Skip to main content

Health Care Compliance, Fraud and Abuse, & Regulatory Counseling

Viewpoints

Filter by:

Health Care Viewpoints Thumbnail
On September 15, 2021, in response to the “proliferation of apps and connected devices that capture sensitive health data” the Federal Trade Commission (FTC) issued a Policy Statement ( the Statement) offering guidance on the scope of the FTC’s Health Breach Notification Rule (Breach Rule). According to the Statement, the Breach Rule applies outside of the traditional health care context (e.g. health care involving diagnosis and treatment by a licensed health care provider) and the FTC intends to bring enforcement actions for noncompliance involving up to $43,792 in civil penalties per violation, per day.
Read more
Health Care Viewpoints Thumbnail
On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients who experience complications after specific joint replacement procedures can receive free items and services to treat the complications. The OIG likened the program to a warranty for joint replacement procedures.
Read more
Health Care Viewpoints Thumbnail
Physician judgment and medical necessity increasingly are a focus of fraud and abuse enforcement actions, with statistical analysis of procedure volumes used to flag potential cases. Last week, the Atlantic published this recent article discussing a significant 2018 decision of the Tenth Circuit Court of Appeals in United States ex rel. Polukoff v. St. Mark’s Hospital, et al., No. 17-4014 (10th Cir. Jul. 9, 2018), in which the court held that a physician’s medical judgment concerning medical necessity of a particular treatment for two specific cardiac conditions could be “false or fraudulent” under the federal False Claims Act (FCA). Our colleague, Brian Dunphy, covered the 2018 decision on this blog here. The Tenth Circuit ultimately held that a “doctor’s certification to the government that a procedure is ‘reasonable and necessary’ is ‘false’ under the FCA if the procedure was not reasonable and necessary under the government’s definition of the phrase.”
Read more
Health Care Viewpoints Thumbnail
On Friday, August 6, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA), the preeminent trade association representing pharmacies companies, announced revisions to its Code on Interactions with Health Care Professionals (PhRMA Code) that will become effective January 1, 2022. The PhRMA Code is a voluntary code for pharmaceutical companies, but its standards are considered to be best practices and are commonly adhered to by pharmaceutical and medical device companies. Moreover, some states (e.g. California, Massachusetts, Nevada, and the District of Columbia) require pharmaceutical companies to adopt a code consistent with the PhRMA Code.

The changes to the PhRMA Code are undoubtedly in response to a November 16, 2020, Special Fraud Alert from the Department of Health and Human Services’ Office of the Inspector General (OIG), on “fraud and abuse risks associated … speaker programs.” (For additional information on the OIG’s Special Fraud Alert, please see our November 25, 2020 blog post.) Speaker programs are a common practice in the industry and generally entail pharmaceutical and medical device companies retaining health care professionals (HCPs) to speak or present to educate their peers on the companies’ drugs or devices.
Read more
Health Care Viewpoints Thumbnail

Bioethics in a Pandemic: Misinformation and Mandates

August 9, 2021 | Blog | By Bridgette Keller, Amy Martin

As the spread of the Delta variant of COVID-19 and the reality of inconsistent vaccine uptake lead to growing case numbers across the country, many of us are wondering, how did we get here and what’s next?
Read more
Health Care Viewpoints Thumbnail

Senator Grassley and Others Propose Amendments to the False Claims Act

August 2, 2021 | Blog | By Samantha Kingsbury, Brian Dunphy, Laurence Freedman

Earlier this week, a bipartisan group of Senators led by Senator Chuck Grassley (R-Iowa) introduced two pieces of proposed legislation, one of which would amend the existing False Claims Act (FCA) and the other of which would amend the Program Fraud Civil Remedies Act of 1986 (the PFCRA) to create the Administrative False Claims Act of 2021 (AFCA). The AFCA would focus on smaller claims than does the FCA. Senator Grassley described the bills as being intended to “help recoup even more money by clarifying confusion after the Escobar case” and as being needed more than ever “to fight the significant amounts of fraud we are already seeing” related to the trillions of dollars Congress has appropriated for COVID relief.
Read more
Health Care Viewpoints Thumbnail
For many health care systems, patient leakage – when patients leave a health care system’s network in favor of out-of-network providers – is a rampant problem that results in substantial lost revenue. While sometimes patient leakage is just a result of patient choice, often the issue lies with employed or contracted physicians referring patients for services outside the network. Many health care systems may be wary of including in their physician contracts requirements that physicians refer patients exclusively within the network (otherwise known as directed referral requirements) based on concerns with interfering with physicians’ medical judgment and/or the common misconception that the Stark Law prohibits directed referral requirements.

To the contrary, the Stark Law actually permits directed referral requirements, provided that certain conditions are met. CMS recently enacted changes to the Stark Law regulations, effective January 19, 2021, that provide additional clarity on how health care providers can permissibly use directed referral requirements. These recent changes have seemingly triggered new awareness and interest in how health care systems can utilize directed referral requirements to combat patient leakage.
Read more
Health Care Viewpoints Thumbnail

California Health Care Legislative Update

June 15, 2021 | Blog | By Lara Compton

Not surprisingly, in the wake of the COVID-19 pandemic, California legislators proposed hundreds of health-related bills in 2021. For those who are unfamiliar with the intricacies of the Golden State’s legislative process, June 5, 2021 was the deadline for the California Legislature to pass bills introduced in their house of origin. Accordingly, during the week of June 7th, the Senate and Assembly resumed policy committee hearings, reviewing measures from the opposite house.

Along with proposed legislation addressing health care funding, health care access, mental health and substance abuse treatment, disaster preparedness, and other issues brought to the forefront by the pandemic, there are multiple bills that seem to be aimed at various concerns raised by corporate involvement in the provision of health care. Below is an update on a few of the bills that fall into the latter category, including SB 642, which we discussed in more detail in a prior post.
Read more
Health Care Viewpoints Thumbnail
On May 3, 2021, the California Senate Health Committee approved SB-642 “Health care: facilities: medical privileges.” The bill is currently pending in the California Senate. AB-705, which is substantially similar to SB-642, is also pending in the California Assembly. If passed, the law will curtail hospital governing bodies’ ability to make decisions about the medical services provided at the facility without medical staff approval, impose new limitations on arrangements between management services organizations and professional corporations, and add additional factors to the Attorney General’s review and approval of nonprofit health care facility transactions.
Read more
Health Care Viewpoints Thumbnail

Biden Administration Throws Down Its First Gauntlet on 340B

May 18, 2021 | Blog | By Ellyn Sternfield

On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program.  In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies. 
Read more
Health Care Viewpoints Thumbnail

The American Families Plan & A Call for Drug Pricing Legislation

May 10, 2021 | Blog | By Theresa Carnegie, Cody Keetch

On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law on March 11, 2021. Notably, in his speech, President Biden called upon Congress to pass drug pricing legislation; however, the current White House Fact Sheet on the AFP does not include specific drug pricing provisions. This blog post discusses the health-related portions of the AFP and provides an overview of the Lower Drug Costs Now Act which seeks to lower prescription drug prices.
Read more
Health Care Viewpoints Thumbnail

FTC Engages in First Enforcement Action under COVID-19 Consumer Protection Act

April 27, 2021 | Blog | By Joanne Hawana, Samantha Kingsbury

In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19 Consumer Protection Act (the COVID-19 Act) and the Federal Trade Commission Act (FTC Act).  The Commission’s allegations focus on the deceptive marketing of products containing Vitamin D and Zinc as being scientifically proven to treat or prevent COVID-19 and as being equally as effective as or more effective than currently available COVID-19 vaccines.
Read more
Health Care Viewpoints Thumbnail
On April 16, 2021, Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15, 2021 purporting to exempt 91 medical device types from the premarket notification requirement under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. HHS’s actions on January 15, signed by then-HHS Secretary Alex Azar, sought to make permanent FDA’s grant of temporary enforcement discretion for the 91 device types for the duration of the COVID-19 public health emergency.
Read more
Health Care Viewpoints Thumbnail
The Department of Health and Human Services’ Office for Civil Rights (OCR) has announced that it will exercise its enforcement discretion for health care providers’ and their business associates’ noncompliance with the HIPAA rules with respect to their good faith use of online or web-based scheduling applications for scheduling COVID-19 vaccination appointments. OCR will not impose penalties for such noncompliance during the COVID-19 nationwide public health emergency.
Read more
Webinar Reference Image

Webinar Recording: Health Care Enforcement Year in Review & 2021 Outlook

February 24, 2021 | | By Eoin Beirne, Brian Dunphy, Hope Foster, Karen Lovitch

In our annual webinar, Mintz’s Health Care Enforcement Defense team reviewed the key policy developments, settlements, and court decisions from 2020 and assessed their likely impact in 2021 and beyond.
Read more
Health Care Viewpoints Thumbnail
As our readers know, we have long been closely watching False Claims Act (FCA) cases across the country alleging the submission of false claims based on the lack of medical necessity, particularly as a possible circuit split seemed to be developing with respect to requiring “objective falsity” to allege such FCA violations.  And we have likewise been waiting to see if the issue will be decided by the Supreme Court.  On February 22, 2021, we got an answer – at least for now – when the Supreme Court denied a petition for certiorari in RollinsNelson LTC Corp. et al v. U.S. ex rel. Winters, a FCA case out of the Ninth Circuit in which the defendant was accused of submitting claims to Medicare for medically unnecessary hospital admissions (which we have been following since last year).
Read more
Webinar Reference Image

Health Care Enforcement Year in Review & 2021 Outlook

February 18, 2021 | | By Eoin Beirne, Brian Dunphy, Karen Lovitch, Kevin McGinty, Samantha Kingsbury, Keshav Ahuja, Grady Campion, Jane Haviland, Caitie Hill

Despite the threat of COVID-19 paralyzing much of the country in 2020, government health care fraud enforcement continued even though the Department of Justice (DOJ) had the added burden of pursuing COVID-19 related fraud. Mintz’s Health Care Enforcement Defense team has reviewed the key policy issues, statistics, settlements, and court decisions from 2020, and in this report we reflect on those developments and also predict the trends in health care enforcement in 2021 and beyond.
Read more
Health Care Viewpoints Thumbnail

340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation

January 18, 2021 | Blog | By Daryl Berke, Ellyn Sternfield

The U.S. Department of Health and Human’s Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.
Read more
Health Care Viewpoints Thumbnail

HIPAA 2021 – What Can We Expect?

December 28, 2020 | Blog | By Dianne Bourque, Ellen Janos

As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only for health care providers, but for all manner of businesses, employers, property owners, and the national media. HIPAA – or more often than not “HIPPA” – was frequently touted in the news and on social media as the reason why COVID-related information could or could not be shared. As we head into 2021 with the pandemic raging on, the vaccination program underway, and a new administration taking over, here is a look at what we expect for “HIPPA” in 2021.
Read more
Health Care Viewpoints Thumbnail
The Department of Health and Human Services (HHS) is pushing ahead in its Regulatory Sprint to Coordinated Care with a new proposed rule, announced by HHS’ Office for Civil Rights on December 10, to modify the HIPAA Privacy Rule. This proposed rule follows HHS’ 2018 Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, which sought to identify regulatory impediments to value-based care presented by HIPAA. With this proposed rule, HHS aims to “reduce burden on providers and support new ways for them to innovate and coordinate care on behalf of patients, while ensuring that [HHS] uphold[s] HIPAA’s promise of privacy and security,” according to HHS Deputy Secretary Eric Hargan. It would achieve these objectives through a variety of updates to the Privacy Rule, which we highlight in this blog post, along with initial reactions from our HIPAA privacy team.
Read more
Sign up to receive email updates from Mintz.
Subscribe Now

Explore Other Viewpoints: