Archives: Regulatory Developments

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Federal Health Fraud Penalties Are Rising Once Again

The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration.  Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements … Continue Reading

CMS Proposes Regulatory Changes to Ease Burden on Medicare, Medicaid Providers

CMS has issued a proposed rule intended streamline the Medicare and Medicaid regulatory burden on numerous types of providers and suppliers.  CMS generally classifies the proposals as falling into the following categories:  (1) those that simplify and streamline processes, (2) those that reduce the frequency of activities and revise timelines, and (3) those that address … Continue Reading

OIG Invites Comments on Potential Changes to Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) has issued a request for information (RFI) on ways to amend or add new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty statute, in order to foster arrangements that promote care … Continue Reading

CMS Proposes Medicare Shared Savings Program Redesign to “Put Real ‘Accountability’ in Accountable Care Organizations”

The Centers for Medicare & Medicaid Services (CMS) is proposing a “new direction” for the Medicare Shared Savings Program, with changes to Medicare accountable care organization (ACO) requirements designed to increase Medicare savings and reduce “gaming opportunities.”  In a press release announcing the “Pathways to Success” redesign, CMS Administrator Seema Verma asserts that “after six … Continue Reading

Medicare Hospital Inpatient and Long-Term Care Hospital Payment Policies Finalized for FY 2019

The Centers for Medicare & Medicaid Services (CMS) has released its final rule updating the Medicare inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2019.  The following are highlights of the lengthy rule, which is scheduled to be published August 17, 2018. IPPS Payments to Rise … Continue Reading

FY 2019 Medicare Inpatient Rehabilitation Facility Payments to Rise by $105 Million under Final Rule

The Centers for Medicare & Medicaid Services (CMS) expects Medicare payments to inpatient rehabilitation facilities (IRFs) to increase by 1.3% ($105 million) in fiscal year (FY) 2019 under the final IRF prospective payment system (PPS) rule.  For FY 2019, the IRF PPS update factor is 1.35%, based on an IRF market basket update of 2.9%, … Continue Reading

PDPM Activated:  CMS Finalizes FY 2019 SNF Rule Largely as Proposed

The Centers for Medicare & Medicaid Services (CMS) has finalized its annual update to Medicare skilled nursing facility (SNF) PPS rates and policies for fiscal year (FY) 2019, without significant changes to the rule as proposed.  Most notably, CMS adopted the Patient-Driven Payment Model (PDPM) case mix classification system.  The PDPM, which will replace the existing … Continue Reading

Trump Administration Finalizes Rule Expanding Availability of Short-Term, Limited Duration Health Insurance

The Departments of Treasury, Labor, and Health and Human Services have issued a final rule that expands the availability of short-term, limited duration insurance policies that are exempt from Affordable Care Act (ACA) qualified health plan standards (e.g., the requirement to provide essential health benefits, prohibition on preexisting condition exclusions, lifetime and annual dollar limits, … Continue Reading

Medicare Hospice Payments to Increase by $340 Million under Final FY 2019 Rule

The Centers for Medicare & Medicaid Services (CMS) has finalized its FY 2019 update to Medicare hospice rates and policies.  As forecast in the May 8, 2018 proposed rule, CMS is increasing FY 2019 hospice rates by 1.8% ($340 million), based on a 2.9% inpatient hospital market basket update that is reduced by both a … Continue Reading

Medicare Inpatient Psychiatric Facility Rates for FY 2019 Finalized

CMS has published its final rule to update fiscal year (FY) 2019 rates and policies for Medicare inpatient psychiatric facility (IPF) services.  CMS estimates that the final rule will increase payments by a total of $50 million (1.1%) compared to FY 2018 levels.  The final rule provides for a 1.35% payment update for FY 2019, … Continue Reading

Citing “Significant Potential for Fraud, Waste, and Abuse,” CMS Extends HHA/Ambulance Enrollment Moratoria in Selected States

The Centers for Medicare & Medicaid Services (CMS) has determined that it should extend for an additional six months its current moratoria on the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollment of new home health agencies (HHAs) and Part B nonemergency ground ambulance suppliers in selected states.  Under the latest notice, the moratoria … Continue Reading

CMS Proposes CY 2019 Medicare OPPS, ASC Update, with Emphasis on Promoting Site-Neutrality

CMS has issued its proposed rule to update Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2019.  In addition to providing routine annual updates, the proposed rule includes several provisions intended to encourage “site-neutral payments” for different types of providers.  CMS also … Continue Reading

CMS Proposes CY 2019 Update to Medicare Physician Fee Schedule Rates, Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its proposed Medicare physician fee schedule (PFS) rule for calendar year (CY) 2019.  In addition to updating rates for physician services, the sweeping rule proposes changes to numerous other Medicare Part B policies.  Highlights of the proposed rule include the following: CMS proposes a 2019 … Continue Reading

OIG Moving Ahead on Changes to Anti-Kickback Safe Harbor Protection for Drug Rebates to Plans, PBMs

On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor … Continue Reading

CMS Proposes Medicare DMEPOS Rate Changes and Competitive Bidding Reforms

Agency Anticipates Temporary Lapse in Competitive Bidding Program after 2018 CMS is proposing a number of changes to Medicare durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) reimbursement policies for 2019, including fee schedule adjustments to account for a “temporary lapse” in the competitive bidding program (CBP). Consistent with the Administration’s stated goal of reducing regulatory … Continue Reading

CMS Proposes Updates to Medicare Home Health Payment Policies for 2019 and 2020

The Centers for Medicare & Medicaid Services (CMS) has proposed its annual update to Medicare home health prospective payment system (HHS PPS) rates for calendar year 2019, along with a broader case-mix methodology reform proposal that would be implemented beginning in 2020. With regard to the 2019 update, CMS proposes a 2.1% rate increase ($400 … Continue Reading

CMS Proposes $220 Million Boost in Medicare ESRD PPS Payments in 2019

The Centers for Medicare & Medicaid Services (CMS) has released its proposed rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2019.  CMS proposes to increase the ESRD PPS base rate from $232.37 in 2018 to $235.82 in 2019 as a result of a proposed 1.5% market basket … Continue Reading

CMS Proposes Tightening Medicaid Provider Reassignment Rules

The Centers for Medicare & Medicaid Services (CMS) is proposing to rescind the authority of states to make Medicaid payments to a third party on behalf of an individual provider, rather than directly to the provider, “for benefits such as health insurance, skills training, and other benefits customary for employees,” under certain circumstances.  This authority, … Continue Reading

HHS Exploring Ways to Promote Innovation, Investment in Healthcare Sector

The Department of Health and Human Services (HHS) is considering forming a workgroup aimed at facilitating “constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry.”  The goal of the initiative is to “spur investment, increase competition, accelerate innovation, and allow capital investment in the healthcare sector to … Continue Reading

CMS Finalizes CJR Extreme and Uncontrollable Circumstances Policy

CMS has finalized an “extreme and uncontrollable circumstances policy” for the Comprehensive Care for Joint Replacement (CJR) payment model.  Under this policy, which was prompted by severe hurricanes and wildfires, CMS will exercise flexibility in the determination of episode spending for CJR participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance … Continue Reading

HHS Delays 340B Ceiling Price/CMP Rule Implementation for Another Year — until July 1, 2019

The Health Resources and Services Administration (HRSA) is once again delaying the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). Specifically, under a final rule published June 5, 2018, HRSA is pushing back the 340B ceiling price/CMP rule’s effective date for an … Continue Reading

CMS Considering Home Health Claims Review Demonstration

CMS is considering implementing a Medicare home health claims review demonstration project intended to help identify, prevent, and prosecute Medicare fraud, waste, and abuse and reduce Medicare appeals. Under this initiative, CMS would offer home health agencies (HHAs) in the demonstration area the choice of demonstrating their compliance with Medicare home health policies through 100% … Continue Reading

CMS Adds 31 Power Mobility Device Codes to Nationwide Prior Authorization Program

CMS is adding 31 power mobility device Healthcare Common Procedure Coding System (HCPCS) codes to the list of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that require prior authorization as a condition of Medicare payment. All of the new codes are currently included in the Medicare Prior Authorization for Power Mobility Devices (PMDs) … Continue Reading

IRF PPS Payments Set to Increase by $75 Million in FY 2019 under Proposed CMS Rule

The Centers for Medicare & Medicaid Services (CMS) has published a proposed rule to update Medicare rates for inpatient rehabilitation facility (IRF) services for fiscal year (FY) 2019. CMS estimates that IRF prospective payment system (PPS) payments would increase by a total of $75 million under the proposed rule compared to FY 2018 levels. Specifically, CMS … Continue Reading
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