Legislative Activity

House and Senate Consider Medical Modernization

Capitol Hill focuses on the future of health care this week. On Tuesday, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will conduct a discussion on medical advancement and improvement with a hearing titled “Continuing America’s Leadership: The Future of Medical Innovation for Patients.” Dr. Christopher P. Austin, Director of the National Center for Advancing Translational Sciences at the National Institutes of Health (NIH); Dr. Roderic I. Pettigrew, Ph.D., Director of the National Institutes of Biomedical Imaging and Bioengineering at the NIH; Dr. Jeffrey E. Shuren, Director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA); and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA are expected to testify.

The House Committee on Energy and Commerce is set to release their second draft of the 21st Century Cures Act early this week. The Committee has undertaken a bipartisan 21st Century Cures Initiative this past year, conducting various events and authoring white papers on topics such as innovating public health agencies, incorporating patient perspectives into the regulatory process, and improving medicine and medical product regulation. The Committee has scheduled a hearing for Thursday to discuss their latest language that reflects the Initiative’s efforts. After testifying on Tuesday on the Senate side, Dr. Shuren and Dr. Woodcock will appear before the House Committee, along with Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the NIH.

This Week’s Hearings:

• Tuesday, April 28: The Senate Committee on Finance will hold a hearing titled “Creating a More Efficient and Level Playing Field: Audit and Appeals Issues in Medicare.”

• Tuesday, April 28: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing titled “Continuing America’s Leadership: The Future of Medical Innovation for Patients.”

• Wednesday, April 29: The House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a “Public and Outside Witness” hearing, with 22 witnesses set to testify.

• Wednesday, April 29: The Senate Committee on Veterans’ Affairs will hold a hearing titled “GAO’s High Risk List and the Veterans Health Administration.”

• Wednesday, April 29: The Senate Committee on Small Business and Entrepreneurship will hold a hearing titled “King vs. Burwell Supreme Court Case and Congressional Action That Can Be Taken to Protect Small Businesses and Their Employees.”

• Thursday, April 30: The House Committee on Energy and Commerce Subcommittee on Health will hold a legislative hearing on 21st Century Cures.

• Thursday, April 30: The House Committee on Veterans’ Affairs will hold a hearing titled “Examining Access and Quality of Care and Services for Women Veterans.”

• Thursday, April 30: The Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, and Related Agencies will hold a hearing to review the FY 2016 funding request and budget justification for the National Institutes of Health.

• Friday, May 1: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “What is the Federal Government Doing to Combat the Opioid Abuse Epidemic?”

• Friday, May 1: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining Microbeads in Cosmetic Products.”

Regulatory Activity

HHS-OIG Releases Oversight Guidance for Health Care Boards

On Monday, April 20, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) jointly released “Practical Guidance for Health Care Governing Boards on Compliance Oversight” with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association.

This document updates previous guidance released by HHS-OIG and AHLA and is intended to provide direction for Boards in overseeing their organizations’ compliance with State and Federal laws that regulate the health care industry. The document establishes an expectation that Boards exercise their oversight responsibility in “good faith” and make inquiries to ensure that: (1) corporate information and reporting systems exist and (2) reporting systems are appropriate to assure that information related to compliance will come to the Board’s attention in a timely, orderly manner.

Murthy Sworn in as Surgeon General

On Wednesday, April 22, Dr. Vivek Murthy was officially sworn in for a four year term as the 19th Surgeon General. Murthy, who was confirmed in December, stated that during his tenure he intends to: combat misinformation against health issues, including the safety of vaccines; publicly address mental illness, with hope of reducing the associated stigma; and combat chronic diseases, such as obesity, diabetes, and heart disease, by promoting physical activity. In previous roles, Murthy has practiced as a physician at Boston’s Brigham and Women’s Hospital and served as a professor at Harvard Medical School.

CMS Proposes Payment Hike and Policy Changes for IRFs

On Thursday, April 23, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2016.” The proposed rule includes a 1.7 percent, or $130 million, increase to the prospective payment rate for inpatient rehabilitation facilities (IRFs). The rates would apply to IRF discharges occurring between October 1, 2015 and September 30, 2016.

Additionally, among other provisions, the proposed rule would implement quality reporting requirements, as mandated by the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014. If adopted in the final rule, IRFs would be required to report on the following: skin integrity and changes in skin integrity; functional status, cognitive function, and changes in function and cognitive function; and the incidence of major falls. The IMPACT Act requires that these same quality reporting measures be implemented for long-term care hospitals, skilled nursing facilities, and home health agencies.

The proposed rule is scheduled for publication in the Federal Register on Monday, April 27. CMS will accept comments received by June 22.

CMS Proposes Update for FY 2016 IPF Payments

On Friday, April 24, CMS released a proposed rule titled “Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System – Update for Fiscal Year Beginning October 1, 2015 (FY 2016).” The proposed rule outlines FY 2016 payment policies and rates for the Inpatient Psychiatric Facilities (IPFs) prospective payment system and modifies the reporting requirements in the IPF Quality Reporting Program. Under the proposed policy, payments to IPFs during FY 2016 would be increased by 1.6 percent, or $80 million, relative to IPF payments during FY 2015.

Of note, the proposed rule would adopt the Office of Management and Budget’s updated Core-Based Statistical Area delineations from 2013. As a result, 37 rural IPFs would be re-designated as urban IPFs and would thus no longer be eligible for the 17 percent rural adjustment. The rule proposes to gradually phase out the rural adjustment, with two-thirds of the adjustment given in FY 2016, one-third of the adjustment given in FY 2017, and no rural adjustment in subsequent years.

The proposed rule is scheduled for publication in the Federal Register on May 1, and comments will be accepted until June 23.