Archives: Regulatory Developments

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Out with the Old Rules? Will Trump and Republicans Target Health Care Regulations for Reversal in the New Year under Congressional Review Act?

The Congressional Review Act (CRA) has been used to overturn only one final rule in 20 years, but that situation may be about to change.  According to a new Congressional Research Service (CRS) analysis, a “specific set of circumstances” will occur when President-elect Trump is sworn in, namely, turnover in White House party control when … Continue Reading

CMS Proposes Restrictions on New Medicaid Managed Care Pass-Through Payments

CMS is proposing to prohibit states from adopting new or increased “pass-through” payments to hospitals, nursing facilities, and physicians under their Medicaid managed care contracts beyond those in place when the pass-through payment transition periods were established in a May 6, 2016 final Medicaid managed care rule. CMS considers pass-through payments to be amounts that … Continue Reading

CMS Publishes Final Rule Updating 2017 Medicare Physician Fee Schedule Rates and Policies

The Centers for Medicare & Medicaid Services (CMS) has issued its final Medicare physician fee schedule (MPFS) for calendar year (CY) 2017.  In addition to updating MPFS rates and policies, the final rule makes numerous other Medicare policy changes, including updates to Stark Law regulations related to unit-based compensation and new enrollment requirements for providers and … Continue Reading

CMS Finalizes Medicare OPPS, ASC Rates and Policies for 2017

CMS has published its final rule with comment period updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for CY 2017.  CMS will accept comments on a limited number of provisions until December 31, 2016. Major provisions impacting outpatient hospital department services include the … Continue Reading

Obama Administration Releases Regulatory Agenda – But Changes Expected Under Trump Administration

The Obama Administration has updated its regulatory agenda, listing the anticipated timing of pending and future regulatory actions, including a number of Department of Health and Human Services regulations. Note, however, that with the transition to the new Trump Administration, federal regulatory priorities can be expected to change.  Indeed, a new Administration often triggers a … Continue Reading

CMS Proposes Updated Fire Safety Standards for Dialysis Facilities

CMS has issued a proposed rule that would require certain dialysis facilities participating in Medicare or Medicaid to meet updated fire safety standards.  The proposed fire safety rule, published November 4, 2016, would apply only to dialysis facilities that do not provide one or more exits to the outside at grade level from the treatment … Continue Reading

FY 2018 Federal Financial Participation Matching Amounts Published

The Department of Health and Human Services (HHS) has published the FY 2018 Federal Medical Assistance Percentages (FMAP), Enhanced FMAP, and disaster-recovery FMAP adjustments.  These amounts will be used to determine federal matching amounts for state expenditures for Medicaid, the Children’s Health Insurance Program, and certain other medical and other social services, applicable from October … Continue Reading

CMS Delays Expanding Medicaid Rebate Program, Price Reporting Requirements to Territories Until 2020

CMS has announced that it is delaying until April 1, 2020 its controversial change in the definitions of “States” and “United States” included in the February 1, 2016 Medicaid covered outpatient drug final rule with comment period.  Specifically, in that rulemaking CMS defined “States” and “United States” to include the U.S. territories (American Samoa, the … Continue Reading

CMS Seeks Input on Ways to Accelerate Medicaid Home and Community-Based Services

CMS is requesting public input on policy options it can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries.  Note that while supporting increased availability of quality HCBS services has been a priority for the Obama Administration, it is unclear what priority future HHS and CMS leadership in the Trump … Continue Reading

CMS Finalizes Two-Track System to Implement MACRA Medicare Physician Payment Policy Changes

Temporary Transition Policies Reduce Threat of Negative Adjustments in 2019, But Adds to Complexity On November 4, 2016, the Centers for Medicare & Medicaid Services (CMS) is publishing a sweeping final rule reforming the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  Beginning … Continue Reading

Medicare Dialysis Payments to Increase by $80 Million in CY 2017

CMS has published its final rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) rates and policies for CY 2017. CMS expects the rule to increase overall Medicare payments to ESRD facilities by 0.73 percent in 2017 compared with CY 2016 levels, for an aggregate increase of $80 million. This update … Continue Reading

CMS Finalizes New Rules for Bidders in Medicare DMEPOS Competitive Bidding Program, Revises DMEPOS Fee Schedule Update Policies

CMS has adopted a number of changes to its Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) policies for 2017, including new competitive bidding program (CBP) requirements and revisions to the methodology for updating Medicare DMEPOS fee schedule amounts based on CBP pricing. With regard to the CBP, the final rule implements a Medicare … Continue Reading

Payments Fall 0.7 Percent for Medicare Home Health Services in CY 2017

Medicare home health prospective payment system (HH PPS) payments will be reduced by 0.7 percent, or $130 million overall, in calendar year 2017 compared to 2016 levels under the final rule to be published by CMS on November 3, 2016. In the final rule, CMS is adopting a 2.5 percent home health payment update percentage (derived from … Continue Reading

Medicaid DSH Allotments Announced

CMS recently finalized the federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2014 and announced preliminary federal share DSH allotments for FY 2016.  CMS also announced the corresponding limitations on aggregate state DSH payments to institutions for mental disease and other mental health facilities.… Continue Reading

ONC Revises Health IT Certification Program Requirements

The HHS Office of the National Coordinator for Health Information Technology (ONC) has adopted a final rule to enable the ONC to directly review certified health information technology (IT) to determine whether it conforms to the requirements of the ONC Health IT Certification Program (‘‘Program’’). Such ONC review would be independent of, and may be … Continue Reading

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 ClinicalTrials.gov. 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
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