ACO Waivers Final Rule Issued
On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) issued its much-anticipated final rule regarding waivers of federal healthcare fraud and abuse laws for participants in the Medicare Shared Savings Program (MSSP). CMS has received comments from MSSP participants advocating for waivers of these fraud and abuse laws, noting that "stakeholders have expressed concern that the restrictions these laws place on certain coordinated care arrangements may impede some of the innovative integrated-care models envisioned" by the MSSP. After considering stakeholder feedback as well as early performance measures by participating MSSP ACOs, CMS created five waivers of federal healthcare fraud and abuse laws for MSSP participants: (1) the 'pre-participation' waiver; (2) the 'participation' waiver; (3) the 'shared savings distribution' waiver; (4) the 'compliance with the physician self-referral law' waiver; and, (5) the 'patient incentive' waiver. This Health Capital Topics article will detail the requirements of the five waivers, discuss how the finalized waivers may impact the MSSP, and address the continuing duties of the Board of Directors of an ACO to maintain compliance with federal standards in today's heightened regulatory environment. (Read more...)

Changes to Stark Law Set for January 1, 2016
On November 16, 2015, the Centers for Medicare and Medicaid Services published its final rule for the 2016 Medicare Physician Fee Schedule (MPFS) in the Federal Register, effective on January 1, 2016. In addition to updating a number of policies, rates, and quality provisions for services covered under the MPFS, the final rule modified various portions of the physician self-referral law (known as the Stark Law). The 2016 MPFS final rule added two new exceptions to Stark - the "assistance to compensate a nonphysician practitioner" exception, and the "timeshare arrangements" exception - as well as altered the requirements for physician-owned hospitals and clarified provisions involving holdover arrangements, writing requirements, and many others. This Health Capital Topics article will discuss the 2016 MPFS final rule, detail the new Stark Law exceptions and alterations, and examine the potential impact of these modifications on the standards of fair market value and commercial reasonableness. (Read more...)

CMS Delays Enforcement of Stage Three Meaningful Use Requirements
Following the establishment of the Health Information Technology for Economic and Clinical Health Act in 2009, the Centers for Medicare and Medicaid Services (CMS) issued rules promoting the use of electronic health records (EHRs) and interoperable health information technology (HIT) by establishing incentives for eligible providers. Each year since 2010, CMS has published updated rules to facilitate the use of EHRs by healthcare organizations, but there has been considerable push-back from both healthcare organizations as well as legislators because of the financial, technological, and logistical difficulties encountered during implementation of HIT. On October 16, 2015, CMS published its Stage Three rule to accommodate some of the complaints received and ease the implementation requirements of meaningful use programs. This Health Capital Topics article will briefly explain each of the three stages and discuss some of the critiques of the newest rule. (Read more...)

ICD-10 Rollout Relatively Smooth, Insurers Say
On October 1, 2015, the medical coding tool International Classification of Diseases, Tenth Edition (ICD-10) went into effect, replacing the previous coding version, ICD-9. The initial launch of ICD-10 has largely been seen as a success by many healthcare industry stakeholders. Sid Hebert, head of Humana's ICD-10 implementation team, stated "it's been a pretty smooth transition so far." While not all insurers have experienced the same success as Humana, most observers noted that any issues that arose were quickly resolved by regulators at the Centers for Medicare and Medicaid Services. This Health Capital Topics article will discuss initial reactions regarding the ICD-10 rollout; the impact ICD-10 may have on patient satisfaction, reimbursement, and physician productivity; and, potential issues related to ICD-10 implementation, such as an increase in the number of claims and administrative load. (Read more...)

FTC Releases Antitrust Guidance for State Medical Boards
In the 2015 decision North Carolina State Board of Dental Examiners v. Federal Trade Commission, the Supreme Court held that medical boards are subject to antitrust scrutiny unless a board satisfies two requirements: (1) the board must establish that the challenged restraint coincides with state policy; and, (2) that the board is "actively supervised" by the state. Various trade organizations, such as the American Medical Association, have expressed concerns that the application of federal antitrust law to state medical boards will have a chilling effect on service on such boards, which may ultimately discourage boards from adequately regulating the medical field. In response to these requests, on October 14, 2015, the Federal Trade Commission (FTC) provided guidelines for how state agencies may comply and move forward in regulating their fields in the wake of the decision. This Health Capital Topics article will discuss the guidelines the FTC provided surrounding the Supreme Court decision, the FTC's view on "active state supervision," the consequences that befall state medical boards if they do or do not fall within these definitions, and the concerns the decision raised with organizations affected by the ruling. (Read more...)