Legislation Seeks to Change Medicare Home Infusion Policies

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Legislation Seeks to Change Medicare Home Infusion Policies

Bipartisan groups in both the Senate and the House have introduced bills aimed at changing the way the professional services benefit for Medicare Part B home infusion therapies is implemented. The current situation, industry experts maintain, has resulted in providers directing these beneficiaries to another setting such as the hospital outpatient department or a skilled nursing facility, which is particularly concerning during the COVID-19 pandemic.

On Aug. 5, Sens. Mark Warner (D-Va.) and Tim Scott (R-S.C.) introduced S.2652, the Preserving Patient Access to Home Infusion Act. A couple weeks later on Aug. 20, Reps. Terri Sewell (D-Ala.), Debbie Dingell (D-Mich.), Fred Upton (R-Mich.) and Vern Buchannan (R-Fla.) introduced a companion bill, H.R.5067. The Senate bill was referred to the Committee on Finance, while the House bill was referred to the Energy and Commerce and Ways and Means committees.

The bills seek to update the Social Security Act “to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program” by taking three steps:

(1) Adding “and pharmacy services” after “nursing services” to recognize the role that pharmacists play in home infusion.

(2) Adding a sentence that would clarify that payment for an “infusion drug administration calendar day” means “payment for the date on which such a drug was administered to the individual (regardless of whether a qualified home infusion therapy supplier was physically present in the home of such individual on such date).”

(3) Broadening the entities that can establish and review a home infusion care plan from solely physicians to include nurse practitioners and physician assistants.

The issue goes back a few years. Traditionally Medicare reimbursed for home infusion drugs but not the professional services associated with the infusions themselves. This changed in December 2016 with the signing of the 21st Century Cures Act, which established a reimbursement structure for the professional services that are provided with home infusion therapies starting Jan. 1, 2021.

The act also changed the reimbursement methodology for Part B infusible drugs furnished through durable medical equipment (DME) to average sales price (ASP) as of Jan. 1, 2017. So rather than being reimbursed at average wholesale price (AWP) -5%, the drugs were paid at the ASP +6% rate used for most Part B drugs. About 30 drugs were affected, and while the impact wasn’t negative for all of them, reimbursement for inotropic agent milrinone dropped about 92%, and subcutaneous immune globulin (IG) Hizentra dropped about 31%. Other subcutaneous IG products such as Gamunex and Gammagard suffered hits of between 21% and 31%.

To address the issue, in 2017, members of Congress introduced legislation to plug the gap between the ASP reimbursement change that went into effect in 2017 and the professional services reimbursement that would go into effect in 2021. The legislation was enacted in February 2018 with President Trump’s signing of the Bipartisan Budget Act (BBA), which established a transitional payment.

But in a July 2018 proposed rule, in describing the “infusion drug administration calendar day,” CMS explained that it understood the act to mean “payment is only for the day on which the nurse is in the patient’s home when an infusion drug is being administered.” In a November 2018 final rule, CMS said it would stay with this definition, despite pushback from various industry stakeholders, as well as congressional members who introduced the original legislation on which the section in the BBA was based.

In comments on the proposed rule, Sens. Johnny Isakson (R-Ga.) and Warner stated that in their legislation, the benefit was intended to cover “professional services, including nursing services.” But the proposed rule “contradicts our intent…and makes the reimbursement required by the bill inadequate.”

No Other Payers Have Requirement

The senators maintained that their intent was to “mirror this benefit as closely as possible to private sector and other governmental home infusion programs. No other payers for home infusion (commercial plans, Medicare Advantage Plans, the Veterans Administration, or others) have such a requirement for a professional to be physically present in order to reimburse for the beneficiary’s home infusion.” They urged CMS to withdraw that requirement, but the agency declined to do so.

This is not the first time similar legislation has been introduced. On March 12, 2020, Rep. Eliot Engel (D-N.Y.) led a bipartisan group that introduced H.R.6218, and Warner led another bipartisan group introducing S.3457. Those bills sought to also include the “pharmacy services” wording and to clarify what an “infusion drug administration calendar day” is.

Patients on infusion therapies may be among the sickest Medicare beneficiaries. If not treated at home, they will need to be treated in another environment such as a hospital or skilled nursing facility. Not only are these costlier treatment settings than the home, but they also put these immune-compromised beneficiaries at risk for a hospital-acquired infection, which is difficult and expensive to treat.

COVID Has Increased Home Infusion Need

“Immunocompromised patients — for example, heart transplant patients — require lifesaving and sustaining specialty infusion services. The best place for these extremely sick patients to receive care is in the home,” maintains Drew Walk, CEO of Soleo Health, a specialty pharmacy and infusion services provider. “CMS’s misguided payment policy disincentivizes the provision of these services in the home setting. It goes so far as to require that a nurse be physically present in the home for the service to be covered under Medicare.

“No other commercial or government payer has this requirement. Given the ongoing concerns about the COVID-19 [pandemic] and the delta variant, along with the high potential for facility-acquired infections, access to home infusion therapy is now more important than ever,” he continues. “An independent analysis estimates that, if passed, this legislation would save Medicare $93 million over 10 years.” The Moran Company released that assessment of the fiscal implications in January 2020.

Walk tells AIS Health, a division of MMIT, that both providers and Medicare beneficiaries have been impacted. “Some home infusion therapy providers have closed or merged with larger companies, and, in general, we are seeing a decline in providers’ abilities to service these Medicare patients due to the reimbursement challenges stemming from the current legislation. Medicare beneficiaries are experiencing decreased access to home infusion therapy due to the current home infusion reimbursement structure. These patients are increasingly being directed to the hospital or outpatient setting.”

The COVID-19 pandemic, he says, has brought a new urgency to the situation: “Patients who are severely immunocompromised would be better served in the home vs. the hospital or outpatient setting, especially due to COVID-19. Those in need of physician-prescribed infusion therapies should have access to care at home. The current CMS requirement for a nurse or other practitioner be physically present with the patient in the home for the service to be reimbursable is contrary to all we have learned about stopping the spread of COVID-19.”

Asked about the odds of the legislation passing, Walk points to the estimated $93.1 million in savings by The Moran Company. “Given Congress’s current work on a new spending bill and the identification of pay-fors and their continuing focus on allowing home-based services, we believe that this bill is a good candidate for inclusion in that or another vehicle this Congress.”

Contact Walk via Susan J. Turkell at sturkell@pairelations.com.

by Angela Maas, AIS Health