Pending PBM-Reform Legislation on Capitol Hill

Health Care PRICE Transparency Act

H.R. 410

Would require hospitals to disclose negotiated rates with insurers, discounts for cash payments, and billing codes.

Would require insurance plans to disclose in-network and out-of-network charges for items and services included in coverage as well as negotiated prices for covered prescription drugs.

Would require a tool that allows people to obtain cost information. Would allow consumers to request additional information regarding items or services covered by their plans.

Rep. Warren Davidson (R-OH-8)

House Energy and Commerce Committee

1/20/2023

Drug Price Transparency in Medicaid Act

H.R. 1613

In Medicaid managed care, would require pharmacy reimbursement based on NADAC plus a dispensing fee based on the applicable state survey and would prohibit spread pricing.  Would require pass-through pricing in contracts between State and PBM or State and a managed care entity or other specified entity (see section 1903(m)(9)(D)).

Would require pharmacies to participate in NADAC surveys, and would require a report to Congress on specialty drug coverage and reimbursement. Among others, the report must include how state Medicaid programs define specialty drugs and pharmacies, how much the state programs pay for specialty drugs, and details on how specialty drugs are dispensed.

Rep. Buddy Carter (R-GA-1)

Other original co-sponsors:

Rep. Vicente Gonzalez (D-TX-34)

Rep. Elise Stefanik (R-NY-21)

Rep. Deborah Ross (D-NC-2)

Rep. Rick Allen (R-GA-12)

Rep. Jake Auchincloss (D-MA-4)

House Energy and Commerce Committee

3/17/2023

PROTECT 340B Act of 2023

H.R. 2534

Would prohibit discriminatory actions by PBMs and others against 340B-covered entities and their pharmacies.

Would impose fines on PBMs that violate the law.

Would authorize the Secretary to employ third parties to collect and review data from state Medicaid agencies and covered entities to prevent Medicaid duplicate discounts.

Rep. Abigail Davis Spanberger (D-VA-7)

Rep. Dusty Johnson (R-SD-At Large)

House Committees (2): Energy and Commerce; Ways and Means

4/6/2023

MVP Act

H.R. 2666

Would codify value-based purchasing arrangements under Medicaid.

For covered outpatient drugs, would require quarterly reports on the pricing structure of the drug based on terms from a value-based purchasing arrangement, and the best price for the drug outside of a value-based purchasing arrangement.

For inpatient drugs under State plans, would allow States to provide medical assistance for drugs in accordance with a value-based purchasing arrangement with drug manufacturers.

Under State plans, outpatient provisions may apply to inpatient drugs, which affects: (1) quarterly price reporting obligation; (2) definition of best price; (3) definition of average manufacturer price; and (4) anti-kickback and physician self-referral safe harbors.

Would allow States to pay for a drug sold under a value-based purchasing agreement separately from other inpatient services.

Would allow States to enter into multi-state agreements to transfer funds between states, which would allow individuals to receive a drug subject to a value-based purchasing agreement in a state other than the state in which they live.

Would require the Comptroller General of the US to perform a study on the extent to which value-based purchasing arrangements facilitate patient access to covered outpatient drugs, lower costs of the health system, and decrease expenses for patients in Federal health care programs.

Rep. Brett Guthrie (R-KY-2)

Other original co-sponsors:

Rep. Anna Eshoo (D-CA-16)

Rep. John Joyce (R-PA-13)

Rep. Jake Auchincloss (D-MA-4)

Rep. Mariannette Miller-Meeks (R-IA-1)

Rep. Scott Peters (D-CA-50)

House Committees (2): Energy and Commerce Ways and Means

4/18/2023

PBM Accountability Act

H.R. 2679

Would require pharmacy benefit managers (PBMs) to regularly furnish employers (plan sponsors)

with detailed data which includes: the total amount of copayment assistance from the drug manufacturer; the list of drugs covered by PBM services; the total gross spending on prescription drugs by the insurance plan/coverage before rebates; the total amount of rebates and all other renumeration that the health plan or insurer receives from drug manufacturers; the health plan or insurer’s total net spending on prescription drugs; and the total amount paid in rebates and renumeration to individuals and firms who referred a health plan or insurer to a PBM.

Rep. Ann Kuster (D-NH-2)

Other co-sponsors:

Rep. Buddy Carter (R-GA-1)

Rep. Anna Eshoo (D-CA-16)

Rep. Brett Guthrie (R-KY-2)

House Committees (3): Energy and Commerce; Education and the Workforce; Ways and Means

4/18/2023

Pharmacy Benefit Manager Sunshine and Accountability Act

H.R. 2816

Would require public disclosure of certain fees, rebates, and post-claim adjudication payments received or collected under a contract.

Fees requiring disclosure include the aggregate dollar amount of all: (1) rebates that a PBM or health benefits plan received under a contract from a drug manufacturer; (2) administrative fees that a PBM or health benefits plan received under a contract; (3) rebates from a pharmaceutical manufacturer that were not passed through; (4) administrative fees from a pharmaceutical manufacturer that were not passed through; (5) total post-claim adjudication payments from a pharmacy and those that were not passed through; and (6) the aggregate retained rebate percentage under a contract.

Rep. Diana Harshbarger (R-TN-1)

Other original co-sponsors:

Rep. Abigail Davis

House Committees (2); Energy and Commerce; Ways and Means

4/25/2023

Protecting Patients Against PBM Abuses Act

H.R. 2880

Proposed amendment to the Social Security Act (SSA) to establish certain requirements for PBMs under Medicare Part D (outpatient prescription drug benefits). PBMs would be prohibited from making a profit on any services under Part D other than the flat dollar amount service fees.

Rep. Buddy Carter (R-GA-1)

Rep. Lisa Blunt Rochester (D-DE-At Large)

Rep. Nicole Malliotakis (R-NY-11)

Rep. Jake Auchincloss (D-MA-4)

House Committees (2): Energy and Commerce; Ways and Means

4/26/2023

To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information.

H.R. 3262

Would require mandatory reporting from specified entities (hospitals; physician-owned physician practices with more than 25 physicians; physician practices owned by a hospital, health plan, private equity company, or venture capital firm; ambulatory surgical centers, independent freestanding emergency department) for health-related ownership information, including mergers, acquisitions, and changes in ownership.

Rep. Janice Schakowsky (D-IL-9)

Rep. Gus Bilirakis (R-FL-12)

House Committees (2): Energy and Commerce; Ways and Means

5/11/2023

Transparent PRICE Act

H.R. 3281

Would require hospitals to provide lists of standard charges for any of services provided under the Centers for Medicare & Medicaid Services-specified shoppable services and any other hospital-selected shoppable services.

Hospitals that fail to comply would be subject to fines based on bed count. Fine may exceed $5M for any continuous 1-year period of non-compliance.

Non-compliant hospitals would be subject to public disclosure of non-compliance and fines imposed.

Would require a self-service tool (internet, paper or phone) that discloses information regarding rates for services, the amount paid toward deductible, etc.

Rep. Cathy McMorris Rodgers (R-WA-5)

House Energy and Commerce Committee

5/15/2023

Promoting Transparency and Healthy Competition in Medicare Act

H.R. 3282

Would require greater data reporting and transparency into vertically

integrated companies contracting with Medicare under Parts C and D of the program

Rep. Diana Harshbarger (R-TN-1)

Rep. Kim Schrier (D-WA-8)

Rep. Gus Bilirakis (R)

Rep. Janice Schakowsky (D)

House Committees (2): Ways and Means; Energy and Commerce

5/15/2023

Providers and Payers COMPETE Act

H.R. 3284

Would require an annual report on the impact of Medicare regulations on provider and payer consolidation. The report must include regulations that implement a change to an applicable payment system, rate schedule, or another payment system; or result in a significant rule affecting provider or payer consolidation.

Also would provide for public comment on the impact of proposed Medicare regulations on provider and payer consolidation

Rep. Michael Burgess (R-TX-26)

Other original co-sponsors:

Rep. Debbie Dingell (D-MI-6)

Rep. Drew Ferguson IV (R-GA-3)

Rep.

House Committees (2): Energy and Commerce; Ways and Means

5/15/2023

Fairness for Patient Medications Act

H.R. 3285

Text unavailable as of 07/05/23

Reportedly would establish patient protections by setting limits on deductibles, cost-sharing, and net prices of high rebate drugs.

Rep. Morgan Griffith (R-VA-9)

House Committees (3): Energy and Commerce; Education and the Workforce; Ways and Means

5/15/2023

H.R. 3561

Would prohibit a prescription drug plan (PDP) sponsor from entering a contract with a PBM for purposes other than performing services under Medicare Part D.

Would require hospitals and health insurance plans to provide pricing information for shoppable services, in-network services and prescription drugs.

Would establish additional disclosure requirements for providers under Medicare. This includes price information disclosures from diagnostic laboratory test providers and prescription drug plan sponsors. Medicare Advantage organizations with an ownership interest in providers would be required to make payment information reports.

Would require the Medicare Payment Advisory Commission to submit a report to Congress every 2 years on the effects of vertical integration in healthcare on Medicare. The report would include analysis of common ownership of PBMs that were previously separately owned.

PBMs under Medicaid would be required to implement pass-through pricing models.

Would establish cost-sharing limits for drugs with high rebates.

Rep. Cathy McMorris Rodgers (R-WA-5)

Rep. Frank Pallone, Jr. (D-NJ-6)

House Committees (3): Energy and Commerce; Ways and Means; Education and the Workforce

5/24/2023

S. 113

FTC would be required to report pharmaceutical supply chain practices that are anticompetitive. FTC would also be required to provide recommendations to prevent anticompetitive practices and increase supply chain transparency. 

Sen. Grassley (R-IA)

Other original co-sponsors:

Sen. Maria Cantwell (D-WA)

Sen. Richard Blumenthal (D-CT)

Sen. James Lankford (R-OK)

Sen. Marsha Blackburn (R-TN)

Sen. Tommy Tuberville (R

Senate Judiciary Committee

1/26/2023

S. 127

Would prohibit spread pricing, clawbacks, and other adjustments made to offset the costs of changes to federally funded health plans.

Would also require PBMs to file annual payment reports to the FTC and give the FTC and state attorneys enforcement authority.

Sen. Maria Cantwell (D-WA)

Other original co-sponsors:

Sen. Chuck Grassley (R-IA)

Sen. Cindy Hyde-Smith (R-MS)

Sen. Mike Braun (R-IN)

Sen. Jerry Moran (R-KS)

Sen. Thomas Tillis (R-NC)

Sen. Jon Tester (D-MT)

Sen. Shelley Moore Capito (R-WV)

Senate Commerce, Science, and Transportation Committee

1/26/2023

Drug Price Transparency in Medicaid Act of 2023

S. 1038

In Medicaid managed care, would require pharmacy reimbursement based on NADAC plus a dispensing fee based on the applicable state survey and would prohibit spread pricing.  Would require pass-through pricing in contracts between State and PBM or State and a managed care entity or other specified entity (see section 1903(m)(9)(D)).

Would require pharmacies to participate in NADAC surveys, and would require a report to Congress on specialty drug coverage and reimbursement. Among others, the report must include how state Medicaid programs define specialty drugs and pharmacies, how much the state programs pay for specialty drugs, and details on how specialty drugs are dispensed.

Sen. Peter Welch (D-VT)

Sen. Roger Marshall (R-KS)

Senate Finance Committee

3/29/2023

Health Care PRICE Transparency Act

S. 1130

Would require hospitals to disclose negotiated rates with insurers, discounts for cash payments, and billing codes.

Would require insurance plans to disclose in-network and out-of-network charges for items and services included in coverage as well as negotiated prices for covered prescription drugs.

Would require a tool that allows people to obtain cost information. Would allow consumers to request additional information regarding items or services covered by their plans.

Sen. Mike Braun (R-IN)

Sen.

Senate Health, Education, Labor, and Pensions Committee

3/30/2023

Drug Price Transparency Act of 2023

S. 1131

Would remove anti-kickback safe harbor protection for rebates involving prescription drugs when reductions in price or other remuneration flow “from a manufacturer of prescription drugs to a sponsor of a prescription drug plan under part D of title XVIII, an MA organization offering an MA-PD plan” under part C of title XVIII, or a PBM “under contract with such a sponsor” or organization.

Would continue to impose penalties for knowing and willful receipt or payment of remuneration in violation 42 U.S.C. 1320a-7b(b) except as provided by the new safe harbor protections.

Would establish new safe harbor protections involving prescription drugs when (1) a reduction in price offered by a manufacturer of prescription drugs to a PBM, and others, is reflected at the point of sale to the buyer; and (2) flat service fees paid by a manufacturer to a PBM relate to a PBMs activities in relation to provision of pharmacy benefit management services to a health plan.

Would prohibit a PBM from receiving from a drug manufacturer a reduction in price or other remuneration in connection with prescription drugs received by a plan participant or beneficiary unless an exception applies (i.e., price reduction reflected at point of sale; and flat fee-based service fee paid to a PBM).

Sen. Mike Braun (R-IN)

Sen. Cindy Hyde-Smith (R-MS)

Senate Health, Education, Labor, and Pensions Committee

3/30/2023

Ending the Prescription Drug Kickback Act of 2023

S. 1217

Would prohibit the distribution and receipt of rebates for prescription drugs by removing anti-kickback safe harbor protections for prescription drug rebates. PBMs would be prohibited from receiving a drug manufacturer rebate or renumeration from group health plans and health insurance issuers.

Sen. Josh Hawley (R-MO)

Senate Health, Education, Labor, and Pensions Committee

4/19/2023

S. 1269

Would require PBMs to remit full rebates for insulin to the group health plan. Would establish a price cap for insulin cost-sharing in the commercial market.

Sen. Jeanne Shaheen (D)

Sen. Susan Collins (R)

Senate Health, Education, Labor, and Pensions Committee

4/25/2023

S. 1339

Would increase oversight of entities that provide pharmacy benefit management services.

Would require PBMs to submit an annual report to group health plan sponsors and health insurance issuers that includes information on copayment costs and formularies.

Sen. Sanders (I-VT)

Sen. Bill Cassidy (R-LA)

Sen. Patty Murray (D-WA)

Sen. Roger Marshall (R-KS)

Senate Health, Education, Labor, and Pensions Committee

4/27/2023

DRUG Act

S. 1542

Would mandate a flat service fee by PBMs for services, not related to drug prices, discounts, rates, fees, or other remuneration..

Would prohibit PBMs from steering, directly or indirectly, patients to a pharmacy owned, controlled by, or affiliated with the PBM.

Would preclude PBM from arbitraging difference between ingredient cost or dispensing fee and amount the PBM reimburses a pharmacy for the drug’s ingredient cost or dispensing fee and preclude PBMs from reimbursing a network pharmacy in amount less than the amount the PBM would reimburse a network that is owned, controlled by, or affiliated with the PBM for dispensing the same drug or providing the same services.

Imposes a $10k penalty each day during which a violation continues.

Sen. Roger Marshall (R-KS)

Other original co-sponsors:

Sen. Jon Tester (D-MT)

Sen. Mike Braun (R-IN)

Sen. Tim Kaine (D-VA)

Sen. Shelley Moore Capito (R-WV)

Senate Health, Education, Labor, and Pensions Committee

5/10/2023

A bill to require regulations concerning the disclosure of direct and indirect compensation from entities providing pharmacy benefit management services or third-party administration services.

S. 1543

Would require the Secretary of Labor to provide regulations that clarify compensation disclosure requirements for PBMs or third-party administration services.

Sen. Roger Marshall (R-KS)

Senate Health, Education, Labor, and Pensions Committee

5/10/2023

Patients Before Middlemen Act

S. 1967

 Would prohibit PBMs from tying their compensation to the price of a drug, discounts, rebates, or other fees, as a condition of entering into a contract with a Medicare Part D plan and would require PBMs to pay to the Secretary any amount received in excess of the designated service fees.

Sen. Robert Menendez (D-NJ)

Other original co-sponsors:

Sen. Marsha Blackburn (R-TN)

Sen. Jon Tester (D-MT)

Sen. Roger Marshall (R-KS)

Sen. Mike Crapo (R-ID)

Senate Finance Committee

6/14/2023

To amend title XVIII of the Social Security Act to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare part D, and for other purposes.

S. 2052

Text unavailable as of 07/05/23

Reportedly would enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare part D.

Sen. Jon Tester (D-MT)

Other co-sponsors:

Sen. Shelley Moore Capito (R-WV)

Sen. Sherrod Brown (D-OH)

Sen. James Lankford (R-OK)

Senate Finance Committee

6/20/2023

Ensuring Access to Lower-Cost Medicines for Seniors Act

A bill to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA-PD plan under part D of the Medicare program that use a formulary to include certain drugs and biosimilar biological products on such formulary, and for other purposes.

S. 2129

Text unavailable as of 07/05/23

Reportedly would require Medicare Part D to cover a generic or biosimilar that is less expensive than

the name-brand drug.

Would require separate formulary pricing tiers for generic drugs or biosimilars and name-brand drugs, with the generic tier having a lower insurance cost-sharing requirement for patients than the name-brand tier.

Would also create a new tier for specialty generics or biosimilars with a lower insurance cost-sharing requirement for patients.

Sen. James Lankford (R-OK)

Sen. Robert Menendez (D-NJ)

Senate Finance Committee

6/22/2023