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HF 4852

Formulary Committee members with a potential conflict of interest permitted to participate in committee communications and discussions, commissioner of human services required to develop a public comment process for recommendations, and committee required to seek expertise from the Minnesota Rare Disease Advisory Council.

2025-2026 Regular Session Introduced by Robert Bierman and 1 co-sponsor

HF 4852 strengthens transparency and public input in Minnesota’s formulary process, expanding MRDAC input on orphan drugs and requiring open, publicly disclosed decisions.

Introduction and first reading, referred to Health Finance and Policy
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Bill Summary · HF 4852

Summary of HF 4852 (Minnesota, 2025-2026)

This bill makes targeted changes to the Formulary Committee framework and related processes for drug listing, prior authorization, and expert input, with a focus on conflict-of-interest rules, public participation, and involvement of the Minnesota Rare Disease Advisory Council.

1) Purpose and intent

  • Clarify rules governing Formulary Committee membership, conflicts of interest, and transparency.
  • Establish public comment and expert consultation pathways for Formulary Committee recommendations.
  • Ensure the Minnesota Rare Disease Advisory Council (MRDAC) provides input on orphan drugs and rare-disease related decisions.
  • Streamline and enhance public access to information about formulary actions, including prior authorization decisions.

2) Key provisions and changes

A. Formulary Committee composition and governance (Section 13c)

  • The Formulary Committee is designated to carry out duties described in Sections 13 to 13g, based on recommendations from medical and consumer groups.
  • Composition requirements:
    • At least five licensed physicians, including:
    • One actively practicing psychiatrist
    • One who specializes in rare diseases
    • One pediatrician
    • One clinician treating persons with disabilities
    • At least three licensed pharmacists, with geographic distribution (one outside the metro area, one in the metro area, and one hospital pharmacist)
    • At least two consumer representatives with medical assistance connections
    • One representative designated by MRDAC
    • The remainder: other licensed health care professionals with relevant clinical knowledge
  • Prohibition on employment by DHS or personal financial interest in pharma/PBM/health plans; DHS staff will provide ex officio, nonvoting support.
  • “Personal interest” defined (ownership thresholds and income) to determine potential conflicts.

B. Conflict of interest and transparency (Section 13c, 13a, 13m)

  • Members must notify the committee of any potential conflict of interest and recuse themselves from matters where a conflict exists.
  • A conflict of interest alone (without a personal financial interest) does not automatically bar service.
  • The commissioner must publicly disclose conflict of interest forms on DHS website at least 48 hours before meetings on the relevant drug agenda.
  • The department’s medical director serves as an ex officio, nonvoting member.

C. Terms, leadership, and meetings (Sections 13c)

  • Terms: three-year terms, with up to two reappointments by the commissioner.
  • Chair and vice-chair elected from among members.
  • Meetings: at least three times per year; the commissioner may require more frequent meetings.
  • Honorarium and travel: $100 per meeting plus mileage reimbursement.

D. Open meetings and expert input (Section 13m)

  • The Formulary Committee is subject to the Open Meeting Law (Chapter 13D).
  • Exceptions to open meetings allow:
    • Staff communication with MRDAC representatives or staff when a quorum is not present.
    • Committee members seeking clinical expertise in advance of meetings; experts may provide public comments.
  • Quorum considerations: vacant positions may not prevent a quorum if at least 60% of positions are filled.
  • MRDAC input: The committee must seek expertise and input from MRDAC before actions related to prior authorization or orphan drug placement on the preferred drug list (PDL), via MRDAC’s designated representative.
  • Prohibition on contracts with PBMs that would limit seeking MRDAC input.

E. Public input and MRDAC collaboration (Sections 13c, 13g, 13f)

  • By statute, the committee must seek MRDAC expertise before taking action on:
    • Prior authorization requirements (subdivision 13f)
    • Placement of orphan drugs on the PDL (subdivision 13g)
  • The commissioner is prohibited from entering into/renewing PBM contracts that would restrict this collaboration.
  • If MRDAC is involved, it can conduct public outreach related to proposed actions as long as it does not involve a quorum of the Formulary Committee.

F. Prior authorization framework and transparency (Section 13f)

  • The Formulary Committee reviews and recommends drugs for prior authorization and sets general criteria for brand-name drugs with generically equivalent options.
  • Before requiring prior authorization, the commissioner must:
    • Share impact and cost data, misuse potential, and relevant Medicaid data with the Committee.
    • Allow public comment (public forum previously; now formalized with public comments and a 15-day public comment window added in a revised draft).
    • Publicly disclose comments on the DHS website within 48 hours of receipt (weekends/holidays excluded); comments retained publicly for a specified period.
  • Specific provisions for:
    • Atypical antipsychotics: exemptions in certain cases (with definitions) and automatic 60-day provisional prior authorizations under specific circumstances when a generically equivalent drug becomes available.
    • Liquid methadone: automatic approval considerations and consistency across versions.
    • Oral liquids: automatic 24-hour approval if prescribed for enteral tube patients, with a streamlined PA form to be implemented by Aug 1, 2026, including a checkbox verification for tube use.
    • FDA post-2005 drugs: potential automaticPA for up to 180 days with general criteria to be established by the Committee.
    • HIV/AIDS medications: exemption from prior authorization.

G. PDL administration and public notices (Section 13g)

  • The Commissioner maintains the PDL, with public notice and opportunities for public comment for modifications or deletions.
  • Consideration of public health impact and health disparities is required before deleting/modifying a drug on the PDL.
  • Public hearings required prior to deletions/modifications, with public analysis disclosed on the DHS website at least 30 days before hearings.
  • Public notice for Formulary Committee meetings must be at least 30 days in advance, including drug-specific details and proposed actions.

3) Affected parties and entities

  • Minnesota Department of Human Services (DHS): administrates Formulary Committee, PDL, and prior authorization processes; must publish conflicts, notices, and public comments.
  • Formulary Committee members: physicians, pharmacists, consumers, and MRDAC-appointed representative; subject to conflict rules and ex officio members from DHS.
  • Minnesota Rare Disease Advisory Council (MRDAC): provides subject-matter expertise on orphan drugs and rare-disease matters; permitted to engage in public outreach through its designated representative.
  • Patients and the public: gains enhanced access to public comment, transparency of prior authorization decisions, and involvement in procedural steps.
  • Vendors/PBMs: restricted from limiting MRDAC input through contracts.

4) Procedural and timeline aspects

  • Formulary Committee term and rotation: three-year terms; reappointment up to two times.
  • Public notice requirements: at least 30 days for Formulary Committee meetings; 30-day public hearing notices for PDL changes.
  • MRDAC engagement: mandatory input on orphan drugs and prior authorization actions; 30-day pre-hearing disclosure of required analyses; post-approval timelines for MRDAC engagement (within 30 days after FDA approval/modification in PA 13f considerations).
  • Public comment: ongoing process with 48-hour disclosure window for comments on DHS site; retention of comments for a defined period.

Overall, HF 4852 strengthens transparency, public involvement, and cross-advisory collaboration in Minnesota’s formulary process, while clarifying conflict-of-interest rules and expanding MRDAC role in orphan drugs and rare-disease deliberations.

Compiled from official sources — confirm details with the bill’s official record.

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