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
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program....more
On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more
On August 21, 2023, CMS issued the first of two draft guidance documents for implementing the Medicare Prescription Payment Plan that was established by section 11202 of the Inflation Reduction Act (IRA) and signed into law...more
This week in Washington: Congressional Democrats reach drug pricing agreement; bipartisan infrastructure bill goes to President Biden’s desk with budget reconciliation bill delayed....more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
This week in Washington: The House and Senate are out for Thanksgiving recess this week. Congress - Hearings/Markups - House Committee on the Judiciary: “The Patent Trial and Appeal Board and the Appointments Clause:...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
CMS recently issued long-awaited draft guidance on hospital co-location with other hospitals or healthcare facilities, providing some potential insight on the otherwise ambiguous prohibition on “shared space.” This...more
Polsinelli is pleased to share the Health Care Reimbursement and Payor Dispute Update. This newsletter is a designated source of news, information and guidance on the constantly evolving reimbursement industry. ...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more
Earlier this month, the Centers for Medicare & Medicaid Services (“CMS”) issued draft “Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities” (the “Draft Guidance”) intended to change earlier CMS...more
On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the...more
As the health care delivery system continues to evolve, on May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a draft guidance document to state survey agency directors entitled, “Guidance for Hospital...more
Summary - On May 3, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited draft guidance addressing compliance with the hospital Conditions of Participation (“CoPs”) and survey procedures in regard...more
On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain...more
On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance formalizing the agency’s policy on hospital co-location with other hospitals and healthcare entities. CMS’ new policy walks back its...more
For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more
On May 3, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a draft of long-awaited guidance for hospitals on how they can share space, services and staff with other co-located hospitals and health care...more
The Centers for Medicare and Medicaid Services has issued long-awaited draft guidance addressing the use of shared space and contracted services. Though aiming to increase transparency into the scope and interpretation of its...more
On May 3, CMS issued a draft letter to State Survey Agency Directors regarding "Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities" ("Guidance") that is intended to provide clarity on how...more
As new healthcare delivery models evolve, we may see an increase in hospitals that share space with other hospitals or healthcare entities. On May 3, 2019, Centers for Medicare and Medicaid Services (CMS) issued draft...more
On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more
Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more
The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop...more