Coverage & Reimbursement

 

Medical technology innovators’ guiding mission is to provide life-saving and life-changing products to patients who need them most while improving health outcomes across the country and around the world.

Challenges associated with establishing timely and adequate reimbursement often, and many times unnecessarily, delay patient access to innovative technologies, diagnostics, and digital services. MDMA works to align coding, coverage, and payment policies and procedures with government healthcare programs and private payers to help ensure patient access to safe and effective medical technology innovations. Without timely and adequate reimbursement in place, patients are denied access to the most effective medical treatments and care.

The MDMA Coverage & Reimbursement Working Group typically meets on the 2nd Wednesday of each month at 2pm ET via teleconference. If you would like to join this working group, click here.

Latest News

Senators Young and Padilla Introduce the “Ensuring Patient Access to Critical Breakthrough Products Act”
Senators Todd Young (IN) and Alex Padilla (CA) today introduced the “Ensuring Patient Access to Critical Breakthrough Products Act"...

CMS Publishes CY 2025 OPPS, ASC, Physician Fee Schedule Final Rules
The Centers for Medicare and Medicaid Services (CMS) today published the Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC)...

MDMA Files Comments to CMS on CY 25 PFS and CY 25 OPPS/ASC Proposed Rules
MDMA submitted comments today to Centers for Medicare and Medicaid Services (CMS) on two key proposed rules...

MDMA Responds to Request for Stakeholder Input on Next-Generation CURES Bill
MDMA submitted comments today to Congressman Larry Bucshon, M.D. (IN) and Congresswoman Diana DeGette’s (CO) regarding their request for stakeholder input on a next-generation cures bill...

MDMA Statement on CMS’ Final TCET Notice and Guidance
MDMA's President and CEO Mark Leahey issued the following statement today regarding the “Transitional Coverage for Emerging Technologies” (TCET) final notice and guidance issued by CMS...

CMS Releases Medicare Physician Fee Schedule and Hospital OPPS and ASC Payment System Calendar Year 2025 Proposed Rules
The Centers for Medicare and Medicaid & Medicaid Services (CMS) today released the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed...

MDMA Statement on Reintroduction of the “Improving Seniors' Timely Access to Care Act”
MDMA President and CEO Mark Leahey issued the following statement today applauding the bipartisan reintroduction of the “Improving Seniors' Timely Access to Care Act,” which is designed to...

MDMA Files Comments to CMS on the Use of Medicare Advantage Data
MDMA filed comments today to the Centers for Medicare & Medicaid Services (CMS) in response to their Request for Information (RFI) on Medicare Advantage (MA) data...

House Budget Committee Examines Impact of Consolidation in the Health Care Ecosystem
The House Budget Committee held a hearing today examining the impact of consolidation in the health care industry and the budgetary effects it is...

Bipartisan Senate Group Releases Roadmap for Artificial Intelligence
A Bipartisan Senate AI Working Group, led by Majority Leader Chuck Schumer (NY) and Senators Mike Rounds (SD), Martin Heinrich (NM) and Todd Young (IN), unveiled...

House Oversight Committee Advances “BIOSECURE Act”
The House Oversight Committee held a markup today of H.R. 8333, the “BIOSECURE Act,” where it passed with overwhelming support in a 40-1 recorded vote...

House Committee Advances Legislation to Extend PHE Telehealth Policies
The House Committee on Ways and Means convened a markup today to consider legislation to expand access to health care in...

MDMA Responds to CMS Request for Public Comment on Prior Authorization Information Collection
MDMA recently submitted a letter in response to the request from the Centers for Medicare & Medicaid Services (CMS) for public comment on the collection of information...

CMS Releases IPPS Proposed Rule, Legislation Introduced to Improve Patient Access to MedTech
The Centers for Medicare & Medicaid Services (CMS) recently released the FY 2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule... 

House Committee Raises Medtech Reimbursement Issues During HHS Budget Hearing
The House Ways & Means Committee held a hearing today with Health and Human Services (HHS) Secretary Xavier Becerra to review the administration’s FY 2025 budget request...

CMS Issues Final Rule Designed to Improve the Prior Authorization Process
The Centers for Medicare and Medicaid Services (CMS) issued a final rule today titled...

MedPAC Recommends Physician, Hospital Pay Increase at January Meeting
The Medicare Payment Advisory Commission (MedPAC) voted on recommendations today for Congress...

Energy & Commerce Clears Health Related Bills in Committee Markup
The House Energy & Commerce Committee marked up 44 pieces of legislation today pertaining...

MDMA Statement on House Subcommittee Passage of the "Ensuring Patient Access to Critical Breakthrough Products Act 2023"
Mark Leahey, President & CEO of MDMA, issued the following statement today regarding...

CMS Publishes OPPS, ASC, Physician Fee Schedule Final Rules
The Centers for Medicare and Medicaid Services (CMS) today published the Calendar Year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule.

House E&C Health Committee Reviews Policies to Improve Access to Innovative Medical Technologies
The House Energy and Commerce (E&C) Committee Health Subcommittee held a hearing today...

MDMA Submits Comments to CMS on CY 2024 PFS Proposed Rule and CY 2024 OPPS Proposed Rule
MDMA filed comments today in response to the proposed changes to the physician fee schedule (PFS) for calendar year (CY) 2024... 

MDMA Files Comments to CMS on Home Health Prospective Payment System Proposed Rule
MDMA filed comments today on the Calendar Year (CY) 2024 Home Health Prospective Payment System (HHPPS) proposed rule...

MDMA Submits Comments to CMS on their TCET Proposal
MDMA's President & CEO, Mark Leahey issued a statement today following the submission of comments

MDMA Submits Comments to CMS on Calendar Year 2024 ESRD Proposed Rule
MDMA submitted comments today to the Centers for Medicare and Medicaid Services (CMS)

MDMA Encourages Congress to Alleviate Physician Clinical Labor Cuts
MDMA along with AdvaMed and MITA recently sent a letter to Congressional leadership urging

House Ways & Means Committee Advances Legislation Intended to Increase Price Transparency
The House Ways and Means (W&M) Committee today held a markup of two bills intended to

MDMA Statement on House Hearing on Medicare Policies to Improve Patient Access to Medtech Innovations
MDMA issued the following statement today following the House Energy and Commerce Subcommittee on Health...

CMS Issues Transitional Coverage for Emerging Technologies (TCET) Proposal
MDMA filed comments today on the Centers for Medicare and Medicaid Services (CMS) proposed rule setting forth proposed changes to the Medicare hospital inpatient prospective payment system (IPPS) and...

MDMA Submits Comments on Medicare Inpatient IPPS Proposed Rule
MDMA filed comments today on the Centers for Medicare and Medicaid Services (CMS) proposed rule setting forth proposed changes to the Medicare hospital inpatient prospective payment system (IPPS) and related policies for...

MDMA Statement on House Hearing Examining Policies to Support Innovation and Patient Access
MDMA President and CEO Mark Leahey issued the following statement today following the House Ways and Means Subcommittee on Health hearing that examined policies to support innovation and patient access to therapies..

MDMA Submits Comments to CMS Urging for Improvement to Prior Authorization
MDMA filed comments today in response to the Centers for Medicare and Medicaid Services (CMS) proposed rule setting forth new requirements that would improve patient access to their health care information, improve the efficiency of...

MDMA Statement on the Introduction of the “Ensuring Patient Access to Critical Breakthrough Products Act 2023”
Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the bipartisan introduction of the “Ensuring Patient Access to Critical Breakthrough Products Act 2023"...

MDMA Submits Comments to CMS on Medicare Advantage Proposed Rule
MDMA submitted comments today to the Centers for Medicare and Medicaid Services (CMS) regarding proposed policy changes for the Medicare Advantage Program for contract year 2024. MDMA’s comments focused on...

Bipartisan Group of Representatives Urge CMS to Improve Patient Access to Novel Technologies
Members of the House of Representatives sent a letter today to the Centers for Medicare and Medicaid Services (CMS) Commissioner Chiquita Brooks-LaSure encouraging the agency to issue the Transitional Coverage for Emerging Technologies...

Prior-Authorization Delays Highlighted during Senate HELP Hearing on Mental Health
The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing today entitled, “Caring for Our Kids: Supporting Mental Health in the Transition from High School to College.”

Members of Congress Reintroduce Bipartisan Legislation Targeting Accelerated Coverage of Novel Treatments
Representatives Brett Guthrie (KY), Anna Eshoo (CA), Morgan Griffith (VA), Scott Peters (C A), Michael Burgess (TX) and Doris Matsui (CA)  today reintroduced the  Pre-approval Information Exchange Act ."

Bipartisan Group of Senators Urge CMS Administrator to Improve Patient Access to Novel Technologies
A group of 16 bipartisan Senators sent a letter today to the Centers for Medicare and Medicaid Services (CMS) Administrator, Chiquita Brooks-LaSure, in support of the transitional coverage for emerging technologies...

MDMA Statement on Unanimous House Passage of Legislation Addressing Excessive Use of “Prior Authorization” by Medicare Advantage Plans
The Medical Device Manufacturers Association’s (MDMA) President and CEO Mark Leahey issued the following statement today following the unanimous passage of H.R. 3173...

MDMA Submits Comments to CMS on Calendar Year 2023 OPPS/ASC Proposed Rule
MDMA submitted comments today to the Centers for Medicare and Medicaid Services (CMS) on the Notice of Proposed Rulemaking setting forth the proposed changes to the Medicare Hospital Outpatient...

MDMA Submits Comments to CMS on Calendar Year 2023 Physician Fee Schedule Proposed Rule
MDMA submitted our comments today to the Centers for Medicare and Medicaid Services (CMS) on the proposed revisions to the Medicare Physician Fee Schedule...

MDMA Submits Recommendations to CMS Regarding the Medicare Advantage Program
MDMA filed comments today in response to the Centers for Medicare and Medicaid Services (CMS) Request for Information (RFI) on the Medicare Advantage (MA) Program...

House Committee Examines Practices of Medicare Advantage Plans
The House Energy and Commerce (E&C) Subcommittee on Oversight and Investigations held a hearing today examining the oversight of private sector Medicare Advantage (MA) plans...

MDMA Submits Comments on IPPS Proposed Rule
MDMA filed comments today on the Centers for Medicare and Medicaid Services (CMS) proposed rule setting forth proposed changes to the Medicare hospital inpatient prospective payment system...

MDMA Submits Comments to CMS on June HCPCS Public Meeting
The Centers for Medicare and Medicaid Services (CMS) held the June 2022 Healthcare Common Procedure Coding System (HCPCS) Public Meeting today...

MDMA Statement on the Introduction of "Cures 2.0" Legislation
Mark Leahey, President & CEO of MDMA, issued the following statement today following the introduction of "Cures 2.0" legislation...

MDMA Statement on CMS' Repeal of the MCIT Final Rule
MDMA President & CEO, Mark Leahey issued the following statement today regarding CMS' repeal...

MDMA Statement on Senate Introduction of "The Improving Seniors' Timely Access to Care Act".
MDMA President & CEO, Mark Leahey issued the following statement today applauding the bipartisan Senate...

MDMA Submits Comments Regarding the Proposed Repeal of the MCIT Pathway
MDMA submitted comments today to the Centers for Medicare and Medicaid Services (CMS) in response...

MDMA Statement on CMS' Proposed Rule for MCIT Repeal and Future Rulemaking
Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issue the following statement today...

MDMA Statement on the Introduction of the "Ensuring Patient Access to Critical Breakthrough Products Act"
Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today regarding the bipartisan introduction of the...

MDMA Statement on the Release of “Cures 2.0” Draft Legislation
Mark Leahey, President and CEO of MDMA, issued the following statement regarding the release of a “Cures 2.0” draft legislation by Congresswoman Diana DeGette (CO) and Congressman Fred Upton (MI)...

"IGNITE American Innovation Act" Reintroduced in the House
Representatives Dean Phillips (MN-03) and Jackie Walorski (IN-02) recently reintroduced the...

MDMA Statement on Chiquita Brooks-LaSure's Confirmation as the Next CMS Administrator
MDMA President & CEO, Mark Leahey issued the following statement today...

Legislation to Improve “Prior Authorization” Process Introduced in the House
Bipartisan legislation was reintroduced in the House of Representatives recently that is...

MDMA Statement on CMS' Additional Delay of MCIT Implementation
MDMA President & CEO, Mark Leahey, issued the following statement today regarding...

MDMA, Broad Coalition Urge CMS to Review "Prior Authorization" Growth
MDMA and a broad coalition of stakeholders sent a letter to CMS today on growing concerns...

MDMA Statement on the Senate Confirmation of Xavier Becerra as HHS Secretary
Mark Leahey, President & CEO of MDMA, issued the following statement today regarding the Senate confirmation...

House Democrats Urge CMS to Move Forward with MCIT Final Rule Implementation
A group of Democratic Members of the House of Representatives sent a letter to Acting CMS Administrator Liz Richter urging her to retain the March 15th effective date...

MDMA Statement on Chiquita Brooks-LaSure’s Nomination as the Next CMS Administrator
Mark Leahey, President and CEO of MDMA issued the following statement today regarding President Biden’s nomination of Chiquita Brooks-LaSure to be the next Administrator of the Centers for Medicare and Medicaid Services (CMS)...

CMS Releases OPPS, ASC & PFS Final Rules
The Centers for Medicare and Medicaid Services (CMS) released final rules this week that will impact the health care delivery system. The first of the two rules released is the Calendar Year (CY) 2021 Physician Fee Schedule (PFS) final rule...

MDMA Files Comments to CMS on CY 2021 OPPS and PFS Proposed Rules
MDMA recently submitted our comment letters to the Centers for Medicare and Medicaid Services (CMS) on the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System and the Physician Fee Schedule (PFS) proposed rules for calendar year (CY) 2021...

MDMA Applauds CMS Proposed Rule to Accelerate Patient Access to Innovative Medical Technologies
The Medical Device Manufacturers Association (MDMA) issued the following statement today applauding the Centers for Medicare and Medicaid Services’ (CMS) proposed rule...

CMS Issues Recommendations on Restoring "Elective" Surgeries
CMS released new guidance today on restoring “elective” surgeries and procedures that have been postponed as a result of COVID-19...

MDMA Statement on the Administration's Announcement on Elective Surgeries
Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement regarding the Administration’s announcement of guidelines to resume elective surgeries in light of the COVID-19 pandemic:

MDMA Statement on Proposed Medical Technology Payment Reforms by CMS
Mark Leahey,
President and CEO of MDMA, issued the following statement on the inclusion of new payment reforms for medical technologies in the CMS proposed rule for the IPPS...

MDMA Statement on Committee Passage of the “Local Coverage Determination Clarification Act”
MDMA issued the following statement today regarding passage in the House Ways and Means Committee of H.R. 3635, the “
Local Coverage Determination Clarification Act of 2017”...

MDMA Statement on CMMI Director Boehler's Selection as Senior Advisor to HHS Secretary Azar
MDMA issued the following statement today regarding the selection of CMMI Director Adam Boehler...

MDMA Statement on Seema Verma's Confirmation as the Next CMS Administrator
MDMA issued the following statement today regarding Seema Verma's confirmation as the new CMS Administrator...

MDMA Statement on Dr. Price's Confirmation as HHS Secretary
MDMA issued the following statement today regarding Congressman Tom Price's confirmation...

MDMA Submits Comments to CMS on Proposed Changes to Comprehensive Care for Joint Replacement Model
MDMA submitted comments to CMS on proposed changes to comprehensive care...

MDMA Submits PFS and OPPS Comments to CMS
MDMA submitted comments today for the proposed revisions under the Medicare Physician Fee...

Senate Introduces Bill to Streamline Breakthrough Technologies

Medicare Payment Advisory Commission (MedPAC) Releases March 2016 Report to Congress
Today the Medicare Payment Advisory Commission (MedPAC) released its 
March 2016 Report to Congress...

CMS Releases FY 16 Hospital Value-based Purchasing Program Results
The Centers for Medicare and Medicaid (CMS) today released the Hospital Value-based...

CMS Releases New Utilization & Payment Data for Medical Equipment & Supplies
As part of their ongoing efforts to provide greater transparency around Medicare data...

ICD-10 System Now Live
The US health care system has officially transitioned to the...

MDMA Submits Comments to CMS on OPPS
MDMA submitted comments to CMS this week on issues impacting patient access...

MDMA Statement on 21st Century Cures Discussion Draft
MDMA issued the following statement today in response to the latest "21st Century Cures" discussion draft...

House of Representatives Overwhelmingly Passes SGR Repeal Legislation
The House of Representatives today voted by an overwhelming number of 392-37 to pass H.R. 2, the "Medicare Access and CHIP Reauthorization Act of 2015."

MDMA Statement on 21st Century Cures Discussion Draft

MDMA FY 2014 OPPS Final Rule Summary

MDMA PFS CY 2014 Final Rule Summary

US District Court Decision on Device Tax (Manufacturer vs. Distributor)

MDMA Raises Concerns About Proposed Changes to IDE Process
MDMA recently filed comments on the CY 2014 proposed rules for the Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS).  MDMA noted that CMS’ revision...

MDMA Submits Comments on CMS's FY 2014 IPPS Proposed Rule
MDMA submitted comments today to the Centers for Medicare and Medicaid Services (CMS) for the FY2014 proposed rule for the Inpatient Prospective Payment System (IPPS)

MDMA Submits Comments on Coverage with Evidence Development Draft Guidance
MDMA submitted comments this week to the Centers for Medicare and Medicaid Services (CMS) regarding their draft guidance for Coverage with Evidence Development (CED)…..