INSIDE COMPLIANCE – Page 76 – Loyola University Chicago School of Law

Revamping America’s Organ Transplant System

March 24, 2020Uncategorized

In December of 2019, two new rules were proposed by the federal government to increase the number of organ transplants in the United States. As of July 2019, 113,000 Americans sat on the national transplant waiting list. The first proposed rule would change the way Organ Procurement Organizations (“OPO”) report data on the number of organs procured. The second proposed rule creates new legislation to assist living donors after their transplant procedures. Both rules were proposed by the Health and Human Services Department (“HHS”) as a follow up to President Trump’s Executive Order on Advancing American Kidney Health.

Data ReportingLiving DonorsJournal of Regulatory ComplianceOPOOrgan TransplantHealthcare Regulations

Promoting Interoperability Among the Electronic Health Record Systems

March 23, 2020Uncategorized

Last year, the Department of Health and Human Services (“HHS”) proposed new rules to improve the interoperability of electronic health information (“EHI”) to fulfill its statutory requirement under the 21st Century Cures Act. These proposed rules were issued by the Center for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) to address both technical and healthcare industry factors that create barriers to the interoperability of health information and limit a patient’s ability to access EHI. Epic, one of the largest programs for maintaining electronic health records (“EHR”), is attempting to halt the finalization of the interoperability rules before they take effect as they believe it posts privacy concerns. On March 9, 2020, HHS announced the joint final rules from CMS and ONC to spur innovation and to end information blocking.

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NCAA and Student Athlete Mental Health: How to Make Help Accessible

March 20, 2020Athletic Regulation, Compliance Spotlight

In a previous article, I discussed the mental health crisis facing student athletes across the country. I called on the NCAA, individual universities, and all coaches to increase efforts to improve the overall health and wellness of their athletes. The stigma is slowly being tackled, making it more commonplace for athletes to speak out when they need help. But how can athletic departments make these services readily available and accessible for student athletes? The NCAA recommends a well-trained psychologist to be a part of athletic departments’ staff. There are, however, other models being utilized.

college athleticsNCAAstudent athletes

Student Loans and Conforming Mortgage Guidelines

March 20, 2020Uncategorized

In the United States, a mortgage is considered “conforming” if it meets the guidelines of Freddie Mac (the Federal Home Loan Mortgage Corporation) and Fannie Mae (the Federal National Mortgage Association). Both Freddie Mac and Fannie Mae buy mortgages, pools them, and then sells them back to the open market for investors. In 2008, the federal government put both organizations into a conservatorship due to the financial meltdown and subsequent economic recession. As such, the government now has stringent guidelines that homebuyers must meet if they want to qualify for a Freddie Mac or Fannie Mae mortgage.

Agencies Approve Notice of Proposed Changes to Volcker Rule

March 18, 2020Uncategorized

At the end of January, the Federal Reserve Board, the Comptroller of the Currency, the Federal Deposit Insurance Corporation, the U.S. Securities and Exchange Commission, and the U.S. Commodity Futures Trading Commission (the “Agencies”) approved a notice of proposed rulemaking (“Proposed Rule”) to amend the “covered fund” provisions of section 13 of the Bank Holding Company Act, also known as the “Volcker Rule” (the “Rule”). The Volcker Rule is a regulation that generally prohibits banks from certain investment activities with their own accounts and limits their dealings with private equity and hedge funds, also known as “covered funds.”

CFTCFDICVolcker RuleSEC

Congress Introduces the Smartwatch Data Act

March 17, 2020HIPAA & Health Information

On November 18th, 2019, Congress introduced the Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act, known as the Smartwatch Data Act. The Smartwatch Data Act was introduced by Democratic Senator Jacky Rosen and Republican Senator Bill Cassidy, due to Google’s desire to acquire fitness tracker manufacturer Fitbit in 2020. Since notice of this acquisition, privacy advocates have raised concerns about how Google will use personal health data collected through Fitbit devices. Therefore, this legislation aims to ensure that health data collected through fitness trackers, smartwatches, and health apps, cannot be sold without consumer consent.

data collection#privacyhealth appPrivacy & Securityphi

CMS Modernizing the Physician Self-Referral and Anti-Kickback Regulations

December 11, 2019Fraud & Abuse

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.

compliance programCMSCMPAKSOIGHHSstarkRegulation

Stark and Anti-Kickback Statute Get Modern Updates to Account for Value-Based Arrangements

December 9, 2019Fraud & Abuse

On October 17, 2019, the U.S. Department of Health and Human Services (HHS) published two proposed rules in the Federal Register that could potentially transform key federal laws restricting health care arrangements. These rules address perceived or actual barriers to care coordination and value-based care under Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty (“CMP”) law. The proposals are intended to “modernize and clarify” the regulations that implement and interpret these laws in order to drive innovation and more towards a more affordable health care delivery and payment system, while also maintaining barriers to prevent fraud and abuse. The proposed rules “will improve outcomes by moving away from the old modes of inpatient hospitalizations.”

AKSAnti-Kickback StatuteJournal of Regulatory CompliancestarkU.S. Department of Health and Human ServicesValue-Based ArrangementRegulation

Should Gift Cards Include Braille in Order to Comply with Title III of the ADA?

December 6, 2019Uncategorized

Over the past year, restaurants and retailers have had to improve access to their physical locations, websites, and mobile applications to ensure that they are accessible to all individuals and comply with the Americans with Disabilities Act (ADA). Now, restaurants and retailers may have another issue that they need to grapple with in order to comply with the ADA – including braille on gift cards.

ADABrailleJournal of Regulatory ComplianceTitle III

Fair Play For Play for Student Athletes: Will the NCAA Embrace or Reject?

October 30, 2019Athletic Regulation

On September 30, 2019, California signed into law the biggest change to college athletics in the modern era of the National Collegiate Athletic Association (“NCAA”). Senate Bill 206 will allow college athletes to profit from the use of their name, image, and likeness, as well as protect the athletes from sanctions by the NCAA for violations stemming from the profits. One of college athletics’ core tenants has been the amateurism of their athletes and the emphasis on scholarship. This monumental change will have far reaching and lasting impact on college athletics and may disrupt the whole system as we know it.

college athleticsNCAA