From Capitol Hill, overnight, the FY 2022 onmnibus appropriations bill language was released. The bill is over twenty one hundred pages long. The American Hospital Association has taken the time to summarize the bill’s healthcare provisions. Federal News Network discusses the bill’s federal workforce provisions. The Wall Street Journal notes
Democratic House leaders said they would remove a contentious $15.6 billion Covid-19 aid provision from the omnibus spending bill to try to get it over the finish line, after angry rank-and-file members rejected clawing back states’ unused coronavirus money to fund the proposal.
The decision to drop the Covid-19 aid was a dramatic setback for both House Speaker Nancy Pelosi (D., Calif.), who negotiated the plan, and President Biden, whose administration originally asked for $22.5 billion for Covid-19 aid and now will get nothing from the bill.
The House of Representative currently is considering the bill and a fourth continuing resolution that would last the four days beyond March 11 that the Senate needs to pass the bill. The House is expected to vote on the bill around 9:15 pm ET. Passage of the bill and the brief continuing resolution is expected.
From the Rx coverage front, Fierce Healthcare informs us
Amazon Pharmacy is partnering with Blue Plans in five states and Prime Therapeutics to tackle the affordability of prescription medications.
The online retail giant’s pharmacy arm is rolling out a prescription discount savings card that’s available to some Blue Plans members.
Integrating this discount card pricing into the shopping experience lets eligible customers compare their co-pay or discount price upfront and then apply purchases for eligible medications to the out-of-pocket maximums and deductibles associated with their insurance plan, according to Nworah Ayogu, M.D., chief medical officer for Amazon Pharmacy. * * *
Eligible plans now include Horizon Blue Cross Blue Shield of New Jersey, Blue Cross Blue Shield of Nebraska, Blue Cross Blue Shield of Alabama, Florida Blue and Blue Cross and Blue Shield of Kansas.
From the miscellany department —
The National Committee for Quality Assurance has created a health equity website.
America’s Health Insurance Plans celebrated International Womens’ Day yesterday with remarks from healthcare leaders on how health plans can improve healthcare for women.
The Centers for Medicare and Medicaid Services issued new guidance for group health plans on submitting a valid documented defense to Medicare overpayment recovery demands.
A long-awaited reform bill that would save the Postal Service more than $100 billion (H.R. 3076) is headed to President Joe Biden’s desk.
The Senate on Tuesday passed the Postal Service Reform Act, which would, among other things, eliminate a 2006 mandate from Congress to pre-fund retiree health benefits.
Postmaster General Louis DeJoy supports the bill, as do postal unions and associations, who say it will address USPS’s long-term financial challenges.
The bill will create a Postal Service Health Benefits Program (PSHBP) within the FEHBP effective January 1, 2025. A recently added feature of the bill creates a transitional Open Season in the fall of 2024. Any Postal employee or annuitant who fails to switch to a PSHBP plan will be added to the rolls of their current carrier’s PSHBP plan. However, the non-selecting Postal employees and annuitants whose current carrier is not participating in the PSHBP will wind up on the rolls of the PSHBP option with the lowest premium that is not a high deductible health plan and does not charge membership dues.
Another new feature of the bill requires the Postal Service to create a Health Benefits Education Program in mid-2023. That HBEP will include ACA navigators. It will be interesting to see, for example, whether the ACA Navigators can hold down the number of non-selecting Postal employees and annuitants in the transitional Open Season.
P.S. For fun, the FEHBlog reviewed the summary of H.R. 3076’s earliest antecedent which was S. 1789 from the 112th Congress titled the 21st Century Postal Service Act of 2012. According to the bill’s summary, this first shot also called for an HBEP. The 2022 twist is the ACA navigator feature in H.R. 3076. More accurately, the FEHBlog should describe these folks as ACA-like navigators.
For perspective on this clarification, NPR Shots discusses the good works of patient navigators in the State of Delaware. These folks have been improving the rates of cancer screenings in underserved communities which in turn has lower cancer mortality rates.
Congressional leaders spent Tuesday afternoon negotiating potential late add-ons to the fiscal 2022 omnibus spending bill, including cybersecurity legislation and a bipartisan deal to revive lapsed Violence Against Women Act authorities, with an eye on releasing final text later that day.
“Republicans and Democrats are very, very close to finalizing the agreement,” Senate Majority Leader Charles E. Schumer, D-N.Y., told reporters Tuesday after Democrats’ early afternoon caucus lunch. “I expect there will be text released in a few hours. And we’re working very hard on a few last-minute issues: cyber and VAWA.”
The schedule leaders are eying would have the House vote on the omnibus Wednesday morning and the Senate clear the measure before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
Lawmakers say they are close to an agreement to provide billions in new coronavirus relief, set to be tied to a massive government funding bill [which step would improve its chances of passage].
Congress is expected to include at least $15 billion in response to the Biden administration’s request for new funding for COVID-19 vaccines, treatments and testing.
Also from Capitol Hill, Congressional Research Service released a report on Health Reimbursement Arrangements, a tool which the Internal Revenue Service created in the early 2000s shortly before Congress added high deductible plans with health savings account to the toolbox in the Medicare Modernization Act of 2003. Nevertheless, HRAs remain handy tools for designing employer sponsored health plans such as those in the FEHBP.
From the Omicron front, the Department of Health and Human Services released a fact sheet about the Administration’s new test to treat program which is launching on a limited basis this week. Here’s a link to the fact sheet. It is evident that these sites will not be using a health department standing order to dispense the Covid medication. Instead
Are pharmacists themselves able to prescribe the oral antiviral pills (Paxlovid and Molnupiravir)?
No. The Test to Treat initiative includes sites that have health care providers available to provide timely and thorough assessment and discussion relevant to oral antiviral treatment option(s) , consistent with FDA requirements regarding these drugs. The Test to Treat initiative does not change existing requirements for a qualified health care provider to write the prescription.
NPR Shots offers more information on the program here.
Biden administration officials say [in the fact sheet] they’ll be launching a “one-stop shop” website later this month, where people will be able to find test-to-treat locations, along with sites where they can get free masks, tests and vaccines.
The test to treat program comes at a time when coronavirus cases are falling steeply in the U.S., and the supply of Pfizer’s Paxlovid pill is ramping up. These are good trends, but it’s not a time to be complacent, says Dr. James Hildreth, president and CEO of Meharry Medical College: “The virus is not done with us yet, right? And, if we do have another surge, having a system like this in place could have a huge impact on controlling it.”
Hildreth says the program holds a lot of promise — so long as it expands its outreach to rural communities, indigenous groups, and other marginalized high-risk people that need it the most.
The National Institutes of Health discusses an NIH funded research finding that the immune response from Covid vaccines improves for months after vaccination.
Govexec tells us “A federal appeals court on Tuesday appeared open to reinstating President Biden’s COVID-19 vaccine mandate, suggesting a lower court’s pause may have been overly broad.” Govexec based its view on the oral argument held before a panel of judges from the U.S. Court of Appeals for the Fifth Circuit in case calling into question the nationwide scope of the injunction created by the district court. The panel should issue its decision later this month.
Two key topics have dominated the industry conversation amid the COVID-19 pandemic: health equity and the role of technology.
But these are not distinct entities, insurance executives said Monday at the inaugural ViVE Conference in Miami, and it’s necessary to find the intersection, or “techquity.” It’s critical, they argued, that technology be viewed through an equity lens to ensure that access is fair and that the tools on offer are working for a diverse array of patients.
The national conversation about disparities, however, has helped enshrine equity as a key part of the technology conversation, said U. Michael Currie, senior vice president and chief health equity officer at Optum and UnitedHealth Group, on a panel at the conference.
and
Health tech veteran Jennifer Schneider, M.D., helped build up chronic condition management startup Livongo, then helped lead the company through a massive IPO and the industry’s largest merger with Teladoc.
Schneider and other Livongo veterans are reuniting and taking on their next challenge—improving rural healthcare.
The executive team, including Amar Kendale, former chief product officer at Livongo, and Bimal Shah, M.D., former chief medical officer at Livongo, announced Monday the launch of Homeward, a startup focused on improving access to high-quality, affordable primary and specialty care in rural communities.
From Capitol Hill, the Senate late this afternoon agreed by a 74-17 vote to end debate on the Postal Reform Act of 2022 (H.R. 3076). “The Senate stands in recess until 10:30 am on Tuesday, March 8, 2022. Following Leader remarks, the Senate will resume consideration of Calendar #273, H.R. 3076, Postal Service Reform Act, post-cloture.” The time for the final Senate vote on H.R. 3076 is yet to be determined. Senate passage, which requires a simple majority vote, is assured.
Federal News Network calls attention to the fact that a month ago today the White House issued a statement of administration policy on H.R. 3076 which reads in pertinent part
H.R. 3076 would also establish a new, separate Postal Service Health Benefits Program (PSHBP) within the existing Federal Employees Health Benefits Program (FEHBP), that integratesPostal employees and annuitants into Medicare. Making these changes would improve the Postal Service’s long-run financial outlook, without sacrificing quality, affordable healthcoverage for Postal employees and retirees. The Administration is mindful that these reforms wouldimpose administrative burdens on the Office of Personnel Management and FEHBP, and further,that there could be potential challenges with operationalizing Medicare integration and withensuring ongoing funding to support administration of the new PSHPB. The Administration looks forward to working with Congress to ensure that the goals of H.R. 3076 are met in anefficient, equitable, and cost-effective manner, while safeguarding the continued stability of the FEHBP
Top appropriators and congressional leaders are aiming to wrap up omnibus negotiations within 24 hours so they can file the massive spending package in the House on Tuesday, vote on it in that chamber Wednesday and get it through the Senate before Friday at midnight when stopgap funding expires.
While so-called open items remained, there was confidence on both sides of the aisle that talks were going well enough on the massive, long-overdue package that a fourth continuing resolution for the fiscal year that began Oct. 1 wouldn’t be necessary.
A new report released Monday charts a path for the transition out of the Covid-19 pandemic, one that outlines both how the country can deal with the challenge of endemic Covid disease and how to prepare for future biosecurity threats.
The report plots a course to what its authors call the “next normal” — living with the SARS-CoV-2 virus as a continuing threat that needs to be managed. Doing so will require improvements on a number of fronts, from better surveillance for Covid and other pathogens to keeping tabs on how taxed hospitals are; and from efforts to address the air quality in buildings to continued investment in antiviral drugs and better vaccines. The authors also call for offering people sick with respiratory symptoms easy access to testing and, if they are positive for Covid or influenza, a quick prescription for the relevant antiviral drug.
The 136-page report was written by nearly two dozen experts, a number of whom have advised the Biden administration on its Covid-19 policies. Thirty other experts contributed to the report, entitled “Getting to and Sustaining the Next Normal: A Roadmap to Living with Covid.”
Helpful. Speaking of which, the Centers for Disease Control offers advice on how to prepare children and teens for Covid vaccination.
From the healthcare cost front, Healthcare Dive reports
Higher-priced emergency care was associated with lower mortality in hospital markets with less hospital concentration, but survival rates were similar for low- and high-priced hospitals in more concentrated markets, according to a working paper released last week from the nonprofit National Bureau of Economic Research.
The researchers determined that additional spending on quality improvements at expensive hospitals in unconcentrated markets is potentially cost-effective.
However, they found no evidence of better outcomes among patients admitted for emergency care to pricier hospitals in markets with less competition, despite substantially higher costs. “In these concentrated markets, high prices likely reflect patients’ lack of alternative options, not hospital quality,” the study said.
From the healthcare business front, Fierce Healthcare tells us
GoodRx is scooping up vitaCare Prescription Services from TherapeuticsMD to beef up its growing pharma manufacturer solutions business.
VitaCare is a technology and services platform designed to make the complex process of filling prescriptions simple, cost-effective and stress-free for patients.
In recent months, the COVID-19 pandemic has highlighted the value of pharmaceutical companies being able to connect directly with patients, according to TherapeuticsMD in its latest earnings release. This in combination with the rise of interest and investment in other hub service and pharmacy services companies has driven outside interest in vitaCare both from pharmaceutical companies seeking to utilize vitaCare for their products and from potential partners or sponsors seeking to acquire a controlling interest in vitaCare.
GoodRx has agreed to acquire vitaCare for $150 million in cash, with an additional $7 million consideration contingent upon vitaCare’s financial performance through 2023, according to the companies.
The transaction is expected to close in mid-2022.
From the telehealth from, HR Tech shares large employer tips on how to promote employee use of telehealth or as its now called virtual care.
March is Women’s History Month, and the Veterans Administration gives us a chance to virtually meet several VA oncologists, some of the women who are making cancer history.
Thanks to ACK15 for sharing their work on Unsplash.
From Capitol Hill, the House of Representatives and the Senate will be in session this week for Committee business and floor voting. Of note, the Senate will continue its voting process on the Postal Reform Act of 2022 (H.R. 3076) at 5:30 pm ET tomorrow. The continuing resolution funding the the federal government expires after 11:59 pm on Friday March 11.
The Wall Street Journal notes “House Democrats set to be in Philadelphia starting Wednesday for a long-planned retreat, negotiators need to make progress quickly.” The Journal’s article adds “Some aides and lawmakers of both parties said that the chances of passing an omnibus spending measure this week had increased, in part because a fiscal 2022 measure would include financing for Ukraine and Eastern European allies and give the military flexibility for any related needs.”
From the Omicron front —
The New York Times reports on the difficulties encountered in the distributing the Evusheld antibiotic treatment that shields immunocompromised Americans who cannot receive a Covid vaccination. According to the article, immunocompromised Americans represent 3% of the population.
Novavax Inc.’s long-awaited Covid-19 vaccine is moving toward U.S. authorization after the company said it resolved manufacturing problems that had held up its application.
Clearance in the U.S. isn’t imminent because the Food and Drug Administration must sort through a large amount of study data from several countries, a person familiar with the matter said. A decision is getting closer, however, since Novavax formally submitted an authorization request in late January.
If the shot is rolled out in the U.S., it could boost vaccination efforts that have flagged among the hesitant, according to Novavax and doctors.
Vaccination campaigns have lagged behind in much of the developing world, as many countries struggle to distribute shots outside major urban areas. In Asia, countries like India, Indonesia and the Philippines have fully vaccinated half their populations. That is higher than the 13% of people living in Africa who are vaccinated, with 4% immunized in Nigeria, the continent’s most populous country. Latin America has done better. Many countries, including Brazil and Peru, have vaccinated more than 70% of their people.
Natural immunity, which refers to antibodies acquired through infection, was widespread in Indonesia when Omicron arrived. One study from October to December of roughly 20,000 Indonesians found that 74% of unvaccinated Indonesians had protective antibodies, according to Pandu Riono, a University of Indonesia epidemiologist who worked with government researchers on the study.
Based in part on the results, Mr. Riono and his colleagues estimate that 70% of Indonesians had been infected with Covid-19 as of December, far higher than the 34% of Americans who had been infected by then, according to a survey by the U.S. Centers for Disease Control and Prevention.
From the federal employment front, Federal News Network offers a transcript of an interview between Federal News Network reporter Tom Temin and American University professor Bob Tobias about the demographic characteristics of federal employees. For example, “74% of the workforce, federal workforce is 40 or older, versus 54% in the private sector.” Unquestionably, the experience of the federal employee population benefits all of us, but older workforce also impacts FEHB premiums.
From the telehealth front, Fierce Healthcare reports
Striking the balance between virtual and in-person care is a key trend to watch heading into the rest of 2022, according to a new survey from Evernorth.
Ipsos surveyed 3,000 consumers, 575 human resources professionals and 58 health plan leaders on behalf on the Cigna subsidiary. The report underscores patients’ growing comfort with virtual care and telemedicine in the wake of COVID-19, with 75% saying they agree more care will be provided virtually; 57% of those surveyed said they used virtual care over the last year.
However, consumers are not enthusiastic about virtual options in all settings, according to the survey. While 35% of those surveyed said they were satisfied with their experience in virtual primary care, just 11% said the same about behavioral health care. Nineteen percent said they were satisfied with virtual care for specialty services, while 5% said the same for physical therapy and 6% for nutrition and diet services.
While satisfaction with virtual behavioral health care was mixed in the survey, a growing number of people are seeking behavioral health services in virtual settings.
Boom!
From the strategery front, Becker’s ASC News discusses the 2022 growth strategies of Optum’s three business divisions:
Optum Health, the healthcare provider division which includes physician groups and ambulatory surgery centers
Optum Insight, which houses the data analytics platforms designed to connect clinical, administrative and financial data, and
Optum Rx, a pharmacy benefits and care services business.
Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases
The Centers for Disease Control and Prevention yesterday said more than 90% of the U.S. population now lives in a county with a low or medium COVID-19 Community Level, a new CDC measure for communities considering whether to require face coverings in public indoor settings. The agency plans to update the county data every Thursday going forward.
Cases of the highly transmissible omicron subvariant appear to be doubling every week in the U.S., but there isn’t clear evidence BA.2 will cause another major surge, epidemiologist Michael Osterholm, PhD, told Becker’s March 2. * * *
Cases will likely continue to drop over time, Dr. Osterholm said, adding he is hopeful cases will reach or fall below levels not seen since last June, when the nation’s new case average fell below 12,000.
It’s worth noting that the FEHBlog weekly chart of new cases found above begins with the low point Dr. Osterholm references, new cases under 12,000 and new deaths under 1,000.
Here’s the FEHBlog’s weekly chart of new COVID deaths
Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the 51st week of 2020 through the 9th week of 2022
From the Covid vaccine front, Bloomberg informs us
Parents still hesitating to get their kids vaccinated may be reassured by reporting that shows Covid inoculations protected children and teenagers from severe disease, even after the rise of the immune-evasive omicron variant.
Omicron came to the U.S. late last year armed with some 30 mutations in its spike protein that make it less recognizable to immune antibodies. Afterward, vaccine protection against infection and urgent care visits declined for 5- to 17-year-olds who’d received primary inoculations, according to U.S. Centers for Disease Control and Prevention data released Tuesday. However, vaccinated children and teens were still less likely to get infected than their unvaccinated peers, the agency said in its Morbidity and Mortality Weekly Report.
The CDC released recommendations last week saying that schools in areas of low and moderate risk can drop indoor mask mandates, the first update to its guidance on the topic since July — and the new findings may add confidence in moves to relax social measures as infections fall across the U.S. But many parents have been slow to get shots for their kids since the vaccine was recommended in November, and vaccinations among kids ages 5 to 11 have fallen to their lowest levels since the shots were first cleared.
While kids generally don’t get as sick as adults from the coronavirus, clearing a vaccine for elementary school-age children marked a major milestone in the pandemic. It provided peace of mind for many concerned parents, allowing kids to resume activities that had been on hold since the virus first began spreading in the U.S.
Pfizer and BioNTech’s is the only shot that has been authorized for use in U.S. children and teens. The CDC looked at vaccine protection against infection, urgent care visits, hospitalization, and death among vaccinated children ages 5 through 11 and adolescents ages 12 through 17 before and during the omicron surge.
That’s solid information for health plans to share with their members.
Here’s a link to the CDC’s Weekly Review of its Covid statistics. Beckers Hospital Review saves you time by breaking down those stats at this link.
The CDC’s weekly FluView tells us “Sporadic influenza activity continues across the country. In some areas, influenza activity is increasing.”
Negotiations over an omnibus spending package remained far from complete Thursday as the late arrival of a White House supplemental funding request threw a wrench in the talks.
The White House on Thursday formally asked lawmakers to attach to the fiscal 2022 spending package $32.5 billion in emergency funds for government response efforts to the ongoing COVID-19 pandemic and Russian war with Ukraine.
The long-awaited details from the administration on its justification for the extra spending, on top of the roughly $1.5 trillion expected to be appropriated for the current fiscal year, come barely a week before stopgap funding expires March 11.
To pass the omnibus before that deadline, Senate Appropriations ranking member Richard C. Shelby, R-Ala., said lawmakers need to get a final deal by Tuesday — and even that may be too late to avoid the need for another short-term continuing resolution.
“We made good progress this week. But we make progress and we’re stalled,” he said. “And we can’t afford to stall this weekend. If we do, we’re headed for a CR.”
From the SOTU front, AHIP released AHIP President Matt Eyles’s comments on the President’s address.
From the health equity front, Mercer Consulting released a report finding a surprising gender gap in employer-sponsored health benefits continues to exist.
From Capitol Hill, the Senate has adjourned until Monday March 7 after setting another cloture vote on the Postal Reform Act of 2022 (HR 3076) for Monday at 5:30 pm. While the FEHBlog is not a Senate procedure expert, it appears that another cloture vote is required because a minor Senate amendment was filed after the first cloture vote. Postal reform must be getting real because the Wall Street Journal posted an account of the decade-long effort to pass this legislation today.
From the Omicron front, the FEHBlog’s favorite part of the President’s new strategy was explained by the White House Covid czar yesterday:
Pfizer’s pill {Paxlovid] is a gamechanger — 90 percent effective at keeping people out of the hospital.
We collaborated with Pfizer to accelerate development of the pill. And we’ve ordered 20 million courses.
As the President announced last night, Pfizer worked overtime to further accelerate delivery. This month alone — the month of March — we’ll have 1 million of these treatment courses available. And in April, that number will more than double.
To ensure these lifesaving treatments are easily accessible, the President’s Plan launches a new “Test to Treat” initiative to provide individuals access to testing and treatment for free, all in one stop.
Hundreds of one-stop sites will open across the country this month, located at local pharmacy clinics, community health centers, long-term care facilities, and veterans’ health centers.
Marketwatch adds today that “CVS Health Corp., the Walgreens Boots Alliance Inc., and Walmart Inc. said they will participate in the test-to-treat initiative, a new program that allows someone who has tested positive for the virus to get antiviral pills during the same visit at no cost.”
Covid treatment costs were astronomical because care principally was given in hospitals and other healthcare facilities, creating a major burden on the healthcare system. Facilitating the use of Flonase for Covid will avoid the vast majority of those hospitalizations, thereby lowering healthcare costs.
Speaking of testing, the Wall Street Journal reports that
Manufacturers are developing new types of at-home tests, including for flu and strep throat, aimed at consumers who are increasingly monitoring and managing their own health through fitness apps and smartwatches.
Boulder, Colo.-based fertility company MFB Fertility Inc. received clearance from the U.S. Food and Drug Administration in February 2020 for its Proov test, designed to help women measure their hormone levels and to know when in a given month they are most likely to become pregnant. A typical kit includes 20 testing strips, allowing a woman to test daily, which the company said would be tough to achieve through visits to a doctor’s office.
Amy Beckley, the company’s chief executive, said the rise of at-home Covid-19 tests over the past year has made it much easier for people to understand her product.
“All of a sudden, home diagnostics and home testing became a thing,” she said.
The U.S. Air Force has inked a $1.3 million deal with MFB Fertility in order to provide military members and their partners the former’s home fertility tests.
The Air Force’s AFWERX office will invest in Proov, an at-home ovulation test with FDA clearance. The test works by measuring Pregnanediol Glucuronide (PdG), the urine metabolite of progesterone, which is released by the ovary after ovulation. High levels of PdG over multiple days can confirm that successful ovulation took place.
The contract will provide free Proov kits to Air Force couples upon request and connect them to fertility specialists.
Two cool innovations.
From the healthcare policy front —
The White House released a fact sheet on steps underway to address the Nation’s opioid epidemic.
The Associated Press reports on the President’s mental healthcare policy proposals made in Tuesday’s State of the Union address. For example, under the President’s plan, “Health insurance plans would have to cover three mental health visits a year at no added cost to patients.” I suggest that the Administration consider the fact that most employers offer employee assistance plans that already offer two or three free mental health therapy visits. The overcomplicated federal mental health parity law fails to look at the big picture.
From the diabetes front —
The AMA offers six tips for screening patients for pre-diabetes. Many of the tips also could be applied by health plan case managers and coaches.
The American Diabetes Association delves into the relationship between diabetes and kidney disease.
The Sackler family owners of Purdue Pharma LP reached a deal with a group of attorneys general to pay up to $6 billion in cash to resolve widespread litigation alleging that they fueled the U.S. opioid epidemic, bringing the OxyContin maker closer to exiting bankruptcy.
The attorneys general for eight states and the District of Columbia, who had blocked a previous settlement that included a $4.3 billion cash payment, announced the deal after weeks of mediation with the Sacklers.
The family agreed to pay at least $5.5 billion in cash, which will be used for abating a crisis that has led to nearly 500,000 U.S. opioid overdose deaths over two decades.
The value of the deal could grow as the family members sell additional assets.
U.S. Bankruptcy Judge Robert Drain must approve the deal, which protects the Sacklers from civil lawsuits. Purdue requested a March 9 hearing for Drain to review the agreement.
From the Rx coverage front, Biopharma Dive reports
Civica is making plans to offer three versions of insulin that can be sold at dramatically lower prices than today’s alternatives, targeting a need highlighted by President Joe Biden during this week’s State of the Union Address.
The nonprofit company, created by hospital systems and philanthropies to address drug shortages, said Wednesday it will recommend pricing of no more than $30 for the vials it produces. Name-brand versions can currently cost 10 times that amount at cash prices.
Civica announced an ambitious timeline, projecting that the first product — designed to be interchangeable with Sanofi’s Lantus — would be available as soon as early 2024. The company also aims to manufacture cheaper versions of Eli Lilly’s Humalog and Novo Nordisk’s Novolog, in both vials and pre-filled pens.
Also the Institute for Clinical and Economic Review (“ICER”) announced
it will assess the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), phentermine / topiramate (Qsymia, Vivus Pharmaceuticals), liraglutide (Saxenda, Novo Nordisk), and naltrexone/bupropion (Contrave, Currax Pharma) for the treatment of obesity.
The assessment will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in September 2022, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
From Capitol Hill, the Senate press gallery informs us “The Senate will convene Thursday at 10:00 am and resume the postal reform bill, which ML Schumer filed cloture on this evening.” It’s worth noting that yesterday “Amendment SA 4955 [was] proposed by Senator Schumer for Senator Peters. (consideration: CR S872; text: CR S872) To modify the deadline for the initial report on the operations and financial condition of the United States Postal Service.” The FEHBlog did not expect any amendments to be offered. Nevertheless, the bill appears on track to passage soon.
From the State of the Union address department
Healthcare Dive discusses the President’s healthcare policy proposals.
The Society for Human Resources Management discusses the President’s employment policy proposals.
From the Omicron front, the Administration announced a new Covid strategy today. Beckers Hospital Review lists eight highlights from the new strategy. The Wall Street Journal adds
The plan underscores the administration’s shifting focus from responding to the pandemic crisis to a new normal that focuses on managing the disease. But the road map, the result of weeks of work with advisers, state leaders and public health experts, relies heavily on Congress approving billions of dollars in new Covid-19 relief funding.
The Sequoia Project’s Emergency Preparedness Information Workgroup (EPIW) has published a free whitepaper that outlines public health recommendations based on lessons learned from COVID-19 response efforts.
EPIW members created a SWOT (strengths, weaknesses, opportunities, threats) analysis of the COVID-19 response. They then consolidated this data into 17 recommendations to help local, state, and federal stakeholders prepare for a more coordinated national response to the next public health emergency.
The Food and Drug Administration issued “three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care.”
The HHS Office for Civil Rights published guidance on gender-affirming care, civil rights, and patient privacy. The underlying policy as explained in the guidance is as follows:
The Department of Health & Human Services (HHS) stands with transgender and gender nonconforming youth and their families—and the significant majority of expert medical associations—in unequivocally stating that gender affirming care for minors, when medically appropriate and necessary, improves their physical and mental health. Attempts to restrict, challenge, or falsely characterize this potentially lifesaving care as abuse is dangerous. Such attempts block parents from making critical health care decisions for their children, create a chilling effect on health care providers who are necessary to provide care for these youth, and ultimately negatively impact the health and well-being of transgender and gender nonconforming youth.
On the Rx coverage front, Beckers Hospital Review informs us “Annual spending on pharmaceutical products has skyrocketed since 2010, though out-of-pocket costs have fallen, according to a Feb. 28 report from ValuePenguin.”
From the truth is stranger than fiction department, Govexec reports
The panel tasked with enforcing [federal] civil service protections has regained a governing quorum after the Senate approved two of President Biden’s three nominees on Tuesday, putting an end to five years of dysfunction.
Both Tristan Leavitt and Raymond Limon won unanimous support in Senate voice votes, giving the Merit Systems Protection Board confirmed members of its central panel for the first time since 2019. The board needs at least two of its three slots filled to have a quorum and hear appeals, which has not occurred since January 2017. Cathy Harris, Biden’s third and final nominee for the board, is still awaiting a vote in the Senate.
The quasi-judicial agency has a backlog of more than 3,500 cases pending before its central board, which the nominees have pledged to quickly address through an expedited process. Regional administrative judges at MSPB have continued to hear cases of alleged violations of prohibited personnel practices by federal agencies, but agencies or individuals that have sought further appeal to the board’s presidentially appointed, Senate-confirmed central panel have seen their causes languish—in some instances, for years.
From Capitol Hill, the Senate approved a motion to proceed to a vote on the Postal Reform Act of 2022 (HR 3076) by a voice vote. This vote suggests to the FEHBlog that the Senate will approve the bill this week.
Roll Call discusses the status of the Consolidated Appropriations Act for Fiscal Year 2022. Congress has a week and half to finish cobbling together this law before it needs a fourth continuing resolution.
From the Omicron vaccine front, the American Hospital Association tells us
The Centers for Disease Control and Prevention today released a study examining the effectiveness of the Pfizer COVID-19 vaccine at preventing emergency department and urgent care visits by children aged 5-11 and 12-17. Among children aged 5-11, effectiveness 14-67 days after dose 2 (the longest interval in this age group) was 46%, significantly lower than overall estimates for adolescents aged 12-17. However, most encounters among children aged 5-11 occurred during omicron predominance, when the vaccine’s effectiveness also significantly declined for adolescents, suggesting that the lower effectiveness for children aged 5-11 was likely driven by the predominant variant rather than differences in effectiveness across age groups, the authors said. During omicron predominance, there was no evidence 2 doses protected adolescents after 150 days; however, a booster dose restored effectiveness to 81% in this age group, the authors said.
Another study released today by the CDC looks at reactions to the Pfizer booster in adolescents aged 12-17, which were generally mild to moderate and transient. Myocarditis was less frequently reported after a booster dose than a second primary dose, the authors said.
Federal agencies can relax their mask and testing protocols in the wake of new public health guidance.
The Centers for Disease Control and Prevention’s released on Friday a “new framework” that “moves beyond just looking at cases and test positivity to evaluate factors that reflect the severity of disease, including hospitalizations and hospital capacity, and helps to determine whether the level of COVID-19 and severe disease are low, medium, or high in a community,” Dr. Rochelle Walensky, the agency’s director, said on a call with reporters. Guidance from the Biden administration’s Safer Federal Workforce Task Force on Monday reflects this new framework.
“This document provides federal agencies with initial implementation guidance they should follow in utilizing the CDC’s COVID-19 Community Levels to determine the appropriate mask-wearing and screening testing requirements for each federal facility at a given time,” said the guidance.
Wild demand swings have been a subplot in the pandemic, from vaccines to hand sanitizer, along with tests. On the first day of the White House test giveaway in January, COVIDtests.gov received over 45 million orders. Now officials say fewer than 100,000 orders a day are coming in for the packages of four free rapid tests per household, delivered by the U.S. Postal Service.
It would be a good idea for the federal government to tell health plans to refer their members to the federal site if they are interested in receiving test kits.
To sum it up from the Omicron front, check out the lead article from the NIH Director’s blog titled “How Covid immunity holds up over time.”
From the tidbits department —
The CDC discusses the unholy connection between diabetes and chronic kidney disease.
UnitedHealth Group is beginning to act on its November promise to shore up its sustainability efforts by halting its mailing paper of prior authorization and clinical decisions to providers, according to a Feb. 25 post on the California Medical Association website.
The first move — a nationwide shift to digital clinical decision letters — is effective March 4 for most UnitedHealthcare Medicare Advantage and commercial plan members. Instead of receiving a mail appeal decision, providers can view the decisions digitally immediately after they are made.
President Joe Biden is calling for more federal employees to return to the office, saying “significant progress” fighting the COVID-19 pandemic has made it safer to do so.
Ahead of his State of the Union address, Biden issued a letter Tuesday thanking the federal workforce for its “tireless work this past year” confronting the pandemic and leading economic recovery efforts.
A return to the office, however, doesn’t necessarily mean a return to the pre-pandemic status quo.
Biden urged agencies to “build on the innovations and technologies that we put to work serving the American people throughout the pandemic, making our government more efficient, resilient, and effective.”
To the FEHBlog’s dismay, the Labor Department’s Employee Benefits Security Administration announced this evening that the federal government is accepting, at least for the time being, Judge Kernodle’s interpretation of the No Surprises Act discussed in yesterday’s Weekend Update post.
The Departments [/ the ACA regulators] are reviewing the court’s decision and considering next steps. This announcement serves as a notification to health care providers, emergency facilities, providers of air ambulance services, group health plans, health insurance issuers, Federal Employees Health Benefits (FEHB) Carriers (“Disputing Parties”), and certified IDR entities of steps the Departments are taking to conform to the court’s order. Specifically, the Departments will:
— Effective immediately, withdraw guidance documents that are based on, or that refer to, the portions of the Rule that the court invalidated. Once these documents have been updated to conform with the court’s order, we will promptly repost the updated documents
— Provide training on the revised guidance for certified IDR entities and Disputing Parties. This training will be offered through webinars and roundtable discussions, and will occur after the above-referenced documents are updated.
— Open the IDR process for submissions through the IDR Portal. For disputes for which the open negotiation period has expired, the Departments will permit submission of a notice of initiation of the IDR process within 15 business days following the opening of the IDR Portal.
The Departments had the option of filing a notice of appeal and asking the court to stay the case pending the appeal’s outcome. The Departments thought this favorable outcome is unlikely. But, in the timeless words of Kenny Rogers, you have to know when to hold them and when to fold them.
The Senate Press Gallery reports this evening the Senate voted 74-20 to invoke cloture on the Postal Reform Act of 2022, H.R. 3076, which means that the bill will be called up on the Senate floor later this week for a final vote. That vote requires a simple majority for passage.
Earlier in the day, the Congressional Budget Office released a supplemental letter on HR 3076 in which
CBO addresses the following questions concerning the agency’s assessment of the budgetary effects of H.R. 3076, the Postal Service Reform Act of 2022, which CBO transmitted on February 4, 2022.
— What are the budgetary effects and costs to the Medicare program of H.R. 3076 over the next 20 years?
— What is the effect of the legislation on the Medicare Hospital Insurance Trust Fund?
— What is the effect on Medicare premiums in Part B and Part D?
In health equity news, Kaiser Permanente announced
Colorectal cancer disparities between Black and white adults were eliminated among Kaiser Permanente members in Northern California after the health care organization instituted a regionwide, structured colorectal cancer screening program, new research shows.
“Our study found that organized screening works to improve colorectal cancer outcomes for all of our members,” said the study’s senior author Theodore R. Levin, MD, a research scientist at the Kaiser Permanente Division of Research and a gastroenterologist with The Permanente Medical Group. “I knew our program had helped to reduce disparities, but I was surprised by the magnitude and the rate of improvement. It exceeded my expectations.”
The article provides details on a structured program. Bravo KP.
From the telehealth front, Healthcare IT News reports
Teladoc Health announced this week that it was partnering with Amazon to launch voice-activated virtual care on Alexa-supported Echo devices.
According to the companies, U.S. customers around the country can connect with a Teladoc provider via audio at any time for general medical needs.
“By introducing and integrating our virtual-first care experience with Echo devices, we are providing an innovative and convenient way for users to connect with a doctor,” Donna Boyer, chief product officer at Teladoc Health, said in a statement.
“We are meeting consumers where they are, to continue to deliver value and high-quality care to members,” Boyer said.
From the looking forward department, ICD 10 Monitor tells us
On Feb. 11, the World Health Organization (WHO) released ICD-11 2022. This is the official version of the 11th revision of the International Classification of Diseases (ICD) coding set that WHO member countries will be implementing worldwide. In fact, according to the WHO release announcement, 35 countries are already using ICD-11.
In addressing implementation timeframes, the WHO anticipates that * * * countries with highly sophisticated information systems, where earlier versions of ICD are already in use [such as the U.S.], may require 4 -5 years to transition to ICD-11. * * *
So, when will the U.S. replace ICD-10-CM and begin using a version of ICD-11 for reporting on healthcare claims? Well, we don’t know yet. But this release of the official ICD-11 is sure to spur activity in this respect.
In September 2021, the National Committee on Vital and Health Statistics (NCVHS) issued recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) advising on a research agenda to evaluate the use of ICD-11 in the U.S. This release of the official ICD-11 2022 version from the WHO is sure to increase research activity.
So, while the timeline for a U.S. transition to ICD-11 is still uncertain, it’s clear that planning for the transition to ICD-11 is underway.
The FEHBlog, whose crystal ball is not the clearest, predicts 2029 as the over/under year for ICD-11 implementation.
Congress is back in session this week for Committee business and floor voting. The Senate calendar notes the cloture motion on the Postal Reform Act of 2022 ripens tomorrow February 28 at 5:30 pm. This means that the Senate can hold a cloture vote on the bill later that evening or the following business day. A cloture vote requires 60 votes in favor.
We are eleven days away from the end of the current continuing resolution funding the federal government. That deadline will grab Congress’s attention.
The President will give his State of the Union address on Tuesday, March 1.
From the No Surprises Act (NSA) front, Prof. Katie Keith breaks down the Texas Medical Association decision rendered last Wednesday in the federal district court for the Eastern District of Texas. At stake were the provisions in the second interim final rule implementing the NSA that the independent dispute resolution entity acting as the arbitrator to resolve payment disputes between health plans and certain out-of-network provider accept the plan’s statutory payment known as the Qualifying Payment Amount “unless a party submits credible information that clearly demonstrates that the QPA is materially different from the appropriate out-of-network rate.”
On February 23, Judge Kernodle * * * issued a decision and final judgment vacating provisions of the interim final rule related to the “rebuttable presumption.” He held that the plaintiffs had standing to challenge the rule, that the rule is inconsistent with the NSA, that the federal agencies should not have bypassed notice and comment procedures, and that the challenged provisions should be vacated and remanded to the agencies for revisions. The vacated provisions, listed here, are:
— The requirement that the IDR entity select the offer closest to the QPA unless there is credible information to demonstrate that this is not the appropriate rate;
— The requirement that “additional information” clearly demonstrate that the QPA is materially different from the out-of-network rate;
— The definition of “material difference;”
— All four examples on how IDR entities should choose between competing offers; and
— The requirement that the IDR entity explain why it chose an offer not closest to the QPA.
As you can see, this is a relatively surgical approach; these are the only provisions in the rule that have been invalidated. But these are important provisions designed to ensure a well-functioning, predictable IDR process and help hold down health care costs and premiums.
Professor Keith adds
Judge Kernodle rejected [the federal government’s] requests for limited relief. Instead, he vacated the challenged provisions on a nationwide basis with a sweeping assertion that “there is nothing the Departments can do on remand to rehabilitate or justify the challenged portions of the Rule as written. * * *
From here, DOJ will presumably appeal Judge Kernodle’s decision to the Fifth Circuit and perhaps request a stay while the case is on appeal. If a stay is not granted, the court’s decision remains in effect, meaning the IDR provisions noted above are unlawful and set aside. The IDR process will still be available and is expected to begin in earnest in March 2022. But the ruling increases the risk that some providers will try to leverage the federal IDR process to obtain higher rates than are warranted, potentially leading to higher health care costs and premiums.
What’s more,
Federal officials have already indicated that they will issue a final IDR rule by May 2022 and will likely be reviewing Judge Kernodle’s decision with an eye towards whether the final rule can include provisions that are similar to those in the interim final rule—as well as whether to rescind or replace the challenged provisions. The final rule will likely affect the timeline of current litigation and perhaps trigger future lawsuits.
It’s not a pretty picture for health plans at this point.
From the Omicron front, the Wall Street Journal discusses the steps that government agencies and public health organizations are taking to make rapid at home Covid tests available and understandable to the most vulnerable of us, “including low-income areas, rural parts of the country and some communities of color.”
From the behavior health care front, Health Payer Intelligence tells us
AHIP called on providers and policymakers to join payers in their efforts to integrate behavioral healthcare and physical healthcare in an issue brief on the subject.
The payer organization laid out three critical strategies for integrating behavioral healthcare.
The collaborative care model (CoCM) uses care management to facilitate patient-centered care, and many of its services are recognized and reimbursed by CMS.
The expanded and integrated care management model uses care management to support individuals with chronic conditions, specifically behavioral healthcare conditions. The model leans on screening tools in the primary care environment to identify conditions earlier.
Finally, the value-based purchasing and alternative payment models incentivize whole-person care financially. However, outcomes-based payment is challenging to measure in behavioral healthcare.
This is straight path to federal mental health parity compliance. Thanks AHIP.
From the OPM front —
Fedscoop lists the important links on the OPM website for federal and Postal employees considering retirement or about to retire.
Govexec discusses a recent GAO report on an OPM information technology project to overhauls it financial system for managing the government’s fringe benefit programs, including the FEHB.
From the good works department, Fierce Healthcare reports
Health Care Service Corporation [a Blue Cross licensee] is teaming up with the National Fitness Campaign to open outdoor fitness centers in Illinois and Texas.
The insurer will invest $850,000 to open 35 Fitness Courts across both states, according to an announcement. Construction is set to begin this summer, with the goal of opening the first locations in the fall.
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