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Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Supreme Court Rejects Government’s Expansive View of FCA Liability but Endorses Implied Certification Theory (with Limits)

On June 16, 2016, the Supreme Court of the United States rendered a unanimous decision in the highly anticipated False Claims Act (“FCA”) case of Universal Health Services, Inc. v. United States ex rel. Escobar.[1] In its...more

Supreme Court Rules That Providers and Suppliers Cannot Challenge Medicaid Reimbursement Rates in Federal Court

On March 31, 2015, a 5-4 plurality of the Supreme Court of the United States ruled that Medicaid providers do not have a private right of action under the Medicaid statute to challenge reimbursement rates. The Supreme Court’s...more

Supreme Court Removes a Major Hurdle for Administrative Agency Rulemaking

On March 9, 2015, the Supreme Court ruled unanimously that when a federal administrative agency wants to amend or repeal an “interpretive rule,” it does not have to follow the notice-and-comment procedures set forth in the...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

CMS Publishes Additional (but Limited) Guidance on the Coverage with Evidence Development Process

On November 20, 2014, the Centers for Medicare and Medicaid Services (“CMS”) published its latest round of guidance on its Coverage with Evidence Development (“CED”) policy for selected items and services under the Medicare...more

CMS Requests Comments on the Dispute Resolution Process Associated with the Physician Payment Sunshine Act

On May 5, 2014, the Centers for Medicare & Medicaid Services ("CMS") announced an opportunity to submit comments on the dispute resolution and correction procedures proposed in the final rule on the Open Payments reporting...more

D.C. Circuit Requires Greater Disclosure of Changes in Medicare Regulations

The rulemaking process often accommodates a variety of interests, including the preference of regulatory agencies to maintain some flexibility and the rights of interested parties to participate in the regulatory process. On...more

OMHA's Medicare Appellant Forum Offers Few Meaningful Answers for Frustrated Medicare Providers and Suppliers

On February 12, 2014, the Office of Medicare Hearings and Appeals ("OMHA") hosted a Medicare Appellant Forum ("Forum") to address its current backlog of appeals. OMHA is responsible for hearings before Administrative Law...more

Supreme Court Opinion in Sebelius v. Auburn Regional Medical Center Rejects a Challenge by Hospitals to Medicare's SSI Fraction...

A unanimous Supreme Court has issued its opinion in Sebelius v. Auburn Regional Medical Center, No. 11-1231 (Jan. 22, 2013), rejecting a challenge by hospitals to Medicare's Supplemental Security Income ("SSI") fraction...more

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