H.R. 6 would authorize appropriations for the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and other agencies within the Department of Health and Human Services (HHS) for programs aimed at promoting the discovery and development of drugs and other technologies that prevent, diagnose, and treat disease or to support activities authorized by the legislation. The bill also would make related changes to those agencies’ programs.
In addition, H.R. 6 contains provisions that would:
Grant additional periods of exclusivity for certain brand-name drugs approved for a new indication that treats a rare disease or condition;
Require Medicare to make an additional payment to hospitals when Medicare beneficiaries use certain antimicrobial drugs during the course of their hospital stay;
Direct the sale of 8 million barrels of oil from the Strategic Petroleum Reserve (SPR) in each of the fiscal years 2018 through 2025;
Delay monthly reinsurance payments to stand-alone prescription drug plans in Medicare Part D by shifting payments between certain fiscal years; and
Limit federal Medicaid reimbursement to states for durable medical equipment (DME).
CBO estimates that implementing the legislation would cost $106.4 billion over the 2016-2020 period, assuming the appropriation of the authorized and necessary amounts.
CBO estimates that enacting H.R. 6 would reduce direct spending, on net, by $11.9 billion over the 2016-2025 period. (Of that amount, CBO estimates that off-budget costs for the U.S. Postal Service would total $6 million over the 2016-2025 period.) Pay-as-you-go procedures apply because enacting the legislation would affect direct spending. Enacting H.R. 6 would not affect revenues.
H.R. 6 contains no intergovernmental mandates as defined in the Unfunded Mandates Reform Act (UMRA). However, because the bill would delay entry into the market of some generic drugs and limit Medicaid payments to states for DME, the bill could increase state Medicaid costs by $2.6 billion over the 2016-2025 period, CBO estimates. States have flexibility in that program to adjust their financial and programmatic responsibilities, so those costs would not result from an intergovernmental mandate.
The bill would impose private-sector mandates, as defined in UMRA, on drug manufacturers. CBO estimates that the aggregate cost of the mandates would fall below the annual threshold established in UMRA ($154 million in 2015, adjusted annually for inflation) in each of the first five years that the mandates are in effect.