Senate Scrutinizes MA Payment Denials, Including Use Of Algorithms

Impossible' Medicare Advantage denials decried during Senate hearing

Medicare Advantage plans’ use of third-party algorithms for coverage determinations is facing some scrutiny in the Senate.

Lawmakers in a Wednesday hearing argued something must be done to pare back burdensome prior authorization requirements allowing payers to delay or deny medical care that would be covered under traditional Medicare — including the use of artificial intelligence — as insurer profits continue to rise.

“Insurers are in effect denying Americans necessary care in order to fatten and pad their bottom lines, and that phenomenon is unacceptable,” said Sen. Richard Blumenthal, D-Conn., chair of the Permanent Subcommittee on Investigations, which held the hearing.

“I want to put these companies on notice. If you deny lifesaving coverage to seniors, we’re watching, we will expose you, we will demand better, we will pass legislation if necessary, but action will be forthcoming,” Blumenthal said.

The subcommittee on Wednesday sent bipartisan letters to some of the biggest MA payers, including UnitedHealth, Humana and CVS, which collectively cover more than 50% of MA beneficiaries. The letters asked for internal documents showing how decisions are made to grant or deny access to care, including the use of AI in coverage determinations, Blumenthal said.

Payment denials

Although the majority of requests for services are approved, it’s not uncommon for private MA plans to wrongly deny medically necessary care that would be covered under traditional Medicare, according to an HHS Office of Inspector General report from last April.

Federal investigators found 13% of prior authorization requests and 18% of payment denials were wrongly denied and should have been approved under Medicare coverage rules.

In addition, a 2018 government audit found MA plans ultimately approved 75% of appealed requests that were originally denied.

MA plans, which can offer more benefits than traditional Medicare, continue to grow in popularity. Currently, 30 million Americans, or roughly half of all Medicare enrollees, are in the privately run Medicare plans. And the number of plans has grown, with the average beneficiary choosing between 43 plans offered by nine different insurers as payers flood into the lucrative market.

“Fast growth has increased vulnerabilities and the need for robust program integrity measures,” testified Megan Tinker, HHS OIG chief of staff, during the hearing.

AI determinations

To cut costs, MA insurers are routinely using algorithms from third-party companies like NaviHealth for coverage determinations, sparking many of the inappropriate denials, according to a STAT investigation earlier this year.

Insurers’ use of the unregulated technology was a major focus of the hearing with senators arguing the need for more oversight.

“Insurers may refer to these algorithms as tools used for guidance, but the denials they generate are too systematic to ignore,” said Blumenthal. “Insurance companies insist those AI mechanisms are proprietary, but part of what needs to happen is to make them more transparent so patients and providers know along with the public how they are being used.”

Gloria Bent, an MA enrollee, shared her husband’s experience with melanoma and how NaviHealth, which is owned by payer giant UnitedHealth, frequently denied care prescribed by his clinician. That resulted in a stressful cycle of coverage denials and appeals and his premature departure from a skilled nursing facility.

“The reappearance of melanoma in 2022 pulled a rug out from under my husband and my family. Then came the added trauma which piled on steadily of having to fight to keep him receiving the care he needed,” Bent testified. “This should not be happening to families and patients. It’s cruel.”

Still, utilization management tools like prior authorization can be valuable for cost containment, testified Lisa Grabert, a visiting research professor at the Marquette College of Nursing. Insurers argue prior authorization is necessary to curb waste and unnecessary medical expense.

Earlier this year, the Biden administration finalized a rule reiterating that MA plans are required to comply with coverage rules in traditional Medicare. Where there isn’t a Medicare coverage determination, MA plans can establish their own internal coverage criteria. That criteria must follow widely accepted available clinical guidelines and be reviewed annually by a clinical committee, the final rule says.

In addition, if a utilization management policy like a prior authorization could lead to a partial or full denial of care, it needs to be reviewed by a clinician. CMS plans to enforce the rule through audits.

Large private health insurers, like UnitedHealthcare, have been paring back their prior authorization requirements in advance of the regulation.

Senator Roger Marshall, R-Kans., asked witnesses if it would be valuable to force plans to report more detailed information on prior authorization delays, denials and appeals by CPT code or individual service level, as the new CMS rule only requires MA payers to share aggregate data.

Witnesses said more data is always helpful for research, oversight and beneficiary shopping between plans.

“The information that is available right now, you have to dig very, very, very deep to get any information on whether a prior authorization may or may not be required, and certainly not at the service level,” testified Jeannie Fuglesten Biniek, associate director of Medicare policy for KFF. “It would be a step in a direction that would help.”

Kaiser Permanente Discloses Timeline, Financial Commitments For Its VBC Megadeal With Geisinger Health

Regulatory filing sheds new light on Kaiser-Geisinger megadealDisclosures included in Kaiser Permanente’s quarterly financial statements offer new details on the timeline for its major value-based care deal with Geisinger Health, as well as the upper and lower limits of its investment commitments toward the new entity and expanding Geisinger’s Pennsylvania market presence.

The statements, released late Monday, recap the definitive agreement announced by the integrated health systems in late April—Kaiser will create a separate non-profit called Risant Health, that would then acquire Geisinger and become its sole member.

Risant would, according to the statements, strategically aim to “expand and accelerate the adoption of value-based care in diverse, multi-payer, multi-provider and community-based health system environments.” Kaiser leadership has also said that Risant would accomplish those goals with “five or six” additional health system acquisitions.

Monday’s filing, however, shares that Kaiser doesn’t expect its deal to close until some time in 2024.

Additionally, the system’s financial commitments into Risant are slated to be made “over the five-year period following closing,” while committed investments and support by Risant into Geisinger will be made through Dec. 31, 2028, according to the filing.

As for the investments themselves, Kaiser leadership previously said it planned to shift $5 billion of the system’s funds into support for the new entity. Per the filing, that $5 billion toward “core Risant Health capabilities, technologies, tools and future investments” represents the upper limit of Kaiser’s potential support, with Kaiser also committing to a minimum investment of $400 million over five years “inclusive of funds generated by Risant Health.”

Risant would then be on the hook to make available to Geisinger a minimum of $2 billion (inclusive of funds generated internally by Geisinger and Risant) through the end of 2028 to “support necessary hospital, ambulatory facility, technology and other strategic and routine capital,” Kaiser wrote.

Further, Risant must assure funding “of no less than $100 million” through 2028 to support expansions of Geisinger’s health plan and care delivery services into bordering Pennsylvania communities (again inclusive of internally generated funds), according to the statements.

Finally, Kaiser wrote that the agreement requires Risant to keep a minimum of $115 million available annually (inclusive of internally generated funds, and adjusted for inflation and other factors) to fund Geisinger’s research and education efforts for at least 10 years after the deal’s close, the system wrote.

Kaiser and Geisinger’s deal is still subject to regulatory approvals, though antitrust agencies have so far been hesitant to challenge deals involving healthcare entities operating in different markets.

Monday’s disclosures came alongside a more fleshed-out report of Kaiser’s first-quarter financials. The integrated giant said it brought in $1.2 billion in net income and $233 in operating income, a welcome turnaround after it lost $4.5 billion across 2022.

The Oakland, California-based nonprofit reports over $95 billion in annual operating revenues and spanned 624 medical offices, 39 hospitals and 43 retail and employee clinics as of March 31. It counted a total of 12.7 million members as of March 31.

Danville, Pennsylvania-based Geisinger reported $6.9 billion in revenue, a $239 million operating loss and a $842 million net loss across 2022. Its 133 care locations, including 10 hospital campuses, are primarily focused in central and northeastern Pennsylvania. It counted roughly 612,050 members as of Dec. 31 and had cared for nearly 1.2 million people across 2022.

Progressives Reintroduce ‘Medicare For All’ Bill

Progressive Lawmakers Revive Medicare for All Bill

Key progressives in the House and Senate have revived the fight in Congress over “Medicare for All,” a single-payer health system based on the Medicare program.

Sen. Bernie Sanders, I-Vermont, and Reps. Pramila Jayapal, D-Washington, and Debbie Dingell, D-Michigan, reintroduced the Medicare for All Act, with 14 Senate Democrats and 110 House Democrats on board with the measure.

The legislation would roll out the Medicare for All model over four years, expanding health coverage to each American. Under the bill, that coverage would come with no premiums, deductibles or copayments and would cover a wide array of services from primary care to vision care to mental health.

Sanders said in a news release that the COVID-19 pandemic threw into stark relief how critical it is to ensure that everyone has access to affordable healthcare.

“As we speak, there are millions of people who would like to go to a doctor but cannot afford to do so,” Sanders said. “That is an outrage. In America, your health and your longevity should not be dependent on your bank account or your stock portfolio.”

The legislators noted that the Congressional Budget Office previously projected that Medicare for All would save the healthcare system $650 billion per year.

“Sadly, the number of people struggling to afford care continues to skyrocket as millions of people lose their current health insurance as pandemic-era programs end,” Jayapal said. “Breaking a bone or getting sick shouldn’t be a reason that people in the richest country in the world go broke.”

Medicare for All faces strong opposition from all corners of the industry. In a statement, the Partnership for America’s Health Care Future, which represents payers and providers, urged legislators to take a more “common sense approach” to ensuring coverage is accessible to everyone.

“Every American deserves access to affordable, high-quality health coverage and care—however one-size-fits-all proposals like Medicare for All that result in government-controlled health care won’t help us get there,” said Executive Director Lauren Crawford Shaver. “With more and more states seeing failed public option approaches, it is more important than ever that Americans have access to quality and affordable health care—not a system that would force them to pay more and wait longer for worse care. ”

A More Aggressive FTC Is Starting to Target Drug Mergers and Industry Middlemen

FTC sues Amgen-Horizon, raising questions about PBM role in drug costsUnder the leadership of an aggressive opponent of anti-competitive business practices, the Federal Trade Commission is moving against drug companies and industry middlemen as part of the Biden administration’s push for lower drug prices at the pharmacy counter.

On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals.

In its lawsuit, the FTC said that if it allowed Amgen’s $27.8 billion purchase to go through, Amgen could pressure the companies that manage access to prescription drugs — pharmacy benefit managers, or PBMs — to boost the two extremely expensive Horizon products in a way that would inhibit any competition.

The suit, the first time since 2009 that the FTC has tried to block a drug company merger, reflects Chair Lina Khan’s strong interest in antitrust action. In announcing the suit, the agency said that by fighting monopoly powers it aimed to tame prices and improve patients’ access to cheaper products.

The FTC’s action is a “shot across the bow for the pharmaceutical industry,” said Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco. David Balto, a former FTC official and attorney who fought the 2019 Bristol-Myers Squibb-Celgene and 2020 AbbVie-Allergan mergers, said FTC’s action was long overdue.

The Horizon-Amgen merger would “cost consumers in higher prices, less choice, and innovation,” he said. “The merger would have given Amgen even more tools to exploit consumers and harm competition.”

The FTC also announced an expansion of a yearlong investigation of the PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services. Critics claim the PBMs set up these companies to conceal profits.

When Amgen announced its purchase of Horizon in December — the biggest biopharma transaction in 2022 — it showed particular interest in Horizon’s drugs for thyroid eye disease (Tepezza) and severe gout (Krystexxa), for which the company was charging up to $350,000 and $650,000, respectively, for a year of treatment. The complaint said the merger would disadvantage biotech rivals that have similar products in advanced clinical testing.

Amgen could promote the Horizon drugs through “cross-market bundling,” the FTC said. That means requiring PBMs to promote some of Amgen’s less popular drugs — the Horizon products, in this case — in exchange for Amgen offering the PBMs large rebates for its blockbusters. Amgen has nine drugs that each earned more than $1 billion last year, according to the complaint, the most popular being Enbrel, which treats rheumatoid arthritis and other diseases.

The three biggest PBMs negotiate prices and access to 80% of prescription drugs in the U.S., giving them enormous bargaining power. Their ability to influence which drugs Americans can get, and at what price, enables the PBMs to obtain billions in rebates from drug manufacturers.

“The prospect that Amgen could leverage its portfolio of blockbuster drugs to gain advantages over potential rivals is not hypothetical,” the FTC complaint states. “Amgen has deployed this very strategy to extract favorable terms from payers to protect sales of Amgen’s struggling drugs.”

The complaint noted that biotech Regeneron last year sued Amgen, alleging that the latter’s rebating strategy harmed Regeneron’s ability to sell its competing cholesterol drug, Praluent. Amgen’s Repatha generated $1.3 billion in global revenue in 2022.

It “may be effectively impossible” for smaller rivals to “match the value of bundled rebates that Amgen would be able to offer” as it leverages placement of the Horizon drugs on health plan formularies, the complaint states.

Business analysts were skeptical that the FTC action would succeed. Until now the commission and the Department of Justice have shied away from challenging pharmaceutical mergers, a precedent that will be hard to overcome.

Research on the impact of mergers has shown that they often benefit shareholders by increasing stock prices, but hurt innovation in drug development by trimming research projects and staffing.

Waves of consolidation shrank the field of leading pharma companies from 60 to 10 from 1995 to 2015. Most of the mergers in recent years have involved “big fish buying up lots of little fish,” such as biotech companies with promising drugs, Feldman said.

The giant Amgen-Horizon merger is an obvious exception, and therefore a good opportunity for the FTC to demonstrate a “theory of harm” around drug industry bundling maneuvers with PBMs, said Aaron Glick, a mergers analyst with Cowen & Co.

But that doesn’t mean the FTC will win.

Amgen may or may not engage in anti-competitive practices, but “a separate question is, how does this lawsuit fit under current antitrust laws and precedent?” Glick said. “The way the law is set up today, it seems unlikely it will hold up in court.”

The FTC’s argument about Amgen’s behavior with Horizon products is hypothetical. The pending Regeneron suit against Amgen, as well as other, successful lawsuits, suggests that rules are in place to suppress this kind of anti-competitive behavior when it occurs, Glick said.

The judge presiding over the case in U.S. District Court in Illinois is John Kness, who was appointed by then-President Donald Trump and is a former member of the Federalist Society, whose membership tends to be skeptical of antitrust efforts. The case is likely to be settled by Dec. 12, the deadline for the merger to go through under current terms.

Amgen sought to undercut the government’s case by agreeing not to bundle Horizon products in future negotiations with pharmacy benefit managers. That promise, while hard to enforce, might get a sympathetic hearing in court, Glick said.

Still, even a loss would enable the FTC to shed light on a problem in the industry and what it sees as a deficiency in antitrust laws that it wants Congress to correct, he said.

The day after suing to stop the merger, the FTC announced it was pushing further into an investigation of pharmacy benefit managers that it began last June. The agency demanded information from Ascent and Zinc, the two so-called rebate aggregators — drug purchasing organizations set up by PBMs Express Scripts and CVS Caremark.

At a May 10 hearing, Eli Lilly & Co. CEO Dave Ricks said that most of the $8 billion in rebate checks his company paid last year went to rebate aggregators, rather than to the PBMs directly. A “big chunk” of the $8 billion went overseas, he said. Ascent is based in Switzerland, while Emisar Pharma Services, an aggregator established by PBM OptumRx, is headquartered in Ireland. Zinc Health Services is registered in the U.S.

Critics say the aggregators enable PBMs to obscure the size and destination of rebates and other fees they charge as intermediaries in the drug business.

The PBMs say their efforts reduce prices at the pharmaceutical counter. Testimony in Congress and in FTC hearings over the past year indicate that, at least in some instances, they actually increase them.

Medicare Spending Could Increase $2 To $5 Billion If Coverage Expands For Lecanemab

Lecanemab could drive up Medicare spending by $5B a year: studyThe anti-dementia medication lecanemab, and its ancillary costs, could add $2 to $5 billion in annual Medicare spending if the Centers for Medicare and Medicaid Services revises its coverage decision, according to a research letter in JAMA Internal Medicine.

Currently, the medication is covered only for patients who are enrolled in clinical trials.

Medicare fee-for-service spending was $37 billion in 2019 for drugs such as lecanemab that are administered in outpatient settings. In addition to higher Medicare spending, lecanemab’s medication and ancillary out-of-pocket costs for patients lacking supplemental coverage could reach $6,600 per year, which is approximately one fifth of the median income of a U.S. Medicare beneficiary, data showed.

Medicare annual spending on lecanemab’s medication costs alone would place it among the most expensive Part B medications delivered in outpatient facilities, authors said.


Lecanemab is currently available as a treatment for mild cognitive impairment and mild dementia under the Food and Drug Administration’s accelerated approval program.

The FDA is expected to grant lecanemab traditional approval later this year, prompting Medicare to reconsider its coverage restrictions and potentially enabling widespread use. Clinical trials have shown that the drug has modest clinical benefit.

Moreover, because of its risk of brain swelling and brain bleeding, also known as amyloid-related imaging abnormalities, or ARIA, the treatment requires frequent monitoring via neurology visits and MRI scans.

The researchers performed a cost analysis using data from the nationally representative 2018 Health and Retirement study (HRS), incorporating both the direct drug costs as well as the indirect ancillary costs for associated health services such as MRIs, neurology visits and other related care.

Limitations to the study include use of plaque rates derived from population studies rather than from HRS participants’ scans, possible misclassification of some cases of dementia prevalence and stage, and responses from participants with cognitive impairment which may not be reliable, although proxies can respond on their behalf.


According to Optum, there’s a high unmet need for treatments for Alzheimer’s disease, since it’s a leading cause of illness and death among the elderly. Existing treatment options have been ineffective.

In June 2021, the FDA approved Aduhelm (aducanumab), the first amyloid beta-directed antibody, via the accelerated approval pathway based on reductions in amyloid beta plaques. Subsequently, a CMS National Coverage Determination limited Medicare coverage for Aduhelm and other beta-amyloid targeted therapies to patients enrolled in clinical trials because of unknown clinical benefit.

Lecanemab would be the second drug in the class with FDA approval through the accelerated approval pathway that was followed to approve Aduhelm, based on the surrogate of reductions in beta-amyloid plaques.

In January, CMS released a proposed National Coverage Determination decision memorandum that said the NCD would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development, meaning for Medicare recipients enrolled in qualifying clinical trials.

Medicaid Unwinding And The Impact On Group And Individual Health Insurance Markets

10 Things to Know About the Unwinding of the Medicaid Continuous Enrollment  Provision | KFF

The Families First Coronavirus Response Act (FFCRA), signed into law in March 2020, created the first major lifeline for Americans during the onset of the COVID-19 pandemic. It particularly addressed the immediate needs of working Americans who had suddenly lost their paychecks and/or their jobs – and their subsequent eligibilities for health insurance. Now that the pandemic has reached its end (although COVID-19 remains a health issue), some of the changes created by FFCRA are expiring – especially for those covered by federal and state Medicaid programs.

Under the FFCRA, states were enticed to expand their Medicaid programs, to ensure continuous enrollment of Medicaid enrollees throughout the COVID-19 National Emergency. Throughout the pandemic, Medicaid beneficiaries have remained enrolled in the program regardless of changes in income or status.

Medicaid is a federally facilitated, state-administered, jointly funded health care program for low-income American families, adults, children, pregnant women, elderly adults, and people with disabilities. While each state’s Medicaid program varies, Medicaid generally provides zero- or low-cost coverage to beneficiaries based on their household income.

In both California and Nevada (and most other states), residents are eligible for Medicaid if they have household incomes of up to 138% of the Federal Poverty Level (FPL). Although ineligible for Medicaid, earners with incomes between 138-400% of FPL are eligible for subsidies called Premium Tax Credits (PTCs), to help them pay the cost of Individual coverage purchased on a state exchange (such as Covered California, Nevada Health Link, etc.).

California’s Medicaid program is called “Medi-Cal,” and it covers nearly one-third of the state’s population. California’s Medi-Cal program increased its enrollment by 16% during the pandemic.

Nevada’s program is called “Nevada Medicaid,” and it also covers roughly one-third of its state population. Nevada Medicaid increased its enrollment by 40% during the pandemic.

Because of the impacts of the pandemic, many people became newly eligible for Medicaid. Due to the “continuous enrollment provision” and other COVID factors, enrollment in the program boomed. Between March 2020 and December 2022, Medicaid experienced a nationwide enrollment increase of 21.1 million Americans, bringing the total number of enrollees to approximately 92.3 million.

The Consolidated Appropriations Act of 2023 declared an official end to Medicaid’s “continuous enrollment provision,” and assigned it a sunset date of March 31, 2023. Beginning April 1, 2023, states could begin to “unwind” their more than three-year COVID protocol and resume Medicaid eligibility determinations – and subsequent disenrollments. The Kaiser Family Foundation reports estimates 5-14 million Americans will have coverage disrupted or eliminated entirely because of Medicaid “unwinding.”

California began its reevaluation of Medi-Cal beneficiaries’ eligibilities in April 2023. Redeterminations are being processed monthly, beginning with people who enrolled in Medi-Cal in the month of June (of any year). June enrollees will have from the beginning of April through the end of June (approx. three calendar months) to recertify. Those who no longer qualify for coverage will be disenrolled from Medi-Cal effective July 1, 2023. California will continue these recertifications on an ongoing, monthly basis until May 2024.

California law requires the state to enroll all Medicaid disenrollees in the lowest-cost silver-tier Individual & Family Plan (IFP) available to that person on Covered California – or the individual’s same managed care plan (if it is available). To qualify, the applicant must also qualify for PTC subsidies to help pay for some, or all, of the silver plan’s premium. Furthermore, enrollees can elect any IFP coverage available to them within Covered California – including bronze, silver, gold, and platinum tier plans.

Disenrollment from Medicaid also triggers a qualifying event that establishes a Special Enrollment Period (SEP). Employees who waived job-based coverage because of ongoing Medicaid enrollment can utilize the SEP to enroll in their group health plans outside of Open Enrollment.

Federal law establishes a 60-day timeframe for SEPs, beginning on the day of the qualifying event. Those who find themselves ineligible for Medicaid (and subsequently disenrolled) with access to alternate group coverage – including for a spouse’s or parent’s plan – will be impacted.

Nevada Medicaid resumed normal operations on April 1, 2023. Nevada Medicaid enrollees will receive a renewal notice prior to the end of their certification sometime over the next 12 months. Like California, recertification will also occur according to the Medicaid enrollee’s renewal month. They will be processed on an ongoing, monthly basis – beginning with June enrollees. For example, a person with a renewal month in June will receive a renewal notice in April. Clients found ineligible in Nevada will lose their coverage effective June 1, 2023. SEPs will also be available for Nevadans who lose eligibility for Medicaid during the recertification process, to enroll in either an IFP or group health plan within 60 days of the coverage loss.

Those who do not respond to attempts for recertification will be disenrolled but may be eligible to enroll again – if eligibility is proven later, a Medicaid process called “churning.” The industry forecasts minorities and non-English speaking residents will be impacted the most by churning, because of address changes and/or the inability to understand the recertification procedure.

Any person covered by Medi-Cal/Medicaid should anticipate recertification and respond to notices in a timely manner. When switching from Medi-Cal/Medicaid to IFP or group insurance, consumers should be cognizant of provider networks, premiums, and cost-sharing within the health plan.

Also note that each state administers its own Medicaid program, so each state’s approach to Medicaid unwinding and recertification will be at least somewhat different; with some variances between states more drastic than others.

Group insurance brokers should educate their clients on these Medicaid unwinding principles, so they can anticipate a potential increase in enrollment and support requests for their group health plans. Furthermore, employers and their employees should be reminded that an offer of “affordable” coverage from an employer (of any size) disqualifies that employee – and potentially the employee’s entire family – from PTC eligibility on a state exchange.

An offer of coverage is considered “affordable” for the employee if the employee’s contribution for the lowest-cost, self-only premium (for a plan that provides minimum value) does not exceed 9.12% of the employee’s pay in 2023. Family coverage is considered affordable if the employee’s contribution for the entire family’s premium, based on the lowest-cost plan, does not exceed 9.12% of household income – which comes from ACA’s “Family Glitch” fix in 2022.

Last Updated 05/24/2023

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