Improving Biosimilars and Patient Care

Holland & Knight's Public Policy & Regulation Group secured a major victory for healthcare client Biosimilars Forum when the Centers for Medicare & Medicaid Services said it will begin issuing unique HCPCS codes to each individual biosimilar product.
Improving Biosimilars and Patient Care

Holland & Knight's Public Policy & Regulation (PP&R) Group secured a major victory for pharmaceutical industry client Biosimilars Forum in the Calendar Year (CY) 2018 Medicare Physician Fee Schedule (MPFS) Final Rule.

In the Final Rule, which was placed on display at the Federal Register on Nov. 2, the Centers for Medicare & Medicaid Services (CMS) announced a change to its present policy on biosimilar reimbursement. CMS stated that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes – often referred to as "J-codes" – to each individual biosimilar product. The new codes will start being issued on or after Jan. 1, 2018.

The reversal of the existing policy received extensive coverage by the healthcare trade media and is considered one of the most significant victories for life sciences companies in the past several years. Holland & Knight's PP&R attorneys and healthcare policy professionals advocated for their biosimilar clients through a comprehensive strategy that included substantial knowledge of the regulatory and reimbursement processes, coalition building and external stakeholder engagement, as well as productive meetings with congressional and Trump Administration officials.

The Forum is a nonprofit organization seeking to advance biosimilars in the United States with the intent of improving healthcare, as well as expanding access and availability of biological medicines. The Forum is the only organization solely representing the biosimilar industry. Holland & Knight manages all aspects of the Forum, including organization management, legislative and regulatory affairs, general counseling, and public relations and media.

Biosimilar refers to a biologic product developed such that there are no clinically meaningful differences between the biosimilar and an existing licensed, originator biologic in terms of efficacy, safety and immunogenicity. Biosimilars have the potential for improving patient care through savings and efficiencies for the healthcare system, increased access to biologic therapies and broadening the number of treatment options available. As a result, the availability of biosimilars could lead to expanded use of biologic therapies, which may result in better health outcomes.

The Forum has long advocated for CMS to reconsider a policy that gives multiple biosimilars of the same reference product one reimbursement code and effectively pays for all the products at the same rate. Without such a change, proponents argued that the industry may introduce fewer biosimilars into the market, resulting in less competition, higher prices for taxpayers and fewer treatment options for Medicare patients.

Until now, CMS had remained committed to its existing reimbursement policy. The latest proposal reversed that policy, and now newly approved biosimilar biological products with a common reference product will no longer be grouped into the same billing code.

The Public Policy Game Plan

CMS' decision comes after countless meetings that the PP&R Group initiated with CMS officials, the Secretary of Health and Human Services (HHS), the Office of Management and Budget (OMB), the White House Domestic Policy Council (DPC), the Office of Information and Regulatory Affairs (OIRA) and the White House deputy chief of staff. The group also engaged dozens of congressional offices to petition CMS, resulting in letters sent by 52 House members and nine senators.

These efforts were supplemented by the firm's regulatory and legal response to the agency. The pharmaceutical, biotechnology and medical device industries attorneys also worked with health economists to generate robust data demonstrating that a policy change would further incentivize manufacturers to invest in and develop biosimilars and could lead to additional cost savings over the long term. CMS cited direct language from the Forum's comment submission in the Final Rule, demonstrating the impact that Holland & Knight's regulatory, healthcare and life sciences attorneys' efforts had on their decision.

The PP&R Group's victory comes after it successfully lobbied on behalf of clients to preserve Medicare reimbursement for lifesaving mammography services and biosimilars in the 2018 Proposed Rule for MPFS, language that remained in the Final Rule.

For a complete analysis of the MPFS Final Rule, see this Holland & Knight memorandum. For deeper insight for Medicare physician and hospital payments in 2018, read the alert "Top Takeaways for Medicare Physician and Hospital Payments in 2018."

About the Public Policy & Regulation Practice Group

Holland & Knight's Public Policy & Regulation Practice Group includes more than 100 lawyers and other professionals engaged in federal, state and local government affairs, as well as regulatory counseling and related disciplines. With a wide range of teams, including Government Representation, Federal Budget & Appropriations, State and Local Government Procurement, State Capitals, Alcohol Beverage, Cybersecurity and Privacy, Energy, Environment, Healthcare & Life Sciences, High-Stake Communications, Telecommunications and Transportation, our attorneys and professionals manage complex client problems and opportunities involving local, state and federal government regulatory, transactional and legislative matters.

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