Archives: Regulatory Developments

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HRSA Delays Final 340B Penalty Rule until July 1, 2018; Additional Rulemaking in the Works

The Health Resources and Services Administration (HRSA) has adopted its proposal to delay the effective date of its final rule revising the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties.  As previously reported, while implementation of the January 5, 2017 rule was already delayed until … Continue Reading

Trump Administration Shelves Additional Obama Medicare/Health Plan Proposals

The Trump Administration has formally withdrawn a number of pending Department of Health and Human Services (HHS) proposals that never reached the final rule stage. This includes:  a controversial Part Medicare B drug payment innovation model; a proposal to protect same sex marriages in certain Medicare and Medicaid facilities (predating a related Supreme Court decision); … Continue Reading

CMS Corrects Final FY 2018 IPPS, LTCH, and SNF Payment Rules

CMS has released corrections to two major fiscal year (FY) 2018 Medicare payment rules. First, CMS has made numerous technical corrections to the FY 2018 inpatient prospective payment systems (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) final rule. CMS has corrected MS-DRG and MS-LTCH-DRG relative weights, budget neutrality adjustment factors, fixed-loss … Continue Reading

CMS Announces CY 2018 Amount in Controversy Thresholds for Medicare Appeals

CMS has released the calendar year (CY) 2018 amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The CY 2018 AIC threshold amounts are $160 for ALJ hearings (the same as 2017) and $1,600 for judicial review (compared to $1,560 in 2017).  These amounts … Continue Reading

Recently Released Enhanced Regulatory Initiatives for Drug Compounders

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have compounded; (2) publishing a guide entitled “Outsourcing Facility Information,” which is a compilation of key … Continue Reading

CMS Corrects Sunshine Act CMP Regulations due to Inflation Adjustment Error

CMS has just corrected an error in a 2016 rulemaking that inadvertently called for a 10-fold increase in certain “Sunshine Act” civil monetary penalties (CMPs). Under section 1128G of the Social Security Act, applicable manufacturers must report annually to CMS any payments or other transfers of value to covered recipients. In addition, the statute requires … Continue Reading

HRSA Proposes Delaying 340B Drug Pricing Program Reforms until July 1, 2018

The Trump Administration is proposing to once again push back the effective date of a January 2017 final rule making changes to the calculation of the 340B “ceiling price” that may be charged to covered entities and related civil money penalties. As previously reported, while implementation of this rule has already been delayed until October … Continue Reading

CMS Issues Final FY 2018 Medicare Hospice Payment Update

CMS has finalized fiscal year (FY) 2018 Medicare hospice reimbursement rates and other updates to Medicare hospice policies. As mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), CMS is increasing FY 2018 hospice rates by 1% (approximately $180 million) for those hospices that submit required quality data; this update is reduced … Continue Reading

CMS Proposes Cancellation of Medicare Cardiac/Hip Fracture Episode Payment Models, Scale-Back of Mandatory CJR Participation

Signals Trump Administration’s About-Face on Obama-Era Mandatory Innovation Models The Centers for Medicare & Medicaid Services (CMS) has just released a proposed rule to cancel a significant — but still-pending — Obama Administration program that would require certain hospitals to participate in Medicare episode payment models (EPMs) for acute myocardial infarction (AMI), coronary artery bypass … Continue Reading

CMS Boosts Medicare Inpatient Psychiatric Facility Rates by $45 Million for FY 2018

CMS has published a notice with comment period updating prospective payment system (PPS) rates for Medicare services furnished by inpatient psychiatric facilities (IPFs) during fiscal year (FY) 2018.  CMS estimates that its policies will increase payments by $45 million (0.99%) compared to FY 2017 levels.  This increase is based on 1.25% payment rate update, offset … Continue Reading

CMS Again Extends HHA/Ambulance Enrollment Moratoria in Selected States to “Prevent and Combat Fraud, Waste, and Abuse”

The Centers for Medicare & Medicaid Services (CMS) has once again extended for six months its “temporary” moratoria on the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) enrollment of new nonemergency ground ambulance suppliers and home health agencies (HHAs) in selected states, effective July 29, 2017. The moratoria on new HHA enrollment (including new … Continue Reading

CMS Finalizes 1% Update to Medicare IRF Rates for FY 2018; Payments to Rise by $75 Million

CMS has finalized Medicare prospective payment system (PPS) rates for inpatient rehabilitation facility (IRF) services for fiscal year (FY) 2018, which begins October 1, 2017. CMS estimates that IRF PPS payments will increase by 0.9% overall ($75 million) under the final rule compared to FY 2017 levels.  As mandated by the  Medicare Access and CHIP … Continue Reading

CMS Issues Final FY 2018 SNF PPS Update; Rates to Increase by 1%

CMS has released its final rule to update Medicare skilled nursing facility (SNF) prospective payment system (PPS) rates and policies for FY 2018, which begins October 1, 2017. The final rule incorporates a 1% increase to SNF PPS rates as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); in the absence … Continue Reading

CMS Proposes Methodology to Implement Statutory Medicaid DSH Reductions

CMS has issued a proposed rule establishing a methodology to reduce state Medicaid disproportionate share hospital (DSH) allotments annually beginning with fiscal year (FY) 2018, as mandated by the Affordable Care Act (and modified in subsequent legislation). CMS estimates that the rule would reduce state DSH allotments/payments by $43 billion for the period of FY … Continue Reading

CMS Proposes $80 Million Cut in Home Health PPS Payments for 2018, Additional Significant Reforms for 2019

CMS is proposing to cut CY 2018 Medicare home health prospective payment system (HH PPS) payments by 0.4% — or $80 million overall — compared to 2017 rates under a proposed rule published on July 28, 2017. Furthermore, the agency plans major revisions to the HH PPS case-mix methodology for 2019 that potentially could cut payments … Continue Reading

CMS Proposes Medicare Physician Fee Schedule Update for 2018

Rule Would Delay Appropriate Use Criteria Requirement until 2019, Cut Rates for Off-Campus Hospital Departments The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (PFS) for calendar year (CY) 2018. The proposed rule addresses numerous Medicare policies, including:  implementation of appropriate use criteria (AUC) … Continue Reading

CMS Proposes Medicare OPPS, ASC Update for CY 2018

CMS has published 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) 2018. In addition to proposing rate updates for the two payment systems, CMS solicits comments on a wide range of topics, including, among others:  deep OPPS … Continue Reading

CMS Issues Corrections to Medicare/Medicaid LTC Conditions of Participation

CMS has made numerous technical and typographical corrections to its October 4, 2016 final rule revising the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. CMS notes that the corrections are consistent with the policy discussion in the final rule and do not result in substantive policy changes. … Continue Reading

CMS Delays Deadline for HHA Conditions of Participation Compliance

CMS is delaying the effective date of its January 13, 2017 final home health agency (HHA) conditions of participation (CoP) rule for six months, until January 13, 2018. While CMS is not making any other substantive changes to the rule’s requirements., the agency is making two other conforming date changes:  (1) CMS is giving HHAs … Continue Reading

CMS Proposes Changes to for Second Year of Medicare Physician Quality Payment Program

CMS has proposed new regulations to continue implementing the “Quality Payment Program” (QPP) — the new Medicare physician fee schedule (MPFS) update framework mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). As previously reported, starting in 2017, physicians will be paid under the Merit-based Incentive Payment System (MIPS) or the Advanced … Continue Reading

CMS Proposes Update to Medicare ESRD PPS Payments for 2018

The Centers for Medicare & Medicaid Services (CMS) has published a proposed rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018. CMS anticipates that the proposed rule would increase total Medicare payments to ESRD facilities by 0.8% in 2018, with hospital-based ESRD facilities having an estimated … Continue Reading

CMS Reverses Course in Pre-Dispute Arbitration Agreement Ban

In a clear turnabout from its previous position, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on June 5, 2017 that would lift the agency’s ban on pre-dispute arbitration agreements in the long term care (LTC) setting. By contrast, less than nine months earlier, CMS prohibited LTC facilities from entering into … Continue Reading

CMS Extends Comment Period on SNF Case Mix Methodology ANPRM

CMS is extending the comment period on its May 4, 2017 advance notice of proposed rulemaking (ANPRM) discussing plans to revise the basis for the Medicare skilled nursing facility (SNF) prospective payment system (PPS).  As previously reported, the ANPRM set forth the outline of CMS’s plan to replace the current RUG-IV case-mix classification methodology with … Continue Reading

As ACA Repeal/Replace Debate Drags On, Trump Seeks Advice on How to Make Improvements to Health Care Markets

In a tacit acknowledgement of the hurdles ahead for enactment of Affordable Care Act (ACA) repeal/replace legislation, the Trump Administration is soliciting suggestion for changes that could be made within the current legal framework to improve health insurance markets and meet Administration reform goals. In particular, the Department of Health and Human Services (HHS) is … Continue Reading
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