Whistleblower lawsuit accuses Cigna of Medicare Advantage fraud


A whistleblower lawsuit accuses Cigna of receiving “billions” in overpayments for its Medicare Advantage plans. The amended complaint, filed by the Department of Justice in the U.S. District Court for the Southern District of New York a year ago, was unsealed on Wednesday.

A former service provider for Cigna’s Medicare Advantage subsidiary alleged that the company sent providers to patients’ homes to conduct a health assessment, which was then improperly submitted to the Centers for Medicare and Medicaid Services for risk adjustment. The whistleblower was a former officer for Texas Health Management, a now-defunct company that worked with Cigna-Healthspring between 2012 and 2017.

Cigna acquired HealthSpring in 2012, and currently offers Medicare Advantage plans in 17 states under this brand.

Commercial insurers who offer Medicare Advantage plans receive a monthly capitated rate from CMS for each of their covered members, which they use to cover the cost of care. For older and sicker patients — who have higher risk scores — they receive a higher rate.

A patient’s risk score is based on diagnoses assigned to the patient in the prior year. To be submitted, a patient must have had a face-to-face encounter with a provider, and the patient must be cared for or assessed.

According to the plaintiff, Cigna ran an assessment program that sent nurses and nurse-practitioners to patients’ homes, where they were expected to see 35 patients per week and generate 20 or more diagnoses per visit. They were reportedly not allowed to provide care, prescribe medications or make referrals to specialists.

The complaint described the program as “…a  data-gathering exercise used to improperly record lucrative diagnoses to fraudulently raise risk cores and increase payments from CMS.”

According to court documents, Cigna-HealthSpring used analytics to sort members into different priority categories based on their medical histories. The company also reportedly sought to recruit primary care physicians to complete the assessments, at one point offering a $150 bonus per completed exam to provider who performed a certain volume of assessments each year

The Department of Justice decided not to intervene in the case in February. Specifically, the government declined to claim that Cigna violated the False Claims Act by conducting nurse home visits that did not involve providing medical treatment.

Cigna did not respond to requests for comment at the time of publication.

This isn’t the first time a Medicare Advantage plan has come under scrutiny for payments.

Last year, the Office of Inspector General reviewed “billions” in estimated Medicare Advantage payments that raised concerns. Looking at 2016 encounter data, the OIG found that Medicare Advantage Organizations almost always used chart reviews to add diagnoses, and that diagnoses reported only on chart reviews — without any service records — resulted in roughly $6.7 billion in risk-adjusted payments for 2017.

Of that, an estimated $2.7 billion in payments were based on diagnoses that did not link to a specific service provided to the member.

Photo credit: zimmytws, Getty Images


Source link


CMS expands telehealth options for Medicare Advantage plans


The Centers for Medicare and Medicaid Services (CMS) will allow Medicare Advantage plans to cover a wider range of telehealth services. The new rule would give Medicare Advantage plans the flexibility to count certain telehealth specialists toward network adequacy requirements, including dermatology, psychiatry, cardiology, and primary care.

The agency said the changes were designed to encourage plans to give members access to telehealth and increase plan choice for those living in rural areas. It’s one of many steps the agency has taken, particularly in light of the Covid-19 pandemic, to cover more telehealth services for Medicare patients.

“CMS’s rapid changes to telehealth are a godsend to patients and providers and allows people to be treated in the safety of their home,” CMS Administrator Seema Verma said in a news release. “The changes we are making will help make telehealth more widely available in Medicare Advantage and are part of larger efforts to advance telehealth.”

The new rules also slightly ease network standards for plans in rural areas. Instead of requiring 90% of members to live within a certain time and distance of a provider, CMS decreased that requirement to 85% to encourage more plan options.

In the final rule, published in the Federal Register on Friday, CMS said it had tried to strike a balance between encouraging access to telehealth services while still ensuring patients could access specialists in-person.

“While health plans clearly favored taking into account telehealth access while evaluating network adequacy, providers had more concerns that telehealth services could be used to replace, rather than supplement, in-person healthcare delivery,” the rule stated. “We explained that it is important and appropriate to account for contracted telehealth providers in evaluating network adequacy consistent with reflecting how MA plans supplement, but do not replace, their in-person networks with telehealth providers.”

Photo credit: cat-scape, Getty Images


Source link


Justice Department accuses Anthem of Medicare fraud


A lawsuit filed by the Department of Justice against Anthem accuses the insurer of collection million of dollars by failing to delete inaccurate diagnosis codes for Medicare Advantage patients. The suit was filed on Friday by Geoffrey Berman, United States Attorney for the Southern District of New York.

The case alleges that Anthem falsely certified the accuracy of the diagnostic data it sent to the Centers for Medicare and Medicaid Services, causing CMS to calculate risk-adjustment payments to the insurer based on inflated diagnosis information. For example, Anthem submitted an ICD-9 diagnosis code for active lung cancer for one patient, but its chart review program did not substantiate the diagnosis, according to court documents.

Anthem implemented a retrospective chart review program using a vendor called Medi-Connect, according to the lawsuit. The insurer reportedly paid Medi-Connect to connect medical records from healthcare providers and review them to identify diagnostic codes supported by the medical records.

According to court documents, from 2014 to 2018, Anthem allegedly used the chart review program to find additional codes to submit to CMS while failing to identify and delete inaccurate codes. The chart review program brought in more than $100 million in revenue per year for Anthem, according to the complaint.

“The integrity of Medicare’s payment system is critical to our healthcare,” Berman said in a news release. “This office is dedicated to vigorously using all of the legal tools available, including the False Claims Act, to ensure the integrity of Medicare payments.  The case against Anthem today is an illustration of that commitment.”

Anthem said it was confident its health plans complied with regulations, and that it would vigorously defend its risk adjustment practices.

“This litigation is the latest in a series of investigations on Medicare Advantage plans. The government is trying to hold Anthem and other Medicare Advantage plans to payment standards that CMS does not apply to original Medicare, and those inconsistent standards violate the law,” the company wrote in an emailed statement. “The suit is another in a pattern that attempts to hold Anthem and other plans to a standard on risk adjustment practices, without providing clear guidance. Where regulations have not been clear, Anthem has been transparent with CMS about its business practices and good faith efforts to comply with program rules.”

Photo credit: zimmytws, Getty Images


Source link


Cigna’s new Medicare Advantage chief talks about growth plans, Covid-19


Shortly before the first Covid-19 outbreak was reported in the U.S., Gina Conflitti stepped into her new role as chief medical officer for Cigna’s Medicare Advantage plans. Now, during a pandemic in which older Americans face a higher risk, Conflitti will help lead the company’s efforts to respond in stride.

Conflitti joined Cigna in January, after serving as CMO for Aetna’s national accounts for 12 years. A licensed physician, she practiced as an internist before working in management.

In a phone interview from her home in Arizona, Conflitti shared her plans for Cigna’s Medicare Advantage plans and what that looks like in the midst of the Covid-19 pandemic.

“This is an unprecedented time. Our seniors are a segment of the American population who are very much as risk,” she said.

Cigna currently offers Medicare Advantage plans in 18 states. The company added plans in more than 40 counties last fall, as well as pilot programs for transportation to doctor’s appointments, grocery stores and places of worship in some of its plans. Though it has a smaller Medicare Advantage market share than some of its competitors, Cigna expects to see its MA customers increase between 13% and 16% this year, it said in its annual earnings.

Now, in light of the quickly-spreading Covid-19 cases in the U.S., Cigna is taking another look at its Medicare Advantage plans. The company, along with its competitors, has waived all costs related to testing for Covid-19. Cigna’s pharmacy benefit manager, Express Scripts, is also delivering three-month supplies of medications.

Cigna is also looking at new guidance from the Centers for Medicare and Medicaid Services (CMS), which significantly broadened access to telehealth. Prior to CMS’ new guidance, telehealth was limited to members in rural locations. Now, Medicare patients in all locations have access to in-home appointments.

“Telehealth is sort of front-and-center right now. … It won’t replace in-person medical exams. But there are certain situations, much like today, where virtual visits will give seniors access to care from their homes,” Conflitti said. “I commend CMS for their (telehealth) expansion efforts in order to mitigate the risk of exposure.”

She said Cigna would follow further CMS guidance on removing barriers to care in light of Covid-19, and was looking into other opportunities to help their members.

“We are definitely on regular calls within the company. Our leadership is speaking with other organizations and businesses in the U.S. and globally to address all aspects of this crisis,” she said.

Photo credit: designer491, Getty Images


Source link


Would ‘Medicare For All’ cost more than U.S. budget? Biden says so. Math says no.


Medicare for All

During the Feb. 7 Democratic presidential debate, former Vice President Joe Biden once again questioned the price tag of “Medicare for All,” the single-payer health care proposal championed by one of his key rivals, Sen. Bernie Sanders of Vermont.

Biden argued that the plan was fiscally irresponsible and would require raising middle-class taxes. Specifically, he claimed, the plan “would cost more than the entire federal budget that we spend now.”

Medicare for All’s price — and whether it’s worth it — is a subject of fierce discussion among Democratic presidential candidates. But we had never heard this figure before. It caught our attention, so we decided to dig in.

Biden’s campaign directed us to the 2018 federal budget, which totaled $4.1 trillion. It compared that amount with the estimated cost of Sanders’ single-payer proposal: between $30 trillion and $40 trillion over a decade. The math, they said, shows Medicare for All would cost more than the national budget.

But it turns out, based on the numbers and interviews with independent experts, Biden’s comparison of Medicare for All’s price to total federal spending misses the mark because the calculation is flawed.

The Numbers

Sanders has said publicly that economists estimate Medicare for All would cost somewhere between $30 trillion and $40 trillion over 10 years. Research by the nonpartisan Urban Institute, a Washington, D.C., think tank, puts the figure in the $32 trillion to $34 trillion range.

We pointed out to Biden’s campaign that comparing 10-year spending estimates to one-year budgets is like comparing apples to oranges. The campaign suggested that if you take 10 times the current federal budget, you get a figure smaller than the estimated cost of Medicare for All over that 10-year window.

That calculation would lead you to multiply $4.1 trillion by 10 to get $41.1 trillion. That result is close to the high mark Sanders set for his program’s cost but well above the $34 trillion that Urban researchers projected.

Still, that’s not the correct way to formulate a comparison, experts say. “That’s not good math,” said Marc Goldwein, the senior vice president and senior policy director at the Committee for a Responsible Federal Budget. “That’s taking a 2018 number and multiplying it by 10, whereas the $34 trillion is a 10-year number that assumes a lot of growth.”

What you would need to do is add up the Congressional Budget Office’s projected budget outlays from 2020 to 2029, and compare the sum to the Medicare for All spending figure.

So we spoke to Linda Blumberg, an institute fellow at Urban’s Health Policy Center, who arrived at the $34 trillion estimate. She ran the CBO’s numbers: The next 10 years of on-budget outlay, the government office projects, add up to $44.8 trillion.

To be clear, $34 trillion (34 followed by 12 zeros) is no small sum. It accounts for about 75% of that nearly $45 trillion budget estimate and would represent a bigger single increase to the federal budget than we’ve ever experienced, Blumberg said.

That raises one point on which Biden may have some ground. Goldwein argued that you would indeed need significant tax increases to finance the Sanders proposal.

But its price tag still would be less than the projected budget.

“If he said [Medicare for All] was as big as the current federal budget, that would be incorrect,” Blumberg said.

Goldwein looked at the numbers another way: Including interest, he found, the federal budget would consume about $55 trillion between now and 2030. Again, that’s more than what Medicare for All would cost during the same period.

Big picture: No matter how you slice Biden’s math, his numbers are off.

“If what he said was Medicare for All will cost as much as the entire rest of the budget, that would be fair,” Goldwein said. But that’s not the same thing.

Our Ruling

Biden argued that Medicare for All “would cost more than the entire federal budget that we spend now.”

This relies on faulty math. Medicare for All would certainly represent a substantial increase to the federal budget. But it would neither match nor dwarf current federal spending overall. We rate this claim False.


Source link


Website errors raise calls for Medicare to Be flexible with seniors’ enrollment


Saturday is the deadline for most people with Medicare coverage to sign up for private drug and medical plans for next year. But members of Congress, health care advocates and insurance agents worry that enrollment decisions based on bad information from the government’s revamped, error-prone Plan Finder website will bring unwelcome surprises.

Beneficiaries could be stuck in plans that cost too much and don’t meet their medical needs — with no way out until 2021.

On Wednesday, the Centers for Medicare & Medicaid Services told Kaiser Health News that beneficiaries would be able to change plans next year because of Plan Finder misinformation, although officials provided few details.

And the website had no information about that option. Representatives reached at Medicare’s call center Thursday, who were busy helping with last-minute enrollments, were unaware of it. On Friday, CMS said those representatives will be retrained and the website will be updated after the current enrollment season wraps up.

The overhauled Plan Finder debuted at the end of August, and 2020 plan information was added in October. Over the past three months, Plan Finder problems reported to CMS by the National Association of Insurance Commissioners, the National Association of Health Underwriters, and state and national consumer advocates included inaccurate details about prices, covered drugs and dosages, and difficulty sorting and saving search results, among other things.

CMS made almost daily corrections and fixes to the website, which is the only tool that can compare dozens of private drug and medical plans ? each with different pharmacy networks, covered drugs and drug prices. The website provides information for more than 60 million people with Medicare and their families, as well as state Medicare counselors and the representatives who answer the 800-MEDICARE help line.

In an unsigned blog article published on a Medicare website last week, officials said they’re “not done improving the Plan Finder.” And they promised “in the coming months we’ll be scoping out additional improvements that we can implement based on lessons we learn this year.”

Although CMS has earned praise for responding to errors identified by Plan Finder users, some people may have signed up for plans before the mistakes were caught ? mistakes they may not notice until their coverage kicks in next year.

“Seniors should be able to choose the plans that work best for them,” said Sen. Susan Collins (R-Maine), chairwoman of the Senate Special Committee on Aging. “Issues with Medicare’s new Plan Finder website, however, have reportedly created confusion among beneficiaries as well as those assisting them.” She added that she was concerned “this problem even occurred.”

Medicare’s response, Collins said, “must be vigorous with extensive outreach to inform seniors of special enrollment periods.”

Sen. Bob Casey of Pennsylvania, the senior Democrat on that committee, also said Medicare needs to reach out so people know they can request a “special enrollment period” if they discover next year they made a wrong choice due to inaccurate Plan Finder information.

“People with Medicare must be aware that this reprieve exists and should not have to jump through hoops to qualify,” he said. The administration should “use all means necessary” to let beneficiaries know about their options for a special enrollment period.

Fifteen Senate Democrats, led by Casey, sent a letter  Thursday to Medicare Administrator Seema Verma asking the agency to “widely publicize the existing SEP for people who were misled by information” in the Medicare Plan Finder and to make switching plans easy.

In its statement to KHN Wednesday, CMS said it provides special enrollment periods for a number of reasons. It added that beneficiaries can get a special enrollment period related to Plan Finder issues anytime next year.

They can “call 1-800-MEDICARE and explain to our call center representatives that they have an issue with their plan choice. It is not CMS’s expectation that beneficiaries will have documentation or screenshots,” the statement said. Beneficiaries will be able to start the process of changing plans during that call, CMS said.

CMS officials refused to be identified but would not give a reason.

Applying for a special enrollment period could be tricky. In the Nov. 27 blog post, Medicare officials said the information on the Plan Finder is “the most current and accurate information on premiums, deductibles and cost sharing that Medicare Advantage and Prescription Drug Plans provide.” They noted that the “information changes frequently because plans regularly update drug formularies and renegotiate drug prices.”

America’s Health Insurance Plans, the trade group representing health insurers, “is not aware of any systematic problems with the Plan Finder, which is operated by CMS,” said spokeswoman Cathryn Donaldson.

People who enroll in a private Medicare Advantage policy, an alternative to traditional government-run Medicare that covers both drugs and medical care, already have an alternative. They have until March 31 to change plans or enroll in traditional Medicare.

Collins and Casey are not the only members of Congress raising the issue. Sen. Sherrod Brown (D-Ohio) wants CMS to provide a special enrollment period in these cases and clearly communicate the details, a spokesman said.

Rep. Richard Neal (D-Mass.), who chairs the House Ways and Means Committee, believes Saturday’s deadline should be extended, a committee aide said. The committee has heard about the Plan Finder’s problems from numerous seniors’ advocates and counselors from state health insurance assistance programs, as well as the insurance companies that sell coverage.

Since enrollment for 2020 coverage began Oct. 1, the National Association of Health Underwriters, which represents 100,000 insurance agents, has sent CMS officials 54 Plan Finder problems and is still receiving reports from agents, said John Greene, the vice president for congressional affairs.

The Medicare counselors at Nebraska’s Senior Health Insurance Information Program  flagged more than 100 issues as of mid-November, said Alicia Jones, the program’s administrator.

After receiving complaints about the Plan Finder, Delaware’s insurance commissioner, Trinidad Navarro, issued a consumer alert last week.

Tatiana Fassieux, education and training specialist at California Health Advocates, said her organization wants CMS to offer a blanket, nationwide special enrollment period instead of  granting it case by case. The group helps train Medicare counselors for California’s Health Insurance Counseling and Advocacy Program, known as HICAP.

Leslie Fried has been an elder law attorney in Washington, D.C., since 1985, so imagine her surprise when she was stumped last weekend helping her mother pick a policy through the Plan Finder.

Fried, who is also senior director of the Center for Benefits Access at the National Council on Aging, did the same search three times for the least expensive plans that cover her mother’s drugs and came up with a different result each time.

“Beneficiaries should be able to have confidence in the Plan Finder after a single search,” she said.

For assistance reviewing drug and medical plans, call your state’s Senior Health Insurance Information Program at 877-839-2675 or the Medicare Rights Center at 800-333-4114.


Source link


Whistleblower alleges Medicare fraud at iconic Seattle-based health plan


Group Health Cooperative in Seattle, one of the nation’s oldest and most respected nonprofit health insurance plans, is accused of bilking Medicare out of millions of dollars in a federal whistleblower case.

Teresa Ross, a former medical billing manager at the insurer, alleges that it sought to reverse financial losses in 2010 by claiming some patients were sicker than they were, or by billing for medical conditions that patients didn’t actually have. As a result, the insurer retroactively collected an estimated $8 million from Medicare for 2010 services, according to the suit.

Ross filed suit in federal court in Buffalo, N.Y., in 2012, but it remained under a court seal until July and is in the initial stages. The suit also names as defendants two medical coding consultants, consulting firm DxID of East Rochester, N.Y., and Independent Health Association, an affiliated health plan in Buffalo, N.Y. All denied wrongdoing in separate court motions filed late Wednesday to dismiss the suit.

The Justice Department has thus far declined to take over the case, but said in a June 21 court filing that “an active investigation is ongoing.”

The whistleblower suit is one of at least 18 such cases documented by KHN that accuse Medicare Advantage managed-care plans of ripping off the government by exaggerating how sick its patients were. The whistleblower cases have emerged as a primary tool for clawing back overpayments. While many of the cases are pending in courts, five have recovered a total of nearly $360 million.

“The fraudulent practices described in this complaint are a product of the belief, common among MA organizations, that the law can be violated without meaningful consequence,” Ross alleges.

Medicare Advantage plans are a privately run alternative to traditional Medicare that often offer extra benefits such as dental and vision coverage, but limit choice of medical providers. They have exploded in popularity in recent years, enrolling more than 22 million people, just over 1 in 3 of those eligible for Medicare.

Word of another whistleblower alleging Medicare Advantage billing fraud comes as the White House is pushing to expand enrollment in the plans. On Oct. 3, President Donald Trump issued an executive order that permits the plans to offer a range of new benefits to attract patients. One, for instance, is partly covering the cost of Apple Watches as an inducement.

Group Health opened for business more than seven decades ago and was among the first managed-care plans to contract with Medicare. Formed by a coalition of unions, farmers and local activists, the HMO grew from just a few hundred families to more than 600,000 patients before its members agreed to join California-based Kaiser Permanente. That happened in early 2017, and the plan is now called Kaiser Foundation Health Plan of Washington. (Kaiser Health News is not affiliated with Kaiser Permanente.)

In an emailed statement, a Kaiser Permanente spokesperson said: “We believe that Group Health complied with the law by submitting its data in good faith, relying on the recommendations of the vendor as well as communications with the federal government, which has not intervened in the case at this time.”

Ross nods to the plan’s history, saying it has “traditionally catered to the public interest, often highlighting its efforts to support low-income patients and provide affordable, quality care.”

The insurer’s Medicare Advantage plans “have also traditionally been well regarded, receiving accolades from industry groups and Medicare itself,” according to the suit.

But Ross, who worked at Group Health for more than 14 years in jobs involving billing and coding, said that from 2008 through 2010 GHC “went from an operating income of almost $57 million to an operating loss of $60 million. Ross said the losses were “due largely to poor business decisions by company management.”

The lawsuit alleges that the insurer manipulated a Medicare billing formula known as a risk score. The formula is supposed to pay health plans higher rates for sicker patients, but Medicare estimates that overpayments triggered by inflated risk scores have cost taxpayers $30 billion over the past three years alone.

According to Ross, a GHC executive attended a meeting of the Alliance of Community Health Plans in 2011 where he heard from a colleague at Independent Health about an “exciting opportunity” to increase risk scores and revenue. The colleague said Independent Health “had made a lot of money” using its consulting company, which specializes in combing patient charts to find overlooked diseases that health plans can bill for retroactively.

In November 2011, Group Health hired the East Rochester firm DxID to review medical charts for 2010. The review resulted in $12 million in new claims, according to the suit. Under the deal, DxID took a percentage of the claims revenue it generated, which came to about $1.5 million that year, the suit says.

Ross said she and a doctor who later reviewed the charts found “systematic” problems with the firm’s coding practices. In one case, the plan billed for “major depression” in a patient described by his doctor as having an “amazingly sunny disposition.” Overall, about three-quarters of its claims for higher charges in 2010 were not justified, according to the suit. Ross estimated that the consultants submitted some $35 million in new claims to Medicare on behalf of GHC for 2010 and 2011.

In its motion to dismiss Ross’ case, GHC called the matter a “difference of opinion between her allegedly ‘conservative’ method for evaluating the underlying documentation for certain medical conditions and her perception of an ‘aggressive’ approach taken by Defendants.”

Independent Health and the DxID consultants took a similar position in their court motion, arguing that Ross “seeks to manufacture a fraud case out of an honest disagreement about the meaning and applicability of unclear, complex, and often conflicting industry-wide coding criteria.”

In a statement, Independent Health spokesman Frank Sava added: “We believe the coding policies being challenged here were lawful and proper and all parties were paid appropriately.

Whistleblowers sue on behalf of the federal government and can share in any money recovered. Typically, the cases remain under a court seal for years while the Justice Department investigates.

Photo: Feodora Chiosea, Getty Images

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.


Source link


Health2047 spins out Medicare Advantage company Zing Health


Healthcare innovation company Health2047 has spun out Zing Health, a tech-enabled Medicare Advantage plan meant for those traditionally underserved by existing healthcare plans.

Menlo Park, California-based Health2047 works to commercialize healthcare technology in partnership with the American Medical Association to make progress on issues including data interoperability, chronic disease management and value-based payments.

Zing Health will build out its presence in the Midwest and focus on elevating the patient-provider relationship to help address social barriers to care have huge impacts on patient health outcomes. The company plans to launch in Cook County with coverage starting in 2020.

Patients will have access to a local field care team that has an on-the-ground understanding of the community landscape and can collaborate on patient care with physicians and hospitals. The information gleaned from these relationships can be used on larger population health initiatives.

The company plans to embed staffers at local hospitals to help ensure patients are getting appropriate care in a timely manner.

Zing Health was co-founded by Health2047, TWG Partners Founder Dr. Eric Whitaker and Harthaven Capital Founding Partner Dr. Ken Alleyne.

Some of the benefits touted by the health plan include its ability to be customized to individual member needs, a broad over-the-counter formulary and easing patient access to care at nontraditional sites like federally qualified health centers.

“We are building a program that is affordable, accessible and repeatable anywhere in the United States,” Zing Health CEO Eric Whitaker said in a statement.

“We will co-locate care teams with community partners to collect real-time, on-the-ground data about our members and help them achieve their best health possible by ensuring they can access convenient, comprehensive care.”

Zing Health is the third spinout from Health2047, which was co-founded by the AMA and has raised more than $40 million in funding from investors. Two other companies were launched by Health2047 last year.

The first was Akiri, a San Francisco-based startup building a subscription-based data network to enable the use and transfer of health information.

First Mile Health was the second spinout and is focused on connecting people with prediabetes with health coaches and appropriate programs to change their behavior.

Picture: tuk69tuk, Getty Images


Source link


A majority of large employers want to expand Medicare, survey says


A recent survey from the National Business Group on Health found that among large employers, 55 percent were in favor of expanding Medicare.


Source link


CMS goes for liberal approach in Medicare CAR-T coverage


A long-awaited decision on coverage of CAR-T cell therapies in cancer under Medicare has finally arrived.

The Centers for Medicare and Medicaid Services said Wednesday evening that it had issued its decision for CAR-Ts, making the immunotherapy treatments available to Medicare beneficiaries nationwide. It addresses a longstanding dilemma, whereby CAR-Ts were covered under Medicare in a more haphazard way, without a consistent policy in place, while also broadening coverage.

“Today’s coverage decision provides consistent and predictable patient access nationwide,” CMS Administrator Seema Verma said in a statement. “CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”

Currently, two Food and Drug Administration-approved CAR-Ts are on the market: Novartis’ Kymriah (tisagenlecleucel), for acute lymphoblastic leukemia in children and young adults and adult diffuse large B-cell lymphoma; and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), for adult DLBCL only.

Ensuring a consistent coverage regime for CAR-Ts is crucial, given the therapies’ high price tags: Both carry list prices of $373,000 for DLBCL and, in the case of Kymriah, $475,000 for ALL, on top of high supportive care costs for conditioning prior to therapy, hospitalization and treatment of side effects. And those costs to the healthcare system will balloon as more CAR-Ts and other cell therapies enter the market in the coming years.

“I’m thrilled to see that CMS listened to commenters and backed away from things it had proposed such as coverage with evidence development, collection of patient-reported outcomes data, among others,” wrote Jugna Shah, president of Nimitt Consulting, in an email. “This is definitely a win for patients and providers. Now we just have to continue working on getting hospitals appropriately reimbursed for this therapy.”

Notably, the finalized decision takes a liberal approach to the way CAR-Ts can be used and monitored.

For one, Medicare will cover off-label use of CAR-Ts as long as they are recommended by CMS-approved compendia, such as the National Comprehensive Cancer Network Guidelines. Compendia like the NCCN Guidelines contain recommended uses for drugs based on clinical data that may not have FDA approval and are used by payers to determine coverage for off-label uses of drugs.

In addition, whereas CMS had initially intended to only cover CAR-Ts if they were administered under registries or clinical trials that include two years of monitoring post-treatment – known as Coverage with Evidence Development, or CED – it will instead cover their administration in any healthcare facility enrolled in the FDA’s Risk Evaluation and Mitigation Strategies, or REMS program.

That also means that CAR-Ts do not necessarily have to be administered strictly in a hospital setting, a limitation many experts had feared, as it would cut off access to patients who live far away from hospitals. Previously, the plan was to only cover the therapies if patients received them at facilities accredited by the Foundation for the Accreditation of Cellular Therapy. “Per the FDA, hospitals and their associated clinics may administer CAR T if the facilities are enrolled in with the REMS requirements,” the decision memo issued Wednesday read.

“Hospitals and their associated clinics” is consistent with the language used in the FDA-approved REMS for Kymriah and Yescarta.

The decision follows an unusually drawn-out delay by CMS. After publishing a proposed decision memo in February, the agency posted a short press release on May 17 stating that the National Coverage Determination had been delayed, but would be “forthcoming.” Nevertheless, until Wednesday it remained mum, and even drugmakers said they had not been given any update or timeline for when the decision would be reached.

Photo: nopparit, Getty Images


Source link