Legislative Activity

The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R. 3350, the “Keep Your Health Plan Act of 2013,” a bill sponsored by House Energy and Commerce Chairman Fred Upton (R-MI) that would allow carriers to continue to offer current health plans outside of the exchange regardless of essential benefits coverage. On the Senate side, Democrats wary of the Administration’s ability to meet the self-imposed November 30 deadline to fix website glitches will consider whether legislation is needed to extend the open enrollment period, among other fixes.

This Week’s Hearings:

  • Wednesday, November 13: The House and Senate conferees will meet to consider the FY 2014 budget resolution. The House Committee on Homeland Security has scheduled a hearing titled “Cyber Side-Effects: How Secure is the Personal Information Entered into the Flawed Healthcare.gov?” The House Committee on Oversight and Government Reform will hold a hearing titled “Obamacare Implementation: The Rollout of Healthcare.gov.” The House Committee on Veterans’ Affairs Oversight and Investigations Subcommittee will also hold a hearing titled “Correcting Kerfuffles: Analyzing Prohibited Practices and Preventable Patient Deaths at Jackson VAMC.”
  • Thursday, November 14: The House Committee on Education and the Workforce will hold a hearing titled “The Effects of the Patient Protection and Affordable Care Act on Schools, Colleges and Universities.” The House Committee on Energy and Commerce Subcommittee on Health has scheduled a hearing titled “Obamacare Implementation Problems: More than Just a Broken Website.” The House Committee on Small Business Subcommittee on Health and Technology will hold a hearing titled “Self-Insurance and Health Benefits: An Affordable Option for Small Business?”

Regulatory Activity

Final Mental Health Parity Rule

The Administration released the long awaited Mental Health Parity Final Rule which implements the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. The law requires “parity between mental health or substance use disorder benefits and medical/surgical benefits with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage.” The rule also contains a technical amendment relating to external review with respect to the multi-state plan program administered by the Office of Personnel Management.

FDA Labeling Changes Proposed Rule

The FDA released the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Proposed Rule. The proposed rule would “create parity among application holders with respect to such labeling changes by permitting holders of abbreviated new drug applications (ANDAs) to distribute revised product labeling that differs in certain respects, on a temporary basis, from the labeling of its reference listed drug (RLD) upon submission to FDA of a “changes being effected” (CBE-0) supplement. The proposed rule describes the process by which information regarding a CBE-0 labeling supplement submitted by a new drug application (NDA) holder, an ANDA holder, or a biologics license application (BLA) holder would be made publicly available during FDA’s review of the labeling change and clarifies requirements for all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA or ANDA holder’s CBE-0 labeling supplement. The proposed rule also would amend the regulations to allow submission of a CBE-0 labeling supplement for certain changes to the “Highlights of Prescribing Information” for drug products with labeling in the “Physician Labeling Rule” (PLR) format.”

Rules at OMB

The Office of Management and Budget (OMB) is currently reviewing the following regulations:

  • OIG- Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute Final Rule;
  • CMS- Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Amending the Exception for Certain Electronic Health Records Arrangements Final Rule; and
  • CMS- Home and Community-Based State Plan Services Program, Waivers, and Provider Payment Reassignments Final Rule.


MACPAC Meeting

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold a public meeting on Thursday and Friday, November 14 and 15. The Commission’s sessions include:

  • The Future of CHIP: Views from CHIP Directors;
  • Long-Term Care Commission: Report from the Commission’s Leadership;
  • Short- and Long-Term Issues for CHIP;
  • Medicaid Interactions with the ACA: Issues and Analyses for Further Consideration; and
  • Medicaid Non-DHS Supplemental Payments.