5/27/2014 The FDA published an extension of the comment period for two proposed rules issued under ACA §4205 to update the Nutrition Facts label for packaged foods. The proposed rules were published in the March 3, 2014 Federal Register. Comments on the proposed rules are now due August 1, 2014 (instead of June 2, 2014).

The first rule, "Food Labeling: Revision of the Nutrition and Supplement Facts Labels," 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 second rule, "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Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments," updates out-of-date serving size requirements to better align with the quantities of food that people really eat, and it features a new design to highlight key parts of nutrition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.

Read the extension regarding Nutrition and Supplement Fact Label at: http://www.gpo.gov/fdsys/pkg/FR-2014-05-27/pdf/2014-12094.pdf

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 extension regarding serving sizes at: http://www.gpo.gov/fdsys/pkg/FR-2014-05-27/pdf/2014-12095.pdf

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

http://www.gpo.gov/fdsys/pkg/FR-2014-05-29/pdf/2014-12362.pdf

5/23/14 HHS/CMS published a final rule called "Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs." The final rule revises the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations and implements certain provisions of the ACA. The rule implements portions of the following ACA sections: 3307, 6002, 6402, 6405, 6408, 6411, and 1128.

According to CMS, the final rule strengthens beneficiary protections, clarifies program requirements and improves payment accuracy. Key provisions of the final rule include: a requirement that Part D prescribers enroll in the Medicare program; revocation of provider enrollment in the Medicare program for abusive prescribing practices and patterns and a broadening of the rules regarding the release of privacy-protected Part D data. The final rule also implements the ACA requirement that MA plans and Part D sponsors report and return identified Medicare overpayments (§1128).

Medicare Advantage Plans, sometimes called "Part C" or "MA Plans," are offered by private companies approved by Medicare and provide both Part A (Hospital Insurance) and Part B (Medical Insurance) coverage. Medicare Advantage Plans may offer extra coverage, such as vision or dental and most include Medicare prescription drug coverage (Part D). Medicare pays a fixed amount for a member's care every month to the companies offering Medicare Advantage Plans and, per §1102 of the ACA, plans can no longer charge higher cost sharing than what a member in traditional Medicare pays.

ACA §6405 requires that physicians and non-physician practitioners who order durable medical equipment, prosthetics, orthotics and supplies or certify home health care must be enrolled in Medicare. The ACA also permits the HHS Secretary to extend these Medicare enrollment requirements to physicians and non-physician practitioners who order or certify all other categories of items or services in Medicare, including covered Part D drugs. Under the proposed regulation, CMS requires that physicians or non-physician practitioners who write prescriptions for covered Part D drugs must be enrolled in Medicare for their prescriptions to be covered under Part D.

Read the rule at: http://www.gpo.gov/fdsys/pkg/FR-2014-05-23/pdf/2014-11734.pdf

5/23/14 HHS/CMS issued a notice under the Paperwork Reduction Act of 1995 (PRA) seeking comments on information collection activities related to Marketplace Quality Standards. In order to support the delivery of quality health care coverage offered in the Exchanges, §1311 direct the HHS Secretary to develop a system that rates qualified health plans (QHPs) based on their relative quality and price.

§1311 also directs HHS to develop an enrollee satisfaction survey system that assesses consumer experience with QHPs. For implementation of a Quality Rating System (QRS) and the enrollee surveys, QHP issuers are required to collect and report certain data to HHS.

Additionally, beginning January 1, 2015, QHPs are required to contract with certain hospitals that meet specific patient safety and health care quality standards. QHP issuers must also demonstrate compliance with patient safety standards and the related recordkeeping and information collection requirements.

Beginning October 1, 2013, qualified individuals and qualified employees could purchase private health insurance coverage through Exchanges (Marketplaces) 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 qualified health plan (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).

Comments are due June 23, 2014.

Read the notice at: http://www.gpo.gov/fdsys/pkg/FR-2014-05-23/pdf/2014-11948.pdf

5/16/14 HHS/CMS issued a file rule called "Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond." The final rule clarifies key policies applicable to Health Insurance Exchanges and the insurance market reforms under Title I of the ACA relating to: qualified health plan (QHP) quality reporting and enrollee satisfaction surveys; standards for consumer notices related to plan policy coverage changes; modifications in the Small Business Health Options Program (SHOP); standards for Navigators and other consumer assisters and modified premium stabilization policies for 2015 and beyond.

Although HHS has previously outlined many of the major provisions in the rule, the rule further addresses various requirements applicable to health insurance issuers in order to improve consumer protections and stabilize premiums. Under the rule, HHS requires that insurers provide clear information to consumers when they make changes to their policies, such as discontinuing or renewing plans. The rule provides additional guidance to Navigator, non-Navigator and certified application counselors to protect consumers and prohibit assisters from specific solicitation activities. 

Building upon the existing QHP certification requirements related to quality reporting and implementation of quality improvement strategies, under the rule HHS requires insurers to submit data to support the calculation of quality ratings which Exchanges will be required to display. Beginning in 2016, Exchanges will be required to present the HHS-calculated quality ratings and enrollee satisfaction survey results in a standardized method designed to help consumers compare and chose health plans.

Beginning October 1, 2013, qualified individuals and qualified employees could purchase private health insurance coverage through Exchanges (Marketplaces) 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 in 2014, where low and moderate income Americans may be eligible for premium tax credits (§1401, §1411) to make purchasing a health plan more affordable by reducing out-of-pocket premium costs. §1311(b)(1)(B) also requires that the Small Business Health Options Program (SHOP) assist qualified small employers in facilitating the enrollment of their employees in qualified health programs (QHPs) offered in the small group market. QHPs are health plans that have been certified by an Exchange, provide essential health benefits ("EHB", §1301) and follow established limits on cost-sharing (like deductibles, copayments, and out-of-pocket maximum amounts).

The ACA established three risk-mitigation programs, which HHS began operationalizing in 2014, to stabilize premiums in the individual insurance market and minimize the effects of adverse selection that may occur as insurance reforms and the Exchanges launch in 2014. These programs include transitional reinsurance (§1341), temporary risk corridors programs (§1342), and a permanent risk adjustment program (§1343) to provide payments to health insurance issuers that cover higher-risk populations and to more evenly spread the financial risk borne by issuers. The transitional reinsurance program and the temporary risk corridors program, which begin in 2014, are designed to provide issuers with greater payment stability as insurance market reforms are implemented. The reinsurance program will reduce the uncertainty of insurance risk in the individual market by partially offsetting risk of high-cost enrollees. The risk corridors program, which is a federally administered program, will protect against uncertainty in rates for qualified health plans by limiting the extent of issuer losses and gains.

Read the CCIIO FAQs about Health Insurance Market Reforms and Marketplace Standards at:

http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/downloads/Final-Master-FAQs-5-16-14.pdf

Read the CCIIO fact sheet about the final rule at:

http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/marketstandards-5-16-2014.html

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

News

5/27/14 The U.S. Preventive Services Task Force (USPSTF) issued a final recommendation statement on screening for hepatitis B virus infection (HBV) in nonpregnant adolescents and adults. The USPSTF recommends screening for HBV infection in individuals who are at high risk for infection. The USPSTF assigned a "B" rating to the recommendation, indicating that the Task Force recommends the service.

According to the USPSTF, although the vaccination rate for hepatitis B among people born in the United States is high (and the most effective way to prevent infection is with vaccination), there are still approximately 1 million people in the U.S. chronically infected with HBV infection. Furthermore, among individuals with chronic HBV infection, 15% - 25% die from liver disease or liver cancer.

The USPSTF's evidence review found that high risk factors for developing HBV infection included: individuals who were born in other countries with a high prevalence of HPV infection, U.S. born individuals who were not vaccinated, individuals who are HIV-positive, injection drug users, men who have sex with men, and patients with a weakened immune system.

However, the prevalence of HBV infection is generally low in the U.S. population, and most infected individuals do not develop complications. Therefore, screening is not recommended in the general population for individuals who are asymptomatic.

The USPSTF is an independent panel of non-federal government experts that conduct reviews of scientific evidence of preventive health care services. The USPSTF then develops and publishes recommendations for primary care clinicians and health systems in the form of recommendation statements. As part of their recommendations process, the USPSTF will assign definitions to the services they review based on the certainty that a patient will receive a substantial benefit from receiving the benefit. Services that are graded "A" and "B" are highly recommended and the USPSTF believes there is a high certainty that patient will receive a substantial or moderate benefit. 

Under ACA §1001, all of the recommended services receiving grades of "A" or "B" must be provided without cost-sharing when delivered by an in-network health insurance provider in the plan years (or, in the individual market, policy years) that begin on or after September 23, 2010. Since the recommendation was finalized with a "B" rating, HBV screenings for high-risk populations will be required to be covered without cost-sharing under the ACA.

Read the final recommendation statement at: http://www.uspreventiveservicestaskforce.org/uspstf12/hepb/hepbfinalrs.htm

Learn more about preventive services covered under the ACA at: HHS.Gov