Archives: Regulatory Developments

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OMB Reviewing OIG Proposed Rule Amending Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care.  The proposed rule presumably builds on the related request … Continue Reading

CMS Releases Draft Guidance for Hospitals on Shared Space and Contracted Services

The Centers for Medicare & Medicaid Services (CMS) released a draft guidance for state survey agencies on May 3, 2019, impacting hospitals that share space, staff, and/or services with another co-located hospital or health care entity. The draft builds on informally followed principles by CMS employees which emphasized that certain payment rules, like those for … Continue Reading

CMS Finalizes Plan to Streamline Medicare Appeals Rules

The Centers for Medicare & Medicaid Services (CMS) has issued a final rule streamlining the process for Medicare Parts A and B claims appeals and for Medicare Part D coverage determination appeals in order to “reduce associated burden on providers, beneficiaries, and appeals adjudicators.”  In particular, the final rule: Removes the requirement in Medicare Parts … Continue Reading

CMS Blocks States from “Diverting” Provider Medicaid Payments to Third Parties

The Centers for Medicare & Medicaid Services (CMS) is revoking the authority of states to “divert” certain Medicaid provider payments to a third party (rather than make the payment directly to the provider) to fund other costs on behalf of the provider “for benefits  such as health insurance, skills training, and other benefits customary for … Continue Reading

CMS Proposes FY 2020 Medicare IPPS/LTCH Update, Including Proposals to Promote Access to New Medical Device Technology

The Centers for Medicare & Medicaid Services (CMS) has released its proposed rule to update the Medicare acute inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) for fiscal year (FY) 2020.  Notably, the proposed rule includes a number of provisions that aim to “unleash medical innovation” by expediting access … Continue Reading

CMS Proposes $540 Million Increase in Medicare Hospice Payments in FY 2020; Agency Seeks Comments on Integrating Hospice Benefit in Coordinated Care Models

The Centers for Medicare & Medicaid Services (CMS) has proposed a 2.7% increase in Medicare hospice payment rates for fiscal year (FY) 2020, which the agency estimates would result in a $540 million increase in Medicare payments to hospices compared with 2019 levels.  The annual update would be reduced by 2 percentage points for hospices that … Continue Reading

CMS Expands DMEPOS Items Subject to Prior Authorization Due to “Unnecessary Utilization”

The Centers for Medicare & Medicaid Services (CMS) is expanding the types of durable medical equipment (DME), prosthetic, orthotics, supplies (DMEPOS) that are subject to Medicare prior authorization requirements on the basis of being “frequently subject to unnecessary utilization.”  Specifically, CMS announced that it is adding to the Required Prior Authorization List: Seven power wheelchair … Continue Reading

CMS Proposes $887 Million Boost in Medicare Payments to Skilled Nursing Facilities in FY 2020 While Floating Expanded Group Therapy Definition

The Centers for Medicare & Medicaid Services (CMS) recently released its 232-page proposed rule to update the Medicare skilled nursing facility (SNF) prospective payment system (PPS) for federal fiscal year (FY) 2020, which begins on October 1, 2019. Overall, CMS projects that SNF PPS payments would rise by $887 million under the proposed rule. Specifically, … Continue Reading

HHS Announces Extended Comment Period for Healthcare Interoperability Proposed Rules, Releases New HIPAA FAQs

Today the U.S. Department of Health and Human Services (HHS) announced that it would extend until June 3, 2019 the comment periods for the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) proposed interoperability and information blocking rules.  CMS also announced that as a result … Continue Reading

Medicare Inpatient Psychiatric Facility Payments Would Increase by $75 Million under FY 2020 Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) is proposing to increase Medicare inpatient psychiatric facility (IPF) payments by $75 million – a 1.7% boost – in fiscal year (FY) 2020.  Specifically, CMS proposes a net market basket update of 1.85%, reflecting a 3.1% market basket update reduced by two statutory reductions. CMS estimates that … Continue Reading

CMS Clarifies Regulatory Requirements for Line Extension Drug Medicaid Rebate Calculations

The Centers for Medicare & Medicaid Service (CMS) has issued regulations to address revised statutory requirements related to manufacturer calculation of Medicaid drug rebates.  Specifically, CMS recently published an interim final rule with comment period that revises the regulatory text at 42 CFR § 447.509(a)(4) to reflect Bipartisan Budget Act (BBA) of 2018 language revising … Continue Reading

CMS Proposes Federal Funding Methodology for ACA Basic Health Program for 2019-2020

CMS has published a proposed rule setting forth its methodology for determining federal payment amounts to states that elect to establish a Basic Health Program (BHP) under the Affordable Care Act (ACA).  Through the BHP, states may offer health benefits to low-income individuals otherwise eligible to purchase coverage through an Affordable Insurance Exchange/Marketplace.  CMS will accept comments … Continue Reading

Supreme Court poised to decide important agency-deference question

In litigation challenging the actions of any federal agency, the level of deference a court must show to the agency often dictates the outcome. This is especially true in cases challenging an agency’s interpretation of its own regulations. In practice, it is extremely difficult to convince a court to reject an agency’s regulatory interpretation. Earlier … Continue Reading

HHS Finalizes Updates to State Medicaid Fraud Control Unit Rules

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized changes to State Medicaid Fraud Control Unit (MFCU) regulations to reflect statutory changes and policies adopted since the MFCU rules were first issued in 1978.  Among other things, the regulations incorporate statutory policies that:  authorize a federal matching … Continue Reading

CMS Seeks Input on How to Promote the Sale of Individual Health Insurance Coverage Across State Lines

The Centers for Medicare & Medicaid Services (CMS) has requested public comments on ways to remove barriers to the sale of health insurance coverage across state lines in order to expand consumer choice.  In particular, CMS is interested in how states can utilize Section 1333 of the Affordable Care Act (ACA), which authorizes two or … Continue Reading

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
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