Topic: Regulatory

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

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

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

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

The Joint Commission Issues Sentinel Event Alert on Direct Oral Anticoagulants

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

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

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

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”

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

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

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

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

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

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

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

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

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

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

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

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

CMS issues CY 2019 home health proposed rule

On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) published its calendar year (CY) 2019 proposed rule for Medicare payment updates and proposed quality reporting changes for home health agencies (HHA) under the home health prospective payment system (HH PPS). CMS proposes certain changes to Medicare payment and quality reporting standards for … Continue reading

CMS solicits comments for easing Stark Law burdens

Last week, the U.S. Centers for Medicare & Medicaid Services (“CMS”) released a Request for Information (“RFI”) that seeks feedback from stakeholders in the healthcare industry on possible regulatory changes to the Stark Law. CMS has expressed concern that the Stark Law may have a negative effect on alternative payment models, integrated delivery models, and … Continue reading

Department of Labor publishes final rule to expand access to Association Health Plans

The United States Department of Labor (DOL) published a final rule on June 19 that relaxes the regulation of, and expands access to, association health plans (AHPs).  President Donald J. Trump’s October 12, 2017 Executive Order instructed the DOL to consider expanding access to association health plans and the Department released a proposed rule on … Continue reading
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