Statement of Regulatory Priorities for FY 2012


The Department of Health and Human Services is the Federal Government's principal agency charged with protecting the health of all Americans and providing essential human services, especially for those least able to help themselves.  The Department operates more than 300 programs covering a wide spectrum of activities, manages almost a quarter of all Federal outlays, and administers more grant dollars than all other Federal agencies combined.  The Department’s major program responsibilities include: Medicare and Medicaid; control and prevention of communicable and chronic disease; support for public health preparedness and emergency response; biomedical research; substance abuse and mental health treatment and prevention; assuring safe and effective drugs, devices, and other medical products; protecting the food supply; assistance to low-income families; the Head Start program; and improving access to health care services to the uninsured, isolated, or medically vulnerable. Currently, the Department is the principal agency charged with implementing one of the President’s signature achievements—transformative health care reform through the Affordable Care Act of 2010.


     To implement this vast program portfolio, the Department develops an active regulatory agenda each year, driven largely by statutory mandates and interactions with stakeholders. The President also called upon Federal agencies to reform the regulatory process in his January 18, 2011, Executive Order 13563 “Improving Regulation and Regulatory Review.”  A key directive in that Executive order was to require agencies to conduct an inventory of existing regulations to determine whether such regulations should be modified, streamlined, expanded, or repealed to make an agency's regulatory scheme more effective or less burdensome in achieving its programmatic objectives.


With these regulatory drivers in mind, Secretary Kathleen Sebelius has worked with HHS agencies to craft a regulatory agenda that reflects her commitments to implementing meaningful health care reform, access to health care coverage, and high value health care services that are safe and effective for all Americans. The agenda also reflects her other strategic initiatives, which include securing and maintaining health care coverage for all Americans; improving quality and patient safety; more rapidly responding to adverse events; implementing a 21st century food safety system; helping Americans achieve and maintain healthy living habits; advancing scientific research; and streamlining regulations to reduce the regulatory burden on industry and States.  Within this agenda, the Secretary has also been mindful of the need to reform the ongoing regulatory process through retrospective review of existing regulations, and this agenda reflects her commitment to that review by incorporating some of the most significant burden reduction reforms across all Federal agencies.  In fact, of the $10 billion in savings from retrospective regulatory review across all Federal agencies announced by the Administrator of the Office of Information and Regulatory Affairs, $5 billion was attributable to regulations contained within this Department’s current regulatory agenda.


What follows is an overview of the Department's regulatory priorities for FY 2012 and some of the regulations on the agenda that best exemplify these priorities.


Making Health Insurance Coverage More Secure for Those Who Have Insurance and Extending Coverage to the Uninsured


As a result of the Affordable Care Act, the Department is making affordable health care coverage more stable and secure through insurance market reforms designed to protect consumers against unreasonable insurance premium increases, provide them with more comprehensive and understandable information with which to make decisions, and enable eligible consumers to receive financial support for health insurance easily and seamlessly.  In 2014, all people who suffer from chronic conditions will no longer be excluded from insurance coverage or charged higher premiums because of a pre-existing condition or medical history.


Already, insurers are prohibited from putting lifetime dollar limits and restrictive annual caps on what they will pay for health care services needed by the people they insure, ensuring that those people have access to medical care throughout their lives, especially when it is most needed.  HHS is working with States to help identify and put a stop to unreasonable health insurance premium rate increases and will require new health plans to implement a comprehensive appeals process for those beneficiaries who have been denied coverage or payment by the insurance plan.  New health insurers will also be required to spend the majority of health insurance premiums on medical care and health care quality improvement, not on administration and overhead.  As well, the Affordable Care Act is providing reimbursement to employers that offer health benefits to early retirees, providing insurance coverage through the Pre-existing Condition Insurance Plan to people who would otherwise be locked out of the insurance market because of their pre-existing health conditions, and requiring plans that offer dependent coverage to make that coverage available to young adults up to age 26.


Moving forward this year, the Department will continue to implement the Affordable Care Act to promote consumer protections, improve quality and safety, provide incentives for more efficient care delivery, and slow the growth of health care costs.  The Centers for Medicare & Medicaid Services (CMS) will finalize three rules that will expand access to health insurance and provide consumers with better options and information about insurance: 


         CMS will issue standards for the establishment of the Affordable Insurance Exchanges (Exchanges) to provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality.  These Exchanges will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.


         Another rule helps to make coverage more secure by offsetting market uncertainty and risk selection to maintain the viability of Exchanges.  Under risk adjustment, HHS, in consultation with the States, will establish criteria and methods to be used by States in determining the actuarial risk of plans within a State to minimize the negative effects of adverse selection.  Under reinsurance, all health insurance issuers, and third-party administrators on behalf of self-insured group health plans, will contribute to a nonprofit reinsurance entity to support reinsurance payments to individual market issuers that cover high risk individuals.


         To extend health insurance to greater numbers of low-income people, Medicaid eligibility in 2014 will expand to cover adults under the age of 65 earning up to 133 percent of the Federal poverty level, and those who earn above that level may be eligible for tax credits through the Exchanges to help pay their premiums.  New, simplified procedures for determining Medicaid, CHIP, and tax credit eligibility will be forthcoming in 2012.  CMS will simplify eligibility rules to make it easier for eligible individuals and families to obtain premium tax credits and Medicaid coverage, including ensuring that Medicaid uses the same eligibility standards as other insurance affordability programs available through the Exchange, as directed by law.  The rule further outlines how Medicaid and CHIP will coordinate closely with the Exchange, including sharing data to ensure that individuals are determined eligible for the appropriate insurance affordability program regardless of where an applicant submits the application.


Improving Health Care Quality and Patient Safety


Across America and for all Americans, the Department is working to improve patient outcomes, ensure patient safety, promote efficiency and accountability, encourage shared responsibility, and reduce health care costs.  Through improved administrative processes, reforms, innovations, and additional information to support consumer decisionmaking, HHS is supporting high-value, safe, and effective care across health care settings and in the community.


In 2011, the Department published a key regulation to advance this priority—the final rule for Accountable Care Organizations.  This rule establishes a system of shared savings for qualified organizations that deliver primary care services to a given patient population.  The objective is to promote accountability and shared responsibility for the delivery of care, especially to those with co-morbidities of chronic health problems in order to prevent unnecessary and costly in-patient hospital care, reduce health care acquired conditions, and improve the quality of life for those individuals.  This rule serves as a companion to additional demonstration programs designed to explore alternative services delivery and payment systems that are being sponsored by the new Center for Medicare and Medicaid Innovation.  Several more key regulations are on the agenda to move forward in meeting these quality and patient safety goals:


         CMS is implementing value-based purchasing programs throughout its payment structure in order to reward hospitals and other health care providers for delivering high-quality care, rather than just a high volume of services.  The payment rules scheduled for publication this year will reflect a mix of standards, processes, outcomes, and patient experience of care measures, including measures of care transition and changes in patient functional status.


         The Department continues to encourage health care providers to become meaningful users of health information technology (IT) by accelerating health IT adoption and promoting electronic health records to help improve the quality of health care, reduce costs, and ultimately, improve health outcomes.  Electronic health records and health information exchange can help clinicians provide higher quality and safer care for their patients.  By adopting electronic health records in a meaningful way, clinicians will know more about their patients to better coordinate and improve the quality of patient care, and they can make better decisions about treatments and conditions.


Improving Response to Adverse Events


In a related activity, the FDA will be proposing a new rule to establish a unique identification system for medical devices in order to track a device from pre-market application through distribution and use.  This system will allow FDA and other public health entities to track individual devices so that when an adverse event occurs, epidemiologists can quickly track down and identify other users of the device to provide guidance and recommendations on what steps to take to prevent additional adverse actions.



Implementing a 21st Century Food Safety System


The Food Safety Modernization Act of 2010, signed into law by the President in January 2011, directs the Food and Drug Administration (FDA), working with a wide range of public and private partners, to build a new system of food safety oversight—one focused on applying the best available science and good common sense to prevent the problems that can make people sick.  In implementing that Act, the Department’s goal is to shift emphasis from removing unsafe products from the market place to keeping unsafe food from entering commerce in the first place.


FDA will propose several new rules to establish a robust, enhanced food safety program.

         FDA will propose regulations establishing preventive controls in the manufacture and distribution of human foods and of animal feeds.  These regulations will constitute the heart of the food safety program by instituting, for the first time, good manufacturing practices for the manufacture and distribution of food products to ensure that those products are safe for consumption and will not cause or spread disease.


         Perhaps most anticipated in light of food borne illnesses occurring in 2011, FDA will introduce a rule addressing produce safety to ensure that produce sold in the marketplace meets rigorous safety standards.  The regulation will set enforceable, science-based standards for the safe production and harvesting of fresh produce at the farm and the packing house to minimize the risk of serious adverse health consequences.


         In another proposed rule, FDA will require food importers to have a foreign supplier verification program that will be adequate to provide assurances that each foreign supplier produces food in a manner that provides the same level of protection as required for domestic production under the Food Drug and Cosmetic Act.


         FDA will establish a program to accredit third-party auditors to conduct food safety audits of foreign entities.  Such a program will relieve importers of having to establish such programs themselves and, instead, allow them to contract with an accredited auditor to meet the audit requirements.


Empowering Americans to Make Healthy Choices in the Marketplace


     Roughly two-thirds of adults and one-third of children in the United States are overweight or obese, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis.  Almost 10 percent of all medical spending is used to treat obesity-related conditions.  In order to reverse the obesity epidemic, HHS is employing a comprehensive approach that includes both clinical and public health strategies and touches people where they live, work, learn, and play.


To help advance this agenda, FDA will finalize two rules aimed at empowering consumers to make healthy eating choices.  The rules require nutrition labeling on standard menu items in restaurants and similar retail food establishments, as well as on food sold in vending machines.  One rule will require restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards.  Other nutrient information—total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber and total protein—would have to be made available in writing upon request.  The other rule will require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items.  The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have nutritional information about the food they are consuming.


Two additional rules will also improve dietary information available to consumers.  One is a revision to the nutrition and supplement facts labels.  Much of the information found on the Nutrition Facts label has not been updated since 1993 when mandatory nutrition labeling of food was first required.  The aim of the proposed revision is to provide updated and easier to read nutrition information on the label to help consumers maintain healthy dietary practices. The other proposed rule will focus on the serving sizes of foods that can reasonably consumed in one serving.  This rule would amend the labeling regulations to provide updated reference amounts for certain food categories with new consumption data derived from the current National Health and Nutrition Survey.



Advancing Scientific Research

To effectively address the challenges the Department faces in crafting the best, evidence-based approaches to advance health services delivery, protect the public health, ensure essential human services, promote biomedical research, and ensure the availability of safe medical and food products, the Department must rely on research.  The lynchpin of this research is found in the ethical rules governing research on human subjects.

In a major undertaking, the Department is in the process of reviewing and revising those ethical rules, commonly referred to as the Common Rule.  The Common Rule serves to guide researchers and investigators in the Department, but also throughout the Federal Government, in the conduct and protocols for doing research on human subjects.  The proposed revisions will be designed to better protect human subjects who are involved in research, while facilitating research and reducing burden, delay, and ambiguity for investigators.



Streamlining Regulations to Reduce Regulatory Burdens

Consistent with the President’s Executive Order 13563, the Department continues its commitment to reducing the regulatory burden on the health care industry through the use of modern technology.  As part of this effort, FDA will advance several rules designed to reduce the reporting and data submission requirements from manufacturers of drugs and medical devices.

In one such rule, FDA will permit manufacturers, importers, and users of medical devices to submit reports of adverse events to the FDA electronically. This proposed change will not only reduce the paper reporting burden on industry, but also allow FDA to more quickly review safety reports and identify emerging public health issues.  Under another proposed rule, FDA would revise existing regulations to allow clinical study data and bioequivalence data for new drug applications and biological license applications to be provided electronically.  Again, this rule will reduce the reporting burden on industry and also permit FDA to more readily process and review applications.

     CMS is also engaged in regulatory reduction and streamlining activities.  Of particular note are several rules on conditions of participation for hospitals and other providers.  The most comprehensive of these rules is the one reducing regulatory burdens on hospitals, which is expected to save as much as $940 million annually over the next 5 years.  This rule will implement changes to hospital conditions of participation to reflect substantial advances in health care delivery and patient safety knowledge and practices.