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Focus on Regulation

Tag Archives: Hospitals

The Antitrust Challenge to the St. Luke’s/Saltzer Medical Group Transaction: Implications for Hospital/Physician Consolidations

On January 24, 2014, the Federal Trade Commission (FTC), along with the Idaho Attorney General and two local hospitals, prevailed in Idaho District Court in their challenge to the St. Luke’s Health System’s acquisition of a group of physicians in Nampa, Idaho. As the first litigated FTC challenge to a hospital acquisition of a physician

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States.  Through its February 4 decision, the court has broadly upheld FDA’s authority to regulate stem cell therapies as drugs.  Thus, any sense that the development of such therapies may be exempt from the pre-market approval

District Court blocks hospital acquisition of a physician practice, concluding that anticompetitive effects outweigh potential quality and efficiency gains from consolidation

In the first ever FTC-litigated challenge to a hospital system’s acquisition of a physician group, the U.S. District Court for Idaho ruled in favor of the plaintiffs (the FTC, Idaho Attorney General, and St. Alphonsus, a competing hospital system). The plaintiffs challenged St. Luke’s Health System’s acquisition of the Saltzer Medical Group, a 41-physician multi-specialty

Medicare Inpatient Hospital Final Rule for Fiscal Year 2014 Released; Includes Changes to Inpatient Admission and Rebilling Policies

The Centers for Medicare & Medicaid Services released the Hospital Inpatient Prospective Payment System (IPPS) final rule for fiscal year (FY) 2014 on August 2, 2013.  The final rule addresses changes in payment rates for general acute care and long-term care hospitals effective October 1, 2013, as well as revisions to the Hospital Value-Based Purchasing

District Court applies Christian Doctrine, upholds hospitals as subcontractors subject to OFCCP anti-discrimination provisions

In a significant decision with implications beyond the healthcare industry, the D.C. District Court upheld a ruling by the U.S. Department of Labor’s Administrative Review Board (ARB) deeming three Pennsylvania hospitals government subcontractors subject to the Office of Federal Contract Compliance Programs’ (OFCCP) jurisdiction. UPMC Braddock v. Harris, No. 1:09-cv-01210-PLF (D.D.C. Mar. 30, 2013).

FDA Seeks Enhanced Cybersecurity Risk Management Efforts, Including Premarket Submission Requirements, for Medical Device Manufacturers and Hospitals

Drawing on the increasing use of wireless, Internet- and network-connected medical devices, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance document for comment on June 14, 2013, proposing that manufacturers of medical devices that contain software, firmware, or programmable logic, address cybersecurity risks in premarket submissions.  The draft guidance, entitled,

Supreme Court tightens the scope of antitrust immunity in government-owned hospital mergers

In a unanimous and favorable decision for the Federal Trade Commission (FTC), the Supreme Court found that the state action immunity doctrine does not shield Phoebe Putney Health System’s acquisition of Palmyra Park Hospital from antitrust scrutiny, sending the parties back to FTC administrative litigation to battle over the legality of the hospital merger. The

FTC issues advisory opinion approving physician hospital organization’s clinical integration model

On February 13, 2013, the FTC staff issued a favorable Advisory Opinion to the Norman Physician Hospital Organization (Norman PHO) allowing it to move forward with its clinical integration plan. The Norman PHO, an affiliation of the Norman Regional Health System and approximately 280 participating physicians, seeks to transition from a messenger model when dealing

Medicare Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule

CMS released a single final rule addressing calendar year (CY) 2013 Medicare payments for hospital outpatient departments and ambulatory surgical centers (ASCs). Under the final rule, Medicare’s payment rates for hospital outpatient services will increase 1.8% overall.  CMS also plans to increase by 0.6% the payment rate to ASCs. CMS estimates that CY 2013 payments to hospitals

CMS Releases Final Rules on Home Health, Primary Care and Dialysis Facility Payments

In a busy week leading up to the election, CMS released several final rules, including final rules pertaining to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), Medicaid payments made to certain primary care physicians and the Home Health Prospective Payment System. ESRD PPS Final Rule In a final rule released on November 2nd, CMS

Money! Money! Money!

CMS released three proposed rules addressing Medicare payment changes for calendar year (CY) 2013 for physicians, hospital outpatient departments and ambulatory surgical centers and home health agencies on Friday, July 6, 2012. The proposed rules will be published in the Federal Register on July 30, 2012, and comments for all three proposed rules are due

The IRS Proposes Additional Requirements for Charitable Hospitals

The Internal Revenue Service (IRS) issued a Notice of Proposed Rulemaking (NPRM) setting forth proposed regulations regarding the requirements for charitable hospital organizations implemented under section 501(r) of the Internal Revenue Code (IRC), added by the Patient Protection and Affordable Care Act (PPACA).  This NPRM, published in the Federal Register on June 26, 2012, builds

Rules Reducing Provider Burden Could Save Them More than $1.1 Billion

The Centers for Medicare & Medicaid Services (CMS) finalized two rules that together are expected to reduce costs for hospitals and other health care providers by over $1.1 billion.  The rules come in response to President Obama’s January 18 Executive Order 13563, which called upon agencies to review existing regulations and to “modify, streamline, expand,