covered entities, and the Secretary for purposes of facilitating the ordering, purchasing,
and delivery of covered outpatient drugs under this section, including the processing of
chargebacks for such drugs.
(v) The imposition of sanctions, in appropriate cases as determined by the Secretary,
additional to those to which covered entities are subject under subsection (a)(5)(D),
through one or more of the following actions:
(I) Where a covered entity knowingly and intentionally violates subsection
(a)(5)(B), the covered entity shall be required to pay a monetary penalty to a
manufacturer or manufacturers in the form of interest on sums for which the
covered entity is found liable under subsection (a)(5)(D), such interest to be
compounded monthly and equal to the current short term interest rate as
determined by the Federal Reserve for the time period for which the covered entity
is liable.
(II) Where the Secretary determines a violation of subsection (a)(5)(B) was
systematic and egregious as well as knowing and intentional, removing the
covered entity from the drug discount program under this section and disqualifying
the entity from re-entry into such program for a reasonable period of time to be
determined by the Secretary.
(III) Referring matters to appropriate Federal authorities within the Food and Drug
Administration, the Office of Inspector General of Department of Health and
Human Services, or other Federal agencies for consideration of appropriate action
under other Federal statutes, such as the Prescription Drug Marketing Act (21
U.S.C. 353).
(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.
(A) IN GENERAL.—Not later than 180 days after the date of enactment of the Patient
Protection and Affordable Care Act, the Secretary shall promulgate regulations to establish
and implement an administrative process for the resolution of claims by covered entities that
they have been overcharged for drugs purchased under this section, and claims by
manufacturers, after the conduct of audits as authorized by subsection (a)(5)(C), of violations
of subsections (a)(5)(A) or (a)(5)(B), including appropriate procedures for the provision of
remedies and enforcement of determinations made pursuant to such process through
mechanisms and sanctions described in paragraphs (1)(B) and (2)(B).
(B) DEADLINES AND PROCEDURES.—Regulations promulgated by the Secretary under
subparagraph (A) shall—
(i) designate or establish a decision making official or decision-making body within
the Department of Health and Human Services to be responsible for reviewing and
finally resolving claims by covered entities that they have been charged prices for
covered outpatient drugs in excess of the ceiling price described in subsection (a)(1),
and claims by manufacturers that violations of subsection (a)(5)(A) or (a)(5)(B) have
occurred;
(ii) establish such deadlines and procedures as may be necessary to ensure that claims
shall be resolved fairly, efficiently, and expeditiously;
(iii) establish procedures by which a covered entity may discover and obtain such
information and documents from manufacturers and third parties as may be relevant to