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New OIG Studies Reveal Clinical Lab Test Payment Trends and CMS’ Progress in Implementing PAMA

Last week, the OIG released two new studies analyzing what and how Medicare pays for clinical laboratory tests (“lab tests”). The first study, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of...more

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...more

CMS Posts PAMA Clinical Lab Fee Schedule Data Reporting Template and User Guide

In order to assist the clinical laboratory community in meeting new Medicare reporting requirements under the Protecting Access to Medicare Act of 2014 (PAMA), CMS has posted a Clinical Laboratory Fee Schedule Data Reporting...more

Game-Changing PAMA Rule Sets off Major Payment Shifts for Lab Tests

The Centers for Medicare & Medicaid Services (CMS) recently published a major final rule that will base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts, as required by the...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more

After a Strong Enforcement Presence in 2015, OCR Starts 2016 with a $239,000 Civil Money Penalty Judgment

It has been a busy winter for the US Department of Health and Human Service, Office for Civil Rights (“OCR”). Since November 2015, the agency has announced three settlements and one civil money penalty judgment amounting to...more

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

On November 24, 2015, the Centers for Medicare & Medicaid Services (CMS) published a significant final rule that will require hospitals in selected geographic areas to participate in a new Medicare Comprehensive Care for...more

12/18/2015  /  BPCI , Bundled Payments , CCJR , CMS , Hospitals , Medicare

Cure of Security Rule Violations Following Breach of EPHI Cannot Save Covered Entities from $750,000 Settlement; Non-Breach...

More than three years after the Cancer Care Group, P.C. (“CCG”) notified the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) of a breach of unsecured electronic protected health...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY)...more

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...more

OCR Announces Settlement and Corrective Action Plan with Pharmacy Stemming from Alleged Violations

On April 24, 2015, the HHS Office for Civil Rights (“OCR”) once again stressed the importance of properly disposing of protected health information (“PHI”) when it announced its settlement and corrective action plan with...more

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...more

Amidst Increasing Security Concerns, Medicare to Drop Social Security Numbers from Cards

In an effort to combat growing concerns of identity left, President Obama signed into law last week a bill that will require the removal of Social Security Numbers (SSNs) from all Medicare beneficiary cards. The change, which...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (3rd Edition)

In this edition: - Introduction - Advertising & Marketing - Brand Protection & Reputational Management - Copyright (EU) - Copyright (U.S.) - Data Privacy & Security -...more

The HITECH Final Rule: The New Privacy/Security Rules of the Road Have Finally Arrived

Since the 2009 enactment of the Health Information Technology for Economic and Clinical Health Act (the “Act” or “HITECH Act”), compliance efforts associated with the Health Insurance Portability and Accountability Act of...more

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