which rebates owed by manufacturers under the Medicaid Drug Rebate
Program are calculated for drugs that are inhaled, infused,
instilled, implanted or injected; increased the minimum Medicaid
rebates owed by most manufacturers under the Medicaid Drug Rebate
Program; extended the Medicaid rebate obligation to utilization of
prescriptions of individuals enrolled in Medicaid managed care
organizations; subjected manufacturers to new annual fees and taxes
for certain branded prescription drugs; and provided incentives to
programs that increase the federal government’s comparative
effectiveness research.
Since its enactment, there have been numerous judicial,
administrative, executive, and legislative challenges to certain
aspects of the ACA. On June 17, 2021, the U.S. Supreme Court
dismissed the most recent judicial challenge to the ACA brought by
several states without specifically ruling on the constitutionality
of the ACA. Prior to the Supreme Court’s decision, President Biden
issued an Executive Order to initiate a special enrollment period
from February 15, 2021 through August 15, 2021 for
purposes of obtaining health insurance coverage through the ACA
marketplace. The Executive Order also instructed certain
governmental agencies to review and reconsider their existing
policies and rules that limit access to healthcare, including among
others, reexamining Medicaid demonstration projects and waiver
programs that include work requirements, and policies that create
unnecessary barriers to obtaining access to health insurance
coverage through Medicaid or the ACA. It is unclear how other
healthcare reform measures of the Biden administrations, if any,
will impact our business.
In addition, other legislative changes have been proposed and
adopted in the United States since the ACA was enacted. For
example, on March 11, 2021, President Biden signed the
American Rescue Plan Act of 2021 into law, which eliminates the
statutory Medicaid drug rebate cap, currently set at 100% of a
drug’s average manufacturer price, beginning January 1, 2024.
Further, in August 2011, the Budget Control Act of 2011, among
other things, included aggregate reductions of Medicare payments to
providers of 2% per fiscal year. These reductions went into effect
on April 1, 2013 and, due to subsequent legislative amendments
to the statute, will remain in effect through 2030, with the
exception of a temporary suspension that lasted from May 1,
2020 through March 31, 2022 due to the COVID-19 pandemic. Following the
suspension, a 1% payment reduction began April 1, 2022,
lasting through June 30, 2022. The 2% payment reduction
resumed on July 1, 2022.
On August 16, 2022, President Biden signed the Inflation
Reduction Act of 2022 (IRA) into law. This statute marks the most
significant action by Congress with respect to the pharmaceutical
industry since adoption of the ACA in 2010. Among other things, the
IRA requires manufacturers of certain drugs to engage in price
negotiations with Medicare (beginning in 2026), imposes rebates
under Medicare Part B and Medicare Part D to penalize price
increases that outpace inflation (first due in 2023), and replaces
the Part D coverage gap discount program with a new discounting
program (beginning in 2025). The IRA permits the Secretary of the
Department of Health and Human Services (HHS) to implement many of
these provisions through guidance, as opposed to regulation, for
the initial years. For that and other reasons, it is currently
unclear how the IRA will be effectuated, and while the impact of
the IRA on the pharmaceutical industry cannot yet be fully
determined, it is likely to be significant.
Further, heightened governmental scrutiny is likely to continue
over the manner in which product manufacturers set prices for their
marketed products, which has already resulted in several
Congressional inquiries and proposed and enacted federal and state
legislation designed to, among other things, bring more
transparency to product pricing, review the relationship between
pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for products. At the state
level, legislatures have increasingly passed legislation and
implemented regulations designed to control pharmaceutical product
pricing, including price or patient reimbursement constraints,
discounts, restrictions on certain product access and marketing
cost disclosure and transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk
purchasing.
We expect that additional U.S. federal or foreign healthcare reform
measures will be adopted in the future, any of which could limit
the amounts that the U.S. federal government or foreign governments
will pay for healthcare products and services, which could result
in reduced demand for our products and therapeutic
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