Overview of CMS Groups

Key CMS groups are involved in Medicare coding, coverage, and payment decisions for new technologies. This page lists and describes these groups and their responsibilities.

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Center for Clinical Standards and Quality (CCSQ)   

Serves as the focal point for all quality, clinical, medical science issues, survey and certification, and policies for CMS’ programs. Provides leadership and coordination for the development and implementation of a cohesive, CMS-wide approach to measuring and promoting quality and leads CMS’ priority-setting process for clinical quality improvement. Coordinates quality-related activities with outside organizations. Monitors quality of Medicare, Medicaid, and the Clinical Laboratory and Improvement Amendments (CLIA). Evaluates the success of interventions. CCSQ has multiple divisions within the Coverage and Analysis Group featured in this guide.

Coverage and Analysis Group (CAG)

Provides leadership and coordination with HHS and CMS components and the healthcare community in the design and implementation of supporting evidence development aimed at improving the care and services for Medicare patients in all settings. Leads the evidentiary review process for all clinical topics, including internal and external technology assessments that identify relevant studies, analyze the study quality and synthesize findings. CAG has multiple divisions:

• Division of Policy and Evidence Review: Leads evidence review, policy development, external engagement, and oversight of national coverage determinations (NCDs) and emerging technologies in the pipeline.

• Evidence Development Division: Leads Coverage with Evidence Development (CED) policy development, protocol reviews, consultations, maintenance, and external collaboration. Oversees Investigational Device Exemptions (IDE) policy, including IDE trial approvals. Oversees clinical trials policy and any future modifications and implementation.

• Division of Policy Coordination and Implementation: Provides oversight of Medicare’s local coverage determination (LCD) process with the Medicare Administrative Contractors (MACs), implementation of national coverage determinations (NCD), and rulemaking for national coverage policies.

• Division of Business Operations: Designs and creates the Agency’s website that announces all NCDs, LCDs, coverage guidance documents, IDEs, CED study approvals, and other related activities. Plans and directs the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) operational/logistical activities. Manages the process to contract with outside parties for technology assessments (TAs) and designs and manages mid to long-term demonstration and other assessments or research projects having coverage implications.

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Center for Medicare (CM)

Serves as CMS’ focal point for the formulation, coordination, integration, implementation, and evaluation of national Medicare program policies and operations. Develops and implements a comprehensive strategic plan, objectives, and measures to carry out CMS’ Medicare program mission and goals and positions the organization to meet future challenges with the Medicare program and its beneficiaries.

Chronic Care Policy Group (CCPG)

Develops, evaluates and maintains policies, regulations and instructions that define the scope of benefits and payment for: 

1. Services delivered in ESRD facilities for the ESRD Prospective Payment System (PPS);
2. Religious non-medical health care institutions;
3. Services provided in inpatient psychiatric facilities for the Inpatient Psychiatric Facility (IPF) PPS;
4. Inpatient services provided in Skilled Nursing Facilities;
5. Inpatient Rehabilitation Facilities services;
6. Services provided by home health agencies and hospices; and
7. The Medicare Fee-for-Service Home Infusion Therapy benefit.

• Division of Chronic Care Management: Develops, evaluates, and reviews payment policies, regulations, and instructions concerning services delivered in ESRD facilities for the ESRD PPS, religious non-medical health care institutions (RNHCIs), and inpatient psychiatric facilities for the IPF PPS.
• Division of Cost Reporting: Develops, analyzes, interprets, and evaluates national payment policies, regulations, and instructions for principles of payment/reimbursement and the reporting of costs incurred by providers of services and other classes of facilities under fee-for-service Medicare.
• Division of Institutional Post-Acute Care: Develops, analyzes, and evaluates the scope of benefits and national Medicare payment policies for Skilled Nursing Facilities (SNFs) and Inpatient Rehabilitation Facilities (IRFs).
• Division of Home Health and Hospice: Develops and evaluates payment policies, regulations, and instructions for national Medicare policies and standards on payment methods for services provided by home health agencies (HHAs) and hospices.

Hospital and Ambulatory Policy Group (HAPG)

Responsible for policy development and rate setting for hospitals, physician offices, and certain other provider types paid by Medicare. Develops, evaluates, and maintains policies, regulations, and instructions that define the scope of benefits and payment amounts for:

1. Hospitals for inpatient services under the inpatient prospective payment system and the long-term care hospital prospective payment system;
2. Inpatient services in hospitals and units excluded from the prospective payment systems;
3. Physicians and non-physician practitioners;
4. Hospital outpatient departments, comprehensive outpatient rehabilitation facilities, and ambulatory surgical centers;
5. Clinical laboratory services;
6. Ambulance services;
7. Prescription drugs, biologicals, and blood, blood products, and hemophilia clotting factors; and
8. Opioid treatment programs, rural health clinics, and federally qualified health centers.

• Division of Acute Care: Defines the scope of Medicare benefits for services provided by hospitals to inpatients, and develops, updates, and evaluates the Inpatient Prospective Payment System (IPPS) for payments to hospitals for inpatient services and associated capital costs. Develops, updates, and evaluates the long-term care hospital prospective payment system. Develops, updates, and evaluates payment policies for hospitals and distinct-part units excluded from IPPS and other prospective payment systems.
• Division of Ambulatory Services: Defines the scope of Medicare benefits for clinical laboratory services; prescription drugs and biologicals; blood, blood products, and hemophilia clotting factors; and services furnished by rural health clinics, federally-qualified health centers, and opioid treatment programs.
• Division of Outpatient Care: Defines the scope of Medicare benefits for services furnished by hospital outpatient departments and ambulatory surgical centers (ASCs). Develops, updates, and evaluates innovative payment policies and systems for hospital outpatient services; the Partial Hospitalization Program (PHP) benefit in hospitals and Community Mental Health Centers; ASC services; and ambulance services. Develops and maintains the Outpatient Prospective Payment System (OPPS) and the ASC fee schedule. Develops Ambulatory Payment Classification (APC) assignments, including for New Technology APCs.
• Division of Practitioner Services: Defines the scope of Medicare benefits for services furnished by physicians, non-physician practitioners, independent diagnostic testing facilities, and comprehensive outpatient rehabilitation facilities (CORFs). Develops, updates, and evaluates innovative payment policies and systems for physicians, non-physician practitioners, independent diagnostic testing facilities, and CORFs.

Technology, Coding, and Pricing Group (TCPG)

Develops, evaluates, and maintains policies, regulations and instructions that define the scope of benefits and payment for:

1. Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS);
2. Splints, prosthetic devices, prosthetics, orthotics, splints and casts, therapeutic shoes lymphedema compression garments;, and surgical dressings;
3. DMEPOS items included in the DMEPOS Competitive Bidding Program (CBP) (e.g., competitive bidding payment rules, definition of mail order, grandfathering rules, traveling beneficiaries, professional exceptions, physician authorization); and
4. Ambulance services.

In addition, TCPG maintains data collection activities for drugs and biological products and the Clinical Laboratory Fee Schedule (CLFS).

TCPG also reviews and makes determinations on applications for:

1. IPPS new technology add-on payment (NTAP);
2. OPPS drug and device pass-through payments;
3. Advanced diagnostic laboratory test designation (ADLT) under the Clinical Laboratory Fee Schedule (CLFS);
4. ESRD PPS Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES); and
5. ESRD PPS Transitional Drug Add-on Payment Adjustment (TDAPA)

• Division of Coding and Diagnosis Related Groups (DCDRG): Maintains the HCPCS Level II code set—one of the standard, national medical code sets adopted under HIPAA for use by all government and private insurers primarily to identify certain drugs, biologicals, and other items and services not suitable for inclusion in other standard, national coding systems, such as the CPT® code set. Formulates CMS policy for development and maintenance of new and revised codes for the ICD-10-PCS. DCDRG leads the formulation and analysis of medical classification systems, such as Medicare Severity Diagnosis Related Groups (MS-DRGs) for the IPPS. Supports coding activity across CMS, such as the review of new CPT® codes and the development of HCPCS Level II codes needed for innovation waivers and models.
• Division of Data Analysis and Market Based Pricing (DDAMBP): Provides technical assistance and data analysis for claims monitoring across several payment systems. Prepares reports on claims volume and utilization as well as beneficiary health outcomes and care delivery. Maintains and operates the data files and crosswalks used for Medicare Part B drug payments and overall data collection and reporting of market-based data for various policy areas, such as the CLFS. DDAMBP is also responsible for the coverage and payment policy under the Ambulance Fee Schedule and the Medicare Ground Ambulance Data Collection System.
• Division of New Technology (DNT): Develops, updates, and evaluates innovative payment policies for new technology in the IPPS and the OPPS. Provides opportunity for public input regarding add-on payments for new medical services and technologies in the hospital inpatient setting. Reviews and makes determinations on applications for IPPS new technology add-on payments and applications for OPPS drug and device pass-through payments. Reviews applications for ESRD PPS TPNIES and TDAPA, and reviews applications for Advanced Diagnostic Laboratory Test (ADLT) designation under the CLFS.
• Division of DMEPOS Policy (DDP): Develops and evaluates national Medicare policies and standards on payment for DMEPOS. Develops and maintains payment and coverage policies related to the following items and services: DME, prosthetic devices, prosthetics, orthotics, splints and casts, therapeutic shoes, lymphedema compression garments, and surgical dressings. Develops and maintains certain payment policies for DMEPOS items subject to the DMEPOS CBP (e.g., competitive bidding payment rules, definition of mail order, grandfathering rules, traveling beneficiaries, professional exceptions, physician authorization).
• Division of DMEPOS Competitive Bidding (DDCB): Develops the operational policies for all phases of the DMEPOS CBP, including methodologies for evaluating bids submitted by suppliers in DMEPOS competitive bidding areas, awarding a sufficient number of contracts to suppliers to meet beneficiary demand, monitoring beneficiary access and health outcomes, and enforcing contract supplier performance.

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Center for Program Integrity (CPI)

Serves as CMS’ focal point for Medicare, Medicaid programs and Children’s Health Insurance Program (CHIP), and Marketplace program integrity issues. Promotes the integrity of the Medicare and Medicaid programs and CHIP through provider/contractor audits and policy reviews, identification and monitoring of program vulnerabilities, and providing support and assistance to states. Recommends modifications to programs and operations as necessary and works with CMS Centers, Offices, and the Chief Operating Officer (COO) to affect changes as appropriate. Maintains the National Correct Coding Initiative (NCCI), which CMS developed to promote national correct coding of Medicare Part B claims.

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Offices of Hearings and Inquires (OHI)

The Offices of Hearings and Inquiries (OHI) currently provides enterprise services supporting all of CMS’ lines of business, which includes This includes supporting the Medicare Beneficiary Ombudsman (MBO) and Competitive Acquisition Ombudsman (CAO) which provide assistance to individuals entitled to benefits under Title XVIII of the Act, resolve complaints, and provide guidance to the Agency to identify and resolve issues.

Medicare Pharmaceutical and Technology Ombudsman (PTO)

The 21st Century Cures Act established the Medicare PTO within CMS to receive and assist with complaints and requests from pharmaceutical, biotechnology, medical device, or diagnostic product manufacturers regarding coverage, coding, and/or payment for products that are covered by Medicare, or for which Medicare coverage is being sought [42 U.S.C. Section 1395b-9]. The Medicare PTO is prohibited from advocating for new coverage, coding, or payment increases within the Medicare program, but can facilitate information exchange and hear feedback from interested parties to share with CMS as appropriate, helping to promote transparency and predictability. The PTO does not duplicate existing processes such as grievance procedures, appeals, judicial hearings, or other formal avenues interested parties may have to communicate with CMS.

The PTO can be reached at PharmTechOmbud@cms.hhs.gov.

New Technology Liaison Team

Many interested parties (i.e., device/biologic/drug developers or manufacturers, industry consultants, others) engage CMS for coverage, coding, and payment questions or concerns. CMS has established a team of new technology liaisons that can serve as an initial resource for interested parties. This team is available to:

• help point interested parties to or provide information and resources regarding process, policies, and timelines;
• coordinate and facilitate opportunities for interested parties to engage with various CMS groups; and
• serve as a primary point of contact for interested parties and provide updates on developments where possible or appropriate.

This webpage is intended to be a resource to our interested parties seeking to identify and understand the pathways to Medicare coverage, coding, and pricing; discern the appropriate pathway relevant to the subject product or service and setting(s) of use; and learn which area(s) of CMS they may need to engage. Interested parties with further questions about Medicare’s coverage, coding, and payment processes, or who want further guidance about how they can navigate these processes, may contact the new technology liaison team at MedicareInnovation@cms.hhs.gov.

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