The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.
Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:
During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:
Special enrollment rights under HIPAA
COBRA elections, payments and notifications
Benefit claims, appeals and external reviews
Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.
This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.
Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.
Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:
Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.
CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,
The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed.
The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.
CMS also offered a fact sheet on the final actions.
From the SDOH front, Health Payer Intelligence informs us
OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.
OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.
The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.
OMB will release changes to Directive No. 15 in 2024.
Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.
Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.
The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.
The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.
With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.
“The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).
This decision must have the American Hospital Association flipping its lid.
The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.
By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.
The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.
Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.
The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.
Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.
Food and Drug Administration officials could make the decision within a few weeks, the people said.
The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.
The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available.
From the primary care front, Healthcare Finance informs us
People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.
That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *
The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.
Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.
From the miscellany department —
Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:
From our Nation’s capital, the President presented his Fiscal Year 2024 budget to Congress today. Roll Call informs us
While spending would increase by $1.9 trillion over a decade, revenue would increase by $4.7 trillion, for over $2.8 trillion in a 10-year deficit reduction. But according to the Office of Management and Budget’s numbers, the budget shortfall would still total more than $17 trillion over the next decade even if Biden’s plans were fully implemented, which seems unlikely.
The Wall Street Journal adds, “Biden’s budget shows the rising cost of leaving Medicare and Social Security untouched. In the President’s blueprint, the two programs plus interest consume a sharply growing share of economic output.
The President’s proposed spending and tax increases will face an unfriendly reception among Republicans in Congress, as lawmakers gear up for a fight over the debt ceiling that could come before the Sept. 30 end of the fiscal year. GOP leaders in the House have called for unspecified spending cuts as a condition of raising the federal debt limit. But the president has said he won’t negotiate over raising the debt ceiling.
Republicans plan to release their own budget proposal in the coming months, though they haven’t agreed on a plan.
The President will make public more budget details over the next few days. Until then, it’s worth noting that the budget includes the following healthcare proposal
The budget proposes $11 billion for a five-year effort the White House hopes will eliminate hepatitis C in the U.S., said Dr. Francis Collins, the former National Institutes of Health director who is spearheading the initiative. Drugs to treat the disease have been on the market since 2013, but normally retail for about $24,000 per patient.
In related news, the American Hospital Association tells us,
“The Centers for Disease Control and Prevention [CDC] today recommended screening all U.S. adults at least once in their lifetime for hepatitis B using three laboratory tests. It also expanded risk-based testing recommendations to certain populations and activities with increased risk for the hepatitis B virus.”
The FEHBlog is unsure how this meshes with the ACA’s preventive services mandate because the current US Preventive Services Task Force recommendation is Grade B for “screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.” The CDC’s new recommendation is significantly broader.
The Office of Personnel Management released on March 7 “a new memorandum today detailing a vision for the future of the workforce: a Federal government with a workforce that is inclusive, agile and engaged, with the right skills to enable mission delivery.”
From the public health front —
The Kaiser Family Foundation notes ten numbers to mark the third anniversary of the Covid pandemic
The Dana Farber Cancer Institute highlights a comprehensive article about colon cancer in young adults.
The Food and Drug Administration “published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
The New York Times reports, “A review of poisonings among children 5 and younger found that opioids contributed to nearly half of the deaths from 2005 to 2018, largely from accidental overdoses, according to new research. * * * The study, published on Wednesday in the journal Pediatrics, analyzed 731 poisoning-related deaths that occurred from 2005 to 2018 across 40 states.”
From weight loss drugs front —
STAT News continues its reporting on obesity drugs. The latest article concerns “‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments.”
Medscape provides the account of a physician who took the new obesity drugs, specifically Ozempic. This article is particularly worth a gander.
From the SDOH front, Mercer Consulting lays out its latest “Must-Do Strategy: Lean in on Benefits Strategy to Support DEI Goals.”
From the miscellany department
Cigna offers its insights on how to choose among virtual care, urgent care centers, and emergency rooms.
“In a March 8 Twitter thread, the FDA acknowledged it’s aware of a potential drug supply disruption after Gurnee, Ill.-based Akorn Operating Co. closed in late February.
“The FDA clarified that the ongoing shortage is of a specific albuterol inhalation solution used in nebulizers, typically in hospitals, for patients having trouble breathing, not in inhalers at the consumer level. The agency said it is working with manufacturers to ease the shortage and “reiterated that outsourcing facilities may compound the specific product.”
Finally, following up on the FEHBlog’s message to Congress about FEHB prescription drug costs, OPM stated its position against carving out prescription drug coverage from FEHB carrier responsibilities in the agency’s FY 2018 annual financial report on page 123:
OPM does not concur with OIG’s suggestion that OPM continue to pursue efforts towards a prescription carve-out program. The Federal Employees Health Benefits (FEHB) Program is a market-based program that provides complete health benefits within each FEHB plan. The FEHB Program is not a self-funded plan and its statutory framework does not contemplate it to be the direct payer of benefits. Each FEHB Program plan offers comprehensive medical services including services provided by physicians and other health care professionals, hospital services, surgical services, prescription medications, medical supplies and devices, and mental health services. FEHB Program plans compete to offer all of these benefits in a high quality manner at the most competitive price possible.
Carving out pharmacy benefits or any of the other services normally covered under an FEHB Program contract and administering the benefit as a separate contract or program, could undermine the fundamental market-based nature ofthe FEHB Program. It would be disruptive and could lead to a reduction in plan participation, and limit the ability of FEHB carriers to focus on comprehensively improving the health of the population. There would likely be less effective
coordination of medical and pharmacy claims, and potentially less effective, one-size-fits-all pharmacy utilization and disease management programs. OPM is now assessing carrier performance on the basis of clinical quality measures that require tight coordination between medical and pharmacy benefits. A carved out pharmacy benefit is not consistent with or supportive of plan performance assessment, and may impair achievement of OPM’s long-term population health goals. As an example, carriers being held accountable for controlling diabetes and hypertension in the population they serve cannot do so readily if they do not have control over pharmacy benefit design and real time access to adherence data.
To control the cost of prescription drugs, OPM works with carriers to better manage pharmacy networks, focus on drug utilization techniques, coordinate coverage of specialty drugs between the medical and pharmacy benefit, optimize the prescription drug benefit via formulary design, and implement effective cost comparison tools for members and prospective enrollees. Additionally, OPM notes that the most recent drug trend reported by FEHB carriers showed a significantly slower rate of growth compared with previous years, in line with industry trends.
This statement continues to warm the FEHBlog’s heart.
American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.
Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men.
The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.
Following up on recent posts —
The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
“Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
“Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.
In other news
JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
“Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
“The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
“The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
NPR discusses efforts to right various healthcare debt collection wrongs:
“Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
“In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
“And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”
The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
“Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
“The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
“The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.”
“That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
OPM should inform Rep. Comer that
The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
In sum, the FEHB Program remains a model employer-sponsored health program.
As we close out Black History Month, let’s join the Trust for American Health in celebrating notable African American in public health.
From the Covid front, the Wall Street Journal reports
The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.
The shift by the Energy Department, which previously was undecided on how the virus emerged, is noted in an update to a 2021 document by Director of National Intelligence Avril Haines’s office.
The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.
From the miscellany department —
Fortune Well provides us with insights on how to manage a life-threatening diagnosis.
Health Payer Intelligence tells us what payers can expect to find in the proposed CMS electronic prior authorization rule. The public comment deadline on the rule is March 13, 2023
Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity. A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
“The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”
From the medical research front
STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.”
Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
The All of Us program shared its research roundup, focusing on heart disease this month.
The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
From the U.S. healthcare business front —
Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.” A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction.
Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA.
Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”
From the miscellany department —
Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below. Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”
From the Omicron and siblings front, the Wall Street Journal reports
Most people would get one Covid-19 shot annually—as they do with the flu shot—under Food and Drug Administration proposals for simplifying the nation’s Covid-19 vaccine procedures.
The drug regulator also proposed that people getting vaccinated for the first time receive vaccines that target both Omicron and the original strain of the coronavirus.
The proposals, outlined in materials the FDA released Monday, would mark the biggest changes to Covid-19 vaccinations since boosters rolled out and are a sign of the nation’s shift to a more endemic-like approach to the coronavirus.
Vaccine experts who advise the FDA are scheduled to meet Thursday to discuss the proposals. The advisers are scheduled to vote on whether to give the bivalent shot as the initial inoculation, as is already allowed in Europe.
Makes sense to the FEHBlog.
From the OPM front, the House Oversight and Reform Committee Chairman James Comer (R-Ky.) has sent OPM Director Kiran Ahuja a letter demanding documents and a staff briefing on the recent GAO report criticizing OPM’s internal controls over family member eligibility in the FEHBP. Here’s a little free advice for my favorite agency. Rather than coming up with your own solutions, adopt solutions that have been proven to work in the private sector — the HIPAA 820 standard enrollment transaction which ties premium payments to enrollees and dependent eligibility verification audits based on statistical sampling.
Elevance Health has inked a deal to acquire Blue Cross and Blue Shield of Louisiana, with the Pelican State insurer joining the Anthem Blue Cross affiliated plans.
The acquisition builds on an existing partnership between the two insurers, according to the announcement. The two jointly own Healthy Blue, a plan that serves Medicaid and dual-eligible beneficiaries.
The combination will also allow BCBSLA to accelerate its push toward improved access, affordability and quality for its 1.9 million members, thanks to the capabilities of Elevance Health’s Carelon subsidiary, the companies said. More than $4 billion has been invested in Carelon over the past several years, building out its behavioral health, complex and chronic care programs and digital health models.
and
CVS Health has named two key leaders for its pharmacy and consumer products business, including a returning face to the company, according to a report from Bloomberg.
David Joyner, a former executive at the company, will make a return as the leader of its pharmacy services segment, which includes the Caremark pharmacy benefit manager, people familiar with the matter told the outlet. Joyner left CVS three years ago and will succeed Alan Lotvin, M.D., who is set to retire.
In addition, former Express Scripts President Amy Bricker will join the company as the chief product officer for the consumer segment, which centers on developing new products for CVS’ consumer health brands, Bloomberg reported.
Fierce Healthcare points out a twist in the second story.
That Bricker had departed Express Scripts, a subsidiary of Cigna, was revealed last week when the PBM announced it had named a new president, veteran supply chain leader Adam Kautzner. What was next for Bricker, however, was conspicuously absent from the announcement.
The FEHBlog often counsels clients on Family and Medical Leave Act issues. He had no idea until today that the Labor Department offers helpful information to healthcare provider and employees on this law. For example,
This background information can fill knowledge gaps for employers too.
From the Rx coverage front —
The Washington Post reports on the reaction to “the American Academy of Pediatrics guidelines, based on decades of scientific research, call[ing] for early and aggressive treatment, instead of “watchful waiting.” They urge intensive therapy for children as young as 6, weight loss drugs for those as young as 12 and surgery for teens as young as 13.”
The Institute for Clinical and Economic Research released a
Final Evidence Report on Fezolinetant for Vasomotor Symptoms Associated with Menopause
— Independent appraisal committee voted that evidence is not yet adequate to demonstrate a net health benefit for fezolinetant when compared to no pharmacological treatment —
— Using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,600 per year for women who cannot or choose not to take menopausal hormone therapy —
— All stakeholders have a responsibility and an important role to play in ensuring that women have access to effective new treatment options for symptoms of menopause
The ICER upshot is “Given that many patients may benefit from readily available, effective, and low cost [menopausal hormone therapy] MHT, clinical experts agreed that it would be reasonable for payers to require prescriber attestation that patients are not appropriate candidates for MHT prior to prescribing fezolinetant.”
From the SDOH front, Health Leaders Media tells us about new ICD-10 diagnosis codes with an SDOH emphasis which will take effect on April 1, 2023.
The study included 387 patients who participated in first-time visits between May 2021 and June 2022 at general surgery clinics across the Vanderbilt system. Researchers used a standard questionnaire to look at the quality of shared decision-making and asked patients and surgeons open-ended questions about their consultations.
In all, 77.8% of patients had an in-person visit, while 22.2% saw their doctor remotely.
Both groups reported high levels of quality communication during these appointments.
Levels of shared decision-making and quality of communication were similar between remote visits and in-person care, the study found.
In responding to the open-ended questions, patients praised the convenience and usefulness of telehealth appointments. Researchers received some negative comments about technical difficulties and not being physically present.
Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.
In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”
Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.
That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.
From the Omicron and siblings front, Healthcare Dive reports that
In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.
Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said.
To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.
The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.
From the CMS front —
CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.
In other HHS news —
HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.
From the drug development front —
The Wall Street Journal reports
A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.
The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.
The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.
Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).
Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.
From the healthcare business front, Fierce Healthcare tells us
Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress.
The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *
Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said.
From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today
The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”
This is Red Ribbon Week, “an ideal way for people and communities to unite and take a visible stand against drugs.”
Speaking of illegal drugs, the Wall Street Journal tells the stories of three “high achieving” New York City dwellers who died on one day in March 2021 due to fentanyl-laced cocaine delivered by a single dealer.
New York City authorities have been warning of the risks of unknowingly taking fentanyl in cocaine and of its increased presence in cocaine seized by police. Health officials put up posters and sent drink coasters to clubs warning cocaine users to start with a small dose and to have naloxone, an opioid reversal drug, on hand to counter an overdose. They are handing out fentanyl testing strips that can be used to test cocaine and other drugs for fentanyl’s presence.
Multiple people died within hours from tainted cocaine in Long Island, N.Y., and in Newport Beach, Calif., last year. Nine were killed in Washington, D.C., in January. Law-enforcement officials said dealers often use coffee grinders or other basic equipment to cut drugs and prepare them for sale, which can result in deadly batches.
From the FEHB front, Tammy Flanagan, writing in Govexec, advises federal and postal employees and annuitants on how to prepare for the upcoming Federal Employee Benefits Open Season. The FEHBlog’s advice is to stack your plan’s summary of benefits and coverage which is available on all FEHB plan websites against other plans in which you are interested. The summary of benefits and coverage, which is an Affordable Care Act requirement, is four double-sided pages including consumer-tested practical information.
From the Omicron and siblings’ front
STAT News reports “FDA’s vaccines chief [Peter Marks, MD] sees the possibility of more Covid boosters — sooner than he’d like.”
Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private market.
The pharmaceutical company is targeting between $110 and $130 per adult vaccine dose after that transition, said Angela Lukin, Pfizer’s head of global primary care and U.S. president, on an analyst and investor call Thursday.
“We feel confident that this range will be seen as highly cost effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine,” Lukin said on the call. Discussions with insurers are still in early stages, she added.
No doubt this charming development seeks to pressure Congress to add more federal Covid dollars in the lame-duck session following the November 8 Congressional election.
In other vaccine news, MedPage Today reports
The CDC’s vaccine advisors updated their recommendations to clarify when to administer the 20-valent conjugate pneumococcal vaccine (PCV20; Prevnar 20) in adults who previously received the 13-valent conjugate vaccine (PCV13; Prevnar 13).
Three doses of hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG; Heplisav-B) notched a perfect mark when it came to seroprotection for people with HIV who had never before been vaccinated against the hepatitis B virus (HBV), early results of a phase III trial showed.
In prescription drug development news, Fierce Healthcare points out “three drugs are set for FDA determinations soon.” The article explains why Optum says payers should take notice.
Cases of monkeypox are continuing to decline in the U.S., but the disease is still disproportionately affecting people of color, a White House official said.
“In the U.S., about 27,635 cases were reported as of yesterday,” Demetre Daskalakis, MD, White House National Monkeypox Response deputy coordinator, said at an online briefing Thursday. “We continue to have a decrease over time — we’re about 85% down from where we were at the peak of the outbreak. So that’s a lot of hopeful news, that we continue to see monkeypox going under better and better control.”
From the mental healthcare front, the Department of Health and Human Services “through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. BSCA, signed into law by President Biden earlier this year, provided unprecedented funding to address the nation’s mental health crisis and make our communities safer.”
From the maternal care front, Health Payer Intelligence informs us Blue Cross and Blue Shield of Michigan has “decided to go beyond traditional maternal healthcare benefits, such as prenatal and postpartum care coverage. They teamed up with a virtual care provider for women and family health, Maven, to offer a suite of solutions that integrated family care and maternal healthcare.”
In a letter to HHS Secretary Xavier Becerra and Management and Budget Office Director Shalanda Young, AHIP explained its vision for how demographic data can be improved and standardized across the healthcare system.
Five things to know about the association’s recommendations for improving demographic data:
1. Current challenges with demographic data include the lack of specificity for questions on race. AHIP highlights that current census and HHS standards do not include an option for people to identify as Arab, Middle Eastern or North African. Additionally, AHIP recommends options should be tailored to the local area, depending on the populations that live there.
2. Current demographic questions do not have an “I choose not to respond” option. AHIP advises that a lack of information about how demographic information is used can lead to a lack of trust from patients.
3. Current regulations that require multiple providers and payers to collect demographic information lead to inconsistent results and greater burden on patients, AHIP says.
4. To reduce burdens on providers and patients, AHIP wants demographic data to be electronic and able to be shared with other places in the healthcare system with patient consent.
5. AHIP wants a wide range of government agencies to adopt its recommendations for demographic data collection, which include questions on race, ethnicity, language preference, sexual orientation, gender, diability status, veteran status and spirtual beliefs.
STAT New discusses weaknesses in traditional Medicare catastrophic coverage. FEHBlog suggests that Congress stop permitting Medicare supplemental plans to impose pre-existing condition limitations unless circumscribed by state law.
The Society for Human Resources Management tells us
Employee 401(k) contributions for 2023 will top off at $22,500—a $2,000 increase from the $20,500 cap for 2022—the IRS announced on Oct. 21. Plan participants age 50 or older next year can contribute an additional $7,500, up $1,000 from 2022. * * *
he limit on total employer-plus-employee contributions to defined contribution plans will increase to $66,000 in 2023, up by $5,000 from $61,000 in 2022. “This limit usually increases by $1,000 at a time but now it’s jumping five steps in one year,” Sit said.
The IRS announced the 2023 adjustments for 401(k) and similar defined contribution plans, and for defined benefit pension plan, in Notice 2022-55.
The American Hospital Association reports “The AHA and American Medical Association Oct. 19 filed a friend-of-the-court brief in support of a Texas Medical Association lawsuit claiming the revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in ways that violate the compromise Congress reached in the Act.”
Business Insurance tells us “The U.S. Department of Justice has asked for more details on CVS Health Corp.’s proposed $8 billion deal to buy Signify Health, in a possible indication that the transaction will face a longer deal review rather than a quick approval, Reuters reports. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts.”
Following up on last Thursday’s post, RSV is a type of common cold according to the CDC.
the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”
Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.
Omicron-tailored shots by Pfizer Inc and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.
The New York Times provides an update on the new Omicron variants, including this critical point
Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.
Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.
The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.
Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.
Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds.
Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff.
“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report.
and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.
In the regard
A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.
Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”
One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.
The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.
In other U.S. healthcare business news, Healthcare Dive reports
As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.
“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.
Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.
Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.
As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13.
Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.
Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.
“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”
The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.
A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.
Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.
The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.
After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.
The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.
The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.
The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”
The FDA Commissioner, Robert Califf, MD, is the final decision maker.
The NCQA has created
A new website adds two key resources in the fight against antibiotic resistance:
* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.
* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.
From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.
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