Document(s) published by this organization: 8
|Emerging Issues Regarding Provider-Based Status|
Joel M. Hamme, Barbara Straub Williams, William H. von Oehsen; Powers Pyles Sutter & Verville, PC;
December 23, 2015, previously published on November 19, 2015This memorandum reports on several recent developments pertaining to Medicare provider - based status and their implications for providers and certain covered entities participating in the 340B drug discount program.
|CMS and OIG Issue Final Rule on ACO Waivers|
Mark R. Fitzgerald, Christina A. Hughes; Powers Pyles Sutter & Verville, PC;
November 6, 2015, previously published on October 29, 2015As part of the Patient Protection and Affordable Care Act’s establishment of the Medicare Shared Savings Program (MSSP), the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG), developed waivers of the federal...
|U.S. House Approves “Native American Energy Act”, Sending Legislation to Senate|
Brian Gunn, Paul G. Moorehead; Powers Pyles Sutter & Verville, PC;
October 23, 2015, previously published on October 12, 2015On October 8, 2015, the U.S. House of Representatives approved (254 to 173) the "Native American Energy Act" (H.R. 538), a bill to remove legal and regulatory barriers to energy resource development on American Indian lands.
|Summary of 340B Drug Pricing Program Proposed Omnibus Guidance|
Joel M. Hamme, Jason B. Reddish, Barbara Straub Williams, William H. von Oehsen; Powers Pyles Sutter & Verville, PC;
September 7, 2015, previously published on September 4, 2015The following summarizes the provisions of the 340B drug pricing program (340B Program) omnibus guidance (Proposed Guidance) released by the Health Resources and Services Administration (HRSA) on August 28, 2015. The Proposed Guidance is attached to this summary. The Proposed Guidance touches on...
|Supreme Court Decision in King v. Burwell on Eligibility for Tax Credits in the Health Insurance Exchanges|
Joel M. Hamme, Caitlyn Yana; Powers Pyles Sutter & Verville, PC;
July 30, 2015, previously published on June 25, 2015In a 6-3 decision issued today, the Supreme Court of the United States held that Section 36B of the Internal Revenue Code authorizes tax credits for all financially eligible individuals who enroll in insurance plans through the health insurance exchanges created by the Affordable Care Act (ACA).
|HRSA Proposed Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties|
Ronald S. Connelly, William H. von Oehsen; Powers Pyles Sutter & Verville, PC;
July 15, 2015, previously published on July 9, 2015On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a notice of
proposed rulemaking related to 340B ceiling prices and the imposition of civil monetary penalties on manufacturers under the 340B Drug Pricing Program. The proposed rule would implement provisions of the...
|Draft 340B Legislation Could Be Included in 21st Century Cures|
Joel M. Hamme, Jason B. Reddish, Peggy Tighe, Barbara Straub Williams; Powers Pyles Sutter & Verville, PC;
July 14, 2015, previously published on May 19, 2015Late Friday, the House Energy and Commerce Committee staff circulated to a small number of organizations a “discussion draft” of 340B program legislation that could significantly alter the 340B program. There is a possibility that the discussion draft, which one committee staffer...
|HHS Releases Practical Guidance for Boards of Directors on Compliance Oversight|
Caroline Gould Bergner, Steve Postal, James C. Pyles, Barbara Straub Williams; Powers Pyles Sutter & Verville, PC;
July 14, 2015, previously published on May 15, 2015On April 20, 2015, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS OIG), in collaboration the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association, released compliance guidance for...