Medicare Medical Devices

News & Analysis as of

OIG Reviews Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors (PODs) of Spinal Devices

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

Recent Ninth Circuit En Banc Decision Makes It Easier for Relators to be an Original Source and the First- to-File

On July 7, 2015, the United States Court of Appeals for the Ninth Circuit issued an en banc decision that potentially makes it easier for relators to prevail on pending False Claim Act qui tam suits and bring new actions in...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

Congress Clears Bipartisan DME & Home Care Bills

On July 15, 2015, the House of Representatives approved by voice vote the following two bills...more

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

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...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

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets...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 Approves Subsidies to Medicare Beneficiaries Provided by a Clinical Research Study

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a medical device manufacturer’s proposed arrangement to provide subsidies to certain...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...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

OIG Releases FY 2015 Work Plan Mid-Year Update

The HHS OIG has updated its FY 2015 Work Plan to reflect new and/or completed items since release of its Work Plan in October 2014. Of note, the OIG has announced its plans to conduct several new Medicare reviews addressing:...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

OIG Releases Mid-Year Update to its Work Plan

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...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 Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of...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

Congressional Health Policy Hearings - April 2015

Congressional committees have held a number of hearings recently on health policy issues, include the following: ..A House Energy and Commerce Health Subcommittee hearing on “Medicare Post-Acute Care Delivery and Options...more

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