Centers for Medicare & Medicaid Services Medical Devices

News & Analysis as of

Washington Healthcare Update

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

CMS Extends Medicare Prior Authorization for Power Mobility Devices Demonstration through August 2018

CMS has announced that it is extending its Medicare Prior Authorization for Power Mobility Devices (PMDs) demonstration for three years, through August 31, 2018. This demonstration was launched on September 1, 2012 in seven...more

Washington Healthcare Update

This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more

Health Care Update - July 2015

In This Issue: - Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

2014 CMS Open Payments Data Released

On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more

CMS Proposes HCPCS Changes for Miscellaneous DME

CMS is proposing to revise the coding used to describe miscellaneous durable medical equipment (DME). The agency notes that HCPCS code E1399, “durable medical equipment, miscellaneous,” is currently used to bill for...more

Washington Healthcare Update

This Week: Leading Up to the SCOTUS King v. Burwell Decision... House Votes to Repeal the Medical Device Tax... CMS Announces It Will Bolster Transitional Reinsurance Payments... MedPAC Releases June Report to Congress....more

OIG Advisory Opinion Approves Patient Subsidies For Clinical Study

On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more

Washington Healthcare Update

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

CMS Considers Whether to Eliminate Certificate of Medical Necessity/DME Information Forms

CMS recently hosted a special open door forum soliciting reactions on whether to eliminate Certificate of Medical Necessity (CMN) and Durable Medical Equipment Information forms as required documents to determine medical...more

CMS Releases Latest Medicare Hospital and Physician Utilization, Payment Data

CMS has released detailed Medicare inpatient hospital, outpatient hospital, and physician utilization and payment data for 2013, including data analysis such as spending breakdowns by specialty and region. The hospital data...more

CMS Excludes Non-Invasive Pressure Support Ventilators from DMEPOS Competitive Bidding; Announces Related Coding Changes

CMS has removed the non-invasive pressure support ventilators product category from Round 1 2017 of the Medicare DMEPOS Competitive Bidding Program. The agency also is revising the HCPCS coding for ventilators in response to...more

Washington Healthcare Update

This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

21st Century Cures Bill Includes Proposal to Broaden Sunshine Act Exclusions Related to Education

As we reported last week, on May 21, 2015, the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace...more

Washington Healthcare Update

This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more

Connecticut Legislature Reduces Mandatory Reporting of Payments to APRNs

On May 11, 2015, Connecticut Governor Dannel P. Malloy signed into law Public Act 15-4, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses” (P.A. 15-4)....more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

Washington Healthcare Update

This Week: Senate HELP Committee Hosts Hearing on Medical Innovation... HHS Announces Next Generation Accountable Care Organization (ACO) Model... CBO Releases New Long-range Cost Estimates for ACA....more

Health Care Update - March 2015

In This Issue: - King v. Burwell before the Supreme Court and the Potential Congressional Response - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional...more

GAO Evaluates CMS Activities to Prepare Health Industry for ICD-10 Launch

According to a recent GAO report, CMS has taken numerous steps to prepare industry for the October 1, 2015 transition to ICD-10 codes, such as developing checklists, timelines, and other educational materials and hosting...more

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting...more

CMS Announces DMEPOS/Home Health/Hospice RAC, Improvements to RAC Process

CMS has announced that it has awarded the Region 5 Recovery Audit contract to Connolly, LLC (although the General Accounting Office subsequently reported that a bid protest has been filed regarding this award). The purpose of...more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

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