Each year, the Wolters Kluwer Health Law Editorial team revisits the major legal and regulatory developments of the past year and provides that information to readers through a series of year-in-review Strategic Perspectives published in Health Law Daily and Health Reform WK-EDGE. This Strategic Perspective lists and links to all of the 2016 year-in-review stories for easy reference.
These 12 Strategic Perspectives provide a broad overview of 2016’s impact on Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), health care compliance, health reform, and the life sciences. They also preview 2017, and provide information about what the incoming Donald J. Trump (R) Administration and the 115th Congress have pledged to do.
Health Care Compliance
Strategic Perspectives following actions taken by the HHS Office of Inspector General (OIG) and others to enforce the False Claims Act (FCA) (31 U.S.C. §3729), the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (P.L. 104-191), and the Anti-Kickback Statute (AKS) (42 U.S.C. §1320a-7b) included:
- Top 5 Things to Know About Cybersecurity as 2016 Ends (December 13, 2016);
- OIG’s 2016 Analysis of Top 5 Proposed Arrangements Types (December 21, 2016);
- Top 5 Things to Know About the OIG’s 2017 Work Plan (December 29, 2016); and
- A Look Back at 5 FCA Cases Appealed in 2016 (January 4, 2017).
Medicare and Medicaid
The following Strategic Perspectives related to Medicare and Medicaid reimbursement and litigation, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10), and administrative decisions issued by the Departmental Appeals Board (DAB) and the Provider Reimbursement Review Board (PRRB):
- Counting Down the Top 5 MACRA Developments of 2016 (December 9, 2016);
- Top 5 Medicaid Litigation Actions of 2016 and a Look at 2017 (December 14, 2016);
- Five 2016 DAB Decisions with Unusual Facts and Resolutions (December 20, 2016); and
- Five Things to Know About the PRRB in 2016 (December 27, 2016).
One Strategic Perspective focused on 2016’s major developments related to the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148): Top 5 ACA-Related Bills, Cases, and Final Rules of 2016 (December 7, 2016).
Strategic Perspectives about judicial and regulatory interpretations of the federal Food, Drug and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.) included:
- The FDA’s Top 5 Drug and Device Actions in 2016 (November 29, 2016);
- Are the Top Five Food Issues in 2016 a Prelude to 2017? (December 2, 2016); and
- Examining the Top Five 2016 Drug & Device Decisions (December 22, 2016).
Trump Administration White Paper
The Trump Administration will likely have significant impact on several areas of law, how corporations do business, and individuals. The white paper Trump’s Win Expected to Bring Significant Legal and Regulatory Changes discusses potential changes to these areas including: Tax, Health, Life Sciences, Labor and Employment, Federal Securities, Banking and Finance, Antitrust and Competition Law, Energy and Environmental Law, Government Contracts, Employee Benefits, Payroll, and Pension and Retirement.
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