Committee on Energy and Commerce to Mark Up 21st Century Cures Act

On Tuesday, May 19, the House Committee on Energy and Commerce will begin its markup of the 21st Century Cures Act, to be continued on Wednesday, May 20. The legislation is the product of the bipartisan 21st Century Cures Initiative that was spearheaded by Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) this past year. The Initiative held various events and authored policy papers on topics such as innovating public health agencies, incorporating patient perspectives into the regulatory process, and modernizing medicine and medical product regulation.

The Act includes an increase of funding for the National Institutes of Health (NIH), changes to the regulatory authority of the Food and Drug Administration (FDA), and provisions focused on electronic health records, telemedicine, and drug manufacturing and development, among others. The Subcommittee on Health passed the legislation by unanimous voice vote last week, though the Committee was still working on finalizing language and determining plans to offset the bill’s costs after the markup.

While Chairman Upton has indicated he would like to consider the 21st Century Cures Act on the House floor in early summer, the Senate is unlikely to consider companion legislation this year. Rather, leaders of the Senate Committee on Health, Education, Labor, and Pensions (HELP) have acknowledged that they do not anticipate significant movement on their parallel legislation until early 2016.

This Week’s Hearings:

• Tuesday, May 19: The House Committee on Ways and Means Subcommittee on Health will hold a hearing titled “Improving Competition in Medicare: Removing Moratoria and Expanding Access.”

• Tuesday, May 19: The House Committee on Energy and Commerce will convene for opening statements for the markup of H.R. ___, the 21st Century Cures Act.

• Wednesday, May 20: The House Committee on Energy and Commerce will reconvene for the markup of H.R. ___, the 21st Century Cures Act.

• Wednesday, May 20: The House Committee on Ways and Means Subcommittee on Oversight will hold a hearing titled “Examining the Use of Administrative Actions in the Implementation of the Affordable Care Act.”

• Wednesday, May 20: The Senate Special Committee on Aging will hold a hearing titled “Challenging the Status Quo: Solutions to the Hospital Observation Stay Crisis.”

• Thursday, May 21: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “What Are the State Governments Doing to Combat the Opioid Abuse Epidemic?”

Regulatory Activity

HHS Issues Guidance on Preventive Services

On Monday, May 11, the Departments of Health and Human Services (HHS), Labor, and Treasury released “FAQs About Affordable Care Act Implementation (Part XXVI),” which clarifies the coverage of preventive services in non-grandfathered group health plans and plans purchased through the individual or group marketplace. This FAQ addresses topics including coverage of: genetic counseling and testing for BRCA-related cancer; FDA-approved contraceptives; sex-specific preventive services; preventive care for dependent children, including preconception and prenatal care; and colonoscopies performed pursuant to U.S. Preventive Services Task Force (USPSTF) guidelines.

This guidance was released following reports by the National Women’s Law Center and the Kaiser Family Foundation, which found that many health insurance plans had not been fully adhering to the preventive service requirements under the Affordable Care Act.

CMS Urges Doctors to Prepare for ICD-10

On Wednesday, May 13, the Centers for Medicare and Medicaid Services (CMS) Deputy Administrator Sean Cavanaugh urged physicians in small practices to prepare for the transition from the ninth edition of the International Classification of Diseases Procedure Coding System (ICD-9) to the tenth edition (ICD-10). Under current law, ICD-10 is set to become the coding system of the United States on October 1, 2015.

Cavanaugh stated that the agency is encouraged by initial testing of the ICD-10 payment system, and believes that most providers are ready for the transition. He stressed that for those that are not ready, “there’s still time and there are plenty of tools” available to assist providers.

Other

GAO Finds Medicaid 1115 Waivers Lack Transparency

On Wednesday, May 13, the Government Accountability Office (GAO) released a report on “Medicaid Demonstrations: Approval Criteria and Documentation Need to Show How Spending Furthers Medicaid Objectives.” The report focuses on section 1115 waivers, which authorize HHS to waive certain Medicaid requirements and authorize expenditures not otherwise allowed for demonstration projects.

After reviewing section 1115 demonstrations approved by HHS between June 2012 and October 2013, GAO found that HHS’ decision-making in approving the waivers has not been clear. HHS has not issued specific criteria for making these determinations, nor do the waiver approval documents specify what approved expenditures are precisely for and how they will promote Medicaid objectives. GAO concluded that in the absence of clear criteria and documentation, the bases for HHS’ decisions “involving tens of billions of Medicaid dollars are not transparent to Congress, states, or the public.”

GAO recommended that HHS take three actions: (1) issue criteria for assessing whether section 1115 expenditure authorities are likely to promote Medicaid objectives; (2) ensure the application of these criteria is documented in all HHS’ approvals of section 1115 demonstrations; and (3) take steps to ensure that demonstration approval documentation consistently provides assurances that states will avoid duplicative spending by offsetting other federal revenues when claiming Medicaid matching funds. Although HHS largely agreed with GAO’s recommendations, HHS was silent on whether it plans to issue written guidance on the “general criteria” it uses in approving section 1115 waivers.

Pari Mody is co-author of this article.