3/5/14 HHS extended the comment period for the proposed rule called "Administrative Simplification: Certification of Compliance for Health Plans," which was published in the January 2, 2014 Federal Register. The comment period for the proposed rule (which would have ended on March 3, 2014) is extended to April 3, 2014.

The proposed rule implements portions of ACA §1104. The proposed rule would require a controlling health plan (CHP) to submit information and documentation demonstrating that it is compliant with certain standards and operating rules adopted by the HHS Secretary under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The proposed rule would also establish penalty fees for a CHP that fails to comply with the certification of compliance requirements.

According to HHS, a CHP either controls its own business activities, actions, or policies; or is controlled by an entity that is not a health plan. The rule proposes that CHPs must submit certain information and documentation that demonstrates compliance with the adopted standards and operating rules for three electronic transactions: eligibility for a health plan, health care claim status, and health care electronic funds transfers (EFT) and remittance advice. Documentation would be an indication that a CHP has completed some internal and external testing.

Read the extension at: http://www.gpo.gov/fdsys/pkg/FR-2014-03-05/pdf/2014-04828.pdf

2/27/2014 The Food and Drug Administration (FDA) issued two proposed rules under ACA §4205 to update the Nutrition Facts label for packaged foods: 1) "Food Labeling: Revision of the Nutrition and Supplement Facts Labels," addresses new scientific information and design changes in labeling, and 2) "Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments," addresses revised serving size requirements, criteria for labeling based on package size, and other issues.

The proposed rule (about the Nutrition and Supplement Fact Label) amends labeling regulations for conventional foods and dietary supplements to reflect new public health and scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed rule (about serving sizes) updates out-of-date serving size requirements to better align with the quantities of food that people really eat, and it features a new design to highlight key parts of nutrition labels such as calories and serving sizes.

According to the FDA, the proposed changes are being made to help combat obesity by assisting consumers in maintaining healthy dietary practices. The FDA proposes that the food industry be given two years to comply after publication of any final rules governing the Nutrition Facts label. The changes would affect all packaged foods except certain meat, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture's Food Safety and Inspection Service. The updates reflect new dietary recommendations, consensus reports and national survey data, nutrient intake recommendations from the Institute of Medicine, and intake data from the National Health and Nutrition Examination Survey.

Comments are due June 2, 2014.

Read the proposed rule about the Nutrition and Supplement Fact Label at: http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04387.pdf

Read the proposed about serving sizes at: http://www.gpo.gov/fdsys/pkg/FR-2014-03-03/pdf/2014-04385.pdf

2/27/14 CCIIO released a bulletin called "CMS Bulletin to Marketplaces on Availability of Retroactive Advance Payments of the PTC and CSRs in 2014 Due to Exceptional Circumstances."

According to CCIIO, the bulletin provides guidance to Exchanges (Marketplaces) that, due to technical issues in establishing automated eligibility and enrollment functionality, have had difficulty in providing timely health insurance eligibility determinations to applicants and enrolling individuals in Qualified Health Plans (QHPs) through an Exchange during the initial open enrollment period for the 2014 coverage year. Such a circumstance may be considered an exceptional circumstance for individuals who were unable to enroll in a QHP through the Marketplace due to these issues.

In the bulletin, CCIIO discusses the availability of advance payments of the premium tax credit (PTC) and advance payments of cost-sharing reductions (CSRs) on a retroactive basis to an issuer once the Exchange has provided a qualified individual with an appropriate eligibility determination and has determined that the individual is eligible for such assistance, and the individual has enrolled in a QHP through the Exchange.

Beginning October 1, 2013, qualified individuals and qualified employees could purchase private health insurance coverage through Exchanges for January 1, 2014 effective dates. The ACA established Affordable Insurance Exchanges (§1311(b)) to provide individuals and small business employees with access to health insurance coverage beginning January 1, 2014. Furthermore, an Exchange makes an advance determination of tax credit eligibility for individuals who enroll in a QHP through the Exchange and pursue financial assistance (§1401, 1411, and 1412). QHPs are health plans that have been certified by an Exchange, provide essential health benefits (EHB, §1301) and follow established limits on cost-sharing (such as reduced deductibles, copayments, and out-of-pocket maximum amounts).

Read the bulletin at: CMS.Gov

Prior guidance can be found at: http://www.hhs.gov/healthcare/index.html