The Medicaid Managed Care Final Rule addresses managed care plan network issues while preserving significant flexibility for the states in designing the standards.  The Rule adds a new regulation (42 C.F.R. § 438.68) on network adequacy standards for medical care and Long-Term Services and Supports (LTSS) as well as one related to availability of services (42 C.F.R. § 438.206).  Although states already regulate network adequacy, the Rule provides a new minimum level of compliance and…

A key event in Congress affecting health information technology occurred last week when two members of the Senate HELP Committee issued a discussion draft of their bipartisan legislation on health information technology (health IT).  This ambitious bill addresses many of the same areas as other recent bills, including information blocking, transparency, a star rating system for electronic health records (EHRs), usability, and interoperability. It also contains provisions on governance of health information exchange, safety, and…

On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection measures” (TPMs) in their software which blocks unauthorized inspection of data to protect copyright.  Under the Act, the Library of…

On December 17, 2014, the Centers for Medicare and Medicaid Services (CMS) published on its website a Frequently Asked Questions (FAQs) on its Quality Rating System (QRS) and Qualified Health Plan (QHP) Enrollee Experience Survey for QHPs on the insurance exchanges. Section 1311(c)(3) of the Affordable Care Act (ACA) requires CMS to develop a system that rates QHPs based on quality and price. All QHP issuers that offered a category of coverage through any exchange…

On November 26, 2014, the U.S. Department of Health and Human Services (HHS) released its proposed Notice of Benefit and Payment Parameters for 2016, also known as the “Payment Notice.” Now that HHS has completed the majority of its major rulemakings implementing the Affordable Care Act, the annual Payment Notice has become the recurring opportunity for HHS to modify Affordable Care Act (ACA) policy in a wide variety of subject areas. The 2016 Payment Notice…

On October 15, 2014, the Centers for Medicare & Medicaid Services (“CMS”) launched a new accountable care organization (“ACO”) program that aims to encourage new Medicare Shared Savings Program (“MSSP”) ACOs in rural and underserved areas. The program, known as the ACO Investment Model, provides up to $114 million to as many as 75 ACOs in the U.S. CMS created the program in response to concerns that the current ACO initiatives do not provide…

On October 16, 2014, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) announced the continuation of the Accountable Care Organization (“ACO”) fraud and abuse waivers for an additional year. The Affordable Care Act (“ACA”) authorized creation of the Shared Savings Program to facilitate development of ACOs in Medicare. The ACA also allows for a waiver of certain fraud and abuse laws to provide ACOs greater flexibility in…