Archives: Regulatory Developments

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CMS Announces Extension of Moratoria on Enrollment of HHAs, Ambulance Suppliers in Designated Areas

CMS published a notice February 2, 2016 announcing an additional 6-month extension of its current temporary Medicare enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs), subunits, and branch locations in designated metropolitan areas.  The moratoria, which also apply to enrollment in Medicaid and the Children’s Health Insurance Program, apply to: New … Continue Reading

CMS Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings

On January 22, 2016, CMS published a rule providing additional explanation of certain methodological choices CMS made in establishing the fiscal year 2004 Medicare Inpatient Prospective Payment System fixed-loss threshold determination, in accordance with court rulings in cases that challenge this methodology.… Continue Reading

CMS Releases Long-Awaited Final Medicaid Covered Outpatient Drug Rule

After months of speculation and waiting, CMS yesterday released its final rule to revise Medicaid reimbursement for covered outpatient drugs and reform Medicaid drug rebate requirements.  While we are still digesting what the rule means for drug manufacturers and other health care providers, we promise a full analysis of the final rule, as well as … Continue Reading

HHS Finalizes HIPAA Amendments to Allow Reporting of Certain Mental Health Information to the National Instant Criminal Background Check System

On January 6, 2016, HHS published a final rule to modify the HIPAA Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving … Continue Reading

CMS Finalizes New Medicare Prior Authorization Rules for DMEPOS Subject to “Unnecessary Utilization,” But Policy Questions Remain

The Centers for Medicare & Medicaid Services (CMS) has issued a final rule to require Medicare prior authorization (PA) for certain durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) items that the agency characterizes as “frequently subject to unnecessary utilization.” Notably, however, key policy decisions — including the items that will initially be subject … Continue Reading

Medicare Launches Its First Mandatory Bundled Payment Model for Joint Replacement Care – What You Need to Know to Get Ready

As previously reported, CMS has published its final rule to establish a Medicare Comprehensive Care for Joint Replacement (CJR) model that establishes a bundled payment framework for acute care hospitals for lower extremity joint replacement surgery (LEJR) episodes of care in selected geographic areas. The CJR initiative is particularly significant given that it is the … Continue Reading

ONC Corrects EHR Certification Criteria Final Rule

The HHS Office of the National Coordinator for Health Information Technology (ONC) has published a notice correcting errors and clarifying provisions of its October 16, 2015 rule that finalized the 2015 edition health information technology certification criteria and a new 2015 Edition Base Electronic Health Record (EHR) definition.… Continue Reading

HHS, Treasury Issue Guidance on ACA State Innovation Waivers

The Departments of Health and Human Services (HHS) and Treasury have issued joint guidance on Affordable Care Act (ACA) “Section 1332” waivers, through which states can apply to implement alternative mechanisms to provide access to health care for their residents if certain conditions are met.  Under the ACA, Section 1332 waivers can only be approved … Continue Reading

CMS Invites Comments on 2014 Medicare IPPS Rate Cut Due to 2-Midnight Policy Changes

CMS has published a notice with comment period describing its rationale for reducing Medicare inpatient prospective payment systems (IPPS) rates by 0.2% in FY 2014 to offset a projected $220 million increase in IPPS spending as a result of adoption of CMS’s “2-midnight” admission policy. The December 1, 2015 notice was issued in response to … Continue Reading

CMS Issues Final Rule on Enhanced Funding for Certain Medicaid Eligibility & Enrollment Systems

On December 4, 2015, CMS published a final rule that extends enhanced federal funding for the design, development, installation, or enhancement of Medicaid eligibility and enrollment systems. The rule also updates standards for Medicaid Management Information Systems (MMIS). According to CMS, the final rules will help states automate the application and renewal process, improve the … Continue Reading

2016 Medicare, Medicaid, CHIP Provider Enrollment Application Fee Announced

CMS has announced that the CY 2016 provider enrollment application fee is $554, up slightly from $553 in 2015. This application fee is required for institutional providers that are initially enrolling or revalidating enrollment in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP) or adding a new Medicare practice location on … Continue Reading

HHS Posts Fall 2015 Regulatory Agenda Listing Rules in Pipeline

The Obama Administration has released its latest regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda includes numerous pending HHS proposed and final rules affecting a wide range of policy areas, including Medicare payment rules, fraud and abuse authorities, the 340B drug pricing program, and … Continue Reading

Obama Administration Proposes 2017 ACA Marketplace Plan Benefit and Payment Parameters

On December 2, 2015, CMS is publishing its annual proposed Notice of Benefit and Payment Parameters, which would govern participation in the Affordable Care Act (ACA) Health Insurance Marketplaces for 2017. The wide-ranging rule includes a number of provisions intended to protect consumers enrolled in Marketplace plans, enhance transparency, improve marketplace premium stabilization programs, and … Continue Reading

Obama Administration Updates Rules for ACA Grandfathered Health Plans

On November 18, 2015, the Obama Administration published final regulations to update requirements for group health plans and health insurance issuers under the ACA, particularly with regard to the changes they can make to the terms of their plan/coverage while retaining their “grandfathered” status. The regulations also address preexisting condition exclusions, lifetime and annual dollar … Continue Reading

CMS Finalizes “Comprehensive Care for Joint Replacement” Model

On November 16, 2015, CMS released its final rule to establish a Medicare Comprehensive Care for Joint Replacement (CJR) model that will test whether bundled payments to acute care hospitals for lower extremity joint replacement surgery (LEJR) episodes of care will reduce Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. … Continue Reading

CMS Finalizes Medicare Physician Fee Schedule Rates, Policies for 2016

Today the Centers for Medicare & Medicaid Services (CMS) published the final rule to update the Medicare physician fee schedule (MPFS) for calendar year (CY) 2016. Despite the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) establishing a 0.5% conversion factor (CF) update for 2016, the final 2016 CF of $35.8279 actually is a decrease … Continue Reading

CMS Publishes Final Rule on Medicaid Fee-For-Service Ratesetting for Assuring Access to Covered Medicaid Services

On November 2, 2015, CMS published a final rule with comment period that is intended to provide a transparent, data-driven process for states to follow when they set Medicaid provider payment rates, effective January 4, 2016. Under the Social Security Act, state plans must ensure that payment rates for Medicaid services “are consistent with efficiency, … Continue Reading

CY 2016 Medicare OPPS Spending to Drop by 0.4% under Final OPPS Rule; ASC Payments Get Small Boost

On November 13, 2015, the Centers for Medicare & Medicaid Services (CMS) is publishing its final rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2016. CMS estimates that total federal expenditures under the OPPS will drop by $133 … Continue Reading

Medicare Home Health PPS Payments to Fall by $260 Million in 2016

CMS published its final CY 2016 Medicare Home Health Prospective Payment System (PPS) rule on November 5, 2015.  CMS projects that overall Medicare payments to home health agencies (HHAs) will be reduced by 1.4% — or $260 million – in CY 2016 compared to 2015 levels as a result of the policies finalized in the … Continue Reading

Final ESRD PPS Rule to Boost Overall Medicare Payment by $10 Million in CY 2016

On November 6, 2015, CMS published its final rule to update the Medicare end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2016. CMS estimates that the rule will increase overall Medicare payments to ESRD facilities by $10 million (0.2%) compared to CY 2015 payments, although the final CY 2016 ESRD PPS … Continue Reading

CMS Publishes Proposed Rule on Hospital/HHA Discharge Planning Requirements

Today the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would modify the discharge planning conditions of participation (COPs) for hospitals, including long-term care hospitals and inpatient rehabilitation facilities, critical access hospitals, and home health agencies (HHAs). The proposed rule would implement the discharge planning requirements of the Improving Medicare Post-Acute … Continue Reading
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