Statement of the National Home Infusion Association, Alexandria, Virginia

Chairman Johnson and Members of the Subcommittee, the National Home Infusion Association (“NHIA”) is pleased to present this written statement for the record in connection with the Subcommittee’s May 3, 2006 hearing on implementation of the Medicare outpatient prescription drug benefit. 

NHIA is a trade association that represents and advances the interests of organizations and individuals that provide infusion and specialized pharmacy products and services to the entire spectrum of home-based patients.

As reflected in the testimony presented at the hearing, the new Part D drug benefit already has been providing access to prescription drugs to seniors who had limited or no coverage prior to enrollment in Part D.  Notwithstanding some initial implementation problems, as a retail drug benefit, Part D seems to be working fairly well.

One group of beneficiaries who are not being adequately served by Part D, however, is those in need of home infusion therapy.  The problem stems from the fact that the Centers for Medicare and Medicaid Services (“CMS”) has interpreted and implemented the Part D benefit largely as a retail drug benefit.  Unfortunately, the structure that can work well for dispensing pills and other prescriptions at the retail pharmacy level is not feasible for more complex intravenous therapies that require more extensive clinical services, care coordination, equipment, and supplies for proper administration.  This is particularly true with respect to home infusion therapy, which private sector health plans typically cover as a comprehensive medical benefit rather than a pharmacy benefit. 

What is Home Infusion Therapy?

Home infusion therapy involves administering medications into the patient’s bloodstream.  It is prescribed when the patient’s condition is so severe that it cannot be treated effectively by oral medications.  Infusion drugs must be:

• Compounded in a sterile environment;
• Maintained in appropriate conditions to ensure sterility and stability;
• Administered at exactly the right dose and on the right schedule;
• Administered using the appropriate vascular access device (often a long-term device) which is placed in the correct anatomical location based on the expected duration of therapy, the pH, osmolarity, and osmolality of the medication;
• Administered using an appropriate drug delivery device;
• Flushed with the proper flushing solution between doses; and
• Monitored for adverse reactions and therapeutic efficacy.

The range of variables that must be managed by the infusion pharmacy to ensure safe and appropriate administration has led commercial payers to treat home infusion therapy as a medical service, reimbursed under their medical benefit (rather than the prescription drug benefit) and paid for using a per diem for clinical services, supplies, and equipment and a payment for nursing visits.  It also has led most commercial payers to require that infusion pharmacies be accredited by nationally recognized accreditation organizations.  Commercial payers have used this model aggressively to reduce overall health care costs while achieving high levels of patient satisfaction.

Home Infusion Pharmacy Services Differ from Retail Pharmacy Services

To ensure safe and proper administration of infusion drugs as outlined above, home infusion pharmacies provide the following services:

• Comprehensive assessment that considers patient history, current physical and mental status, lab reports, cognitive and psychosocial status, family/care partner support, prescribed treatment, concurrent oral prescriptions, and over-the-counter medications;
• Maintenance of appropriate procedures for the compounding and distribution of sterile infusion products as outlined in the national standards and state and federal regulations;
• Drug interaction monitoring and identification of potential drug, dose or drug-catheter incompatibilities;
• Comprehensive admission procedures that include patient education of medical and disposable equipment use, medication storage and handling, emergency procedures, vascular access device management, recognition and reporting of adverse drug reactions;
• Comprehensive care planning that considers actual or potential drug or equipment-related problems, therapy monitoring with specific patient goals, and coordination of activities with other providers such as home health agencies and physicians;
• Ongoing patient monitoring and reassessment activities to continually assess for response to treatment, drug complications, adverse reactions, and patient compliance;
• Laboratory report reviews, as applicable, and subsequent consults with care professionals to adjust medication orders if necessary;
• Maintenance of appropriate physical facilities for storage, preparation, dispensing, and quality control of all infusion medications and equipment;
• Ongoing employee education and competence validation activities; and
• Performance improvement programs that include collection of clinical outcomes data, patient perception data, trending and analysis of these and other performance measurement data, and root cause evaluations of all sentinel events.

Most retail pharmacies are not designed or equipped to provide all of the above services. 

Home Infusion Therapy is not a Good Fit under Part D

CMS’s final Part D rule limits coverage of infusion therapy to the cost of the drugs alone and a retail-like dispensing fee.  The regulation expressly disallows coverage for the professional services, supplies, or equipment necessary to safely provide home infusion therapy that typically represent more than half the cost of caring for these patients.  This fundamental coverage shortfall, as well as the general inapplicability of the retail benefit design to home infusion therapies, has adversely affected the care of Medicare beneficiaries in several ways. 

Dual-eligible beneficiaries typically had full coverage of home infusion therapy under Medicaid prior to their enrollment in Part D.  Once enrolled in Part D, however, many dual-eligible beneficiaries initially experienced a disruption in care due to the states’ uncertainty as to their role in providing Medicaid “wrap-around” coverage to fill in the gaps left by the drug-only coverage offered by Part D.  CMS has been working to clarify the states’ role and resolve these issues, which has helped to minimize disruptions in care.  However, dual-eligibles continue to be adversely affected by restricted formularies, cumbersome prior authorization processes, inadequate coordination of care, and a lack of access to qualified providers in Part D home infusion networks.  These issues have led to unnecessary hospital admissions and hospital discharge delays that continue to this day.

It has been our experience that Part D enrollees who have no Medicaid or supplemental insurance have little or no access to home infusion therapies or qualified home infusion therapy pharmacies through Medicare Part D. Since the non-covered home infusion supplies, equipment, and professional services constitute over 60 percent of the costs associated with home infusion therapy, these Medicare beneficiaries are effectively denied access to home infusion.  They are being forced to seek treatment in hospitals and skilled nursing facilities at a significantly higher cost to Medicare and at much greater inconvenience to the patients. 

In addition, Part D coverage limitations pose a very real threat to health and safety.  There are reports that non-infusion pharmacies have sent non-compounded intravenous drugs by mail to beneficiaries, without educating the patients on how to mix and administer the drug, without any clinical oversight that should be provided based on community standards of care, and without the necessary supplies and equipment that are integral to the drug’s safe and proper administration.  CMS has been quick to recognize the serious safety concerns and is taking steps to minimize or eliminate these occurrences.  While these efforts have helped to address the worst abuses observed during the early weeks of Part D, the root causes of poor quality of care remain intact: a fundamental coverage shortfall, a lack of appropriate quality standards, and an alignment of incentives that do not foster quality patient care.

Since the Part D benefit went into effect on January 1 of this year, the following issues have arisen and remain with respect to the coverage and provision of home infusion therapy under this benefit:

• The absence of coverage for the professional services, supplies and equipment has discouraged the participation of qualified home infusion pharmacies in Part D.

• A disturbing number of PDPs have omitted home infusion drugs from their formularies and have not implemented a timely exceptions process that permits infusion patients who have acute needs to access these drugs.

• Other PDPs are genuinely concerned and frustrated about Part D’s incomplete coverage for home infusion therapy and are waiting for CMS or Congress to correct this situation.

• Part D does not provide quality standards applicable to home infusion therapy.  Consequently, Medicare beneficiaries are at risk of receiving infusion drugs from entities that do not meet well-established standards of care.

• Many Medicare Advantage enrollees who had comprehensive home infusion therapy coverage under a Medicare + Choice (Medicare Advantage) program prior to January 1 have actually lost this coverage and are now exposed to the same quality and coverage shortfalls as described above.

Proposed Solution:

CMS believes that it does not have the authority to cover infusion therapy services, supplies, and equipment.  Yet, CMS acknowledges openly that its policies leave “gaps in coverage” for home infusion.  These gaps are jeopardizing patient safety and are actually adding costs to the Medicare program to the extent that patients are forced into more expensive treatment settings or are receiving inappropriate care.  As long as Congress allows incomplete coverage of and access to home infusion therapy in Medicare, the program will not realize the efficiencies, cost-savings, and quality improvements employed in the private sector, where home infusion has been utilized and fully covered for decades. 

We believe strongly that home infusion therapy coverage should be consolidated under Part B as a separate medical benefit.  This can be accomplished through legislation that provides permanent, complete coverage for home infusion therapy under Part B or authorizes a demonstration project to provide such coverage.

Why Part B?  Some home infusion drugs already are covered under Part B.  Part B was designed to cover multi-faceted therapies and procedures.  It is the most logical part of the Medicare program in which to consolidate coverage for home infusion therapy because it could accommodate the various aspects of the therapy - the services, supplies, equipment and drugs.  Thus, infusion therapy could be defined and covered accurately under Part B.  By contrast, even if Congress were to amend Part D to require full coverage for home infusion, it would remain an awkward fit since the entire Part D administrative apparatus is designed for a drug-only benefit and is not one that can easily be adjusted to accommodate what CMS acknowledges to be a complex medical benefit.

Every day that passes without complete Medicare coverage of home infusion therapy is a missed opportunity to bring cost-effective care in the most convenient setting to beneficiaries.  Medicare beneficiaries have a legitimate expectation that they now can obtain home infusion therapy through the Medicare program.  We stand ready to work with Congress to fulfill this expectation for our seniors.  Thank you for your interest in overseeing and improving the implementation of this important benefit.