101 CMR 801.05 - Referral to the Health Policy Commission

(1) General.

(a) EOHHS may refer a manufacturer to the HPC for review of a covered drug under M.G.L. c. 6D, § 8A, provided that the following conditions are met:

1. The covered drug meets the requirements of 101 CMR 801.04(1), and EOHHS and the manufacturer have not subsequently executed an SRA for the covered drug under 101 CMR 801.04(4) or otherwise;

2. EOHHS has posted a final target value for the covered drug under 101 CMR 801.04(2)(g) and not more than 180 days have passed since EOHHS has posted said final target value; and

3. The Secretary has provided written notice of the referral to the HPC, with a copy to the manufacturer.

(b) EOHHS may publicly post a copy of the referral notice on a dedicated location of the EOHHS website.

(2) Referral Contents.

(a) Upon referral of a manufacturer under 101 CMR 801.05(1), and notwithstanding 101 CMR 801.06, EOHHS may share or make available to the HPC any records that describe or relate to manufacturer's pricing of the covered drug, including any information shared with the manufacturer under 101 CMR 801.04(2)(e), and any information received from the manufacturer under 101 CMR 801.04(2)(f), provided that the status of any information subject to 101 CMR 801.06 will not be impacted by making such information available to the HPC.

(b) EOHHS considers any information shared with the HPC under 101 CMR 801.05(2)(a) to be a disclosure made for the express purpose of carrying out Title XIX of the Social Security Act ( 42 U.S.C. § 1396 et seq.).

(3) Opportunity to Reopen Negotiations.

(a) EOHHS may initiate a request, or consider a request by a manufacturer to reopen direct negotiations at any time after referring a covered drug to the HPC under 101 CMR 801.05, provided that nothing obligates EOHHS to enter into such further negotiations.

(b) The fact that EOHHS enters into direct negotiations with a manufacturer under 101 CMR 801.05(3)(a) will have no impact on the referral of that manufacturer to the HPC unless EOHHS withdraws the referral under 101 CMR 801.05(4).

(4) Withdrawal of Referral.

(a) At any time prior to the issuance of the determination described in M.G.L. c. 6D, § 8A(h), EOHHS may withdraw the referral of a manufacturer to the HPC under 101 CMR 801.05(1)(a) upon written notice to the HPC, with a copy to the manufacturer.

(b) If EOHHS has publicly posted a copy of the referral notice under 101 CMR 801.05(1)(b), EOHHS will post a copy of the withdrawal notice on a dedicated location of the EOHHS website.

Notes

101 CMR 801.05

Adopted by Mass Register Issue 1412, eff. 3/6/2020.