Legislative measures aim to solve problems as defined by members of Congress. Once a bill passes both Chambers, the President will either sign the bill into law or veto it. If passed, the new law — or act — is codified in the United States Code (U.S.C).
Once codified, federal agencies create rules and regulations — published in the Federal Register (FR) — to implement the laws passed by Congress. Regulatory agencies act with broad discretionary authority and within parameters set by Congress and the Constitution.
LEGISLATION TO WATCH
- S.2460 – Every Prescription Conveyed Securely Act – If passed in its current form, this bill will amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances.
- S.2453 – Ensuring the Value of the 340B Program Act of 2018 – If passed in its current form, this bill will amend title XVIII of the Social Security Act to require hospitals to provide the Secretary with information on the hospital’s acquisition costs for 340B drugs and the total revenues received by the hospital for such drugs.
- S.2476 – Expanding Access to Low Cost Generic Drugs Act – If passed in its current form, this bill will amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.
- S.2478 – End Taxpayer Subsidies for Drug Ads Act – If passed in its current form, this bill will amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs.
- S.2554 – Patient Right to Know Drug Prices Act – If passed in its current form, this bill will amend Section 1311(e) of the Patient Protection and Affordable Care Act by adding at the end the following:
“(4) INFORMATION ON PRESCRIPTION DRUGS. —The Exchange shall require health plans seeking certification as qualified health plans to ensure that— “(A) the health insurance issuer does not restrict any pharmacy that dispenses a prescription drug to an enrollee in the plan from informing (or penalize such pharmacy for informing) an enrollee of any differential between the price of the drug to the enrollee under the plan and the price the individual would pay for the drug if the enrollee obtained the drug without using any health insurance coverage; and
“(B) any entity that provides pharmacy benefits management services under a contract with any such health plan does not, with respect to such plan or any health benefits plan that the entity contracts with to provide pharmacy benefits management services and that is offered by an entity other than such sponsor or organization, restrict a pharmacy that dispenses a prescription drug from informing (or penalize such pharmacy for informing) an enrollee of any differential between the price of the drug to the enrollee under the plan and the price the individual would pay for the drug if the enrollee obtained the drug without using any health insurance coverage.”
(b) Other Health Plans. —The provisions of section 1311(e)(4) of the Patient Protection and Affordable Care Act (as added by subsection (a)) shall apply to all health insurance issuers with respect to health insurance coverage and to all group health plans (as such terms are defined in section 2791 of the Public Health Service Act).
Notably, (a) not all measures [necessarily] pass through the Chamber in which they are introduced — similarly, not all measures that pass through one or both Chambers will [necessarily] pass in their current form and (b) it is important to consider the (Party) composition of Congress in relation to the political (Party) affiliation(s) of the President and a bill’s sponsor — and co-sponsor(s) when gauging the likelihood of a legislative measure becoming law [this should not be taken to mean that ALL legislative measures lack bipartisan support].
LEGISLATION BEGETS REGULATION
The pharmaceutical industry, the 340B program, health plans, hospitals, and Medicare Part D are highly regulated. Government action profoundly impacts industry’s operations, products and business development goals. Strategically, the value of proactively tracking legislation cannot — and should not — be underscored.