This Week: Congress returned from the elections and plans for next year.

Congress

House

• Likely New Health Leadership

Senate

• New Finance Committee Leadership

Administration

• HHS Issues Rules on Religious, Moral Objections to Contraceptive Coverage
• CMS Reverses Overhaul of E/M Codes, Expands Telehealth
• FDA Aims for Transparency in Final Guidance on Mandatory Food Recalls
• CMS Proposes Rule for ACA Insurers to Bill Abortion Coverage Separately
• CMS Announces New Medicaid Demonstration Opportunity to Expand Mental Health Treatment Services
• FDA Proposes Rule to Waive Informed Consent in Minimal Risk Trials

Reports

• GAO Report: VA Should Establish Goals and Measures to Enable Improved Oversight of Facilities’ Conditions
• GAO Report: Leading Practices for State Programs to Certify Peer Support Specialists

Congress

House

Likely New Health Leadership

With the change in control of the House of Representatives in the next Congress, there will be “new” faces leading the health care agenda.

At the Ways and Means Committee, which has jurisdiction of Medicare, Rep. Neal (D-MA) will be chairman. Rep. Neal hails from a state in which health care is an important issue. He has vast experience in health policy and assisted in the development and passage of the Affordable Care Act. He is likely to focus on stabilizing the individual insurance market.

The Ways and Means Subcommittee on Health is not yet decided on leadership. It could be Rep. Lloyd Doggett of Texas or Mike Thompson of California.

The Energy and Commerce Committee, which has jurisdiction over the FDA, Medicaid and Medicare Part B, will be led by Rep. Frank Pallone of New Jersey. He has already stated that he wants to focus on drug prices and providing more options for substance abuse treatment under Medicaid.

The Energy and Commerce Subcommittee on Health is not yet decided on leadership, but Rep. Anna Eschoo of California is the leading candidate.

Senate

New Finance Committee Leadership

Because Senate Finance Chairman Orin Hatch (R-UT) is retiring, the next chairman is likely to be Sen. Charles Grassley (R-IA). He was chairman of the committee for four years previously (2002-2006) and under Senate Republican rules he could serve another two years as Finance chairman. In the past, in the Finance Committee and in his current chairmanship at the Judiciary Committee, he has used the chairmanship to lead oversight activities over programs and specific health care sectors. He is likely to continue to use the Finance chairmanship to lead more oversight activity in health care.

Administration

HHS Issues Rules on Religious, Moral Objections to Contraceptive Coverage

On Nov. 7, the Department of Health and Human Services (HHS) released two final rules that offer exemptions to the Affordable Care Act’s contraceptive mandate for entities that have either religious or moral objections to contraceptive services. The rules expand exemptions for the contraceptive mandate to individuals or entities with strong religious beliefs. The Office of Management and Budget (OMB) cleared the final rules on Oct. 25.

Read the final rule on exemptions for religious beliefs here.

Read the final rule on exemptions for moral convictions here.

CMS Reverses Overhaul of E/M Codes, Expands Telehealth

On Nov. 1, the Centers for Medicare and Medicaid Services (CMS) released a final rule that backtracked on a proposal to overhaul how to pay doctors for office visits. The rule finalized policies to expand telehealth services in the 2019 Physician Fee Schedule and Quality Payment Program. CMS will not propose to pay a single rate for most doctors’ office visits regardless of their level of complexity. The rule finalized a number of documentation, coding and payment changes to reduce administrative burden and improve payment accuracy for office/outpatient evaluation and management (E/M) visits over several years.

Read the final rule here.

FDA Aims for Transparency in Final Guidance on Mandatory Food Recalls

On Nov. 5, the Food and Drug Administration (FDA) released a final guidance on more transparency by the FDA in the mandatory recall authority of unsafe foods. The guidance included the process for issuing a mandatory recall, which the FDA did only once since Congress granted it the authority in 2011.

Read the guidance here.

CMS Proposes Rule for ACA Insurers to Bill Abortion Coverage Separately

On Nov. 7, the Centers for Medicare and Medicaid Services (CMS) proposed a rule that the Affordable Care Act insurers are required to send separate invoices for the part of plan members’ monthly premiums that cover abortion.

Read the proposed rule here.

CMS Announces New Medicaid Demonstration Opportunity to Expand Mental Health Treatment Services

On Nov. 13, the Centers for Medicare & Medicaid Services (CMS) sent a letter to state Medicaid directors that outlines both existing and new opportunities for states to design service delivery systems for adults with serious mental illness (SMI) and children with serious emotional disturbance (SED). The letter includes a new opportunity for states to receive authority to pay for short-term residential treatment services in an institution for mental disease (IMD) for these patients.

Read the guidance letter here.

FDA Proposes Rule to Waive Informed Consent in Minimal Risk Trials

On Nov. 15, the Food and Drug Administration (FDA) proposed a rule to fulfill provisions in the 21st Century Cures Act that allow the FDA to waive or alter informed consent regulations for minimal risk clinical investigations, as long as there are appropriate human subject protections in place. The FDA’s proposed rule would replace a 2017 guidance that outlines a similar policy shift.

Read the proposed rule here.

Reports

GAO Report: VA Should Establish Goals and Measures to Enable Improved Oversight of Facilities’ Conditions

On Nov. 13, the Government Accountability Office (GAO) released a report on the Veterans Health Administration’s (VHA) keeping its facilities clean and well maintained. The GAO recommended that the VHA develop ways to better measure the program’s effectiveness and target areas in need of improvement.

Read the report here.

GAO Report: Leading Practices for State Programs to Certify Peer Support Specialists

On Nov. 13, the Government Accountability Office (GAO) released a report on the increased use of peer support specialists, individuals who use their own experience recovering from mental illnesses to support others. The GAO looked at how six states certify that the specialists have basic competencies and the ability to support others and found six leading practices, including training specialists in person and requiring continuing education.

Read the report here.