Legislative Activity

Centerstage: Affordable Care Act

The Affordable Care Act (ACA) remains in the spotlight this week with Tuesday, October 1 marking a major deadline as open enrollment in the health insurance exchanges officially begins.

ACA defund and delay provisions, however, remain a key issue in the ping-pong over the continuing resolution (CR). The Senate voted to approve H.J. Res. 59 last week after removing the ACA defunding language. The House then approved a revised version of the bill that included a one year delay of ACA implementation, a repeal of the medical device tax, as well as a “conscience clause” that would allow employers and carriers to opt out of reproductive care coverage requirements.

There is some hope for bipartisanship in health care, with the House and Senate reaching a bipartisan compromise on compounding legislation. The bill enhances federal oversight of compounding pharmacies and includes a track and trace provision that establishes a system to follow drugs through distribution in order to prevent counterfeits from entering the drug supply. The compromise was announced last week, and while the stakeholder community will certainly weigh in, the bill could move as soon as this week.

This Week

  • Tuesday, October 1: The Senate Committee on Foreign Relations has scheduled a markup of S. 1545, a bill to extend authorities related to global HIV/AIDS and to promote oversight of United States programs.
  • Wednesday, October 2: The House Committee on Oversight and Government Reform Subcommittee on Government Operations will hold a hearing on Examining the Federal Response to Marijuana Legalization.
  • Wednesday, October 2: The Senate Committee on Health, Education, Labor and Pensions will hold a full committee markup to consider pending legislation and nominations including:
  1. The school Access to Emergency Epinephrine Act (H.R. 2094);
  2. A draft of the Childrens Hospital Graduate Medical Education Support Reauthorization Act of 2013;
  3. A draft of the Chimpanzee Health Improvement, Maintenance, and Protection Act Amendments of 2013; and
  4. A draft of the Older Americans Act Reauthorization Act of 2013.
  • Thursday, October 3: The House Committee on Energy and Commerce Health Subcommittee will hold a hearing to review the implementation of the Food and Drug Administration Safety and Innovation Act.

Regulatory Activity

SHOP Delay

The Administration announced a delay in the online enrollment for the Small Business Health Option Program (SHOP) Marketplace, which was scheduled to open on Tuesday, October 1. Small business employers will be able to get an overview of available plans and premiums in their area and submit a paper application, but all (online) functions for SHOP will not be available until November. Employers and employees must enroll by December 15 for coverage to begin January 1.

ACA Exchange Premium Data

The Department of Health and Human Services (HHS) released a report on premiums in the health insurance exchanges. The disclosure is the first release of rates for the 36 online marketplaces being run entirely or partly by the federal government, and the most comprehensive look yet at exchange rates overall. Some important details, such as which insurers were offering which plans, are not included in the announcement. Overall, the average premium is 16 percent below what the Congressional Budget Office projected last year.

FDA Pediatric Medical Device Grants

The U.S. Food and Drug Administration (FDA) today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children. A panel of experts with experience in the clinical, business, and regulatory aspects of pediatric device development reviewed applications for the grants, which will be administered by the FDAs Office of Orphan Products Development.