Archives: Proposed Rule

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HHS Abandons Proposal to Reform Drug Manufacturer Rebate System

On Thursday, July 11, 2019, the White House administration reversed course on the Department of Health and Human Services’ (HHS) recent proposal to reform drug manufacturer rebate system. As we previously reported, HHS’s February 6, 2019 proposed rule sought to modify the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product … Continue Reading

HHS Proposes Changes to the Discount Safe Harbor Framework to Realign Incentives and Put Downward Pressure on Drug Prices

On February 6, 2019, the Department of Health and Human Services (HHS) published a Proposed Rule modifying the Anti-Kickback Statute safe harbor protection with the aim of lowering prescription pharmaceutical product prices and out-of-pocket costs for (primarily Medicare Part D and Medicaid Managed Care Plan) consumers. With the Proposed Rule, HHS hopes to encourage medication … Continue Reading

CMS Proposes to Lower Drug Prices and Reduce Out-of-Pocket Drug Spending with Respect to Medicare Coverage

On Friday, November 30, 2018, the US Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) to revise Medicare Part D (Part D) and Medicare Advantage (MA) regulations to promote health plan negotiation of lower drug prices and to reduce out-of-pocket spending for enrollees. The Proposed Rule contains four areas of … Continue Reading

CMS Proposes Invalidating Adjuster Methodology and Recouping Past Improper Payments From Medicare Advantage Organizations

On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that will, among others initiatives, allow CMS to recover higher dollar amounts of improper payments made to Medicare Advantage Organizations.  Improper payments are identified through Risk Adjustment Data Validation (“RADV”) audits, which are audits conducted to determine whether the … Continue Reading

Comment Dates Set For Federal Communications Commission Rulemaking On $400 Million Rural Health Care Program

The FCC’s Notice of Proposed Rulemaking (NPRM) to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP), has now been published in the Federal Register. Interested parties may submit initial comments on the FCC’s proposals by February … Continue Reading

FCC Focuses on Critical Role of $400 Million Rural Health Care Program

Noting that technology and telemedicine are assuming an increasingly critical role in healthcare delivery, the FCC has initiated a proceeding to consider changes to its Rural Health Care Program (RHCP), which provides $400 million in annual subsidies for telecommunications and broadband services to eligible rural healthcare providers (HCP). These changes would potentially affect existing as … Continue Reading

2018 Proposed Changes to the Physician Fee Schedule

On July 21, 2017, the Center for Medicare & Medicaid Services (CMS) published a proposed rule that addresses Part B Medicare payments and policies for calendar year (CY) 2018. The major proposed rule is one of several Medicare payment rules for CY 2018 reflecting a broader strategy to relieve regulatory burdens for providers; support the … Continue Reading

Ohio Expands Prescriptive Authority for Certain Advanced Practice Registered Nurses

On May 17, the Ohio Board of Nursing (the Board) adopted a new formulary which expands the prescriptive authority for certain of Ohio’s advanced practice registered nurses (APRNs). Specifically, this new “exclusionary” formulary applies to Ohio’s certified nurse practitioners, clinical nurse specialists and certified nurse midwives.  The new formulary was adopted pursuant to Ohio’s House … Continue Reading

Hospitals and CMS To Update Court About Two-Midnight Rule Challenge After Final Inpatient Rule Is Published in August

This is an update on the hospital lawsuit challenging CMS’s fiscal year 2014 “Two-Midnight” rule and the agency’s corresponding 0.2% reduction to inpatient prospective payment rates, in Shands Jacksonville Medical Center v. Burwell. As previously reported, the court ruled that CMS had violated mandatory notice and comment requirements regarding key information the agency had used … Continue Reading

CMS Issues Proposed Rule on MACRA Physician Payment Systems

The Centers for Medicare and Medicaid Services (CMS) recently released a proposed rule (the “Proposed Rule”) establishing two physician payment systems introduced by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).  These two systems, the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Models (APM), change the way Medicare incorporates quality metrics … Continue Reading

Two-Midnight Rule Update: CMS Proposes to Eliminate .2% Payment Reduction By Increasing FY 2017 IPPS Rates

Today, CMS submitted to the Federal Register (for publication on April 27th) its annual notice of proposed IPPS rates and policy changes for federal fiscal year (“FY”) 2017.  Today’s notice contains a proposal to eliminate permanently the .2% payment reduction that CMS had implemented in FY 2014 to offset a projected net increase in IPPS … Continue Reading

Ransomware Scandals Rock Hospital Systems; HHS’ Proposed Rule May Help

Hospital systems are on notice for ransomware attacking their health IT systems after three hospital systems are reported to be victims of computer viruses.   In response, one hospital system paid almost $17,000 in Bitcoin to retrieve their EHR, while the other two hospital systems worked off paper records and backup systems for a few days … Continue Reading

Healthcare Facilities Face New Rules for Disposing Pharmaceuticals

On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals rule outlining management and disposal standards for hazardous waste pharmaceuticals that are generated specifically by healthcare facilities. Additionally, this rule “clarif[ies] the regulation of the reverse distribution mechanism used by healthcare facilities for the management of … Continue Reading
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