Monday Roundup

Rx coverage

Monday Roundup

David Ermer–COVID-19, Employee Wellness Programs, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Bloomberg reports that

The Covid-19 variant that’s become the dominant strain in the U.S isn’t as deadly as earlier research indicated, although it’s confirmed to be faster-spreading than other versions, according to a study.

Among 339 patients with the coronavirus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published Monday in the Lancet Infectious Diseases journal, compared with 38% of those who had non-B.1.1.7 infections.

“We’re not saying it’s nothing, but it’s not worse in terms of outcome in our study, in our setting,” said Eleni Nastouli, a co-author of the study and an associate professor at University College London. She noted that the study differed from some earlier research, looking at patients in hospitals, rather than in the community, and making precise identifications of variants with whole-genome sequencing.

Earlier data released by a U.K. advisory group and cited by the U.S. Centers for Disease Control and Prevention indicated that B.1.1.7 might be as much as a third more deadly than other variants of the virus. 

FLASH: Bloomberg reports Tuesday morning that

U.S. health officials recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine on concerns about rare and severe blood clotting side effects. A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said Tuesday in a joint statement. As of April 12, more than 6.8 million doses of the vaccine have been administered, the agencies said.

If you had to pause one of the vaccines this would be the week to pause the Johnson & Johnson vaccine due to the manufacturing / distribution problems. Fingers crossed for a short pause.

The Department of Health and Human Services today

marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. A new data brief shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months post-partum and disruptions in Medicaid coverage often lead to periods of uninsurance, delayed care, and less preventive care. The American Rescue Plan provides an easier pathway for states to extend Medicaid postpartum coverage from 60 days to 12 months.

Secretary Becerra also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. For the first time, applicants are required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

For more information on the fourth Black Maternal Health Week, check out the Black Mamas Matter Alliance’s website.

From the prescription drug front —

  • Cigna’s Evernorth unit, which includes the Express Scripts PBM, has released its 2020 Drug Trends report. The report’s by the numbers webpage is quite illuminating.
  • STAT News informs us that

Patrizia Cavazzoni has been named the permanent leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, the agency’s acting commissioner, Janet Woodcock, announced Monday morning. The position of CDER director is one of the most influential at the sprawling agency. Cavazzoni, who is in her late 50s, was handpicked by Woodcock to join the agency in 2018 and has been leading the drug center in an acting role since last spring. Cavazzoni is known as a problem-solver who has taken on some of the FDA’s most pressing problems, former top FDA officials told STAT last year.

From the healthcare technology front —

Healthcare Dive lets us know that

Microsoft is acquiring clinical documentation and artificial intelligence company Nuance Communications for $19.7 billion, two years after first inking an R&D partnership with the speech-to-text market leader. The Redmond, Washington-based tech giant said Monday it has entered into a definitive agreement to acquire Nuance for $56 a share — a hefty price tag, representing a 23% premium on the closing price on Friday. Nuance develops conversational artificial intelligence and cloud-based ambient clinical intelligence for doctor’s offices and hospitals.

Jingle bells to Nuance Communications. Healthcare AI is obviously a big deal.

  • Becker’s Hospital Review reports that “Google is in the early stages of a new project that aims to explore and develop a new consumer-facing health records tool for Android users, according to an April 9 STAT report. * * * The project could support the development of a medical records tool similar to Apple’s Health Records app, according to the report.”

Finally here’s an interesting smoking cessation twist from Healio:

A parental smoking intervention was effective and “inexpensive” to implement in pediatric primary care practices, with costs per quit that were comparable to other interventions, according to researchers. * * * “The impetus for screening parents for tobacco use in the pediatric setting is to protect children from exposure to secondhand smoke,” Douglas E. Levy, PhD, MPH, associate professor of medicine at Harvard Medical School and associate investigator at the Mongan Institute Health Policy Center at Massachusetts General Hospital, told Healio Primary Care. “Parents may be more receptive to smoking cessation messages when the recommendation comes from pediatric health care providers because the benefits are framed in terms of protecting their child’s health.”

Thursday Miscellany

David Ermer–CMS, COVID-19, COVID-19 vaccine, OPM, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Yesterday, the Office of Personnel Management issued its technical guidance supporting the call letter for 2022 benefit and rate proposals which are due by May 31, 2021. The guidance provides insight into the call letter’s priorities.

The FEHBlog’s priority is supporting the COVID-19 vaccination effort. STAT News reports that

Useful Covid-19 information isn’t reaching the Instagram generation [Z]. There’s almost no messaging specifically tailored to them from federal or state public health officials. There’s hardly anything official on Tik Tok. And even the limited efforts to reach them where they are — like Instagram’s links to its “Covid-19 information center”— aren’t working. * * * Numerous public health officials told STAT that the issue of growing vaccine reluctance among young people can be solved with a coordinated campaign of reliable, useful information that makes it both easy and enticing for young people to get vaccinated, even if they may not personally benefit much. Those same officials acknowledged, however, that much of the groundwork for messaging to young people is yet to be done.

Recognizing a problem is the first step toward solving it.

Govexec.com informs us that

FEMA has sent about 3,000 employees to vaccination sites and is fully running 30 mass vaccination centers. It declined to say how many volunteers it was seeking from other agencies. The emergency response agency is standing up community vaccination centers fully run and staffed by federal employees, providing funding and staffing to state-run sites and deploying mobile vaccination centers.

Thanks Feds.

The Centers for Medicare and Medicaid Services announced yesterday a proposed rule “that would update Medicare payment policies and rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for Fiscal Year (FY) 2022 and propose changes to the IPF Quality Reporting (IPFQR) Program. * * * Total estimated payments to IPFs are estimated to increase by 2.3% or $90 million in FY 2022 relative to IPF payments in FY 2021.  For FY 2022, CMS is proposing to update the IPF PPS payment rates by 2.1% based on the proposed IPF market basket update of 2.3%, less a 0.2 percentage point productivity adjustment.”

Fierce Healthcare alerts us that “Drugs for inflammatory autoimmune conditions account for a growing chunk of pharmacy spend, according to new data from Prime Therapeutics. The pharmacy benefit manager studied (PDF) data on its 15 million commercially insured members in 2019 and 2020 and found that fewer than 1% of members had an inflammatory autoimmune condition such as psoriasis, rheumatoid arthritis, ulcerative colitis or Crohn’s disease. However, drugs treating these conditions accounted for nearly 20% of drug spend in the medical and pharmacy benefit, Prime Therapeutics found.” Wow.

Healthcare Dive reports that

  • While urgent care centers do keep some lower-acuity patients from visiting costly emergency departments, their presence is not associated with a drop in total healthcare costs, according to a report in Health Affairs.
  • Using commercial claims and enrollment data from 2008 to 2019, researchers found an increase of 1,000 lower-acuity urgent care visits resulted in 27 fewer lower-acuity ER visits. The entry of a high-volume urgent care center into a ZIP code was associated with a 31% drop in emergency visits.
  • However, while ER trips were far more costly ($1,716 vs. $178), each $1,646 ER visit was offset by $6,327 more in urgent care costs because the number of urgent care visits per enrollee required to reduce one ER visit was 37.

Hmmm.

Health Payer Intelligence discusses a three ways for employers to fund their employee health benefit plans — insured, self-funded and an approach (with which the FEHBlog was not familiar) level funding.

In the level-funded model, the employer pays the insurer each month to cover expected healthcare expenditures, the Society for Human Resource Management (SHRM) website explains. The funds go towards claim payments, stop-loss insurance premiums, and administrative costs.

If this sounds familiar that is because this model borrows from both the fully-insured and self-insured models.

However, the distinction is that in a level-funded health plan, the insurer will return to the employer any funds that remain at the end of the year, if the volume of medical claims is not as high as anticipated. Alternatively, if the volume of medical claims exceeds the projected cost, employers will face a higher stop-loss insurance premium.

Although this is the general template for a level-funded plan, contracts may include various specifications, the SHRM site says. For example, some insurers may require that their company retain a certain percentage of the savings or that these funds roll over to be spent on medical claims in the subsequent year.

In this model, insurers—specifically larger insurers—may have cemented their level-funded plan offerings or they may work with employers to tailor the funding plan to fit the business’s needs.

Level-funded plans cater to smaller firms that want a self-insured health plan but may not be able to afford the high cost of medical claims and stop-loss insurance.

You do learn something new everyday.

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, STAT News reports that Senate leaders have reached an agreement to extend a Medicare pay bump for health care providers through 2021, a major lobbying win for hospitals.”

The Wall Street Journal reports two Senate confirmations in healthcare positions:

The Senate [today] confirmed Dr. Rachel Levine as assistant health secretary, making her the first openly transgender federal official approved by the Senate.

The vote was 52 to 48, largely along party lines, with GOP Sens. Lisa Murkowski of Alaska and Susan Collins of Maine joining all 50 Democrats.

The pediatrician and former Pennsylvania secretary of health helped steer the state’s response to Covid-19. She has also worked to increase awareness of equity issues that the LGBT community faces and is a professor of pediatrics and psychiatry at Penn State College of Medicine. 

and

Yesterday, the Senate approved Vivek Murthy, President Biden’s pick for surgeon general, by a 57-to-43 vote, marking his second stint in the post, which he held from 2014 through 2017. Dr. Murthy, who was co-chairman of Mr. Biden’s Covid-19 advisory board, has said he would use his position to provide science-based guidelines for ending the coronavirus pandemic.

From the COVID vaccine front, Medscape informs us that

White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

FLASH — The Washington Post reported at 10:30 pm Wednesday night that

An updated company analysis of the coronavirus vaccine developed by AstraZeneca and the University of Oxford showed that the two-shot regimen was robustly effective — 76 percent at preventing symptomatic illness — according to a news release from the drugmaker late Wednesday.

The finding, only slightly lower than results announced days earlier, underscores that the vaccine being widely used by many countries appears to be a powerful tool to help end the pandemic. No severe cases of illness were reported in study volunteers who received the vaccine. Among people 65 and older, the vaccine was 85 percent effective, the company reported.

Yesterday, the FEHBlog watched a Wall Street Journal interview with Mr. Slavitt as part of the WSJ’s Health Forum. The FEHBlog really enjoyed this WSJ video featuring reporter Joanna Stern with a COVID vaccine hunter from New Jersey. It’s certainly worth five and half minutes of your day.

HR Dive reports that

Employers should offer paid sick leave to employees with “signs and symptoms” following COVID-19 vaccination, according to guidance updated March 16 by the Centers for Disease Control and Prevention.

Employers should consider on-site vaccination programs if they have a large workforce with predictable schedules and enough space to run a clinic that meets social distancing requirements, CDC said. Employers that choose to offer vaccinations should record each offer and employees’ decisions. Employers should consider off-site vaccination if they are a small- or medium-sized organization lacking the resources to host a vaccination clinic, it said.

The agency also said that whether an employer may require COVID-19 vaccinations is a matter of state or other applicable law but noted that exemptions may apply: Medical exemptions for people who are at risk for an adverse reaction because of an allergy to one of the components used in the vaccine or a medical condition; and religious exemptions for people who reject being vaccinated because of their religious beliefs.

In healthcare business news, Fierce Healthcare lets us know that

Uber is ramping up its prescription delivery business by teaming up with software company ScriptDrop. The ride-share giant will be the default delivery service for ScriptDrop pharmacies in 37 states and will eventually expand to others.

ScriptDrop works with some of the top grocery chains, pharmacy chains and health systems in the U.S., including Albertsons, Jewel-Osco, Safeway and Vons. Through the tie-up with Uber, those pharmacies will be able to leverage the company’s technology to deliver more prescriptions to more customers.

From the report front, the FEHBlog noticed

Finally March 22 to 28, 2021, is National Drug and Alcohol Facts Week. “Held since 2010, NDAFW brings teens and scientific experts together to discuss the scientific facts about drugs, as well as their potential health effects on teen bodies and brains. ”

Tuesday Tidbits

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

The Wall Street Journal reports this evening that “President Biden said the U.S. would have enough Covid-19 vaccines for all American adults by the end of May, two months earlier than he had previously said, after regulators authorized the one-shot Johnson & Johnson vaccine and Merck & Co. agreed to help produce it.” That is very encouraging news.

Politico reports that the President has agreed to comply with Neera Tanden’s request that he withdraw her nomination as Office of Management and Budget Director. “Biden’s statement indicated that he expects Tanden to serve in another role in his administration.”

And here are some tidbits for you —

  • The House Energy and Commerce Committee held a future of telehealth hearing today. “It is critical to the health, safety and equitable access of our patients to ensure we can continue to provide telehealth services after the end of the public health emergency,” said Megan Mahoney, M.D., chief of staff at Stanford Health Care, who testified at the hearing.
  • Medpage Today reports that ” Insufficient evidence exists to support any strategy where patients either delay their second dose or only receive one dose of COVID-19 mRNA vaccines [Pfizer and Moderna], even if they have been previously infected with the virus, CDC staff told the agency’s Advisory Committee on Immunization Practices (ACIP) at its Monday meeting. And ACIP committee members seemed to agree * * *.”
  • Fierce Pharma reports on two recent Food and Drug Administration emergency use authorizations of at home COVID-19 tests.
  • A friend of the FEHBlog pointed him to this STAT News article written by HHS Office of Inspector General Officials discussing the “importance of adding patients’ diagnoses to their prescriptions.” For example, [d]iagnosis information on prescriptions could help pharmacists identify safety issues,” and electronic prescription systems can accommodate diagnosis information.
  • CMS, which enforces the HIPAA electronic transaction rules, issued a factsheet on savings available to healthcare providers who use those electronic transactions. “According to data from the 2020 CAQH Index, 16% of medical plans and 36% of dental plans do not fully use electronic HIPAA standard transactions to conduct eligibility and benefits inquiries and responses. The CAQH Index estimates that medical and dental providers could save approximately $7 billion per year by completing eligibility and benefits checks using the HIPAA standard.” Health plans should share this information with their recalcitrant network providers.
  • Healthcare Dive informs us about four healthcare anti-trust issues to watch in 2021.
  • Health Payer Intelligence reports that “Blue Cross and Blue Shield of Illinois (BCBSIL) is tackling maternal care disparities in its state by financially supporting community-based interventions that focus on increasing education among new mothers and providing in-person and digital support. ‘By taking a holistic approach to supporting prenatal care that considers the social and economic factors impacting the health of mothers and newborns, we are working to help create an environment that fosters access to affordable benefits, equitable care delivery and wherever possible, better health outcomes,’ said Anita Stewart, MD, medical director at BCBSIL.” Well done.

Thursday Miscellany

David Ermer–Congress, Rx coverage, Telehealth–
Photo by Juliane Liebermann on Unsplash

The American Hospital Association informs us that “President Biden yesterday [February 24] continued the national emergency for the COVID-19 pandemic [indefinitely] beyond March 1. The renewed national emergency, along with the recently renewed public health emergency, allow the Department of Health and Human Services to continue Section 1135 waivers and other flexibilities to ensure sufficient health care services and items to respond to the pandemic.” In the FEHBlog’s opinion, this action also applies to the Labor Department’s May 4, 2020, extension of various deadlines applicable to ERISA-governed health plans and their members.

From Capitol Hill Reuters reports on the evenly divided Senate’s measured reaction to the House of Representatives COVID-19 relief budget reconciliation bill which is expected to pass the House on party lines tomorrow. Politico reports this evening that

The Senate parliamentarian ruled Thursday that Democrats would be deemed out of order if they include a $15 minimum wage hike in their coronavirus relief package, a major blow to Senate Budget Committee Chair Bernie Sanders (I-Vt.) and progressives. The parliamentarian’s ruling means that any senator could raise a point order against the minimum wage increase, which would force the provision to be axed from the bill. House Democrats still plan to pass the minimum wage hike on their version of the Covid bill on Friday, but the Senate decision means the party needs to find an alternative route to increasing the minimum wage, a key campaign promise.

Healthcare Dive reports that Xavier Becerra favorably weathered his two Senate confirmation hearings this week.

“If I was a betting man, I’d bet that you’ve got the votes to be approved,” Sen. Bill Cassidy, R-La., said Wednesday at the Senate Finance Committee hearing. In both hearings he distanced himself from previous endorsements of “Medicare for All,” in several rounds of questioning from Republicans seeking to tie him to the policy idea. The former House lawmaker noted that President Joe Biden has no intention of pursuing such a policy and said he stands ready to build on the Affordable Care Act, including with a public option. * * * At the finance panel, Becerra also voiced support for continuing to expand reimbursement of telehealth services beyond the COVID-19 pandemic. “I don’t think we’re going back to the old days when it comes to telehealth,” he said.

In that regard, according to Fierce Healthcare, Teladoc reported its fourth quarter 2020 earnings today:

Teladoc’s 2020 revenue reached $1.1 billion as virtual care visits continued to soar. The telehealth giant reported it delivered 10.6 million virtual visits last year, up 156% from 2019. The company’s U.S. paid membership hit 51.8 million, up about 41% from 36.7 million users in 2019. Teladoc, one of the nation’s top telehealth providers, reported 3 million total virtual visits during the fourth quarter, up 139% from 1.2 million visits in the fourth quarter of 2019.

The FEHBlog firmly believes that our country’ patent laws lie at the root of soaring prices for specialty drugs. He therefore was pleased to read today this STAT News article reporting that

 [A] U.S. appeals court [for the Federal Circuit] recently restricted wide-ranging patent claims for antibody treatments, a ruling legal experts say may force [specialty drug]/biologics makers to re-examine patent protections for their products.

In this instance, Amgen (AMGN) and Sanofi (SNY) were battling over the market for injectable cholesterol-lowering medicines called PCSK9 inhibitors. For the past several years, the companies have been locked in patent disputes, but earlier this month the appeals court decided that two Amgen patents for its Repatha cholesterol medication were invalid.

In the process, the ruling is raising questions about the sort of patent claims that companies can make about monoclonal antibodies, which is the type of medicine that was at issue in this case. The upshot is that, because of the way Amgen went about asserting claims in its patents, companies will have to be more careful about crafting their patents and can also expect more legal challenges.

“I think this is a huge deal,” said Jacob Sherkow, a law professor at the University of Illinois at Urbana-Champaign who specializes in patents and life sciences. “A huge swath of antibody patents out there is just like Amgen’s patents. So if those are not valid under this new standard [issued by the appeals court], then one can think the other patents are also likely not to be valid.”

Tuesday Tidbits

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

The Wall Street Journal reports tonight that

The most severe surge of the Covid-19 pandemic in the U.S. has weakened significantly, according to key metrics, though public-health experts and epidemiologists urge caution, given the spread of highly contagious new variants.

Newly reported cases have dropped 56% over the past month, based on a seven-day average, marking a significantly steeper fall than the U.S. saw after the spring and summer surges. Hospitalizations have declined 38% since Jan 6. The seven-day average of Covid-19 tests returning positive fell over the past week to 6.93%, the lowest since Oct. 31.

“The concern right now is that while we’re seeing a decline in cases from the holiday surges, as we identify more transmission of the variants within the U.S., this could lead to another surge,” said Saskia Popescu, an assistant professor at the Schar School of Policy and Government at George Mason University.

The American Medical Association reports

[A]s part of its “Understanding Coronavirus in America” study, researchers from the University of Southern California Center for Economic and Social Research recently analyzed data from 6,000 members drawn from its “Understanding America Study.” Data was collected between March 10, 2020, and Jan. 6, 2021, and found that 83% of adults surveyed view wearing a mask as an effective way to stay safe from COVID-19, but that their behavior is inconsistent.

The analysis found:

Two-thirds reported being within less than six feet of someone outside their household in early December, but only half mostly or always wore a mask while doing so.
White people were the least likely to consistently wear a mask when in close contact with people from other households, with 46% reporting wearing a mask compared to 67% of black people, 63% of Latinos and 65% of people of other races.
In rural areas, 42% reported always wearing a mask or wearing one most of the time when they were with people outside of their household. In suburban areas, the number jumped to 52% and it was highest in urban areas at 57%.
Among the 81% who said they went grocery shopping in early December, 90% reported wearing a mask.

This is why the vaccination campaign is so important.

On the Capitol Hill front

  • The Hill explains Sen. Ron Wyden’s plans as the new Chair of the Senate Finance Committee. The Senator has been a critic of high prescription drug prices.
  • The Hill also reports the House of Representatives is developing a COVID-19 relief budget reconciliation bill that would increase and expand the availability of Affordable Care Act subsidies as well as offer 85% subsidies for employer sponsored plan continuation coverage, i.e., COBRA and TCC, during 2021 and 2022.

On the Biden Administration transition front —

  • NPR discusses Office of Management and Budget Director nominee * Neera Tanden’s confirmation hearing before the Senate Homeland Security and Governmental Affairs Committee today. Ms Tanden has a second confirmation hearing scheduled before the Senate Budget Committee tomorrow morning.
  • Federal News Network informs us that President “Biden recently appointed Pam Coleman as OMB’s new associate director for performance management, the agency’s point person on federal workforce issues. * * * Coleman comes from the New Mexico state government, where she led the personnel office for the last two years. Coleman had multiple roles in the Obama administration, including as a leadership development team lead in the White House Presidential Personnel Office and as a liaison to DHS. The OMB associate director for performance management is usually the agency’s go-to on everything from federal pay and benefits to hiring and labor relations. Biden hasn’t yet nominated a new director for the Office of Personnel Management.”
  • STAT News compares the two leading contenders for Food and Drug Administration Dr. Janet Woodcock, the current acting commissioner, “and Josh Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health who served as the FDA’s second-in-command during the Obama administration.” Dr. Woodcock is an FDA vet while Dean Sharfstein would be “only the second FDA commissioner in modern history to serve as a local public health official. While most FDA commissioners typically come from backgrounds in academic medicine or from other federal agencies, and thus tend to focus primarily on the regulation of drugs, Sharfstein has been far more outspoken about the FDA’s lesser known responsibilities, like regulating cigarettes and food.”

In other tidbits —

  • Beckers Hospital Review lists the HealthGrades top fifty U.S. hospitals for January 2021.
  • Govexec reports on the Postal Service’s latest quarterly financial report and a looming Postal Board of Governors power shift from Republicans to Democrats.
  • The Society for Human Resource Management seeks to keep us up to date on “evolving COVID-19 testing and safety guidelines [for employers] as the pandemic persists.”

Thursday Miscellany

David Ermer–Congress, COVID-19, Medicare, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the COVID-19 front —

  • Politico reports that “Johnson & Johnson filed Thursday for emergency use authorization [“EUA”] of its single-dose coronavirus vaccine, readying for a pivotal third option in the battle to immunize hundreds of millions of Americans.” This is the single dose vaccine that can be stored in regular pharmacy refrigerators. Following the same pattern as the first two EUA applications for COVID-19 vaccines, the Food and Drug Administration has set an advisory committee hearing on the Johnson & Johnson EUA for February 26. This indicates that the FDA will approve the application on February 28 / this month. That is very good news.
  • Healthcare coaching service TrestleTree has made available its useful “State-by-State COVID-19 Vaccination Access Guide.” Muchos gracias.
  • The American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association (ANA) released a [joint] public service announcement (PSA) today urging the American public to get the COVID-19 vaccination when it is their turn. 
  • Reuters reports that “Almost all people previously infected with COVID-19 have high levels of antibodies for at least six months that are likely to protect them from reinfection with the disease, results of a major UK study showed on Wednesday. Scientists said the study, which measured levels of previous COVID-19 infection in populations across Britain, as well as how long antibodies persisted in those infected, should provide some reassurance that swift cases of reinfection will be rare.”

From Capitol Hill, CBS News informs us that “The Senate is expected to vote on a budget resolution sometime before the weekend, an important step to passing President Biden’s $1.9 trillion COVID-19 relief proposal through the process of reconciliation, which allows legislation to pass with only a simple majority instead of the typical 60-vote threshold.  But before there can be a final vote on the resolution, Republicans are forcing Democrats to go on the record with a series of votes on a slew of amendments in a politically painful process known as a “vote-a-rama.” Bloomberg adds that this afternoon, “[t]he Senate backed by 99-1 a non-binding call to oppose stimulus checks going to “upper-income taxpayers” — one of a series of messaging votes the chamber is taking in a complex process of preparing President Joe Biden’s $1.9 trillion Covid-19 relief plan for passage through Congress.”

Health Payer Intelligence tells us about health plan trade association efforts to convince the Biden Administration to undo certain Trump Administration actions.

In healthcare corporate news, Healthcare Dive reports

  • Cigna’s net income for the fourth quarter of 2020 was $4.1 billion, a huge increase from the $977 million in the fourth quarter of 2019, partly because of the $6.2 billion sale of its life insurance business, which was completed on Dec. 31. The payer’s medical cost ratio in the fourth quarter was 85.8%, up from 82.3% the prior year because of COVID-19 treatment and testing costs and above Wall Street expectations. In a call with investors Thursday morning, CFO Brian Evanko said deferred care increased in the latter part of the quarter but was outweighed by COVID-19 costs.

and

  • UnitedHealth CEO Dave Wichmann is retiring and will be replaced as chief executive by Andrew Witty, currently the CEO of health services unit Optum. Witty will continue running Optum and become CEO immediately, with Wichmann assisting in a transition period through March, UnitedHealth announced Thursday. Dirk McMahon, CEO of payer business UnitedHealthcare, will become president and chief operating officer, and joins CFO John Rex to round out the Minnetonka, Minnesota-based healthcare behemoth’s C-suite.

From the opioid front

  • The Wall Street Journal reports that “State attorneys general intensified pressure on drug companies to settle claims over the opioid crisis, following consulting firm McKinsey & Co.’s agreement to pay nearly $600 million over its advice to pharmaceutical companies to rev up sales. * * * States have been negotiating since 2019 with the nation’s three largest drug distributors, McKesson Corp. , AmerisourceBergen Corp. , Cardinal Health Inc., as well as drugmaker Johnson & Johnson. The companies have publicly disclosed that they have set aside a collective $26 billion for the deal, most of it to be paid over 18 years, but no final agreement has been reached. In news conferences Thursday, attorneys general said they hoped the McKinsey deal would provide momentum for a bigger settlement, if others facing litigation follow the consulting company’s lead.”
  • Late last month, the Bloomberg School of Public Health announced that “A coalition of 31 professional and advocacy organizations has released a set of principles aimed at guiding state and local spending of the forthcoming opioid litigation settlement funds. The coalition, coordinated by faculty at the Johns Hopkins Bloomberg School of Public Health, is urging state and local officials to avoid the mistakes of the 1998 tobacco settlement and use the expected settlement funds to support evidence-based strategies that save lives. The need for evidence-based funding strategies is especially urgent now, as deaths due to opioid drug overdoses have significantly increased since the COVID-19 pandemic began, with some states reporting increases of 30%.”
  • The Health and Human Services Office of Inspector General today released a report on opioid use in Medicare Part D during the first phase of the COVID-19 public health emergency. “As the pandemic took hold, about 5,000 Medicare beneficiaries per month suffered an opioid overdose during the first 8 months of 2020.”

Monday Roundup

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Good news on the COVID-19 front —

Bloomberg’s headline story this evening is that

More Americans have received at least one dose of a Covid-19 vaccine than have tested positive for the virus, an early but hopeful milestone in the race to end the pandemic.

As of Monday afternoon, 26.5 million Americans had received one or both doses of the current vaccines, according to data gathered by the Bloomberg Vaccine Tracker. Since the first U.S. patient tested positive outside of Seattle a year ago, 26.2 million people in the country have tested positive for the disease, and 441,000 have died, according to data from Johns Hopkins University.

The U.S. has been administering shots at a faster daily rate than any country in the world, giving about 1.35 million doses a day, according to data gathered by Bloomberg. While the rollout stumbled in its early days, in the six weeks since the first shots went into arms almost 7.8% of Americans have gotten one or more doses, and 1.8% are fully vaccinated.

“It’s worth noting that today, for the first time, the data said that more people were vaccinated than were reported as newly diagnosed cases,” said Paula Cannon, a professor of microbiology at the University of Southern California’s Keck School of Medicine. “That’s worth celebrating. I’m all for that win.

A New York Times columnist earlier today explained

Right now, public discussion of the vaccines is full of warnings about their limitations: They’re not 100 percent effective. Even vaccinated people may be able to spread the virus. And people shouldn’t change their behavior once they get their shots.

These warnings have a basis in truth, just as it’s true that masks are imperfect. But the sum total of the warnings is misleading, as I heard from multiple doctors and epidemiologists last week.

“It’s driving me a little bit crazy,” Dr. Ashish Jha, dean of the Brown School of Public Health, told me.

“We’re underselling the vaccine,” Dr. Aaron Richterman, an infectious-disease specialist at the University of Pennsylvania, said.

“It’s going to save your life — that’s where the emphasis has to be right now,” Dr. Peter Hotez of the Baylor College of Medicine said.

The Moderna and Pfizer vaccines are “essentially 100 percent effective against serious disease,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said. “It’s ridiculously encouraging.”

Let’s go.

On the COVID-19 testing front, the Wall Street Journal reports that

The Biden administration said it has reached a $230 million deal with Australian diagnostics company Ellume USA LLC to produce at-home, over-the-counter Covid-19 tests. 

The Food and Drug Administration previously authorized the test. So far, the FDA has cleared three Covid-19 tests that can be processed entirely at home, but Ellume’s is the only one that doesn’t require a prescription. None are widely available at this point. 

The company is expected to produce 19 million tests a month by the end of the year, Andy Slavitt, senior adviser to the White House Covid-19 response team, said Monday. Based on the agreement, 8.5 million tests will be guaranteed to the U.S. government. 

Smart move.

In other news —

  • Roll Call brings us up to date on the COVID-19 relief bill developments on Capitol Hill.
  • Katie Keith helpfully updates us on Affordable Care Act litigation in the Health Affairs blog.
  • Dispatch Health and Humana announced ” an [interesting] agreement to provide Humana members with access to an advanced level of care in the home – to help enhance patients’ experience and health outcomes. These services will be available in Denver, Colo., and Tacoma, Wash., with expansion to additional markets in Texas, Arizona and Nevada planned for later this year. The agreement will provide members living with multiple chronic conditions – such as cellulitis, kidney and urinary tract infections, chronic obstructive pulmonary disease, heart failure and many others – an opportunity to be treated safely at home and thereby avoid hospital visits. Last November, the U.S. Centers for Medicare & Medicaid Services announced a waiver program to allow qualified health care providers to offer acute, hospital-level care in the home. The Dispatch-Humana agreement is believed to be the country’s first program to provide hospital-level care involving a national payer.

In pharmacy C-suite news —

  • Healthcare Dive reports that “Karen Lynch has officially stepped into the CEO role at CVS Health [on February 1, 2021]. Lynch previously served as president of the Aetna business, and was a key figure in directing CVS Health’s COVID-19 response.”
  • AP reported last week that “Walgreens has tapped Starbucks executive Roz Brewer as its new CEO, which will make her the only Black woman leading a Fortune 500 company. Starbucks announced Tuesday January 26 that Brewer was departing after a little more than three years as its chief operating officer. Walgreens later confirmed that Brewer will take over as its CEO on March 15.

Good luck.

Thursday Miscellany

David Ermer–COVID-19, HIPAA Privacy and Security Rules, Rx coverage, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

President Biden has issued a blizzard of executive orders over the last day and a half. The Hill summarizes them in this article, and for more details you can find the text of each order on Whitehouse.gov.

STAT News reports that

The Biden administration is willing to consider almost anything to boost the nation’s dwindling supply of Covid-19 vaccines.

A new strategy document released Thursday, totaling nearly 200 pages, offers the first clear list of the options President Biden has before him, though it doesn’t specifically say he’ll actually take all of the steps. On the list are some controversial ideas, like cutting the amount of vaccine being administered to each American. He’s also made it clear he wants to utilize the Defense Production Act to ramp up production of key supplies, and some more straightforward options like buying more doses.

Governors and mayors around the country have complained in recent weeks that they do not have enough vaccines to meet current demand. Biden, too, has acknowledged that the supply of physical vaccines is not where it needs to be to vaccinate a majority of Americans. Already, the Trump administration stopped holding vials in reserve, in hopes of releasing more vaccines to the public.

As of today, the CDC reports that nearly 38 million doses of the two dose vaccines have been distributed and around 17.5 million have been administered. 2.1 million of those doses have been administered at long term care facilities.

In that regard, the AP reports that

Drugmaker Eli Lilly said Thursday its antibody drug can prevent COVID-19 illness in residents and staff of nursing homes and other long-term care locations.

It’s the first major study to show such a treatment may prevent illness in a group that has been devastated by the pandemic. 

Residents and staff who got the drug had up to a 57% lower risk of getting COVID-19 compared to others at the same facility who got a placebo, the drugmaker said. Among nursing home residents only, the risk was reduced by up to 80%.

The study involved more than 1,000 residents and staff at nursing homes and other long-term care locations like assisted living homes. The vast majority tested negative at the start of the study. Some were assigned to get the drug, called bamlanivimab and which is given through an IV, and others got placebo infusions.

Also on the prescription drug front, STAT News informs us that

The Food and Drug Administration has approved a monthly injectable medication, a regimen designed to rival pills that must be taken daily.

The newly approved medicine, which is called Cabenuva, represents a significant advance in treating what continues to be a highly infectious disease. In 2018, for instance, there were approximately 36,400 newly infected patients living with HIV in the U.S., according to the Centers for Disease Control and Prevention. About 1.7 million people worldwide became newly infected in 2019, according to UNAIDS.

Although several medicines exist for treating HIV, ViiV Healthcare is banking on the improved convenience of getting a monthly shot, even if it must be administered by a health care provider. The company, which is largely controlled by GlaxoSmithKline (GSK), gathered data showing nine of 10 patients in pivotal studies claimed to prefer the shot over taking pills each day.

The Wall Street Journal reports on a phenomenon that has attracted the FEHBlog’s attention — the low levels of flu infections this winter across the Northern Hemisphere, including the U.S.

The WHO says the measures people and governments are taking to prevent the spread of Covid-19, such as wearing masks and limiting public gatherings, have probably helped keep the flu in check. Increased flu vaccination rates may also be contributing, it says.

Another hypothesis holds that the broad spread of SARS-CoV-2, the virus that causes Covid-19, in countries like the U.S. may play a role in blocking the flu by lifting people’s immunity against other viruses. One study in the spring of 2020 in New York City found that people testing positive for SARS-CoV-2 were far less likely to be carrying other common viruses such as influenza viruses. Still, research into that hypothesis is just beginning.

What is clear is the historically low number of people with the flu.

The FEHBlog also ran across another interesting Cyberscoop article with more of the backstory on the SolarWinds backdoor hack as uncovered by Microsoft.

Attackers behind an espionage campaign that exploited software built by the federal contractor SolarWinds separated their most prized hacking tool from other malicious code on victim networks to avoid detection, Microsoft said Wednesday.

The findings make clear that, while the hackers have relied on a variety of tools in their spying, the tampered SolarWinds software functioned as the cornerstone of an operation that Microsoft described as “one of the most sophisticated and protracted” of the decade. Multiple U.S. federal agencies focused on national security have been breached in the campaign, which U.S. officials have linked to Russia. * * *

After the SolarWinds trojan was delivered to organizations, the attackers spent about a month pinpointing victims, according to Microsoft. As early as May 2020, the hackers were doing the “real hands-on-keyboard activity” of moving through victim networks for valuable data, Microsoft said.

The hackers were meticulous in covering their tracks. They prepared unique malicious code implants for each victim machine, according to Microsoft, and changed timestamps of the digital clues they left behind to complicate the recovery process for organizations. Microsoft called the former technique an “incredible effort normally not seen with other adversaries and done to prevent full identification of all compromised assets.”

Midweek Update

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

Bloomberg reports that Johnson & Johnson now expects to receive Food and Drug Administration emergency use authorization for its single dose COVID-19 vaccination in late February or early March 2021 which is later than initially anticipated.

J&J’s vaccine offers advantages in ease of distribution and administration [over the currently authorized Pfizer and Moderna vaccines]. Health systems have been navigating relatively complex two-shot campaigns for vaccines from Pfizer and Moderna. J&J’s shot will likely protect people with a single dose, and can be stored at refrigerator temperatures for three months; the Pfizer and Moderna vaccines must be frozen. Speaking Wednesday at a JPMorgan Healthcare Conference event, [Moncef] Slaoui said he expects the J&J shot to have 80% to 85% efficacy, surpassing the objective the company outlined in its clinical trial design.

Speaking of the virtual annual JPMorgan Healthcare Conference, the National Law Review reports on Day 1 of the conference here and Day 2 of the conference there. Take a gander at this interesting tidbit from Day 1

[Blue Shield of California CEO] Paul Markovich spoke to the need for real-time quality information that can result in real-time feedback and incentivization to physicians and other providers, rather than the costly and slow HEDIS pursuits we see today.  One health plan noted that it spends about $500 million a year going into physician offices looking at medical records for HEDIS pursuits, but the information is totally “in the rearview mirror” as it is too old when finally received and digested to allow for real-time treatment changes, improvement or planning.  Markovich suggested four initiatives (including the above, pay for value and shared decision making through better, more open data access) that he thought could save $100 billion per year for the country.  Markovich stressed that all of these four initiatives required a digital ecosystem and asked for help and partnership in creating one. He also noted that the State of California is close to creating a digital mandate and statewide health information exchange that could be the launching point for this exciting vision of data sharing and a digital ecosystem where the electronic health record is the beginning, but not the end of the healthcare data journey.

Health Payer Intelligence informs us that

The tension between payers and pharmaceutical companies over drug pricing has carried into 2021, as evidenced by a press release from America’s Health Insurance Plans (AHIP) criticizing pharmaceutical companies for January 2021 drug pricing increases.

“Americans are being hurt by out-of-control drug prices, which are set and fully controlled by Big Pharma alone,” Matt Eyles, president and chief executive officer of AHIP, said in a related blog post.

“The incoming Biden-Harris administration should focus on bipartisan, workable solutions to protect patients, taxpayers, and all Americans from higher drug prices, especially in the midst of the ongoing COVID-19 crisis.”

Meanwhile STAT News reports that

In an unexpected move, the high-profile billionaire [Mark Cuban] has launched the Mark Cuban Cost Plus Drug Company, which its website says is “dedicated to producing low-cost versions of high-cost generic drugs” and claims that everyone will get the same low price for every drug it makes.

As part of its mission, the company pledged to provide “radical transparency” about its manufacturing, distribution, and marketing costs. The plan is to add a flat 15% margin to wholesale prices to ensure profitability, but Cuban also promised there will be no hidden costs, no middlemen, and no rebates available only to insurers.

“This is our first step towards taking on the pricing of generic drugs,” Cuban tweeted in announcing the company, which will start by producing a medicine to treat parasites, but plans to introduce more than 100 other medicines by the end of 2021. There are also plans to build a factory in Dallas by next year, according to its web site.

The article reminds us that

[In 2018] several large hospital systems form[ed] Civica Rx, a nonprofit that contracts with manufacturers to ensure sufficient supplies to hospitals across the U.S. The idea is to entice companies, which make injectable and infused medicines but have a minimum amount of sales, to ramp up investment in production. The Civica network, which began with $100 million in capital and loans from three philanthropic organizations, now has more than 50 health systems that represent more than 1,200 hospitals and over 30% of all licensed U.S. hospital beds. The nonprofit is also teaming with the Blue Cross Blue Shield Association and 18 of its health plans to supply copycat medicines and combat rising prices.

Bleeping Computer provides us with an update on the SolarWinds backdoor hack, including an explanation of how the hack was implemented and the hacker’s various malware strains.

A week ago, the FBI, CISA, and the NSA also disclosed in a joint statement that a Russian-backed Advanced Persistent Threat (APT) group is likely behind the SolarWinds hack.

“The U.S. government and many private-sector experts have stated the belief that a foreign nation-state conducted this intrusive operation as part of a widespread attack against America’s cyberinfrastructure,” SolarWinds CEO Sudhakar Ramakrishna said today.

“To date, our investigations have not independently verified the identity of the perpetrators.”