Washington Watch

Carter L. Alleman, J.D.

Senate Repeal and Replace Efforts Fail

In the early hours of July 28, Senate Republicans’ attempt to repeal and replace the Affordable Care Act (ACA) fell apart. Majority Leader Mitch McConnell had offered amendment #667, the Health Care Freedom Act, referred to as the “skinny bill,” in hopes of passing something in the Senate that could engage the House of Representatives in conference negotiations to build consensus toward a final repeal and replace package. The final vote was 49- 51 with Sens. John McCain (R-Ariz.), Lisa Murkowski (R-Alaska), and Susan Collins (R-Maine) joining Senate Democrats to oppose the amendment.

The House adjourned for August recess on Friday. The Senate previously made the decision to delay its recess for two weeks. At this point, the Senate is poised only to complete work on nominations, but it may also take up the bipartisan Food and Drug Administration Reauthorization Act (FDARA), which previously passed the House by voice vote. Timely passage of FDARA is necessary to ensure that FDA review and approval of pharmaceuticals and medical devices is not disrupted as the user fees authorized by the bill provide more than half of the agency’s funding.

CMS Releases New QPP Web Page for Small Practices

The Centers for Medicare & Medicaid Services (CMS) recently launched a new web page to help providers in small practices, including those in rural or underserved areas, participate in the Quality Payment Program (QPP). The web page contains information and resources that may be especially useful to participants in the Merit-based Incentive Payment System (MIPS).

A key feature of the web page is an interactive map that provides contact information for organizations that participate in CMS’ Small, Underserved, and Rural Support program. These experienced community-based organizations (CBOs) offer hands-on training to small practices in historically under-resourced areas, including rural areas, health professional shortage areas, and medically underserved areas. The resources provided by the CBOs are available nationwide and at no cost to eligible clinicians and practices.

The CMS website has more information, including QPP flexibility and exemption details and additional resources

CMS Releases CY 2018 OPPS/ASC Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2018 Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) proposed rule on July 13. Under the OPPS proposed rule, CMS projects an overall 2 percent payment increase for most hospital outpatient departments in CY 2018. CMS also proposes changes in how Medicare pays hospitals for drugs that are acquired under the 340B Drug Discount Program. CMS would reimburse separately payable, non-pass-through drugs purchased at a discount through the 340B program at the average sales price (ASP) minus 22.5 percent, rather than the ASP plus 6 percent. The proposed rule places a moratorium through CY 2019 on the direct physician supervision requirement for outpatient therapeutic services at rural and critical access hospitals with 100 or fewer beds. CMS proposes additional provisions to remove six measures from the Hospital Outpatient Quality Reporting (OQR) Program and to remove total knee arthroplasty procedures from the inpatient-only list.

Under the ASC rule, CMS estimates a 1.9 percent payment increase for CY 2018 for services provided at these facilities. CMS proposes to add three procedures to the ASC list of covered surgical procedures and to the ASC Quality Reporting Program.

Ways and Means Launches Project to Cut Medicare Red Tape

The House Ways and Means Committee has launched an initiative aimed at scaling back regulatory and legislative burdens in the Medicare program. The Medicare Red Tape Relief Project requests comments from health care stakeholders about mandates that raise costs and hinder innovation and care quality. Lawmakers hope to work with the health care industry to find and eliminate such regulations either through legislation or administrative action, in conjunction with the U.S. Department of Health and Human Services (HHS). Health Subcommittee Chairman Pat Tiberi’s (R-Ohio) ultimate goal is to improve efficiency and care quality for Medicare beneficiaries. The initiative will also include congressional roundtables with stakeholders across the country. Comments are due by August 25.

House Votes to Extend VA Choice Program

The House of Representatives passed a revised version of S. 114, the VA Choice and Quality Employment Act. The bill provides $2.1 billion in mandatory funds for the Veterans Choice Program, which allows care delivery outside of VA facilities. The legislation also authorizes $274.6 million for VA facility leases, and would expand the VA’s efforts to recruit and retain qualified health professionals. The program is set to run out of funding as early as mid-August. The funding included in S. 114 will extend the program for an additional six months.

CMS Releases CY 2018 MPFS Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) on issued the calendar year (CY) 2018 Medicare Physician Fee Schedule (MPFS) proposed rule. Under this rule, CMS estimates a 1 percent reduction in total Medicare payments for general surgery services in 2018 from 2017. The pay cut can be attributed to proposed changes in the relative value units assigned to Current Procedural Terminology codes. CMS seeks feedback from stakeholders on specific changes the agency should undertake to update evaluation and management (E/M) visit codes to reduce administrative burdens and better align E/M coding and documentation with modern health care delivery.

The rule also proposes several changes to policies for the 2018 Physician Value-Based Modifier to better align incentives and provide a smoother transition to the Quality Payment Program’s Merit-based Incentive Payment System. Specifically, CMS proposes to reduce the automatic downward payment adjustment for not meeting minimum quality reporting requirements from -4 percent to -2 percent for groups of 10 or more clinicians, and from -2 percent to -1 percent for solo practitioners and groups of two to nine clinicians. In addition, CMS proposes to hold harmless all physician groups and solo practitioners who met minimum quality reporting requirements from downward payment adjustments for performance under quality tiering for the last year of the program and to align the maximum upward adjustment amount to two times the adjustment factor for all physician groups and solo practitioners.

Lawmakers Request Information on CMS MU Overpayments

Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) and Senate Finance Committee Chairman Orrin Hatch (R-Utah) are requesting information on what the Centers for Medicare and Medicaid Services (CMS) is doing to recover overpayments from the Meaningful Use (MU) program. The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) estimates that the agency overspent $729 million on the program between 2011 and 2014. The lawmakers also criticize CMS’ targeted audits aimed at improving the integrity of MU, which the OIG found are ineffective in correcting the errors it identified.

House Passes Medical Controlled Substances Transportation Act

The House of Representatives has passed legislation that would allow health practitioners to transport controlled substances across state lines. Under H.R. 1492, the Medical Controlled Substances Transportation Act, emergency medical services personnel and sports team physicians could register with the Drug Enforcement Administration (DEA) to transport controlled substances and administer them to patients outside of their registered work places. After 72 hours, the medicines would need to be returned to where they are stored, and doctors would be required to maintain records of where the medication was administered. Schedule I drugs are excluded from the changes in the legislation. H.R. 1492 passed by a vote of 416-2.

2017 Trustees Report Released; IPAB Not Triggered

The 2017 Medicare Trustees Report, which projects the long-term finances of the Medicare program, was released last week. The Board of Trustees finds that Medicare spending will not trigger the Independent Payment Advisory Board (IPAB) until 2021. The Board had previously forecast that the cost-cutting panel would be triggered this year. The 2017 report also indicates that the Medicare trust fund will remain solvent until 2029, a year later than previously predicted, though the reason for the slowdown is unclear.

Senators Comment on Zika Vaccine Pricing

Senators have written to the French drug company Sanofi to express concerns about the manufacturer’s refusal to commit to a reasonable licensing agreement for a Zika vaccine. The lawmakers state that they will urge the U.S. Army not to finalize any contracts with Sanofi until terms that will ensure an affordable price are met. The Army began a $43 million partnership with Sanofi last year to bring a vaccine to market, with the potential for Sanofi to earn an additional $130 million in funding. Separately, the senators have requested a public hearing on the acquisition of a Zika vaccine.

Lawmakers Investigate NIH Research Protocol

Leadership of the House Energy and Commerce Committee are investigating a medical research protocol that allegedly does not align with the Food and Drug Administration’s (FDA) rules for informed consent. Chairman Greg Walden (R-Ore.) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-Pa.) have written to the National Institutes of Health (NIH) on behalf of a constituent whose now-deceased wife went into cardiac arrest, and was later considered a participant in the Resuscitation Outcomes Consortium (ROC), sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The constituent learned that participants have to actively opt-out of the study. Because his wife was unconscious, she was automatically enrolled in the ROC.

Trump Nominates New Surgeon General

President Trump nominated Jerome Adams to be U.S. Surgeon General. Adams is an anesthesiologist and is currently serving as the health commissioner for the state of Indiana, a post he was appointed to in 2014 by now-Vice President Mike Pence. He has previously worked as a staff anesthesiologist and assistant professor of anesthesiology at the Indiana University School of Medicine.