The CMS Interoperability and Prior Authorization Rules
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Hospice and Home Health Survey Perspectives: A Conversation with Kim Skehan, VP of Accreditation at CHAP
Transparency and the Open Payments Program
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin Bennett, the Director of the Research Center for Transforming Health and the
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Podcast: Health Equity – Behind the Buzzwords – Diagnosing Health Care
A Very “Special” Episode: Amid Controversy, CMS Launches the Hospice Special Focus Program
Grace from CMS: Unexpected Good News on HIS and CAHPS Appeals
This Bandwagon Has a Broken Wheel: OIG Joins the Inconsistent Approach to Hospice GIP Claims
Behind the Curtain: Enhanced Provider Enrollment Oversight
Survey Woes: CMS Ramps Up Hospice Survey Program and Consequences
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
A Glimpse Into the Other Side: Understanding the Perspective of Government Enforcers
I Understood There Would Be No Math: Audits, Extrapolations, and a New Set of Rules
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Quick Takeaways From the 2024 Proposed Hospice Wage Index Rule
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The U.S. Food and Drug Administration (FDA) is taking definitive steps to reinforce regulations surrounding laboratory-developed tests (LDTs). On September 29, 2023, the FDA announced its Proposed Rule seeking to clarify...more
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The changes, part of the...more
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more
On March 19, 2021, a Southern District of New York judge denied a motion to dismiss a False Claims Act (“FCA”) suit alleging that Omnicare - a subsidiary of CVS Health Corp. - “dispensed drugs based on invalid prescriptions...more
Trump Administration Finalizes Rulemaking on Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes - On December 21, 2020, the Centers for Medicare & Medicaid Services...more
HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more
On December 1, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote patient monitoring aka remote physiologic monitoring or “RPM,” reimbursed under the Medicare program. The...more
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more