Code of Massachusetts Regulations
101 CMR - EXECUTIVE OFFICE FOR HEALTH AND HUMAN SERVICES
Title 101 CMR 801.00 - Drug Manufacturer Negotiations and Accountability
Section 801.05 - Referral to the Health Policy Commission
Universal Citation: 101 MA Code of Regs 101.801
Current through Register 1518, March 29, 2024
(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.
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