Archives: Regulatory Developments

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FDA & CMS Extend Medical Device Parallel Review Program

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program.  The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal … Continue Reading

October 16 Deadlines Quickly Approaching for the ACA’s Nondiscrimination Requirements: Are You Ready?

By October 16, 2016, all health programs and activities receiving federal financial assistance from the Department of Health and Human Services (HHS), those administered by HHS, and Health Insurance Marketplaces (Covered Entities), must be in compliance with the final pieces of the final rule issued by the Office for Civil Rights (OCR) issued May 18, … Continue Reading

CMS Corrects FY 2017 Medicare IPPS/LTCH Final Rule

CMS has corrected a series of technical and typographical errors in its final rule updating the Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) payments and policies for fiscal year (FY) 2017. Among other things, CMS is making changes to the budget neutrality factors, uncompensated care … Continue Reading

SAMHSA Final Rule on Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based medication-assisted treatment for opioid disorders under the Controlled Substances Act. As previously reported, SAMHSA published a rule on July 8, 2016 that expanded from 100 to 275 the … Continue Reading

NIH Finalizes New Drug and Device Clinical Trial Reporting Requirements

The National Institutes of Health (NIH) has finalized the requirements for submitting clinical trial information for applicable clinical trials of drug products (including biological products) and device products on The rule is intended to clarify as well as establish additional procedures and requirements for submitting: (i) registration, (ii) summary results, and (iii) adverse event … Continue Reading

CMS Finalizes Major Changes to Medicare/Medicaid Requirements for Long-Term Care Facilities

On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) released a highly-anticipated final rule to strengthen requirements that long-term care (LTC) facilities must meet to participate in the Medicare and Medicaid programs.  The sweeping rule – more than 700 pages – is intended to improve the safety, quality, and effectiveness of care … Continue Reading

HHS Proposes Changes to State Medicaid Fraud Control Unit Rules

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have proposed amendments to the regulations governing State Medicaid Fraud Control Units (MFCUs). The proposed rule would reflect statutory changes and policies adopted since the MFCU regulations were initially issued in 1978. Among other things, the rule would incorporate statutory … Continue Reading

CMS Announces Flexibility for Physician First-Year Participation in MACRA Quality Payment Program

In a recent blog post, CMS Acting Administrator Andy Slavitt announced CMS’s plans to give physicians more options for complying with significant upcoming changes to Medicare physician fee schedule (MPFS) rules – which will help physicians avoid triggering a negative payment adjustment in the first year of the program. As previously reported, the Medicare Access … Continue Reading

CMS Finalizes Emergency Preparedness Requirements for Medicare/Medicaid Providers

The Centers for Medicare & Medicaid Services (CMS) has released a long-awaited final rule establishing emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they can meet the needs of patients and residents during emergency situations, both natural and man-made. According to CMS, the final requirements “establish a comprehensive, consistent, flexible, … Continue Reading

CMS Proposes ACA Marketplace Benefit and Payment Parameters for 2018

CMS has proposed its annual Notice of Benefit and Payment Parameters, which would apply to participation in Affordable Care Act (ACA) Health Insurance Marketplaces for 2018. In particular, the rule proposes revisions to the risk adjustment methodology to address, among other things:   risk associated with enrollees who are not enrolled for a full 12 months; … Continue Reading

HHS Inflation Adjustment Rule Hikes CMPs Across Department Programs

The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (which was part of the Bipartisan Budget Act of 2015).  The magnitude of the individual CMP increases varies depending … Continue Reading

CMS Flags Potential Provider “Steering” of Medicare/Medicaid Beneficiaries to Favorable ACA Marketplace Plans to Obtain Higher Rates

CMS is putting health care providers on notice that it considers it “inappropriate” for providers to offer premium or cost-sharing assistance to Medicare or Medicaid beneficiaries in order to “steer” the patient to an individual market plan “for a provider’s financial gain.”  In a request for information to be published on August 23, 2016, CMS … Continue Reading

CMS Proposes Reforms to PACE Program

CMS is proposing numerous changes to the regulations governing the Programs of All-Inclusive Care for the Elderly (PACE) program, which is a Medicare/Medicaid managed care service delivery model designed to enable nursing home-eligible elderly individuals to remain in the community.  Notably, the rule would require each PACE organization (PO) to develop compliance oversight requirements and adopt … Continue Reading

CMS Proposes Clarification of Treatment of Third Party Payments in Calculating Uncompensated Care Costs under Medicaid DSH Payments Rules

CMS has proposed regulatory changes to specify that the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments is based on uncompensated care costs net of third-party payments received. Under the proposed rule – which is intended to align with CMS’s existing interpretation – a hospital’s uncompensated care costs would not include care provided to … Continue Reading

CMS Proposes Three New “Episode Payment Models” for Cardiac Care, Hip/Femur Fracture Cases, Plus Changes to CJR Model

The Centers for Medicare & Medicaid Services (CMS) has announced proposals for three new “episode payment models” that, like the Comprehensive Care for Joint Replacement (CJR) model, would mandate provider participation in selected geographic areas. The episodes included in these payment models would address care for heart attacks, coronary artery bypass graft, and surgical hip/femur … Continue Reading

CMS Finalizes FY 2017 Update to Medicare IPPS, LTCH PPS Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has released its final rule to update Medicare acute hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) payments and policies for fiscal year (FY) 2017.  With regard to the IPPS, CMS projects that the cumulative rate and policy changes in … Continue Reading

CMS Proposes New Rule in an Effort to Address Significant Medicare Appeals Backlog

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to address the significant backlog resulting from “an unprecedented and sustained increase” in its Medicare appeals. According to CMS, the Office of Medicare Hearings and Appeals (OMHA) had more than 750,000 pending appeals as of April 30, 2016, while it has only an adjudication capacity … Continue Reading

CMS Announces Changes to HHA/Ambulance Supplier Enrollment Moratoria, New Exception Process Demo

CMS has announced a number of changes to its temporary Medicare enrollment moratoria for certain provider types in select geographic areas as a mechanism to address fraud, waste, and abuse. First, CMS is extending for six months and expanding statewide its current moratoria on the enrollment of new Medicare Part B nonemergency ground ambulance suppliers … Continue Reading

CMS Finalizes Medicare IRF PPS Update for FY 2017

On August 5, 2016, CMS is publishing its final rule to update Medicare prospective payment system (PPS) rates for inpatient rehabilitation facilities (IRFs) for FY 2017, which begins October 1, 2016. CMS estimates that payments to IRFs will increase by 1.9% overall ($145 million) in FY 2017 compared to FY 2016 levels based on all … Continue Reading

CMS Issues Final Update to Medicare Hospice Payment Rules for FY 2017

CMS has released a final rule that updates the Medicare hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. CMS estimates that the final rule will increase overall Medicare payments to hospices by 2.1%, or $350 million, in FY 2017. This increase reflects a 2.7% market basket update, which will be … Continue Reading

CMS Adopts Final SNF PPS Rates and Policies for FY 2017

CMS has published its final rule to update Medicare skilled nursing facility (SNF) PPS rates and policies for FY 2017. CMS projects that the final rule will increase overall payments to SNFs by $920 million, or 2.4%, compared to FY 2016 levels (and compared to the $800 million/2.1% increase forecast in the proposed rule). The … Continue Reading

CMS Publishes FY 2017 Rate Update for Medicare Inpatient Psychiatric Facilities

On August 1, 2016, CMS published a notice updating prospective payment system (PPS) rates for Medicare services furnished by inpatient psychiatric facilities (IPFs) during fiscal year (FY) 2017. CMS is providing a 2.3% rate update for FY 2017, derived from a 2.8% IPF market basket update that is reduced by a 0.3 percentage point productivity … Continue Reading

CMS Unveils New Mandatory Medicare Bundled Payment Models for Cardiac & Hip Fracture Cases, Plus Proposed Refinements to CJR Program

On July 25, 2016, CMS announced ambitious, multi-pronged plans to expand mandatory Medicare coordinated care/bundled payment programs, promote the use of cardiac rehabilitation services, refine current Comprehensive Care for Joint Replacement Model (CJR) rules, and integrate bundled payment programs into the upcoming Medicare physician quality/payment framework. The proposed “Advancing Care Coordination through Episode Payment Model” … Continue Reading

CMS Proposes Medicare Physician Fee Schedule Update for 2017

The Centers for Medicare & Medicaid Services (CMS) has published its proposed rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2017. The proposed rule contains numerous Medicare payment and policy proposals, including consideration of potentially misvalued codes, revisions to diagnostic imaging policies, updates to Stark Law regulations, and new enrollment … Continue Reading