Search Results for: Final Rule

CMS’ Web Portal: Final Rule 21 CFR § 411.39 Promises Quick and Efficient Conditional Payment Resolution for Those Able to Abide by Its Strict Guidelines

The Centers for Medicare & Medicaid Services (CMS) has published its long-awaited final rule entitled “Medicare Program: Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal.” From the outset of litigation, a plaintiff who is a Medicare beneficiary (or his or her attorney) must report a pending claim to CMS.  This allows Medicare … Continue Reading

CMS Corrects Medicare Physician Fee Schedule, Electronic Health Record Incentive Program Final Rules

CMS has published corrections to its November 16, 2015 Medicare physician fee schedule final rule with comment period for 2016, applicable beginning January 1, 2016. Among other things, CMS is correcting an omission of language restating the Consumer Assessment of Healthcare Providers and Systems (CAHPS) requirements that apply to groups of 100 or more eligible … Continue Reading

CMS Eases 60-Day Overpayment Requirement in Final Rule While Raising New Questions

The Centers for Medicare & Medicaid Services (“CMS”) released today the long awaited final rule clarifying the statutory requirement under the Affordable Care Act for providers and suppliers to report and return Medicare overpayments within 60 days (the “Overpayment Final Rule”).  The Rule only applies to Medicare Part A and Part B providers and suppliers … 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

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

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

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). … Continue Reading

Final Rule Implements HIV Organ Policy Equity Act

On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs from … Continue Reading

CMS Publishes Corrections to 2015 Medicare Physician Fee Schedule Final Rule

CMS has published corrections to its final 2015 Medicare physician fee schedule rule. Among other things, the rule reflects a previously-announced correction to the conversion factor for the first quarter of 2015 ($35.7547), revises the April 1 – December 31, 2015 conversion factor to $28.1872 (assuming that Congress does not take action to avert this … Continue Reading

CMS Corrects 2015 Medicare OPPS/ASC Final Rule, Impacts Rates

Today CMS published a notice correcting its November 10, 2014 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 2015. In addition to fixing various technical errors (e.g., status indicator and addenda corrections for specific codes), the notice increases the OPPS … Continue Reading

ONC Final Rule on EHR Certification Criteria

The Office of the National Coordinator for Health Information Technology (ONC) published a final rule on September 11, 2014 that is intended to introduce regulatory flexibilities with regard to certification to the 2014 Edition Electronic Health Records (EHR) Certification Criteria. The rule also codifies certain revisions to the ONC Health Information Technology (HIT) Certification Program … Continue Reading

DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, … Continue Reading

CMS Final Rule Revises EHR Meaningful Use Timeline

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have issued a final rule that gives providers additional options in how they use certified electronic health record (EHR) technology (CEHRT) to meet meaningful use requirements for the 2014 EHR Incentive Program reporting period. Under the … Continue Reading

CMS Issues FY 2015 Medicare SNF PPS Final Rule

The Centers for Medicare & Medicaid Services (CMS) published the final FY 2015 Medicare skilled nursing facility (SNF) prospective payment system (PPS) rule on August 5, 2014 (Final Rule). The Final Rule largely adopts the proposals set forth in the FY 2015 proposed SNF PPS rule (Proposed Rule). CMS estimates that the Final Rule will result in a … Continue Reading

CMS Adopts Final Rule to Reduce Provider Regulatory Burdens

On May 12, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that reforms federal health policy regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. The rule also is intended to eliminate or reduce requirements that impede quality patient care or that … Continue Reading

Final Rules Issued Extending Protections of Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the “sunset” provisions).… Continue Reading

CMS Final Rule Refines FY 2014 DSH Payment Calculations

On October 3, 2013, CMS published an interim final rule with comment period revising disproportionate share hospital (DSH) payment calculations. By way of background, in the FY 2014 inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment (PPS) final rule, CMS established a methodology for determining the amount of uncompensated care payments … Continue Reading

CMS Releases ACA Medicaid DSH Funding Final Rule

CMS has put on display a final rule that implements reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments mandated by the ACA. The final rule sets forth the methodology to implement the annual reductions for fiscal years (FYs) 2014 and 2015, and it establishes additional DSH reporting requirements for use in implementing the DSH … Continue Reading

OIG Final Rule on Data Mining by State Medicaid Fraud Control Units

On May 17, 2013, the HHS Office of Inspector General (OIG) published a final rule amending current regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using federal matching funds to identify fraud through screening and analyzing State Medicaid data (known as data mining). In order to “support and modernize MFCU efforts to effectively pursue … Continue Reading

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