NHIA Advocacy Priorities

NHIA Priority Issue: Meaningful Coverage in Medicare

Meaningful Medicare coverage of home infusion drug therapies has long been a top priority for NHIA.

Senators Blanche L. Lincoln (D-AR) and Olympia J. Snowe (R-ME) and Representatives Eliot L. Engel (D-NY-17) and Timothy F. Murphy (R-PA-18) have re-introduced legislation in the 111th Congress that would provide Americans on Medicare with much needed access to high-quality, life-saving home infusion therapy denied to them under the current program. 

The “Medicare Home Infusion Therapy Coverage Act of 2009”, introduced concurrently in the Senate (S.254) and in the House (H.R. 574) would close a gap that currently exists in coverage where the medicines used in infusions to treat serious diseases are covered, but not the medical services, supplies or equipment needed to deliver the home therapy.

This combined effort by both the Senate and House emphasizes the significance of this piece of legislation to both the patient and our healthcare system.  As the 111th Congress addresses healthcare reform, there is no better example of a positive change that can be made that will save the Medicare system significant amounts of money while ensuring Medicare beneficiaries receive the same access to quality home infusion therapy enjoyed by private sector patients.  There has never been a better time than now to get the bills passed, and with your help we must achieve passsage..

Take steps now to support this effort!  See our Grassroots Action Center for more that you can do.

Introduction of these bills followed introduction of bills in the previous two sessions of Congress, significant steps that raised the visibility of the issues.  Since the passage of the Medicare Modernization Act of 2003 (MMA), NHIA has worked with Congress and the Centers for Medicare & Medicaid Services (CMS) to create meaningful coverage for home infusion therapies under Medicare.  Unfortunately, most Medicare Part D beneficiaries are being forced into receiving infusion therapy in hospitals and skilled nursing facilities at a significantly higher cost to Medicare and at great inconvenience to the patients.  NHIA's congressional campaign to obtain meaningful Medicare coverage for home infusion therapy is bipartisan.

Other Key Issue Areas

Medicare Part B Reimbursement and Regulation – Medicare Part B reimbursement for the limited set of home infusion drugs that are covered under the Durable Medical Equipment benefit is 95% of Average Wholesale Price.  NHIA was instrumental in securing provisions in the MMA that legislated Medicare home infusion drug reimbursement at this level and we will continue to work towards maintaining it for so long as Durable Medical Equipment (DME) coverage for infusion continues.  NHIA always monitors proposed Part B regulations and other related government actions, and comments on behalf of infusion providers wherever needed.

DME MAC Advisory Councils – Coordinated within our Payer Relations Committee, NHIA is a member of each of the four DME MAC Advisory Councils (DACs) organized by medical suppliers that bill Medicare Part B claims to a Durable Medical Equipment Medicare Administrative Contractor (DME MAC).  Our NHIA-member DAC representatives raise issues pertaining to coverage and billing for infusion therapy at DAC meetings and teleconferences.  An example of an accomplishment involved a "widespread" probe of Total Parenteral Nutrition claims which started in August 2006 in Jurisdiction B.  These actions by a Medicare contractor resulted in pre-payment delays of claims and unreasonable audit denials.  NHIA became directly involved with the contractor’s medical director to demonstrate the unreasonable denials and press for timely improvement of the audit process.  The contractor’s probe was discontinued.

Medicare Part D Infusion Drug Coverage - While most infusion drugs are covered under the Medicare’s prescription drug benefit, there is no coverage for the infusion related services, supplies and equipment under Part D.  As a result, most Medicare Part D beneficiaries are effectively denied access to home infusion therapy in their homes and S.254/H.R. 574 (above) will address this situation.  Nevertheless, many home infusion therapy providers undertake their best efforts to service Part D patients if feasible.  While the traditional retail pharmacy structure of Part D is not a good match for covering home infusion drugs, NHIA has maintained an ongoing communications line to CMS about the program to point out problems and comment on regulations and other CMS publications.  From this, CMS has taken some actions to overcome obstacles such as in the areas of safety and formularies.  NHIA members may learn more at our Medicare Part D resource center.

DME Competitive Bidding – NHIA urged CMS to exclude external infusion pumps and related drugs, and enteral nutrition, from the Medicare Part B competitive acquisition program mandated by the MMA.  While it is unfortunate that enteral nutrition therapy was included in the first round, NHIA is pleased that CMS paid attention to our arguments as to why selection of infusion drug therapies would not be appropriate in round one of the program.  Importantly, they were also excluded from the second round of the program that had been announced by CMS prior to delay of the whole program by the Medicare Improvement for Patients and Providers Act of 2008.  The most assured way to make certain infusion drug therapies are never included in the program is through passage of legislation to establish a meaningful Medicare benefit for home infusion therapy (above).  We are monitoring as CMS rolls out its competitive bidding program and providing resources to our members on it.  NHIA members may learn more at our Medicare competitive bidding resource center.

Quality Standards – The MMA gave CMS the authority to establish quality standards and accreditation requirements for Medicare Part B suppliers.  NHIA has been very involved in this process.  Learn more at our Medicare competitive bidding resource center, which includes information on the Part B quality standards.  Through the ongoing activities of NHIA staff working with our Standards/Accreditation Committee, NHIA also has liaison relationships with all major, third-party accrediting bodies and professional-standards setting organizations affecting infusion providers.

Sterile Compounding - Pharmacists have a crucial role in providing extemporaneously compounded sterile preparations to patients and for ensuring the sterility, safety and efficacy of these preparations.  NHIA is committed to application of appropriate standards for infusion pharmacies.  We are also committed to providing ongoing education and information regarding appropriate implementation of sterile compounding standards in the infusion pharmacy sector, including the important USP <797> standards.  NHIA is also a founding member of the Pharmacy Compounding Accreditation Board, a voluntary accreditation program for compounding pharmacies.  NHIA members may learn more at our sterile compounding resource center.

HIEC - Standardized electronic claiming and coding for home infusion continues to be one of NHIA's important priorities. The Home Infusion EDI Coalition (HIEC) was formed in 1994 as a broad-based coalition of providers, payers, and claims clearinghouse organizations seeking a sensible national standardized electronic claiming system for home infusion.  Since 2002, NHIA has annually published the premier infusion industry coding and claiming educational tool, the NHIA National Coding Standard for Home Infusion Claims under HIPAA.  Used by providers and payers throughout the United States, maintaining the document is an ongoing activity for NHIA staff working with our HIEC Committee.  Learn more at our HIEC resource center.

Medicaid - NHIA strongly opposes Medicaid reimbursement cuts, including the federal rule to set caps on reimbursement for general drugs with Average Manufacturer Price (AMP) as well as any move towards average sales price (ASP) methodology for reimbursement.  NHIA encourages Medicaid programs to take advantage of the cost savings associated with home infusion therapies, rather than drive down reimbursement so far that providers cannot serve patients, resulting in transfers to higher cost settings.  NHIA has also assisted individual members and statewide provider coalitions working with various state Medicaid programs including Tennessee, Nevada, California, Pennsylvania, and others.