Topic: Regulatory

CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations

On Thursday, October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will publish in the Federal Register two proposals to implement major changes to Stark Law and Anti-Kickback Statute (AKS) regulations. We have summarized a portion of those proposed … Continue reading

US regulators to align key health care regulations with transformation to value-based care system; CMS and OIG propose major overhaul of Stark Law and AKS regulations

By Thomas Dowdell (US), Debbi Johnstone (US), Stacey Murphy (US) and Benjamin Wallfisch (US) on October 14, 2019 Posted in General, News from DC, Regulatory

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two sweeping proposals aimed at revising the Stark Law and Anti-Kickback Statute (AKS) regulations to adapt to and promote the US health care system’s transformation to value-based payment … Continue reading

Medicaid Update: D.C. Circuit Court of Appeals Reviews CMS Approval of Medicaid Work and Community Engagement Eligibility Requirements

By Jeff Wurzburg (US) on October 11, 2019 Posted in General, News from DC, Regulatory

Today, October 11, 2019, the United States Court of Appeals for the D.C. Circuit is hearing oral arguments in Stewart v. Azar (Case No. 19-5095), an appeal from the federal district court’s rulings invalidating three prior approvals of Section 1115 Waivers in Kentucky and Arkansas that would have implemented work and community engagement requirements as … Continue reading

U.S. District Court vacates CY 2019 OPPS final rule reducing Medicare payment rates for evaluation and management services furnished in hospital excepted off-campus provider-based departments

By Thomas Dowdell (US) on September 18, 2019 Posted in Regulatory

On September 17, United States District Judge Rosemary M. Collyer, United States District Court for the District of Columbia, ruled that CMS in its CY 2019 OPPS final rule reducing Medicare payment rates for evaluation and management (E/M) services furnished to Medicare beneficiaries in hospital excepted off-campus hospital provider-based departments exceeded its statutory authority and … Continue reading

The Joint Commission releases sentinel event statistics for first six Months of 2019

By Yvonne Puig (US) and Jeff Wurzburg (US) on August 15, 2019 Posted in Regulatory

On August 14, 2019 The Joint Commission (TJC) released sentinel event statistics for the first half of 2019, which included 426 events. 83% of the events were voluntarily self-reported by an accredited or certified organization. The five most frequently reported sentinel events were: Unintended retention of a foreign body part – 60 Wrong-site surgery – … Continue reading

CMS releases FY 2020 IPPS and LTCH PPS final rule

By Jeff Wurzburg (US), Mark Faccenda (US) and Thomas Dowdell (US) on August 9, 2019 Posted in Regulatory

On August 2, 2019, the Centers for Medicare & Medicaid Services (CMS) published its Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (PPS) final rule (CMS-1716-F). The final rule is scheduled to be published in the Federal Register on August 16, 2019. … Continue reading

CMS Publishes FY 2020 Medicare Hospital IPPS and LTCH PPS Final Rule

By Thomas Dowdell (US) on August 2, 2019 Posted in Regulatory

On August 2, 2019, the Centers for Medicare & Medicaid Services (CMS) published its Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Acute Care Hospital (LTCH) Prospective Payment System (PPS) final rule (CMS-1716-F). The final rule is scheduled to be published in the Federal Register on August 16, … Continue reading

CMS Publishes FY 2020 Final Rules for IRF PPS and Hospice Payments

By Thomas Dowdell (US) on August 1, 2019 Posted in Regulatory

On July 31, the Centers for Medicare & Medicaid Services (CMS) published two federal fiscal year (FY) 2020 final rules – inpatient rehabilitation facility (IRF) prospective payment system (PPS) and hospice payments.… Continue reading

The Joint Commission Issues Sentinel Event Alert on Direct Oral Anticoagulants

By Yvonne Puig (US) and Jeff Wurzburg (US) on July 31, 2019 Posted in Regulatory

On July 30, 2019, The Joint Commission (TJC) issued Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants (“DOACs”). The alert may be found here. According to TJC, “anticoagulants have been named second of the top medications involved in error incidents causing death or serious harm.” Because there are not FDA-approved reversal agents … Continue reading

CMS Publishes FY 2020 Final Rules for Inpatient Psychiatric Facility PPS and Skilled Nursing Facility PPS

By Thomas Dowdell (US) on July 31, 2019 Posted in Regulatory

On July 30, the Centers for Medicare & Medicaid Services (CMS) published two federal fiscal year 2020 final rules: (i) inpatient psychiatric facilities (IPFs) prospective payment system (PPS) and quality reporting updates; and (ii) skilled nursing facilities (SNFs) PPS and consolidated billing, including updates to the quality reporting program and value-based purchasing program.… Continue reading

CMS Publishes CY 2020 Proposed Rules for Hospital OPPS and ASC, MPFS, and ESRD and DMEPOS Policies and Payments

By Thomas Dowdell (US) on July 30, 2019 Posted in Regulatory

On July 29, the Centers for Medicare & Medicaid Services (CMS) published three proposed rules for Calendar Year (CY) 2020: Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule; Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule (MPFS); and End State Renal Disease … Continue reading

Texas Attorney General addresses prompt pay requirements for out-of-network emergency services

By Yvonne Puig (US) and Jeff Wurzburg (US) on May 23, 2019 Posted in Regulatory

An Attorney General Opinion (KP-0250) released on May 22 provides that a court would likely find that the deadline provisions in the Texas Insurance Code applicable to Health Maintenance Organizations (“HMOs”) and Preferred Provider Organizations (“PPOs”) relating to prompt payment apply to out-of-network emergency care providers, while the penalty provisions contained do not apply to … Continue reading

CMS publishes draft “Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities”

By Thomas Dowdell (US) on May 6, 2019 Posted in Regulatory

On May 3, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited draft “Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities.” The draft guidance is specific to compliance with the general Conditions of Participation for hospitals (CoPs) and does not address the specific location and separateness requirements that apply to other … Continue reading

The Joint Commission releases sentinel events for 2018

By Yvonne Puig (US) and Jeff Wurzburg (US) on March 14, 2019 Posted in Regulatory

On March 13, 2019, The Joint Commission released Sentinel Event statistics for 2018. There were 801 sentinel events in 2018, with 87% being voluntarily self-reported. According to the Joint Commission, it is estimated that less than 2 percent of all sentinel events are reported. The Joint Commission defines a sentinel event as: Any unexpected occurrence … Continue reading

Centers for Medicare and Medicaid Innovation announces emergency transportation model

By Jeff Wurzburg (US) on February 18, 2019 Posted in Regulatory

On February 14, 2019, the Center for Medicare and Medicaid Innovation (CMMI) announced the Emergency Triage, Treat, and Transport (ET3) Model that aims to transform the ambulance system. Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers will participate in the model. CMMI believes this model will improve quality and lower costs by reducing hospitalizations and … Continue reading

OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

By Carol Poindexter (US) and Savannah Wiseman (US) on February 5, 2019 Posted in Regulatory

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

Hospital alert: CMS hospital transparency requirements in effect January 1, 2019

By Yvonne Puig (US) and Jeff Wurzburg (US) on December 31, 2018 Posted in Regulatory

On January 1, 2019, all hospitals are required to make public a list of their standard charges. As a reminder, Section 2718(e) of the Public Health Service Act, as enacted by the Affordable Care Act, requires: “each hospital operating within the United States” to “make public (in accordance with guidelines developed by the Secretary) a … Continue reading

CMS publishes CY 2019 physician fee schedule final rule

By Jeff Wurzburg (US) on November 6, 2018 Posted in Regulatory

On November 2, 2018, CMS published its CY 2019 physician fee schedule final rule. The final rule implements a number of significant changes to the way practitioners receive reimbursement for items and services provided to Medicare beneficiaries, including: Eliminating the requirement for a practitioner to document the medical necessity of a home visit in lieu … Continue reading

OIG considers new safe harbors and other incentives to promote coordinated care

By Elise LeGros (US) on September 5, 2018 Posted in Regulatory

As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

CMS proposes to expand payment for telehealth services

By on August 28, 2018 Posted in Regulatory

On July 12, 2018, CMS included three proposed changes to telehealth reimbursements within the CY 2019 Physician Fee Schedule (the “Proposed Rule”). Currently, subject to certain exceptions, Medicare reimbursements for certain telehealth services are statutorily limited by the type of health care professional providing the service, and the geographic location of the patient (namely, the … Continue reading

CMS further crystalizes Stark liberalizations

By Joseph Keillor (US) and Debbi Johnstone (US) on August 21, 2018 Posted in Regulatory

On July 12, 2018, CMS included within the CY 2019 Physician Fee Schedule (the “Proposed Rule”) two revisions to Stark Law regulations aimed at further clarifying any actual or perceived differences between current regulations and the recently enacted Bipartisan Budget Act of 2018 (“2018 BBA”). As we previously reported, Section 50404 of the 2018 BBA … Continue reading

CMS issues Pathway to Success ACO proposed rule

By Jeff Wurzburg (US) on August 10, 2018 Posted in Regulatory

On August 9, 2018, CMS published the long-awaited Pathways to Success proposed rule. CMS Administrator Seema Verma published a related article on the Health Affairs Blog. The proposed rule would usher in significant changes for Accountable Care Organizations (ACOs). Groups of providers, such as doctors and hospitals, can join together to form an ACO and … Continue reading

The US Departments of HHS, Labor, and Treasury finalize expanded access to short-term, limited duration insurance

By Jeff Wurzburg (US) on August 1, 2018 Posted in Regulatory

On August 1 the Departments of Treasury, Labor, and Health and Human Services (the Departments) published a final rule that will expand the availability of short-term limited duration insurance (STLDI). A Health Law Pulse summary of the proposed rule may be read here. STLDI is not required to comply with the Affordable Care Act (ACA) … Continue reading

CMS proposes significant Medicare OPPS and ASC payment system changes for 2019

By Thomas Dowdell (US) and Jeff Wurzburg (US) on July 26, 2018 Posted in Regulatory

On July 25, 2018, the Centers for Medicare & Medicaid Services published its 2019 Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system proposed rule. A fact sheet describing the proposed rule is available here. The proposed rule can be accessed here. CMS proposes to update hospital OPPS payment rates … Continue reading