CMS proposes improved ambulatory BP coverage

The U.S. Centers for Medicare & Medicaid Services recently released a proposed decision memo stating that it believes there is evidence sufficient to support the use of ambulatory blood pressure monitoring for diagnosing and treating hypertension in its beneficiaries.

The agency laid out circumstances for reimbursement coverage, including white coat hypertension verified through at least two separate clinic or office visits with separate measurements three months apart or suspected masked hypertension, measured similarly.

To qualify for coverage, the devices must be quality certified and validated for use in the intended patient population, capable of producing standardized plots of blood pressure measurements for 24 hours, include written and oral instructions and be read by treating physicians or a treating non-physician practitioner, according toe the release.

CMS said that ambulatory blood pressure monitoring will be covered once a year, and that other indications for it would come at the discretion of the Medicare Administrative Contractors.

The agency said that it is seeking comments on the proposed decision, and that it will respond to public comments in a final decision memorandum, according to the release.

CMS touts ‘more flexibility’ in new TAVR coverage requirements

The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs.

The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures.

The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine and evaluate patient suitability for open aortic valve replacement surgery or TAVR from two to one.

“We believe this modification is appropriate given the advancements and progress made since 2012 as TAVR becomes more widely performed,” CMS wrote in its proposal.

Volume requirements for existing TAVR programs at hospitals looking to receive CMS reimbursement were raised slightly, according to the new proposal. Previously, hospitals were only required to perform 20 aortic valve replacements per year or 40 per two years – that requirement has been more than doubled to either 50 AVRs per year or 100 AVRs per two years.

For new programs looking to begin TAVR programs, the volume requirements stayed mostly the same, but language was shifted from 50 total AVRs per year to 50 open heart surgeries in the year prior to the program launch and at least 20 aortic valve related procedures in the two years prior to launch.

“When reassessing this requirement, CMS endeavored to balance ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases while limiting the burden and barriers unnecessary requirements may have on both hospitals and patients flexibility. Therefore CMS proposes to maintain the annual volume of cases (≥ 50) in the previous year prior to TAVR but have provided flexibility on how that is met,” CMS wrote in its proposal.

In a press release, CMS said it met with “numerous stakeholders” as it sought new requirements for providers to perform a certain volume of heart procedures. The agency said that the volume procedures are included “given the link between heart procedure volume and patient outcomes in the medical literature and the risks from receiving care in low-volume settings.”

CMS added that it believes the new decisions will provide “more flexibility” in how providers meet those requirements, and that it reflects the “latest evidence on volume and outcomes.”

“CMS must continually refine our policies and requirements in light of emerging evidence. Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries,” CMS Administrator Seema Verma said in a press release.

The agency also said it is looking to gather more information about metrics other than volume that could be used to asses quality and safety, and said it is “specifically proposing a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Earlier this month, results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) TAVR systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.

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Can a lifetime guarantee boost value-based care?

Cheryl Bednar, 54, of Laflin, Penn., suffered from chronic pain from hip deterioration until Geisinger Dr. James Murphy performed a hip replacement in February 2018 and offered the lifetime guarantee. (Image from Geisinger)

Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries.

The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes. Medacta and Geisinger will share the costs of the implant and associated hospital fees while patients remain on the Geisinger Health Plan and are treated by Geisinger providers.

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

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Insightec wins expanded Medicare coverage for essential tremor treatment

Insightec updated logoIncisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019.

Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor that has not responded to medication. The approval extends coverage for the procedure to a total of 38 U.S states.

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

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Medicare’s bundled ortho payments yield modest savings

Medicare’s randomized trial of a new bundled payment model for hip and knee replacement surgeries led to $812 in savings per procedure, a 3.1% reduction in costs when compared with traditional means of paying for care, according to new research.

The study from Harvard T.H. Chan School of Public Health and Harvard Medical School found that the bundled payment model was also associated with a reduction in the use of skilled nursing care after hospitalization, but had no effects on complication rates among patients.

Published online today in the New England Journal of Medicine, the study confirms what an earlier Medicare study had found in terms of savings. In September, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare payments for lower extremity joint replacement care fell by 3.3% among participating hospitals compared to a control group in the first year of its bundled payment pilot program. Quality of care was maintained in both settings, the federal health insurer said.

“Interest in bundled payments has exploded the past few years,” said Michael Barnett, one of the lead authors on the study and assistant professor of health policy and management at Harvard Chan School. “The big question has always been whether this new model can lead hospitals to meaningfully reduce spending without harming patients. This study indicates that with the right financial incentive, hospitals can save money without compromising quality by sending more patients home rather than to a nursing facility.”

Bundled payments are an alternative payment strategy that health plans, Medicare, and Medicaid are experimenting with to reduce expenses. Unlike traditional fee-for-service payments, bundled payments provide a single, fixed payment for a procedure and follow-up care rather than individually paying all parties separately.

In January 2016, CMS required all hospitals in 67 geographic areas to participate in the five-year “Comprehensive Care for Joint Replacement” (CJR) program aimed at lowering healthcare costs and improving outcomes. The program bundles payments for hip and knee replacements from hospital admission to 90 days after discharge.

Under the model, hospitals in the selected cities received bonuses or penalties depending on how much they spent on follow-up care 90 days after joint-replacement patients were discharged. The program is the largest randomized policy experiment in Medicare to date of a new payment model.

To determine if the bundled payment model was effective at reducing costs and complications, the Harvard researchers analyzed data from the first two years of the program (2016-2017). They compared costs associated with 280,161 joint replacement procedures in 803 hospitals that were required to participate in the bundled payment program with 377,278 procedures in 962 hospitals that were not participating in the program.

The analysis showed that before accounting for administrative costs, bonuses and penalties, the bundled payment model resulted in a modest 3% savings for each patient and that complications rates did not increase. The cost savings were driven almost exclusively from reducing the use of post-acute care nursing facilities, the researchers said.

One concern that has been expressed over bundled payments is that such models may incentivize hospitals to avoid operating on sicker, more costly patients. The Harvard study, however, showed that the model had little impact on the number of higher-risk patients who received lower extremity joint replacements.

The study adds to the growing body of evidence that bundled payment models reduce spending without sacrificing quality of care, the researchers said. They added that the cost savings associated with bundled payments grew during the 18-month study period and that it is likely savings would continue to grow as the bundled payment model matured.

“While there is widespread agreement that we need to move away from our typical payment system, how to do so remains unclear,” said Ateev Mehrotra, senior author and associate professor of health care policy at Harvard Medical School. “We need more rigorous experiments such as this one.”


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Medtech reporting would change under new opioid law

A section of the recently-passed bill to address the opioid crisis could have implications for medtech.

The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.”

“Covered recipients,” as originally written in the sunshine provision of the Affordable Care Act, were only physicians and teaching hospitals. Section 6111 of SUPPORT would expand that to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives as of January 1, 2022. Also known as H.R. 6, the bill has passed both houses of Congress and is awaiting President Trump’s signature.

The reporting changes needn’t have anything to do with opioids, and this provision’s effective date is ambiguous, according to an FDA law blog post by the Washington, D.C. law firm Hyman, Phelps & McNamara. Stay tuned for CMS to clear this up in forthcoming regulations.






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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.