Health and Human Services Regulatory Agenda for 2016

 

The Department of Health and Human Services recently released their semi-annual regulatory agenda, a listing of rules the Department plans to issue in the foreseeable future. There are two separate lists, the shorter version in the Federal Register, and the lengthier version on the Office of Management and Budget website. Those on the Federal Register list are likely to affect a significant number of small entities.

This agenda focuses on HHS’ six arcs for implementation of its strategic plan:

• Leaving the Department Stronger;
• Keeping People Healthy and Safe;
• Reducing the Number of Uninsured and Providing Access to Affordable Quality Care;
• Leading in Science and Innovation;
• Delivering High Quality Care and Spending Out Health Care Dollars More Wisely; and
• Ensuring the Building Blocks for Success at Every Stage of Life.

Below is a summary of some of the proposed and final rules by both the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).

Centers for Medicare and Medicaid Services (CMS)

• Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (RIN 0938-AS21), a proposed rule addressing Medicare and Medicaid participation requirements. Estimated February 2016.

 

• Medicare Clinical Diagnostic Laboratory Test Payment System (RIN 0938-AS33), a final rule implementing the Protecting Access to Medicare Act of 2014, requiring Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017.

 

• Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (RIN 0938-AS69), a proposed rule implementing the physician payment reforms that are part of the Medicare Access and CHIP Reauthorization Act (MACRA). The MACRA deadline for establishing physician-focused payment model criteria is November 1, 2016, the statutory deadline to establish MIPS policies is January 1, 2017, and the CMS proposed rule target date is March 2016.

 

• Covered Outpatient Drugs (RIN 0938-AQ41), a final rule addressing several Affordable Care Act provisions, including requirements related to covered outpatient drugs and key aspects of Medicaid coverage, payment, and drug rebate programs. November 2015 target date.

 

• Reform of Requirements for Long-Term Care Facilities (RIN 0938-AR61), a final rule with an update of Medicare and Medicaid participation requirements to reflect substantial advances that have been made in the theory and practice of service delivery and safety. September 2016 target date.

 

• Home Health Agency Conditions of Participation (RIN 0938-AG81), a final rule that started with the Notice of Proposed Rulemaking in March 1997. The final rule focuses on the actual care delivered to patients and allows home health agencies a greater flexibility in meeting quality standards. October 2017 target date.

 

• Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers (RIN 0938-AO91), a final rule establishing emergency preparedness requirements to ensure providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. December 2016 target date.

Food and Drug Administration (FDA)

• Format and Content of Reports Intended to Demonstrate Substantial Equivalence (RIN 0910-AG96), July 2016 target date.

 

• Investigational New Drug Application Annual Reporting (0910-AH07), a proposed rule revising the requirements of annual reports submitted to INDAs by replacing the current annual reporting requirement with a requirement that is generally consistent with the format, content, and timing submission of the development safety update report devised by the ICH. October 2016 target date.

 

• Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs (RIN 0910-AA49), a final rule set to reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs and animal drugs. Target date April 2016.

 

• Abbreviated New Drug Applications and 505(b)(2) (RIN 0910-AF97), a final rule that would make procedural changes to generic drug applications and patent certifications. August 2016 target date.

 

• Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products (RIN 0910-AG18), a final rule that would require electronic package inserts for human drug and biological prescription products with limited exceptions. October 2016 target date.

 

• Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices (RIN 0910-AG48), a final rule that will amend the FDA’s regulations on acceptance of data for medical devices to require that clinical investigations submitted are conducted in accordance with good clinical practice when conducted inside the United States. Target date May 2016.

 

• Regulations on Human Drug Compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (RIN 0910-AH10), a proposed rule that will define and implement statutory conditions under which compounded products may qualify for exemptions from certain requirements. December 2016 target date.