US Health Officials Propose Annual COVID-19 Vaccination for Most Americans

Associated Press
 
WASHINGTON — U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot.

The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus.
 
This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster.
 
The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those eligible have received the latest boosters authorized in August.
 
The FDA will ask its panel of outside vaccine experts to weigh in at a meeting Thursday. The agency is expected to take their advice into consideration while deciding future vaccine requirements for manufacturers.
 
In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.
 
For adults with weakened immune systems and very small children, a two-dose combination may be needed for protection. FDA scientists and vaccine companies would study vaccination, infection rates and other data to decide who should receive a single shot versus a two-dose series.
 
FDA will also ask its panel to vote on whether all vaccines should target the same strains. That step would be needed to make the shots interchangeable, doing away with the current complicated system of primary vaccinations and boosters.
 
The initial shots from Pfizer and Moderna — called the primary series — target the strain of the virus that first emerged in 2020 and quickly swept across the world. The updated boosters launched last fall were also tweaked to target omicron relatives that had been dominant.
 
Under FDA's proposal, the agency, independent experts and manufacturers would decide annually on which strains to target by the early summer, allowing several months to produce and launch updated shots before the fall. That’s roughly the same approach long used to select the strains for the annual flu shot.
 
Ultimately, FDA officials say moving to an annual schedule would make it easier to promote future vaccination campaigns, which could ultimately boost vaccination rates nationwide.

The original two-dose COVID shots have offered strong protection against severe disease and death no matter the variant, but protection against mild infection wanes. Experts continue to debate whether the latest round of boosters significantly enhanced protection, particularly for younger, healthy Americans.

What's Ahead for Health IT Policy and Legislation in 2023

Healthcare IT News | By Andrea Fox
 
With Congress providing telehealth waivers as part of its omnibus spending bill at the close of 2022, delaying the "telehealth cliff" for two years, HIMSS says it's now ready to make the case for permanent reimbursement of virtual care.
 
Also on its policy agenda for the year ahead: advocating for data standardization, offering input for interoperability rulemaking and engaging with agencies and states to increase telehealth access. We spoke with the HIMSS government relations team for their thoughts on those priorities and more in 2023 and beyond.
 
Making telehealth's case for cost control
 
Telehealth has proven to reduce burdens on healthcare providers and improve access and has been a priority for HIMSS for many years, but the Congressional Budget Office has long complained that all of the data has been for non-Medicare patients, explained Tom Leary, senior vice president and head of government relations at HIMSS, parent company of Healthcare IT News.
 
Budget leaders have asked, "How do you really know what the impact on the Medicare population and the Medicare Trust Fund will be? We now have three years of data on the impact to the Medicare Trust Fund," he said.
 
While the pandemic-era telehealth waivers answered many questions at the federal level, the two-year extension to offer telehealth in high-deductible health plans with health savings accounts included in the final legislative package of 2022 has opened a new window to pursue making the changes permanent. 
 
HIMSS will "use the next two years to gather additional data to inform both Congress and CBO on either the cost of avoidance or the cost control aspects," said Leary.
 
In addition to making telehealth coverage permanent, simplifying access for patients is another goal for the mission-driven non-profit, whose goal is to reform the global health ecosystem through the power of information and technology

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Medicare Advantage Plans Brace for Final Controversial Risk Adjustment Rule by Feb. 1

Fierce Healthcare | By Robert King
 
Medicare Advantage (MA) plans are bracing for a final rule that could overhaul the risk adjustment process and may leave them on the hook for errors going back more than a decade. 
 
Plans have circled Feb. 1 as the date they expect the Centers for Medicare & Medicaid Services (CMS) to publish the final Risk Adjustment Data Validation (RADV) rule, which will govern how CMS audits for coding errors. Some plans have said they want to make sure a fee-for-service (FFS) adjuster to the audits is included, which would limit error rates made by MA plans to a similar rate in FFS. 
 
“What we will be looking for is hopefully the acknowledgment that a FFS adjuster is necessary to recognize the inherent error rate in all claims data sets within Medicare,” said Susan Diamond, chief financial officer for Humana, during a presentation at the J.P. Morgan Healthcare Conference earlier this month. 
 
Currently, CMS audits a subset of around 200 MA beneficiaries in a plan. It compares all of the diagnosis codes for those beneficiaries to their medical records to determine whether Medicare over- or underpaid for the diagnoses. CMS has tried since 2012 to instead extrapolate the results of the audit to the entire population of that plan.
 
In 2018, the agency released a proposed rule that got rid of the FFS adjuster. It also would apply the new rule’s methodology retroactively to plans dating back to 2011. 
 
CMS did not finalize the rule for several years in part due to a delay caused by the COVID-19 pandemic and has announced a new deadline of Feb. 1 to publish the final version. A copy of the final rule has been sent to the Office of Management and Budget, a key final step before publishing a regulation.
 
Insurers have said they are not opposed to additional oversight.
 
“Like all government programs, taxpayers and beneficiaries need to know that the Medicare Advantage program is well-managed,” said Tim Noel, CEO of UnitedHealthcare’ medicare and retirement business, during a briefing with reporters Tuesday.
 
But Noel cautioned that leaving out the adjuster could lead to “flawed” audit results and shift away from a well-established CMS position.
 
The problem with getting rid of the FFS adjuster is that it will hold plans to an impossible burden of no errors whatsoever in its claims, insurers argue.
  
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More MA Insurer Audits Mean More Scrutiny on Providers

Modern Healthcare | By Lauren Berryman
 
Tougher audits of Medicare Advantage insurers could lead them to more stringently review the patient codes providers submit and the physician-enablement companies that help clinicians take on patient risk.
 
That may dampen the already cool market for value-based primary care startups and digital health businesses, and intensify contract disputes between insurers and companies such as Oak Street Health and Agilon Health, said Jason Silberberg, a partner at Frier Levitt’s healthcare litigation section and co-chair of the law firm’s value-based care litigation group.
 
“Medicare Advantage organizations are going to do whatever they can to try and offset the major losses they're going to take onto the providers,” said Silberberg, who primarily represents providers. “One way I could perceive that happening is them effectively pushing the fraud narrative on the providers.”
 
On Feb. 1, the Centers for Medicare and Medicaid Services is slated to finalize the Risk Adjustment Data Validation rule, which would increase the amount of overpayments Medicare Advantage insurers must return to the government. Private Medicare carriers generated an estimated $17 billion through overpayments last year, according to a report the Medicare Payment Advisory Commission, a federal expert panel that makes policy recommendations to Congress, issued this month.
 
The insurance industry is gearing up to fight the policy. Industry lobbying group AHIP, which declined to comment, reportedly would sue if the rule were enacted as-is. Medicare Advantage heavyweights Humana, CVS Health's Aetna and Centene have also signaled they would fight the regulation in court.
 
The Alliance of Community Health Plans called on CMS to reopen the comment period on the rule, which has been pending since 2018. “The comments that [CMS is] using for this rulemaking are now several years outdated and therefore require additional review and new consideration,” said Michael Bagel, associate vice president of public policy for the Alliance of Community Health Plans, a trade group for nonprofit insurers.
 
Insurers could ask a court to stay the regulation, which would delay implementation, Silberberg said. But the sue-to-stop strategy has not been successful so far, he said. The Supreme Court dealt the industry a blow in June when it declined to hear UnitedHealth Group’s challenge to a regulation that makes Medicare Advantage insurers liable for False Claims Act lawsuits when they fail to return overpayments. That opened the door to more Justice Department lawsuits against Medicare Advantage carriers—and providers.
 
Companies such as Oak Street Health and Agilon Health bear the greatest legal and financial risk if the Medicare Advantage audit process changes, Silberberg said.
 
Insurers typically pay these risk-bearing providers flat, monthly rates to cover members’ anticipated expenses. Providers that take care of sicker patients, and document more risk codes, receive higher capitated rates. These companies therefore have a financial incentive to capture as many codes as possible, and potentially to exaggerate patient conditions, Silberberg said. Insurers that ink shared savings agreements with these companies often also dispense bonuses when they help reach savings targets.

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