson, chief of the mortality statistics branch at the CDC’s National Center for Health Statistics. Since 2020, it has trailed only heart disease and cancer, significantly reducing life expectancy. * * *

The health system AdventHealth counted 24 deaths related to Covid-19 at its Orlando, Fla.-area hospitals in August. Age was the biggest factor, although younger patients with compromised immune systems were also at risk, doctors with the health system said. All but one Covid-19 patient who died had serious health problems such as diabetes, chronic obstructive pulmonary disease, heart failure and obesity.

Unfortunately, the Journal’s article discusses vaccination status but does not factor in the Paxlovid pill or other available treatments, which should be a game changer for older folks with Covid.

From the mental healthcare front — ‘

Yesterday, September 10, was World Suicide Awareness Day. McKinsey and Company reported,

The suicide rate in the United States has risen over the past 20 years to become the second-leading cause of death for people between the ages of ten and 34, write partner Erica Hutchins Coe, senior partner Martin Dewhurst, senior partner Tom Latkovic, and co-authors in a recent report from the McKinsey Health Institute (MHI). And by winter of 2021, the weekly rate of ER visits by adolescents who attempted suicide was 39 percent higher than pre-pandemic levels. By taking action to address this urgent public health issue, organizations, educators, healthcare professionals, governments, and society at large could help millions in crisis. This #WorldSuicidePreventionDay, learn about ongoing efforts by MHI and its collaborators to improve crisis care in the United States * * * .

The article provides links to relevant McKinsey publications on this important topic.

The American Medical Association’s “What Doctors Wish Their Patients Knew” column delves into loneliness and health.

From the social determinants of health front, Fierce Healthcare looks into CVS’s Healths efforts to improve health equity.

When the CVS Caremark team geared up to take on health disparities, it quickly realized that any initiative would require a significant basis in data to succeed.

That entailed both gathering more data and building the tools necessary to track and analyze them.  For example, Joel Helle, vice president of physician services at CVS Specialty, told Fierce Healthcare that Caremark has not historically gathered race and ethnicity data, but now asks payers and plans sponsors for that information to more accurately target where disparities are occurring.

“It’s real race and ethnicity data, and we know who those patients are,” he said. “That’s the future, in my mind, of what everybody needs to do.”

In addition, the company built a proprietary tool that combs data from 17 different indexes to identify where disparities exist, he said. That tool, he said, puts “red dots” on the map to highlight risks, and the Caremark team can then use its internal data to further drill down to challenges in specific communities.

Friday Stats and More

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first week, here is the FEHBlog’s updated weekly chart of new Covid cases for 2022:

The enormous surge on the right is the original Omicron strain. Its sibling variants follow. The CDC’s weekly review of its Covid stats is back this week:

As of September 7, 2022, the current 7-day moving average of daily new cases (70,488) decreased 18.8% compared with the previous 7-day moving average (86,853).

CDC Nowcast projections* for the week ending September 10, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 87.5% (95% PI 86.2-88.7%).

Here is the CDC’s current chart of daily trends of new Covid hospitalizations:

The CDC’s weekly review adds “The current 7-day daily average for August 31–September 6, 2022, was 4,620. This is a 10.5% decrease from the prior 7-day average (5,163) from August 24–30, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths for 2022 which also is trending down.

The CDC’s weekly review adds “The current 7-day moving average of new deaths (314) has decreased 28.1% compared with the previous 7-day moving average (437).”

Here’s the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era (51st week of 2020) through the 36th week of 2022.

The CDC’s weekly review adds

As of September 7, 2022, 610.7 million vaccine doses have been administered in the United States. Overall, about 263.1 million people, or 79.2% of the total U.S. population, have received at least one dose of vaccine. About 224.4 million people, or 67.6% of the total U.S. population, have been fully vaccinated.*

Of those fully vaccinated, about 109.0 million people have received a booster dose,* but 50.0% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

Last week, according to the CDC’s stat review, the CDC’s Covid community level evaluations saw an 8.6% decrease in high-level communities and a 10.2% increase in low-level communities.

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.

In other Covid news, Benefits Pro discusses a Brookings Institution report on long Covid’s impact of the U.S. workforce, and the Society for Human Resource Management offers an article confirming the FEHBlog’s take on the recent federal appellate court decision concerning the federal government’s stayed vaccine mandate on federal government contractors.

In other federal litigation news —

A federal judge grilled the Justice Department on Thursday over its antitrust claims that UnitedHealth Group Inc.’s $13 billion acquisition of health-technology firm Change Healthcare Inc.  would suppress competition and limit innovation in health insurance markets.

During closing arguments, U.S. District Judge Carl J. Nichols questioned the department’s arguments that he should block the deal because it would limit competition for technology used in claims processing and would give UnitedHealth access to sensitive industry data that it could use to harm competitors. * * *

Judge Nichols is expected to issue his ruling in the coming weeks.

Home improvement retailer Home Depot and two other, smaller employers are appealing a recent $2.67 billion settlement that covers allegedly anticompetitive behavior from Blue Cross Blue Shield insurers.

The appeals could potentially delay the release of the funds and the broader terms of the settlement, which U.S. District Judge R. David Proctor finalized in August.

STAT News also tells us from Capitol Hill

Negotiations are intensifying over massive, multibillion-dollar legislation to fund the Food and Drug Administration, with just weeks left before the current agreement expires, four sources following the talks said. * * *

Talks are still fluid, and there is no final agreement yet. Lawmakers are aiming to finalize a package by early next week.

The FDA agreement could ride along with a government funding package before the end of September, when government funding runs out. There’s a chance the user fee legislation could pass on its own, however, if there is a bipartisan deal. The Democrats’ user fee offer was a full five-year agreement, not a shorter-term deal.

From the fraud, waste, and abuse front, Beckers Hospital Review informs us

A small number of primary care providers have been responsible for most of the recent growth in remote patient monitoring, though it’s not known how much their patients needed that type of potentially expensive care, a new Health Affairs study found.

Remote patient monitoring grew fourfold during the pandemic’s first year, according to the analysis of OptumLabs Data Warehouse data from January 1, 2019, to March 31, 2021. The database includes Medicare Advantage claims that total about 20 million people annually.

Out of a group of 342 high-volume providers, 0.1 percent accounted for 69 percent of all general remote patient monitoring claims, the Sept. 6 study found.

But the Harvard University researchers said they didn’t observe that the high-volume providers targeted patients with more severe or uncontrolled disease. They said growth rates “indicate that total spending on remote patient monitoring could quickly escalate” and potentially burden CMS and other payers financially.

“More research is needed to identify which patients and use cases benefit most from remote patient monitoring,” the study’s authors wrote. “In the meantime, payers and policymakers should closely monitor its use and be prepared to establish appropriate controls as informed by new evidence.”

From the mental healthcare front, the American Hospital Association relates

The Department of Health and Human Services today reported a 45% increase in call volume and improved answer rates and wait times for the 988 Suicide and Crisis Lifeline this August compared to a year ago. The 10-digit National Suicide Prevention Lifeline in July transitioned to the 988 Suicide and Crisis Lifeline, meaning individuals experiencing a suicide, mental health or substance use crisis can simply call, chat or text 988 to connect with a trained crisis counselor.

The Substance Abuse and Mental Health Services Administration also announced a $35 million grant opportunity to better support 988 Lifeline services in tribal communities, which face unique challenges to accessing technology and crisis services. 

Thursday Miscellany

David Ermer–Congress, COVID-19, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Fierce Healthcare tells us

Republican lawmakers are pushing back on the Biden administration’s request for an additional $26 billion in COVID-19 and monkeypox funding, the AP, Politico and other news sources reported. 

The White House’s ask came as Congress begins negotiations for a short-term funding bill needed to avoid a shutdown at the end of the month.

In comments to reporters, conservatives said their disapproval of additional pandemic spending was tied to inflation and concerns about how prior funds were used. 

“The problem is they want to keep spending more money and throw more gasoline on the inflation fire,” Senator John Cornyn (R-Texas) told the AP. “I think that’s a bad idea.”

The lawmakers said that the White House should instead repurpose funds left over from earlier pandemic asks and begin transitioning the costs for certain efforts, such as vaccines, to the private sector or general public. 

“There’s really no reason that the government should be paying for all of that,” Senator Roy Blunt (R-Mo) told the AP. 

From the Omicron and siblings front —

Bloomberg discusses post Paxlovid rebound Covid.

Infectious disease specialists [writing in a recent New England Journal of Medicine report] say the rebounds aren’t uncommon, and patients should watch for them. They should also feel reassured that symptoms are almost always mild when a rebound occurs. 

Because a rebounder can become contagious again, the Centers for Disease and Control and Prevention urges people to re-isolate and mask if symptoms recur and rapid tests turn positive again.

Specialists emphasize that though rebounds are an inconvenience, Paxlovid remains the treatment of choice for people at high risk of severe Covid.

Politico reports that doctors and Reuters reports that researchers are colloborating to understand and treat long Covid.

As the FEHBlog received his bivalent mRNA booster yesterday, it’s worth pointing out this advice from STAT News

If you’re planning to double up your new Covid booster with your annual flu shot in one visit this month, you might want to reconsider. Even though White House Covid coordinator Ashish Jha believes “this is why God gave us two arms — one for the flu shot and the other one for the Covid shot,” it’s still early to get a flu shot, STAT’s Helen Branswell warns. That’s because protection generated by flu vaccines erodes pretty quickly over the course of a flu season.

A flu vaccine dose given in early September may offer limited protection if the flu season doesn’t peak until February or even March, as it did during the unusually late 2021-2022 season. “You’ve got about four months of pretty solid protection,” Emily Martin, an epidemiologist who specializes in flu at the University of Michigan School of Public Health, told Helen. Read what other experts had to say.

From the monkeypox front, CNBC informs us

* Demetre Daskalakis, a White House health official, said the monkeypox outbreak has slowed significantly since July as vaccination efforts have ramped up.

* The U.S. is still battling the largest monkeypox outbreak in the world with nearly 21,000 cases reported across all 50 states, Washington D.C. and Puerto Rico, according to CDC.

* The U.S. has administered more than 460,000 monkeypox vaccine doses so far, according to data from 35 states.

From the healthcare costs front, Health Payer Intelligence reports

Almost 83 cents of the average healthcare premium dollar goes towards prescription drugs and medical services, including inpatient and outpatient costs, emergency room costs, and doctor visits, according to research from AHIP.

AHIP analyzed data from commercial health insurance plans between 2018 and 2020 to determine how payers spend member premiums. The research reflects spending by employer-sponsored health plans and health plans in the individual market.

“This 3-year trend data includes the first year of the COVID-19 pandemic, when healthcare utilization was down dramatically as patients deferred care and isolated due to the risk of infection,” Matt Eyles, president and chief executive officer of AHIP, said in a press release.

Prescription drugs accounted for the largest portion of the premium dollar at 22.2 cents—up from 21.5 cents between 2016 and 2018. Prescription drug expenses include payments for outpatient prescription medications obtained from the pharmacy or medicines administered in a physician’s office or clinic.

The next largest chunk of the healthcare dollar (19.9 cents) went toward outpatient hospital costs. This includes physician and facility payments for treatment in the outpatient department of hospitals, such as receiving an X-ray or seeing a primary care physician. However, it does not include emergency room costs, such as payments for emergency room visits and ambulance transportation, which accounted for 3.3 cents of the premium dollar.

Inpatient costs represented 19 cents of the dollar, AHIP found. These expenses include payments for all services during hospitalization, including payments to physicians, facility payments, costs for prescription drug administration, and room and board costs.

Almost 12 cents per dollar went toward doctor visits, which included payments to physicians for services provided in an office, clinic, or urgent care facility. The 11.8 cents also went toward equipment and supplies used during a visit and nursing staff salaries.

The National Alliance of Healthcare Consumer Coalitions is offering at no charge its

playbook, “Beyond Hospital Transparency: Getting to Fair Price,” helps purchasers navigate and understand how to best leverage newly available hospital price and quality transparency data and tools from Sage Transparency which incorporates content from RAND Corporation, the National Academy for State Health Policy (NASHP), and other sources. It also offers guidance on rights and responsibilities as plan sponsor fiduciaries to determine fair prices for hospital services, market- and policy-based strategies, and ways to work individually and through coalitions to achieve fair pricing for hospital services.

While there isn’t a one-size-fits-all approach as available data and market conditions vary among regions and states, the methodology and action steps in the playbook to help plan sponsors determine and achieve a fair price include:

Identify breakeven costs – Uncover what hospitals need to charge commercial customers to break even considering all other incomes and expenses plus a reasonable margin.

Compare costs among peer hospital systems – Determine how hospital charges compare to other hospitals with similar services and quality.

Determine a fair market price – Use data from Sage Transparency to negotiate fees based on a reasonable markup of hospital costs.

The playbook also includes an overview of the Consolidated Appropriations Act and debunks many of the inaccuracies around hospital pricing with a comprehensive resource – “Myths and Facts: Revealing Hospital Price Transparency Truths.”

Enjoy.

Tuesday’s Tibits

David Ermer–ACA, CMS, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare points out four legislative items that providers should be tracking for the remainder of this year.

From the Omicron and siblings front, the Washington Post reports

Cold weather favors the coronavirus. But as summer gives way to fall, infectious-disease experts are guardedly optimistic that the spread of covid-19 this autumn and winter won’t be as brutal as in the previous two years of the pandemic.

Coronavirus scenarios from multiple research teams, shared in recent weeks with federal officials, foresee stable or declining hospitalizations in early fall. The scenarios show the possibility of a late-fall surge. A new variant remains the biggest wild card. But several factors — including the approval this week of reformulated boosters and the buildup of immunity against the latest strain of the virus — could suppress some of the cold-season spread, experts say.

In related news, the Wall Street Journal informs us

U.S. health authorities plan to recommend that people get Covid-19 boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.

The annual cadence would be similar to that of flu shots, White House officials said Tuesday, though elderly people and those with weakened immune systems may need more frequent inoculations. 

A shift to annual Covid-19 boosters would be a departure from current practice and comes after many people in the U.S. have ignored calls to get a first or second booster, partly due to fatigue with repeat inoculations. 

“Barring any new variant curveball,” said White House coronavirus coordinator Ashish Jha, “for a large majority of Americans, we are moving to a point where a single annual Covid shot should provide a high degree of protection all year.”

A very sensible approach, indeed!

From the healthcare business front, Healthcare Dive tells us

Amazon and One Medical said Friday that antitrust regulators want more information about the online retailer’s proposed $3.9 billion acquisition of the primary care group. 

The Federal Trade Commission sent a second request for information on Friday, One Medical said in a filing with the U.S. Securities and Exchange Commission.

A second request from the FTC means the two cannot move forward with the deal “until the companies have substantially complied with the additional investigatory request,” according to the FTC.

Amazon and One Medical will “promptly respond” to the second request, the primary care group said in the SEC filing.

In July, Amazon agreed to purchase One Medical for $3.9 billion in an all-cash deal.

From the tidbits department

  • Drug Channels surveys the upcoming Humira price war as biosimilar competitors take the field.
  • CMS posted new information about available group health plan defenses to CMS contractor assertions that the GHP has failed to properly coordinate its benefits with Medicare.
  • Beckers Payer Issues offers expert opinions on the impact of the transparency in coverage rule on consumerism now that the three machine-readable files of health plan pricing data have been posted for two months. For example, “Neil Mayle is the founder and president of Visible Charges, a Cambridge, Mass.-based company that provides clients with curated datasets of both payer- and provider-negotiated service prices. * * * ‘I think we’ve gone from nothing to a lot,’ Mr. Mayle said. ‘We haven’t gone to perfect.'” Of course, it was only the first of three stages in transparency in coverage rule disclosures.
  • The FEHBlog noticed today these CMS and DOL fact sheets on the No Surprises Act which are worth a gander.

.

Labor Day Weekend Update

David Ermer–Congress, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by Jim Stapleton on Unsplash

Happy Labor Day!

The Senate returns to Capitol Hill for committee business and floor voting tomorrow. The Wall Street Journal adds “Between now and Election Day, senators are scheduled to be back in Washington for four weeks, then gone a week, and then back for two weeks in October.” The House of Representatives will be engaged in committee business but not floor voting this week. The House resumes floor voting next week.

The Wall Street Journal informs us

The White House is asking Congress for $47.1 billion in emergency funding for Covid-19 and monkeypox and to back Ukraine in its war with Russia, as well as spending for natural disasters, according to administration officials.

Congress must vote on a spending bill by the end of September to avoid a partial government shutdown. Lawmakers are expected to use a stopgap funding measure that will maintain funding levels for the short term.

The White House is asking Congress to add the emergency funding on top of that, with about $22.4 billion for Covid-19 vaccines, testing programs, clinical trials and research; $4.5 billion to bolster efforts to fight monkeypox; and $6.5 billion to help areas of the country prepare for and recover from natural disasters. * * *

The emergency funds wouldn’t be paid for with new or shifted revenue, and would be new money that hasn’t been previously appropriated.

[As of last Friday, September 2] Senate Republican leadership didn’t immediately respond to a request for comment about the White House’s request for emergency funding. Spending bills require 60 votes, and in the 50-50 Senate at least 10 Republicans would need to back any bill that contained the administration’s request.

Govexec notes

[President] Biden intends to nominate Richard Revesz, the AnBryce Professor of Law and Dean Emeritus at the New York University School of Law, to be administrator of the Office of Information and Regulatory Affairs, which is housed within the White House Office of Management and Budget. Biden has not had a permanent OIRA head since taking office.

From the U.S. healthcare business front, the Wall Street Journal reports this afternoon that CVS Health has struck a deal to purchase Signify Health:

The drugstore giant’s deal to acquire home-healthcare company Signify Health Inc., announced Monday, will add 10,000 contracted doctors and clinicians and give CVS a hand in coordinating medical care for millions of Americans.

CVS, the nation’s biggest healthcare company by revenue, said that it agreed to acquire Signify for $30.50 per share in an all-cash deal, confirming earlier Wall Street Journal reports. CVS said it expects the deal, finalized over the weekend after a sales process that drew interest from companies from Amazon.com Inc. to UnitedHealth Group Inc., to close in the first half of 2023.

CVS for years has worked to transform itself from a pharmacy chain to an integrated provider of medical services, with the biggest step being its 2018 acquisition of insurer Aetna. Initially, CVS envisioned a model centered on pharmacists, in-store clinics and a giant insurance business.

But Karen Lynch, who took over as CVS CEO last year, determined that the company needs doctors on its payroll to fulfill those ambitions. She also set out to expand CVS’s presence in home healthcare, demand for which has been rising as the U.S. population has aged.

Signify’s model is based on an analytics-and-technology platform, used by doctors that go into homes equipped with connected iPads, that allows the clinicians to assess patient needs and connect them with follow-up services.

The clinicians “operate much like Uber drivers,” said Kyle Armbrester, Signify Health chief executive. “We’re in a gig economy and this is a flexible model.”

The deal is the latest for a home-health company. Rival Walgreens Boots Alliance Inc. last week finalized a deal to purchase a majority stake in CareCentrix, Inc., another home-healthcare platform.

This spring, UnitedHealth agreed to buy LHC Group Inc., one of the country’s largest home-health firms, for about $5.4 billion. Last year, Humana Inc. agreed to take full control of home-health provider Kindred at Home. Both LHC and Kindred provide continuous home-healthcare services.

Signify has grown to serving more than 2.5 million homes from around 300,000 five years ago, said Mr. Armbrester, who is set to remain CEO of Signify Health after the acquisition.

From the public health front, NPR Shots discusses the new Covid boosters and Precision Vaccinations discusses flu shots. The FEHBlog checked chain pharmacies in his locality in Dripping Springs, TX. Flu shots are already available, and the new Covid boosters will be available mid-week.

Weekend Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, Mental health care, U.S. Healthcare–
Mount Rushmore
Mount Rushmore

Congress’s State / District work break ends next Monday Labor Day.

From the Omicron and siblings front, Federal News Network tells us that last Friday the U.S. Court of Appeals for the Eleventh Circuit, which is based in Atlanta, issued a ruling on the federal government’s appeal of a district court preliminary injunction of the Biden Administration’s Covid vaccination mandate on federal government contractors.

The three-judge panel’s majority found that a narrower injunction to block the mandate would have been warranted, and that once the case is fully litigated, the plaintiffs are at least “reasonably” likely to win their claim that the president can’t use his authority under procurement law to mandate vaccines for contractors.

But the court found Georgia District Court Judge Stan Baker went too far by applying the injunction nationwide during the case’s earliest stages last December. Instead, the court ruled, the injunction can only apply to the handful of parties who actually sued. * * *

In this case, that means the government is barred from enforcing the mandate against members of the Associated Builders and Contractors (ABC), and state agencies from seven states that were part of the same suit: Georgia, Alabama, Idaho, Kansas, South Carolina, Utah and West Virginia. * * *

The administration completely suspended enforcement of the contractor mandate right after Judge Baker’s decision last December, and hasn’t yet said how it will respond to the new ruling partially lifting his injunction. A spokesman for the Office of Management and Budget did not immediately respond to an inquiry Friday evening.

From the healthcare cost front, Fierce Healthcare informs us

Healthcare price increases during the past year pale in comparison to those seen across the rest of the economy, suggesting that the healthcare sector has so far been spared from the full impact of 2022’s rapid inflation.

Healthcare’s upward price movement has so far been led by hospitals and nursing homes as opposed to other medical care spend, per an analysis of Bureau of Labor Statistics data released Wednesday.

Policy analysts affiliated with the Kaiser Family Foundation and the Peterson Center on Healthcare wrote that those quicker increases are likely a reflection of staff shortages and rising average wages and are likely to continue “unless hospitals can find ways to operate with fewer staff.”

With health prices often set in advance by the Centers for Medicare & Medicaid Services or private insurance contracting, however, the analysts wrote that “the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.”

In post-Dobb’s news, the Department of Health and Human Services brings us up to date on the steps that the Biden Administration has taken to protect access to abortion services. Most recently,

Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. The letter also underscored that current or proposed abortion restriction laws do not negate providers’ responsibilities to comply with federal laws protecting access to emergency health care. Also today, HHS issued a report and plan of action in response to the Dobbs v. Jackson Women’s Health Organization Supreme Court decision. 

From the mental healthcare front, NPR brings us inside the operations of 988 call centers in Pennsylvania.

The 2020 law enacting the 988 number also allows states to pass legislation to add a small fee to cell phone bills as a permanent source of funds for 988 and associated mental health services. So far, only four states have done so, and only two more have proposed legislation.

Pennsylvania is not one of those states, and doesn’t have any other funding plan implemented. That worries Kevin Boozel, who heads the County Commissioners Association of Pennsylvania.

“This is life or death,” Boozel says. “And you can’t halfway do it.”

He pointed out that Pennsylvania has decided to hold back on publicizing the new 988 number until next year. The fear is that too many calls could flood the system, and counties need more time to set up funding, hire workers and build capacity for things like those mobile crisis teams.

Challenges aside, In Centre County, Herr McCann emphasizes that calling the hotline works. In most cases, just talking with someone is enough to defuse a crisis.

“When they have someone who is empathetic and who listens, that connection helps them,” she said. That lets people know that “it isn’t hopeless. There is hope out there. There is help out there.”

From the health benefit plan design front, Fierce Healthcare reports

Bicycle Health, a virtual provider for opioid use disorder treatment, has announced it is now part of Cigna Evernorth’s behavioral health network.

The startup’s services will now be available to all Evernorth and Cigna health plan customers in the 24 states where Bicycle Health operates. The potential reach is millions of patients, the company told Fierce Healthcare without disclosing additional details. 

In Postal Service news, Govexec reports

More than 200 post offices and other U.S. Postal Service facilities are set to shed some of their operations as soon as this year as the mailing agency seeks to consolidate those functions at larger buildings, according to documents shared by management. 

The changes will mean letter carriers no longer go to their local facility to pick up mail for their route, instead traveling farther distances after starting at a consolidated location. The impacted post offices will still conduct their retail operations, but many of the back-end functions will be stripped away and relocated. They are connected to an initial 10 buildings that USPS previously announced it was standing up in previously closed facilities, as well as an additional 11 centers. 

Most post offices around the country operate as delivery units, meaning mail carriers go to them to pick up mail and packages for their routes before bringing them to homes and businesses. Postmaster General Louis DeJoy has repeatedly decried this model, saying it is inefficient and can lead to as many as dozens of such units in one metropolitan area. Instead, he is looking to open “sorting and delivery centers” around the country, as well as larger mega-centers, that can take on more work in less space. Letter carriers will have to travel farther to take mail to its final destination, but DeJoy said it will save costs on the contracted trucks that USPS hires to bring mail between various facilities.

The impacted sites are located in Georgia, New York, Texas, Florida, Michigan, Pennsylvania, Ohio, Kansas, Maryland, Massachusetts, West Virginia, Kentucky, Washington, North Carolina, Indiana and Arkansas. The initial consolidations are expected to begin as soon as next month. 

Weekend update

David Ermer–Congress, COVID-19, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Congress is on a State / District work break again this week.

The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.

Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.

Here’s a link to a Fierce Healthcare article on the new rules.

From the omicron and unusual viruses front —

The Wall Street Journal reports

The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.

But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.

As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S. 

This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.

The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce. 

The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.

Fingers crossed.

On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.

NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. 

The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.

The Wall Street Journal offers articles on “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York” and “Am I Protected Against Polio? Here’s What to Know About the Vaccine.”

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.

The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.

Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.

Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.

STAT News adds

Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.

Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.

CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.

There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.

From the miscellany front

  • Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization.  The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
  • Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”