Archives: Regulatory Compliance

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Summary of FDA Statement on Laboratory Developed Tests Issued January 13, 2017

On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT) synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs.  FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience … Continue Reading

FDA Issues Guidance for Classification Pathways for New Accessory Types

Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law … Continue Reading

EU Agrees on New Medical Device and IVD Regulation

An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices. The regulations seek to fill the regulatory gaps uncovered as technology evolved faster … Continue Reading

FDA Working to Modernize Medical Device Reporting in Hospitals

Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals.  FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading

BREAKING: Deal Reached on New EU Medical Device and IVD Regulations

On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations.  The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … 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

FDA Considers Regulating Refurbishers and Other Third Parties

The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading

FDA Announces Commitment to MDSAP

The FDA announced on December 17 that it would participate in the operational phase of the Medical Device Single Audit Program (MDSAP), starting January 1, 2017.  The FDA currently participates in the ongoing MDSAP pilot program, scheduled to run until the end of 2016. The MDSAP program was created by the International Medical Device Regulators … Continue Reading

The Out-of-State Practice of Telemedicine: Licensure Challenges and Opportunities

Telemedicine, Follow-Up Care and State Licensure: The Problem Illustrated As the delivery of healthcare services adapts to the digital age, providers, payers and patients are gradually exploring telemedicine’s possibilities. Evidence that delivering certain routine services via telemedicine may increase patient access to care and decrease cost without sacrificing quality has only served to accelerate this … Continue Reading

OIG Puts Muscle Behind Its Alert

Only two days after releasing its latest fraud alert, a deputy director from HHS’s Office of Inspector General announced that the OIG will be hiring additional attorneys to look into taking more administrative actions against physicians in their individual capacity. This announcement emphasizes that the OIG means serious business – not only is the OIG … Continue Reading

Release of the 2015 OIG Work Plan

Happy Halloween!  In addition to costumes and candy, October 31 saw the release of the 2015 Work Plan by the Office of Inspector General for Health and Human Services.  Always a lengthy document, the Work Plan can indicate areas that providers and suppliers want to monitor closely, as they are areas receiving attention from the government.  In … Continue Reading

Hardship Exception Applications to Avoid the 2015 Medicare Payment Adjustment Due November 30, 2014

Last week, CMS announced that it intends to reopen the submission period for hardship exception applications for eligible professionals and eligible hospitals to avoid the 2015 Medicare payment adjustments for not demonstrating meaningful use of Certified Electronic Health Record Technology (CEHRT).  This reopening process will be addressed through future rulemaking.  Previously, the hardship exception application … Continue Reading

FBI Warns of “Spear Phishing” for Your Data and Ideas

The widely reported data breach at Community Health Systems, Inc. (CHS) appears to have relied upon a “spear phish email” to launch the initial malware, according to a recent alert from the FBI. Experts engaged by CHS believe that the attacker is an “Advanced Persistent Threat.” The FBI alert provides tips for organizations to prevent … Continue Reading

Best Practice on Data Privacy

 Most organizations would agree that data privacy must be treated as a priority issue, not least because of the financial and reputational consequences of a data breach.  Squire Patton Boggs has a global team of specialists advising clients on local and global data issues. Two members of our team, Tom Zeno and Lindsay Holmes have written a two … Continue Reading

CMS Issues Medicare and Medicaid Final Rule: Significant Changes to Conditions of Participation

On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations.  The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”)  include significant easing of Conditions of … Continue Reading

Is CMS Prepared for Evolving Medical Records Technology?

Health care fraud accounts for billions of the US health expenditure each year. This week HHS published a study addressing possible deficiencies in CMS’ capability to address fraud vulnerabilities and ensure the integrity of electronic health records (“EHR”) systems which CMS and its contractors use to pay Medicare claims. Concerns about whether CMS’ oversight and … Continue Reading

CMS Ushers in the New Year with Medicare Part C and Part D Proposed Rules: HHS Hopes to Save $1.3 Billion

On January 10, 2014, CMS will publish the proposed rule titled Medicare Program: Contract Year 2015 and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (the “Proposed Rule”).  The Proposed Rule propositions extensive reforms to the Medicare Advantage (“Part C”) and Medicare Prescription Drug Benefit Program (“Part D”), partly through … Continue Reading

CMS and OIG Ring in the New Year with Final Rules on EHR Donations

On December 27, 2013, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General of the Department of Health and Human Services (“OIG”) published final rules (“Final Rules”) regarding the electronic health records (“EHR”) donations Stark Law Exception (42 C.F.R. 411.357(w)) and Anti-Kickback Statute Safe Harbor (“AKS Safe Harbor”) (42 C.F.R. … Continue Reading

Facing the Medical Device Tax Head On: Strategic Contracting for Hospital Cost-Reduction

With approximately two months having passed since the end of the government shutdown, the fundamental question still remains; what exactly did Congress achieve through the contentious shutdown negotiations?  The shutdown was spurred in part by certain Congressional Members’  opposition to the funding and implementation  of the Affordable Care Act (“ACA”).  A centerpiece of these oppositional … Continue Reading

Data Security: Pay IT Now or Pay Out Later

The price of compliance may be high, but the price of non-compliance is even higher. Based on its recent $3 million data breach settlement, AvMed, and many other entities that have experienced data breach litigation, would likely agree that paying for security upgrades now, is far superior to paying for data breaches later. In 2009, … Continue Reading

Non-Medicare Patients Only? Not Necessarily an Excuse. New OIG Opinion Shows Government Skepticism of “Carve-Out” Arrangements

Yesterday, the U.S. Dept. of Health and Human Services Office of Inspector General (“OIG”) clarified its stance on a growing practice – provider attempts to circumvent fraud and abuse laws by structuring financial arrangements to apply only to business concerning non-Federal program beneficiaries.  The OIG reiterated its dim view of this practice, citing an underlying … Continue Reading

Certification for Electronic Health Record Products Revoked

Following the revocation of two previously certified electronic health record products to be used as part of the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, Farzad Mostashari, M.D., the national coordinator for health information technology, announced that the products do not meet standards and providers cannot use these products to meet the requirements … Continue Reading

Is CMS Having Second Thoughts About Preferred Pharmacy Networks?

In January of 2005, the Centers for Medicare and Medicaid Services (“CMS”) finalized its regulation permitting Medicare Part D plans to establish networks of “preferred” and “non-preferred pharmacies,” meaning that the plans may offer lower cost-sharing to enrolled Medicare beneficiaries who receive items or services from a preferred pharmacy.  70 Fed. Reg. 4194 (Jan. 28, … Continue Reading

Sixth Circuit Overturns $11.1 Million Judgment Against MedQuest for FCA Violations

On April 1, 2013, the United States Court of Appeals for the Sixth Circuit overturned the $11.1 million judgment against MedQuest for its submission of claims to Medicare for tests in diagnostic testing facilities that were not supervised by approved physicians.  The whistleblower action was initiated by a former MedQuest employee, alleging that MedQuest, a … Continue Reading
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