Archives: Regulatory Developments

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HHS Proposes Updates to CLIA Proficiency Testing Rules

The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have proposed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing (PT) regulations to address the evolution in laboratory testing technology since the CLIA PT regulations were initially established in 1992.  The proposed rule would, … Continue Reading

OIG’s Proposed Drug Pricing Safe Harbor Amendments: “Hot Takes”

Late yesterday, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule to amend the anti-kickback safe harbors[1] in response to perceived risks that rebates paid by pharmaceutical manufacturers to payors and pharmacy benefit managers (PBMs) may contribute to pharmaceutical list price inflation and not benefit … Continue Reading

HHS Proposes Changes to HIPAA Transaction Standard for Prescriptions for Schedule II Drugs in Retail Pharmacy Transactions

The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.  HHS states that the change would enable covered entities to … Continue Reading

CMS Restructures Medicare Shared Savings Program to Encourage Transition to Performance-based Risk

The Centers for Medicare & Medicaid Services (CMS) has finalized a major restructuring of the Medicare Shared Savings Program, dubbed “Pathways to Success.”  According to CMS, the program changes “are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles.”  Most notably, CMS is … Continue Reading

CMS Seeks Input on Potential Conflicts of Interest Arising from Accrediting Organizations Offering Consulting Services to Providers they Survey

The Centers for Medicare & Medicaid Services (CMS) is requesting public comments on actual or perceived conflicts of interest that could arise when Medicare-approved accrediting organizations (AOs) also offer fee-based consulting services for Medicare-participating providers and suppliers.  Such services — which CMS points out are not currently prohibited by law or regulation — may include: … Continue Reading

HHS Proposes Rescinding Standard Unique Health Plan Identifier and Other Entity Identifier

The Department of Health and Human Services (HHS) is proposing to rescind the standard unique health plan identifier (HPID) and the other entity identifier (OEID), along with related implementation specifications and requirements for their use. HHS adopted the HPID and OEID in a September 5, 2012 final rule, but HHS announced a delay in enforcement … Continue Reading

OCR Seeks Feedback on HIPAA Rule Reforms to Reduce Burdens, Promote Value-Based Care

The Office for Civil Rights (OCR) is requesting public input on reforms to Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules to promote care coordination and the health system’s transformation to value-based health care while protecting the privacy and security of individuals’ protected health information (PHI).  Specifically, in a request for information … Continue Reading

It’s Official:  January 1, 2019 is Effective Date for HRSA 340B Ceiling Price/CMP Rule

The Health Resources and Services Administration (HRSA) has announced that it will implement its January 5, 2017 340B drug pricing program rule on January 1, 2019.  The oft-delayed final rule addresses:  (i) the calculation of the 340B “ceiling price” that may be charged to covered entities; (ii) the substantive standards applicable to civil monetary penalties … Continue Reading

Medicare ESRD PPS Payments to Rise by 1.6% in 2019

Medicare end-stage renal disease (ESRD) prospective payment system (PPS) payments are expected to increase by 1.6% — or about $210 million — in calendar year (CY) 2019 under the final rule published on November 14, 2018.  The Centers for Medicare & Medicaid Services (CMS) has adopted a CY 2019 ESRD PPS base rate of $235.27, … Continue Reading

Trump Administration International Pricing Index Plan for Medicare Part B Drugs:  Key Issues and Implications

The Trump Administration is considering a controversial plan, the International Pricing Index (IPI) model, which would tie Medicare Part B prescription drug payment rates to amounts paid for such drugs in other developed countries.  The Centers for Medicare and Medicaid Services’ proposed IPI model also would replace the current “buy and bill” system for Part … Continue Reading

Two-Year Break in Store for Medicare DMEPOS Competitive Bidding Program, But CMS Gears Up for 2021 Restart with Expanded Product Categories and New Rules

The Centers for Medicare & Medicaid Services has confirmed that it expects to have a “temporary gap” in the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program (CBP) during calendar years 2010-2020.  As a result, beginning January 1, 2019, Medicare beneficiaries may receive DMEPOS items from any Medicare-enrolled supplier until such time … Continue Reading

Medicare Home Health Payments to Rise by 2.2% in 2019, Broader Reforms Adopted for 2020

The Centers for Medicare & Medicaid Services’ (CMS) final calendar year 2019 Medicare home health prospective payment system (HH PPS) rule boosts rates by 2.2% next year and ushers in broader case-mix methodology reforms for 2020. With regard to the 2019 update, the final rule increases HH PPS rates by 2.2% ($420 million) compared with 2018 … Continue Reading

HRSA Changes Course on 340B Ceiling Price/CMP Rule Implementation, Proposes Accelerating Effective Date to January 1, 2019

After multiple implementation delays, the Health Resources and Services Administration (HRSA) now seeks to move up the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs).  By way of background, HRSA most recently delayed implementation of the 2017 rule because the Trump Administration was “developing … Continue Reading

Trump Administration Highlights Regulatory and Deregulatory Priorities for HHS

As part of the Trump Administration’s fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment to “reducing and streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes.”  One of the specific deregulatory initiatives noted is a future proposed rule to remove outdated Medicare and Medicaid … Continue Reading

CMS Proposes Tweaks to Medicare Appeals Rules to Reduce Administrative Burdens

The Centers for Medicare & Medicaid Services (CMS) has proposed revising its rules governing the process Medicare beneficiaries, providers, and suppliers use to appeal adverse determinations regarding claims for Medicare Part A and Part B benefits or determinations for Part D prescription drug coverage.  According to CMS, the revisions “would help streamline the appeals process … Continue Reading

FY 2020 IPPS New Technology Add-On Payment Applications to be Weighed at December 4, 2018 CMS Town Hall Meeting

The Centers for Medicare & Medicaid Services (CMS) is holding a Town Hall Meeting on December 4, 2018 to discuss fiscal year (FY) 2020 applications for add-on payments for new medical services and technologies under the Medicare inpatient prospective payment system (IPPS).  Interested parties will have an opportunity to present recommendations and data regarding whether … Continue Reading

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
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