National Home Infusion Association Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

Targeted News Service

WASHINGTON, Nov. 23 -- Connie Sullivan, president and CEO of the National Home Infusion Association, Alexandria, Virginia, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary". The comment was written on Nov. 2, 2020, and posted on Nov. 12, 2020:

* * *

The National Home Infusion Association (NHIA) appreciates the opportunity to submit comments on the proposed rule: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" (the "Proposed Rule") issued by the Centers for Medicare & Medicaid Services (CMS) in the Federal Register on September 1, 2020./1

NHIA is a trade association that represents home infusion therapy providers, as well as companies that manufacture and supply infusion and specialty pharmacy products. As the leading voice for the home and specialty infusion community, we write to share our feedback on the proposed definition of "reasonable and necessary."

Defining "Reasonable and Necessary"

CMS proposes to codify in regulation its long-standing definition of "reasonable and necessary" contained in the Medicare Program Integrity Manual. Section 13.5.4 of the Medicare Program Integrity Manual requires that in determining whether an item or service may be covered by a Medicare Local Coverage Determination (LCD), Medicare contractors must determine whether the item is (1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service. Regarding this third aspect of the definition, CMS currently looks at a variety of factors, including whether the item or service is furnished in a setting appropriate to the patient's medical needs and condition and is at least as beneficial as an existing and available medically appropriate alternative.

CMS is proposing to add an additional basis under which an item or service would be "appropriate" under the third factor above. Specifically, CMS proposes that an item or service would meet the third factor above if it is covered under a plan's coverage policy in the commercial insurance market, unless there is evidence to support that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. CMS notes that Medicaid managed care, Medicare Advantage, and other programs administered by the government would not be considered "commercial insurance." The new criterion would be based on commercial health insurers' coverage policies. CMS proposes to use this new criterion if an item or service is safe and effective and not experimental or investigational, but fails to meet the existing "appropriate for Medicare beneficiaries" criteria. CMS notes that each Medicare Administrative Contractor (MAC) would be responsible for reviewing commercial offerings to determine their LCDs or individual claim decisions, including individual medical necessity decisions.

NHIA supports looking to commercial insurance coverage in determining what is appropriate for Medicare patients under the "reasonable and necessary" definition. Indeed, NHIA has repeatedly asked CMS to look to commercial insurance coverage of home infusion therapy services in establishing its coverage policies for the Medicare home infusion therapy services benefit.

Commercial payers have long-embraced home infusion as a high-quality, cost-effective benefit for their enrollees. Commercial home infusion benefits are generally structured as a pharmacy-coordinated service through which a home infusion pharmacy assumes responsibility for case-managing the therapy and providing oversight for all of the professional services. As such, commercial payers reimburse home infusion providers for each day the drug is infused.

Unfortunately, in implementing the Medicare home infusion therapy services benefit, CMS issued regulations that limit reimbursement to days when a nurse or other skilled professional is physically present in the patient's home, rather than reimbursing each day the drug is infused.

This flawed policy is unique to Medicare - no other payors for home infusion therapy require a professional to be physically present in the home in order to reimburse for a patient's home infusion therapy services. This difference in policy has led to a major disparity in patient access between commercial and Medicare patients.

NHIA Recommendation:

In the context of determining coverage for professional services associated with home infusion therapy, NHIA supports CMS' proposal that a service would be considered "appropriate" if it is covered under a plan's coverage policy in the commercial insurance market, unless there is evidence to support that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. In addition, NHIA again asks CMS to apply this policy rationale to the home infusion therapy services benefit. That is, NHIA asks CMS to reimburse for home infusion therapy professional services on each day the drug is infused, consistent with the Level II HCPCS service codes used in the commercial insurance market.

NHIA appreciates the opportunity to provide comments on this important issue and we welcome the opportunity to continue working with CMS to improve the Medicare home infusion therapy benefit for Medicare beneficiaries. For questions or additional information, please contact me at [email protected].

Sincerely,

Connie Sullivan, B.S. Pharm

President and Chief Executive Officer

* * *

Footnote:

1/ 85 Fed. Reg. 54,327 (September 1, 2020).

* * *

The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0098-0002

TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact MYRON STRUCK, editor, [email protected], Springfield, Virginia; 703/304-1897; https://targetednews.com