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The federal regulatory or rulemaking process, like the legislative process, can be lengthy and complicated. The rulemaking process is “the process by which federal agencies develop, amend or repeal rules“.(i) Shortly after passage of Public Law 111-148 and 111-152 (the Patient Protection and Affordable Care Act & the Health Care and Education Reconciliation Act), various federal government agencies began publishing interim final rules often referred to as regulations. Ultimately, the interim final rules will become the final rule or regulations that enforce the law authorized by the health care reform legislation. A number of federal agencies will participate in the federal regulatory/rulemaking process. These agencies include but are not limited to:

• Office of Consumer Information and Insurance Oversight

• Centers for Medicare and Medicaid Services

• Food and Drug Administration

• Internal Revenue Service

• U.S. Department of Labor

A number of interim rules that enforce the new health law have been published. Regulations are published in the Federal Register, “the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents”. Many of the rules are listed on the relevant agency’s website.

The public has an opportunity to comment on the regulations before the regulations become final. Comments can be submitted to regulations.gov, the online source for U.S. government regulations from nearly 300 federal agencies. Regulations.gov asserts their commitment to “improving your access to and participation in the federal regulatory process”. As such, the website allows you to search for a regulation, submit comments on a regulation, and sign up for alerts about a specific regulation.

Over the summer the HFA, the American Plasma Users Coalition (A-PLUS) and the National Organization for Rare Disorders (NORD) have written joint comments in response to proposed rules (interim regulations). The first set of comments, were submitted in response to the Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as Grandfathered Health Plan under the Patient Protection and Affordable Care Act. The groups’ also submitted joint comments in response to the Interim Final Rules for Group Health Plans and Health Insurance Coverage Regarding Preexisting Condition Exclusions, Lifetime and Annual Dollar Limits on Benefits, Rescissions, and Patient Protections under the Patient Protection and Affordable Care Act.

As the interim regulations are released, the HFA will continue to participate in the rulemaking process. All comments will be posted and can be read on the HFA website under the Advocacy tab. HFA encourages individuals and organizations to participate in the regulatory process. Interim regulations have been published for the Pre-Existing Condition Insurance Plan Program (temporary high risk pools) and comments have been requested for the types of standards the health insurance exchanges should be required to meet.

For more information about regulations and the regulatory process please visit the following websites:

www.hhs.gov/ociio/regulations/index.html
www.gpoaccess.gov/fr/
www.regulations.gov
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i Copeland, Curtis; CRS Report for Congress: The Federal Rulemaking Process: An Overview; August 28, 2008

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