Legislative Activity

House To Vote On ACA Repeal Provisions

House Majority Leader Kevin McCarthy (R-CA) has included two health-related bills on this week’s floor schedule. On Wednesday, the House is expected to consider S. 1362, a bill to amend title XI of the Social Security Act to clarify waiver authority regarding programs of all-inclusive care for the elderly (PACE programs), under suspension of the rules. On Friday, the House is expected to vote on H.R. ___, Restoring Americans’ Healthcare Freedom Reconciliation Act, which would repeal the Affordable Care Act’s individual and employer mandates, excise taxes on medical devices and high cost employer-sponsored health coverage (also known as the Cadillac tax), Independent Payment Advisory Board (IPAB), auto-enrollment requirement, and Prevention and Public Health Fund, as well as defund Planned Parenthood for one year.

This Week’s Hearings:

• Tuesday, October 20: The House Committee on Energy and Commerce Subcommittee on Health will continue its hearing from two weeks ago titled “Examining Legislative Proposals to Combat Our Nation’s Drug Abuse Crisis.”

• Wednesday, October 21: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining the Medicare Part D Medication Therapy Management Program.”

• Thursday, October 22: The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing titled “Evaluating VA Primary Care Delivery, Workload, and Cost.”

• Friday, October 23: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Reviewing the Accuracy of Medicaid and Exchange Eligibility Determinations.”

Regulatory Activity

HHS Projects 2016 ACA Marketplace Enrollment

On Thursday, October 15, the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released an issue brief titled “How Many Individuals Might Have Marketplace Coverage at the End of 2016.” This brief estimates that approximately 10 million individuals might have effectuated coverage through the health insurance marketplace at the end of 2016. This would be an approximately one million individual increase over the number of individuals expected to be enrolled at the end of 2015. While HHS Secretary Sylvia Mathews Burwell called the projection a “strong and realistic goal,” the New York Times referred to it as a “surprisingly pessimistic forecast.”

Judicial Activity

HRSA’s 340B Orphan Drug Policy Struck Down Again

On Wednesday, October 14, the United States District Court for the District of Columbia struck down the Health Resources and Services Administration’s (HRSA) 340B drug pricing program’s orphan drug policy for the second time. In this case, Pharmaceutical Research and Manufacturers of America v. U.S. Department of Health and Human Services, the court held that HRSA’s interpretive rule  is a final agency action that “contravenes the plain language” of the statute.

While the Affordable Care Act expanded the list of eligible entities under the 340B program to include critical access hospitals, rural referral centers, sole community hospitals, and freestanding cancer centers, the law excluded discounts for orphan drugs provided to the newly added eligible entities. This case centers on an interpretive rule issued by HRSA last year, which stated that orphan drug discounts are indeed available to the newly added entities when used for diseases that are not rare. The court declined to defer to the agency’s interpretation and held that the statute “unambiguously indicates that Congress intended to exclude all drugs carrying an orphan-designation from 340B Program eligibility for the newly added entities.”