Centers for Medicare and Medicaid Services (CMS) Archives - Page 3 of 4

Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

“As we recover from the pandemic and build a stronger health care system, [CMS] needs experienced, steady leadership,” HHS Secretary Xavier Becerra wrote in a Tweet. “Chiquita Brooks-LaSure is that leader. Her confirmation as the first Black woman to lead CMS is historic, and I look forward to swearing her in this week.”

According to a report from The Hill, GOP lawmakers had opposed Brooks-Lasure’s nomination after the…

Medicrea to pay $2M in alleged Medicare kickback scheme

French medical device manufacturer Medicrea International and its American affiliate Medicrea USA have agreed to pay $2 million to settle alleged kickbacks to physicians and other Medicare Open Payments program violations.

The company agreed to pay $1 million to the U.S. and participating states to resolve civil whistleblower allegations that the company violated the Anti-Kickback Statute and the False Claims Act and similar state statutes, according to a U.S. Dept. of Justice news release. Medicrea will pay an additional $1 million to the U.S. to resolve allegations that the companies violated the Physician Open Payments Program by “failing to fully report those physician-entertainment expenses to the Centers for Medicare and Medicaid,” the DOJ said.

The Anti-Kickback Statute prohibits medical device companies from directly or indirectly paying anything of value to induce the referral of items or services covered by federal healthcare programs. Med…

CMS delays Medicare payments for breakthrough devices until December

Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support.

The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years.

Immediately upon taking office, the Biden administration asked federal agencies to consider delaying the effective date of rules published in the Federal Register to review questions of fact, law and policy the rules may raise. CMS officials decided that coverage of breakthrough devices warranted further review.

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

CMS extends joint replacement pricing by 3 years

The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years.

The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic areas to accept bundled payments for hip and knee replacements from hospital admission to 90 days after discharge.

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

Boston Scientific, Stryker may get extension on Medicare payments

CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker.

Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute care hospitals and for certain hospitals and hospital units excluded from the IPPS for fiscal 2022.

CMS’ aim for the proposal is to close healthcare equity gaps and support greater access to certain diagnostics nad therapies during the ongoing public health emergency brought on by COVID-19 and beyond.

Within the proposal is a list of technologies that would receive an additional year of new technology add-on payments (NTAP), which includes devices from Boston Scientific and Stryker, among several other medtech companies.

Boston Scientific’s E…

CMS delays breakthrough device Medicare coverage

Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support.

The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of Innovative Technology (MCIT) final rule by 60 days to give the public more opportunities to comment, the agency said in a Federal Register notice.

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

CMS delays shift to new payment model for chronic kidney disease treatments

CMS will now wait until Jan. 1, 2022 to start its Kidney Care Choices model, meant to shift the way the U.S. treats chronic kidney disease.

The new payment model was supposed to start on Jan. 1 of this year, but health providers are still grappling with the COVID-19 pandemic.

The new model could have a major effect on dialysis treatment providers including DaVita Healthcare (NYSE:DVA) and Fresenius Medical Care (NYSE:FMS; ETR:FRE). Baxter (NYSE:BAX) meanwhile announced in 2019 that it was investing in technologies to support the effort.

The new model’s roots go back to former President Donald Trump’s 2019 executive order to emphasize transplants and home hemodialysis over in-clinic treatment. End-stage renal disease is one of the few conditions in the United States where there is already a single-payer system, thanks to a law signed by President Richard Nixon in 1972.

The Kidney Care Choices (KCC) model would provide strong financial i…

CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant

Intersect ENT (NSDQ:XENT) announced today that it received consolidated Medicare coverage for its Sinuva sinus implant.

Menlo Park, Calif.-based Intersect ENT said in a news release that CMS published an average selling price (ASP) for the Sinuva implant, providing predictability, transparency and confidence of reimbursement for providers and payers in the future.

Get the full story at our sister site, Drug Delivery Business News.

Abbott’s MitraClip receives boost as CMS expands coverage for TMVR

The MitraClip TMVR device [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device.

The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.

According to an Abbott news release, the CMS decision significantly increases the number of people eligible for insurance coverage for mitral valve repair with MitraClip. Abbott said the revision is critically important to secondary MR patients as most impacted by MR are older, while several would be required to pay out of pocket for the procedure, creating a barrier of access.

“Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,” Abbott structural heart business…

Medicare to cover breakthrough devices

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS).

The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and certain diagnostic tests. The coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.

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

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

The top 5 MassDevice stories of the week — September 4, 2020

Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week.

As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. FDA approves Medtronic MiniMed 770G insulin pump for young children

The FDA has approved the Medtronic MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose mon…