C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

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Addressing Health Privacy and Security Gaps in ONC Report

Posted in Health IT, HIPAA & Privacy
On July 19th, the Office of the National Coordinator for Health Information Technology (“ONC”) released a report expressing concerns about major gaps in policies and oversight surrounding the access to, security, and privacy of health information held by certain mobile health (“mHealth”) technology companies and health social media.  While the report frames the issue well,… Continue Reading

FDA Finalizes Guidance on Low Risk “General Wellness Products”

Posted in Health IT
In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides… Continue Reading

6 Trends in the Health Care Economy’s Internet of Things

Posted in Events, Health IT, HIPAA & Privacy
Crowell & Moring and Accenture co-hosted a conference, “Fostering Innovative Digital Health Strategies,” in late-June. The program aimed to provide a broad analysis of the business and legal issues that must be addressed as health care organizations and technology companies consider innovative strategies to use digital health technologies. The first session of the conference, “Trends… Continue Reading

OIG Issues a Favorable Opinion Regarding a Drug Savings Card Program

Posted in Fraud, Waste & Abuse, Medicare
On June 27, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a favorable Advisory Opinion, No. 16-07, relating to a savings card program under which individuals who have prescription drug coverage under Medicare Part D receive discounts on a drug that is statutorily excluded from Part D coverage. According… Continue Reading

Tell HHS How to Measure Interoperability

Posted in Health IT
Congress set its sights on achieving the widespread exchange of health information through interoperable-certified electronic health records (“EHR”) by declaring it a national objective in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). To accomplish this goal, MACRA directs the Department of Health and Human Services (“HHS”) to establish metrics in consultation with… Continue Reading

$9.9 Million Settlement To Resolve Allegations That Hospital System Overpaid Physicians Approved by Georgia Federal Court

Posted in Fraud, Waste & Abuse
On February 8, 2016, the United States District Court in the Southern District of Georgia approved the settlement agreement ending a whistleblower lawsuit initiated on March 9, 2011 against Memorial Health University Medical Center (“Memorial Medical Center”) and three affiliated entities in a case that highlights the Department of Justice’s (“DOJ”) vigorous scrutiny of physician… Continue Reading

New Core Quality Measures Seek to Align Payers and Reduce Burden for Providers

Posted in Health Care Reform & ACA
On February 16th, CMS, AHIP, and other Core Quality Measures Collaborative members unveiled new measure sets in an effort to streamline quality metrics reporting across commercial and government payers.  The seven new measure sets include metrics for accountable care organizations/patient-centered medical homes, primary care cardiology, gastroenterology, HIV/hepatitis C, medical oncology, orthopedics, obstetrics and gynecology.   For… Continue Reading

CMS’s Two-Midnight Rule Delayed Again

Posted in Medicare
Once again, the Centers for Medicare & Medicaid Services (“CMS”) has delayed the enforcement of its controversial two-midnight rule.  On April 1st, the agency announced that it would postpone enforcement of the rule until April 30th, an additional month after the previous deadline, in order to give Congress additional time to pass a bill repealing… Continue Reading

CMS Confirms 2015 Deadline for ICD-10 Implementation

Posted in Medicaid, Medicare
On July 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule establishing October 1, 2015 as the official deadline for the implementation of the International Classification of Diseases, 10th Edition diagnosis and procedures codes (ICD-10). ICD-10 codes are used to classify diagnoses and procedures on claims submitted to Medicare and private… Continue Reading

OIG Recommends that CMS Step Up its Oversight of Clinical Laboratory Billing

Posted in Fraud, Waste & Abuse, Medicare
On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a special fraud alert titled Laboratory Payments to Referring Physicians, identifying “specific vulnerabilities with Medicare payments for lab services that need to be addressed to more effectively safeguard the Medicare program.” In 2010, the Centers for Medicare… Continue Reading

Doctors Must Document “Intent to Admit as an Inpatient” under Two-Midnight Rule

Posted in Medicare
With enforcement of the Two-Midnight Rule delayed through September 30, 2014, providers should ensure that they are sufficiently documenting the basis for inpatient admissions. As a condition of payment for hospital inpatient services under Medicare Part A, section 1814(a) of the Social Security Act requires physicians to certify that it is medically necessary for such… Continue Reading

FDA May Consider Lifting Controversial Ban on Blood Donations from Men Who Have Sex with Men

Posted in FDA
The Food and Drug Administration (“FDA”) is considering whether to revise a controversial policy prohibiting blood donations from men who have sex with other men. Dating to 1983, the FDA policy, commonly referred to as the “MSM Deferral Policy,” which prohibits men who have had sex with other men (referred to in medical literature as… Continue Reading

Fourth Circuit Upholds Constitutionality of Both Individual and Employer Mandate

Posted in Exchanges, Health Care Reform & ACA, Litigation
On July 11, 2013, the U.S. Court of Appeals for the Fourth Circuit, reconsidering a case in light of National Federal of Independent Business v. Sebelius, 132 S. Ct. 2566 (2012) (hereinafter NFIB), upheld the constitutionality of both the individual mandate and employer mandate of the Patient Protection and Affordable Care Act (ACA). In Liberty University… Continue Reading