Other Major Innovatix Policy Successes POLICY ISSUE
BACKGROUND
PROVIDERS AFFECTED
INNOVATIX IN ACTION
OUTCOME
The United States Food and Drug Administration (FDA) Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
The FDA issued a draft guidance in 2015 that would have prevented long-term care pharmacies (LTCPs) from repackaging or prepacking pharmaceutical products without the receipt of a patient-specific prescription or chart order. If finalized, the guidance would have restricted LTCPs from stocking emergency kits and remote dispensing machines at nursing homes. It would also severely limit or eliminate prepackaging medications.
Pharmacists and longterm care providers
• Submitted comments to the FDA in 2015.
In January 2017, the FDA released final guidance that addressed our concerns and allows LTCPs to continue to stock emergency kits and remote dispensing machines and removes any prepackaging limits.
• The FDA selected Innovatix, among a small group of organizations, to participate in a listening session about the proposed guidance. • Expressed industry concerns on Capitol Hill.
Medicare Part D Lock-In
The Center for Medicare & Medicaid Services (CMS) Proposed Part B Drug Payment Model
Draft Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products Between the State of [Insert State] and the U.S. Food and Drug Administration
Congress is intensely focused on the opioid crisis and is considering a number of proposals, including pharmacy lockin to curb substance abuse. Such a proposal could require Medicare Part D beneficiaries to use the same pharmacy for all prescriptions, which does not fit with the long-term care model where one long-term care facility contracts with one pharmacy.
Long-term care pharmacies and providers
In 2016, CMS proposed a new reimbursement model for all drugs that fall under Medicare Part B. The model was designed as a national demonstration to test how alternative incentive structures impact prescribing behavior with the aim of lowering pharmaceutical spending. However, the demonstration was far- reaching in terms of its timeframe and scope, and warranted additional consideration and input from the stakeholders impacted by the proposed rule.
All providers who bill under Medicare Part B
This is one of several draft documents that the FDA released in 2015 to bring increased scrutiny to those pharmacies crossing into manufacturing territory. While we support the intent to ensure patient safety, the guidance inappropriately proposed an arbitrary 30% cap on interstate compounded drugs and interchanged the terms “distribute” and “dispense.”
Infusion providers
• Weighed in with the House Energy & Commerce Committee. • Advocated on Capitol Hill for a long-term care exemption to pharmacy lockin proposals.
• Submitted comments to CMS that it should not move forward with this demonstration as proposed.
The House Energy & Commerce Committee in 2015 included legislative language, which was later enacted, that exempted Part D beneficiaries in skilled nursing facilities and long-term care settings from a proposed pharmacy lock-in provision. The Comprehensive Addiction and Recovery Act of 2016 was enacted into law with a provision exempting Medicare Part D beneficiaries in skilled nursing facilities and other LTC settings from the inappropriate pharmacy lock-in provision that is otherwise applied to Medicare Part D beneficiaries. In December 2016, CMS announced it would not move forward with the Medicare Part B Drug Payment Model.
• Expressed our concerns on Capitol Hill. • Submitted comments to the FDA in 2015. • Expressed our concerns on Capitol Hill.
The FDA’s 2018 Compounding Policy Priorities Plan indicated an intent to issue a revised draft Memorandum of Understanding to change the percentage of compounded drugs that could be shipped interstate by 503A compounders to 50%, which would be a notable improvement from the previously proposed 30%.
REFERENCES 1. U.S. Senate. n.d. “Reference: Glossary: ‘Christmas tree’ bill.” https://www.senate.gov/reference/glossary_term/christmas_tree_bill.htm. 2. U.S. Congress. “Legislation: 115th Congress: H.R.1892 - Bipartisan Budget Act of 2018. Sec. 50401. Home infusion therapy services temporary transitional payment.” February 9, 2018. https://www.congress.gov/bill/115th-congress/house-bill/1892/text?q=%7B%22search%22%3A%5B%22bipartisan+budget+act%22% 5D%7D&r=1#toc-HFDE57FDDC9714574BFEEF9BF935EF488. 3. U.S. Congress. “Legislation: 115th Congress: H.R.1892 - Bipartisan Budget Act of 2018. Sec. 50401. Home infusion therapy services temporary transitional payment.” February 9, 2018. https://www.congress.gov/bill/115th-congress/house-bill/1892/text?q=%7B%22search%22%3A%5B%22bipartisan+budget+act%22% 5D%7D&r=1#toc-HFDE57FDDC9714574BFEEF9BF935EF488.
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