Alston & Bird Healthcare Week in Review, March 10, 2017

I. Regulations, Notices, & Guidance

• On March 7, 2017, the Government Accountability Office (GAO) issued a notice entitled, Health Information Technology Advisory Committee Nominations; Request for letters of nomination and resumes. The Health Information Technology Advisory Committee provides recommendations to the National Coordinator for Health Information Technology on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information. The GAO is currently accepting nominations of individuals for this committee. Letters of nomination and resumes are due by April 14, 2017.
• On March 8, 2017, the Office of Management and Budget (OMB) received a proposed rule from the Department of Health and Human Services (HHS) entitled, Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2018 Rates. The annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems (PPS) for operating and capital-related costs. The proposed rule would implement changes arising from HHS’ continuing experience with these systems.
• On March 9, 2017, the OMB received a proposed rule from HHS entitled, FY 2018 Inpatient Rehabilitation Facility (IRF) Prospective Payment System. The annual proposed rule would update the prospective payment rates for IRFs for fiscal year 2018. The proposed rule includes the classification and weighting factors for the IRF PPS’ case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2018. The proposed rule also proposes revisions and updates to the quality measures and reporting requirements under the IRF quality reporting program.

• March 30, 2017: HHS announced a meeting of the Health Resources and Services Administration CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. During the March 30, 2017 meeting, the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment will deliberate and vote on a proposed resolution regarding the HIV workforce, a proposal to expand the existing HCV (hepatitis C virus) Workgroup, and a proposal to develop an HIV Disparities Workgroup.
• April 24, 2017: The Food and Drug Administration (FDA) announced a regional public meeting entitled, S. Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The goal of this meeting is to provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Montreal. The topics to be covered in the public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting in Montreal. The purpose of this public meeting is also to solicit public input prior to the ICH Assembly meeting and the Expert Working Group meetings in Montreal, Canada, scheduled for May 28 through June 1, 2017.

II. Congressional Legislation & Committee Action

• On March 8, 2017, the Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held a hearing entitled, Saving Lives Through Medical Research. The witnesses present included Timothy Eberlein, Director of the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine; Thomas Grabowski Jr., Director of the Memory and Brain Wellness Center, Alzheimer’s Disease Research Center, Integrated Brain Imaging Center at the University of Washington; Stacey Schultz-Cherry, Member of the Department of Infectious Diseases at the St. Jude Children’s Research Hospital; and Jennifer Sasser, Assistant Professor at the University of Mississippi Medical Center.

• On March 8, 2017, the House Education and the Workforce Committee held a markup of H.R.1304, the "Self-Insurance Protection Act"; H.R.1101, the "Small Business Health Fairness Act of 2017"; and H.R.1313, the "Preserving Employee Wellness Programs Act." H.R. 1304 passed the Committee by a voice vote; H.R. 1101 passed the Committee by a roll call vote of 22-17; and H.R. 1313 passed the Committee by a roll call vote of 22-17.
• On March 8, 2017, the House Energy & Commerce Committee held a markup of Committee Print, Budget Reconciliation Legislative Recommendations and H. Res. 154. The Committee approved and transmitted to the House Budget Committee the Amendment in the Nature of a Substitute to the American Health Care Act (AHCA), as amended, along party lines.  Only one amendment was agreed to (by voice vote): the Walden Amendment, to make a technical correction on page 50, line 19, by striking “An allocation” and inserting “Subject to section 2204(a), an allocation.”
• On March 8, 2017, the House Ways & Means Committee held a markup entitled, Budget Reconciliation Recommendations to Repeal and Replace Obamacare.  The Committee approved and transmitted to the House Budget Committee the Amendments in the Nature of a Substitute to the AHCA. These included: (1) Remuneration from Certain Insurers; (2) Repeal of Tanning Tax; (3) Repeal of Certain Consumer Taxes; (4) Repeal of Net Investment Income Tax; and (5) Repeal and Replace of Health-Related Tax Policy. Only one amendment was agreed to (by voice vote): the Brady Amendment, which amends the definition of eligible health insurance by prohibiting excepted benefits from being eligible for the new tax credit.

Upcoming Congressional Floor and Committee Action

U.S. Senate

• On March 15, 2017, the Senate Special Aging Committee will hold a hearing entitled, Raising Grandchildren in the Opioid Crisis. The hearing will take place at 2:30 p.m. in 562 Dirksen. The witnesses are TBD.
• On March 15, 2017, the Senate Veterans’ Affairs Committee will hold a hearing entitled, GAO’s High Risk List and the Veterans Health Administration. The hearing will take place at 2:30 p.m. in 418 Russell. The witnesses are TBD.

• There are currently no healthcare-related hearings scheduled for next week.

• On March 7, 2017, the Congressional Budget Office (CBO) released a report entitled, Federal Debt and the Statutory Limit, March 2017. The report found that under current law, as of March 16, the Treasury will be at the statutory borrowing limit and will need to use “extraordinary measures” to continue raising cash. According to the CBO, those measures would probably be exhausted sometime this fall.
• On March 7, 2017, the Centers for Medicare & Medicaid Services (CMS) released a new evaluation report for the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents. The report analyzes Medicare expenditures, utilization measures, and MDS-based quality measures through the end of 2015 and includes qualitative findings through mid-2016.
• On March 8, 2017, the Office of Inspector General (OIG) released a report entitled, New York Improperly Claimed Federal Medicaid Reimbursement for Partial Hospitalization Services. The report found that New York claimed Federal Medicaid reimbursement for partial hospitalization services claims that did not comply with Federal and State requirements. Specifically, of the 100 claims in the OIG’s random sample, 59 claims complied with Federal and State requirements, but 41 claims did not. The deficiencies occurred because certain providers did not comply with partial hospitalization program requirements. In addition, although New York performed licensing renewal visits to providers at least every 3 years, these visits were not effective in preventing instances of noncompliance during our audit period. On the basis of the OIG’s sample results, the OIG estimated that New York improperly claimed at least $4 million in Federal Medicaid reimbursement over 5 years for partial hospitalization services that did not meet Federal and State requirements.
• On March 9, 2017, the OIG released a report entitled, Review of Blue Cross Blue Shield Association Final Administrative Cost Proposals for Fiscal years 2010 through 2015. The report found that the administrative costs received by the Blue Cross Blue Shield Association on its FYs 2010 through 2015 FACPs were generally reasonable, allowable, and allocable and in compliance with Federal regulations. However, we identified $161,000 in unspent termination funds, a $7,000 severance benefit overpayment, and $6,000 in unallowable costs.
• On March 9, 2017, the OIG released a report entitled, Medicare Contractors’ Payments to Providers for Hospital Outpatient Dental Services Generally Did Not Comply With Medicare Requirements. The report found that in the OIG’s previous audits of six Medicare contractors, the OIG found that payments made to providers for hospital outpatient dental services generally did not comply with Medicare requirements. Of the 600 dental services in the OIG’s 6 stratified random samples, 542 did not comply with Medicare requirements. The OIG did not determine Medicare compliance for 3 dental services because the payments were refunded before the OIG’s audit work, and the OIG did not determine Medicare compliance for 28 dental services because the providers of those services submitted claims to a different Medicare contractor. Medicare contractors properly paid providers for the remaining 27 dental services. On the basis of these results, the OIG estimated that the six Medicare contractors in their audits improperly paid providers an estimated $9.8 million for hospital outpatient dental services that did not comply with Medicare requirements.
• On March 9, 2017, the OIG released a report entitled, Nebraska Did Not Always Comply With Federal and State Requirements for Claims Submitted for the Nonemergency Transportation Program. The report found that the Nebraska Department of Health and Human Services (State agency) claimed Federal Medicaid reimbursement for some nonemergency medical transportation (NET) services claims submitted by NET providers that did not comply with Federal and State requirements during fiscal years (FYs) 2012 through 2014. On the basis of the OIG’s sample results, the OIG estimated that the State agency improperly claimed at least $1.9 million (Federal share) in unallowable Medicaid reimbursement for NET services during this period. In addition, NET providers did not have documentation to support that State-mandated driver background checks, vehicle maintenance checks, and driver qualification verifications had been performed. The report found that these errors occurred because the State agency's policies and procedures did not ensure that NET providers complied with Federal and State requirements for documenting and claiming NET services. Additionally, the State agency's policies and procedures did not ensure that NET providers maintained documentation to support that driver and vehicle checks were performed in accordance with State requirements.

IV. Other Health Policy News

• On March 10, 2017, the OIG issued Advisory Opinion 17-01. The Advisory Opinion addresses a hospital system’s proposal to provide free or reduced-cost lodging and meals to certain financially needy patients (Proposed Arrangement). Specifically, it addresses whether the Proposed Arrangement would constitute grounds for imposition of sanctions. The OIG found that the Proposed Arrangement would not constitute ground for the imposition of civil monetary penalties.
• On March 10, 2017, the OIG issued a Notice of Modification of OIG Advisory Opinion 02-1. The Advisory opinion concerns a non-profit, tax-exempt, charitable organization's providing cost-sharing and premium assistance to financially needy patients diagnosed with specific chronic illnesses and rare disorders, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs. The modification of OIG Advisory Opinion 02-1 means that the opinion continues in full force and effect in modified form.

V. ACA Repeal News

• On March 7, 2017, House Ways & Means Chair Kevin Brady (R-TX) says the Congressional Budget Office has yet to score the GOP's ACA replacement bill because of difficulties in calculating the implications of returning health care oversight to the states. Energy & Commerce Chair Greg Walden (R-OR) said Wednesday a score should be ready when the bill hits the floor, but Frank Pallone (D-NJ) raised concerns the White House Office of Management and Budget might try to cover a bad CBO score, which he said would set a dangerous precedent.
• On March 8, 2017, the House Energy and Commerce Committee held a markup of Committee Print, Budget Reconciliation Legislative Recommendations and H. Res. 154. The Committee approved and transmitted to the House Budget Committee the Amendment in the Nature of a Substitute to the AHCA, as amended, along party lines.  Only one amendment was agreed to (by voice vote): the Walden Amendment, to make a technical correction on page 50, line 19, by striking “An allocation” and inserting “Subject to section 2204(a), an allocation.”
• On March 8, 2017, the House Ways and Means Committee held a markup entitled, Budget Reconciliation Recommendations to Repeal and Replace Obamacare.  The Committee approved and transmitted to the House Budget Committee the Amendments in the Nature of a Substitute to the AHCA. These included: (1) Remuneration From Certain Insurers; (2) Repeal of Tanning Tax; (3) Repeal of Certain Consumer Taxes; (4) Repeal of Net Investment Income Tax; and (5) Repeal and Replace of Health-Related Tax Policy. Only one amendment was agreed to (by voice vote): the Brady Amendment, which amends the definition of eligible health insurance by prohibiting excepted benefits from being eligible for the new tax credit.
• On March 9, 2017, House Speaker Paul Ryan (R-WI) said the House will consider health care legislation and the budget reconciliation bill separately in the same week. However, other Republicans said they are not familiar with a plan to vote on elements of the GOP’s third phase of health reform at the same time as the reconciliation bill that is being used to overhaul the Affordable Care Act.
• On March 9, 2017, Republican Student Committee (RSC) Chairman Mark Walker (R-NC) said RSC members are holding out for a quicker enrollment freeze and roll-back of Medicaid expansion before they can support the AHCA.