For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan during each reporting period—
(A)
in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period—
(i)
a list of drugs for which a claim was filed and, with respect to each such drug on such list—
(I)
the contracted compensation paid by the group health plan for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan;
(II)
the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan, for each covered drug (identified by the National Drug Code);
(III)
for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);
(IV)
the proprietary name, established name or proper name, and the National Drug Code;
(V)
for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy;
(VI)
with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—
(aa)
whether such drug is a brand name drug or a generic drug, and—
(AA)
in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and
(BB)
in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and
(bb)
the total number of—
(AA)
prescription claims (including original prescriptions and refills);
(BB)
participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;
(CC)
dosage units and dosage units per fill of such drug; and
(DD)
days supply of such drug per fill;
(VII)
the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan after rebates, fees, alternative discounts, or other remuneration received from applicable entities;
(VIII)
the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan, or for which no claim is submitted under the plan;
(IX)
the total net spending on the drug;
(X)
the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration;
(XI)
the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities—
(aa)
for claims incurred during the reporting period; and
(bb)
that is related to utilization of such drug or spending on such drug; and
(XII)
to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan;
(ii)
a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan during the reporting period, and, with respect to each such therapeutic class—
(I)
the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
(II)
the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities;
(III)
the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities—
(aa)
for claims incurred during the reporting period; and
(bb)
that is related to utilization of drugs or drug spending;
(IV)
the average net spending per 30-day supply and per 90-day supply by the plan and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period;
(V)
the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug;
(VI)
if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and
(VII)
the total out-of-pocket spending under the plan by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted under the plan;
(iii)
with respect to any drug for which gross spending under the group health plan exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period—
(I)
a list of all other drugs in the same therapeutic class as such drug;
(II)
if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and
(III)
any change in formulary placement compared to the prior plan year; and
(iv)
in the case that such plan (or an entity providing pharmacy benefit management services on behalf of such plan) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services—
(I)
an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order, specialty, or retail pharmacies;
(II)
the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan; and
(III)
a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan, and, with respect to each drug dispensed—
(aa)
the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan, and to participants and beneficiaries;
(bb)
the median amount charged to such plan, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants and beneficiaries, when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan;
(cc)
the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan and to participants and beneficiaries, that is available from any pharmacy included in the network of such plan; and
(dd)
the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount; and
(B)
with respect to any group health plan, regardless of whether the plan is offered by a specified large employer or whether it is a specified large plan—
(i)
a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary;
(ii)
a summary document for plans to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan, that—
(I)
contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or benefits under such plan;
(II)
contains only aggregate information; and
(III)
states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan; and
(iii)
with respect to drugs covered by such plan during such reporting period—
(I)
the total net spending by the plan for all such drugs;
(II)
the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and
(III)
to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries;
(iv)
amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act
1
So in original. Probably should be followed by “of 1974”.
(
29 U.S.C. 1108(b)(2)(B)(ii)(dd)(AA)) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for—
(I)
the referral of the group health plan’s business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts;
(II)
consideration of the entity providing pharmacy benefit management services by the group health plan; or
(III)
the retention of the entity by the group health plan;
(v)
an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity
; and
(vi)
total gross spending on all drugs under the plan during the reporting period.