Tag archives: rulemaking

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

Judge declines to certify order for appeal in Texas Teladoc case

On August 15, 2016, United States District Judge Robert Pitman denied the motion of the Texas Medical Board (“TMB”) to certify order for an immediate appeal of the court’s decision not to dismiss the Teladoc case.  The court previously denied the TMB’s attempt to have the case against it dismissed, which was brought by Teladoc … Continue reading

Administrative dispute resolution process is proposed to resolve 340B drug pricing program disputes

On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in the 340B drug pricing program. The rule if implemented as proposed will establish and implement … Continue reading

CMS proposes rule regarding changes to Medicare appeals procedures

The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process.  … Continue reading

Senate agriculture committee reaches deal on national GMO labeling bill

On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry … Continue reading

House bill addresses reduced payments to new off-campus hospital outpatient departments

On May 18, 2016, the U.S. House of Representatives Ways and Means Committee introduced the Helping Hospitals Improve Patient Care Act of 2016 (Act) to exempt certain newly-enrolled provider-based, off campus hospital outpatient departments (HOPDs) from reduced payments under the Bipartisan Budget Act of 2015 (BBA).… Continue reading

House passes comprehensive opioid legislation in advance of negotiations with the Senate

During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016.  This bill authorizes … Continue reading

CMS announces final rule on fire safety requirements for certain health care facilities

On May 4th, the Centers for Medicare & Medicaid Services (CMS) will publish a final rule to update health care facilities’ fire protection guidelines to improve protections for all Medicare beneficiaries in facilities from fire. This final rule applies to certain providers, including hospitals, critical access hospitals, ambulatory surgery centers, long term care facilities, and … Continue reading

FDA issues final rule for sanitary food transport, giving companies 1 year to comply

On April 6, 2016, the Food and Drug Administration (FDA) published the final rule for the sanitary transportation of human and animal food.  The rule aims to prevent food contamination during transportation by requiring covered entities involved in transporting human and animal food to follow recognized best practices for sanitary transportation.  The rule seeks to … Continue reading

Senate blocks anti-GMO labeling bill

On March 16, 2016, the U.S. Senate voted 48-49 against invoking cloture to cut off a filibuster on the Biotechnology Labeling Solutions Act.  The bill would have established a federal standard of voluntary labeling and preempted any mandatory GMO labeling state laws.  In July 2015, a similar bill called the  Safe and Accurate Food Labeling … Continue reading

CMS increases Medicare enrollment screening for providers and suppliers

On February 22, the Centers for Medicare and Medicaid Services (CMS) announced its intention to further enhance CMS’s ability to screen providers and suppliers enrolling or currently enrolled in Medicare for compliance with Medicare enrollment requirements. Specifically, CMS will strengthen existing screening measures by increasing the number of site visits to Medicare enrolled providers and … Continue reading

CMS publishes final rule addressing the reporting and returning of self-identified overpayments; detailed post to follow

This morning the Centers for Medicare and Medicaid Services issued a final rule that addresses the obligation of health care providers and suppliers to report and return overpayments by the later of 60 days from the date an overpayment is identified or the due date of any corresponding cost report. According to the CMS Fact … Continue reading

CMS issues final rule requiring face-to-face encounters for Medicaid home health services

On January 27, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring documentation of face-to-face encounters for physicians ordering home health services and certain medical equipment for Medicaid beneficiaries as required by the Patient Protection and Affordable Care Act of 2010. While the final rule becomes effective on July 1, … Continue reading

HHS modifies HIPAA rules to facilitate criminal background check reporting

On January 6, 2015, the Office for Civil Rights (OCR) of the United States Department of Health and Human Services (HHS) issued a final rule modifying certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The modifications grant to certain covered entities a narrowly tailored permission to disclose limited … Continue reading

Supreme court to consider viability of False Claims Act implied certification theory

On Friday, the US Supreme Court agreed to consider two questions involving the so-called “implied certification theory” under the federal False Claims Act (FCA).  First, the Court will consider whether the implied certification theory is ever viable for establishing FCA liability.  If it is, the Court will also consider under what circumstances FCA liability may … Continue reading