CMS opens NCA to reconsider TAVR coverage

The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures.

Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers.

Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry.

In a letter requesting reconsideration of the decision, Providence Health & Services of Southern California’s Dr. Peter Pelikan, Dr. Richard Wright and Dr. John Robertson said that since 2012, TAVR procedures have become more standard and safer, and urged for reconsideration of coverage.

The doctors said that initial approval of TAVR hospital programs were based on volumes of non-TAVR procedures, and that procedural volume was used “as a surrogate for program quality,” which was understandable given the novel nature of the procedure.

“Today, TAVR has become a commonplace and safe procedure, with indications now expanded from high risk to intermediate risk patients as well. Procedural volumes across the country are increasing, with excellent outcomes. Thus, the early motivation for the NCD, insuring quality for a new and high risk procedure, is no longer relevant,” Providence Health & Services authors wrote in their letter.

Medtech dev Edwards Lifesciences (NYSE:EW), maker of the Centera and Sapien lines of TAVR devices, also showed support for the reconsideration and urged CMS to expand availability to reach more patients.

“As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients’ access to this life-saving care,” Edwards wrote in a press release.

CMS said that on July 25, it will convene a panel of its Medicare Evidence Development & Coverage Advisory Committee seeking its recommendations “regarding the evidence on procedural volume requirements for hospitals and heart team members” necessary to launch and maintain TAVR programs.

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CMS administrator Verma calls on insurers, providers to give patients their data

For the millions covered by Medicare, accessing their healthcare data ought to be simple – after all, the data belongs to them, according to Centers for Medicare & Medicaid Services administrator Seema Verma.

Earlier this year, CMS launched the latest version of the Blue Button initiative, a program designed to allow Medicare beneficiaries to collect their claims data and transfer it to secure applications, providers, services and researchers.

Verma called on private insurers to give the same opportunity to their patients, saying that the agency is going to reexamine their relationships with private payers.

She also floated another idea: should providers participating in the Medicare program be required to give patients their data?

“We’re doing it. We’re giving our patients our data. The expectation will be that other people are giving the data,” Verma told recently at the World Medical Innovation Forum conference in Boston. “So we’re making it very clear to the industry that if you’re going to be in the Medicare program, these are the requirements. The patients’ needs are the most important.”

In recent weeks, the agency has signaled an interest in tackling drug prices and helping ensure that patients can access their own data – issues that are top-of-mind for Verma. But the problem that keeps her awake at night? How much money the U.S. spends on healthcare.

“We’re still on target to spend 1 in 5 dollars on our healthcare services,” she said at the forum last month.

In an attempt to cut costs across the industry and boost outcomes for patients, Verma and CMS – like many private insurers – are looking towards the promise of value-based payment models. She wants CMS to “move away from a system that’s pay for volume and towards one that’s paying for value,” she explained.

Verma said she wants to modernize CMS programs and reevaluate the way that the agency thinks about value, starting with giving patients more information when they interact with healthcare systems.

“Over the past years, we haven’t been able to bend the cost curve and I always think, ‘Where’s the patient in this discussion?’ We’ve all had the experience of going to a provider and not having information in terms of cost and quality,” she said.

Hospitals are already required under CMS guidelines to make a list available, upon request, of their standard charges. But in late April, CMS updated those rules, requiring hospitals to post that information. The agency also requested comment from stakeholders to identify ways that hospitals can create interfaces for consumers to compare providers.

Millions of people are covered by CMS – the agency is the single largest payer of healthcare in the United States. And the woman in charge of it knows that her decisions can move the needle on a number of trending topics in healthcare.

“If it’s not happening at CMS and it’s not happening through Medicaid and Medicare, it’s probably not going to happen nationwide,” Verma said.

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Jury convicts four in CMS-Deerfield insider trading case

A federal jury yesterday reportedly convicted a Centers for Medicare & Medicaid Services worker and three others of using inside information as the “secret sauce” in a $7 million insider trading scheme with a well-known healthcare hedge fund.

Consultant David Blaszczak, founder of Precipio Health Strategies and the one-time colleague at CMS of Christopher Worrall, pleaded not guilty last June to charges that Worrall used his position in the CMS director’s office for access to advance notice of reimbursement rate changes. Traders at Deerfield Management, Ted Huber and Rob Olan, allegedly used the inside dope to make moves on healthcare stocks affected by the changes for radiation treatments and dialysis. Another Deerfield trader, Jordan Fogel, pleaded guilty in May 2017.

The trades allegedly involved radiosurgery companies Accuray (NSDQ:ARAY), Varian Medical (NYSE:VAR) and Elekta (STO:EKTA B) and dialysis providers DaVita Healthcare(NYSE:DVA) and Fresenius (NYSE:FMS), prosecutors alleged.

Deerfield agreed last year to pay $4.6 million to settle a related U.S. Securities & Exchange Commission case, without admitting any wrongdoing.

After a four-week trial and four days of deliberations, a jury in the U.S. District Court for Southern New York yesterday convicted all four defendants on counts including wire fraud, securities fraud and conversion of government property; Worrall was acquitted of the securities fraud charges, Reuters reported.


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US Senators urge CMS head Verma to include med device ID on claims


Centers for Medicare & Medicaid Services (CMS)

Two US Senators this week wrote to Centers for Medicare and Medicaid head Seema Verma urging her to add a field for unique medical device identifier information on insurance claim forms.

The letter, from Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), cited a report from the Department of Health and Human Services’ Office of Inspector General from September.

The report claims that nearly $1.5 billion in costs to Medicare came from patients treated with seven specific cardiac devices from 3 manufacturers that were recalled or showed high failure rates over a 10 year period.

The OIG release also claimed that the defective items led to an estimated $140 million in copayment and deductible liabilities for beneficiaries.

“To facilitate the use of claim data to identify and track the additional health care costs incurred by Medicare from recalled or prematurely failed medical devices, we specifically recommend that CMS: (1) continue to work with the Accredited Standards Committee X12 to ensure that the Device Identifier is included on the next version of claim forms and (2) require hospitals to use condition codes 49 or 50 on claims for reporting a device replacement procedure if the procedure resulted from a recall or premature failure independent of whether there was a device provided at no cost or with a credit,” the OIG wrote in its report.

In their letter, Senators Warren and Grassley wrote that they were “encouraged” by CMS head Verma’s statement after the OIG report which stated that the addition could help CMS “more effectively identify and track Medicare’s aggregate costs related to recalled ore prematurely failed devices, reduce medicare costs by identifying poorly performing devices more quickly, facilitate device recipients’ chances of receiving timely follow up care, and protect beneficiaries from unnecessary costs.”

The Senators cited, however, that CMS chief medical officer Kate Goodrich did not confirm whether CMS would take the recommendations of the OIG during testimony before the Senate Committee on
Health, Education, Labor, and Pensions.

In response, Senators Warren and Grassley directly requested that CMS head Verma respond directly to three questions, including whether CMS supports capturing unique device IDs for implantable devices on claim forms. Senators also requested clarity on whether CMS follows recommendations from the HHS OIG and MedPac and is working with the Accredited Standards Committee X12 to “ensure that the DI is included on the next version of claim forms” and what, if any timeline CMS has for it’s ‘review’ of DI inclusion on claims forms.

Value-based care: CMS’s new administrator wants more of it

CMS Seema-Verma

Seema Verma, CMS’s administrator

Seven months into her tenure, CMS administrator Seema Verma is turning out to be highly supportive of value-based care models. In fact, she recently told an audience in Cleveland that she wants them implemented faster.

The situation appears to dispel doubts that alternative payment models – such as Accountable Care Organizations or “comprehensive care” models for such big-ticket items as joint replacements – would remain a priority under President Donald Trump’s administration. The move toward paying for “value” versus the old fee-for-service models are a big deal for the medical device industry, which have been shifting their strategies and focus in response.

Alternative payment methods are important for driving innovation and driving value and cost-effective care, Verma said during an appearance at the annual Cleveland Clinic Medical Innovation Summit, which took place Oct. 23–25 in Cleveland. Different models will help drive the market toward value and quality and away from a fee-for-service system, according to Verma, who shared the stage with Cleveland Clinic CEO Toby Cosgrove.

Get the full story on our sister site, Medical Design & Outsourcing.

Trump proposes deep cuts to Medicaid, NIH funding


Capitol HillPresident Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention.

The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier this week that Medicaid cuts wouldn’t get through Congress.

“I think the tradition is presidents write budget proposals and that the Senate and the House substitute their own, and so I wouldn’t expect that would carry the day,” he told The Hill.

The potential $610 billion cut to Medicaid would add to the $839 billion cut proposed by the American Health Care Act that passed in the House earlier this month.

The proposal to slash Medicaid funding goes against Trump’s campaign promise to leave Medicaid, Medicare and Social Security funds untouched.

Among the more significant reductions proposed in Trump’s budget are an -19% cut to the National Cancer Institute and a -28% cut to spending on environmental health. The budget would also trim funding for the National Science Foundation by $776 million, or -11%.

According to the president’s proposal, the FDA would receive $1.89 billion in direct government funding. The 31% decrease would be offset by an increase of $1.3 billion in user fees.

Rep. Tom Cole (R-Okla.) said the proposed $5.8 billion cut to NIH funding “penny-wise and pound-foolish”, according to Stat. Cole is the chair of the House health appropriations subcommittee.

The proposal did not include any direct cuts to Medicare.

CDC director Dr. Tom Frieden took to Twitter to respond to the administration’s proposal, calling it an “assault on science.”

Also today, Rep. Tom Macarthur (R-NJ) resigned as co-chairman of the so-called Tuesday Group, a caucus of moderate House Republicans, citing divisions over efforts to repeal and replace former President Barack Obama’s healthcare law, according to a report from Politico. 

CMS updates on criteria for Dexcom G5 coverage

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