Tag Archive for: Mary Holloway Richard

Avoiding costly violations to the Anti-Kickback Statute

In this article, Oklahoma City Healthcare Attorney Mary Holloway Richard discusses the “Anti-Kickback Statute” and potential, federal violations of the statute as it relates to providers in the healthcare industry.

What is the authority for the federal government to oversee providers’ relationships with durable medical equipment (DME) and device suppliers and drug companies, such as educational programs that would seem to benefit the patient? How active is that oversight?

The Anti-Kickback Statute (AKS) prohibits remuneration to induce referrals or use of products reimbursement by Medicare, Medicaid or other federal healthcare programs. The federal government, through its investigators and prosecutors, pursue civil remedies including fines for remuneration considered as kickbacks. Remuneration may be cash of in-kind contributions. Under the AKS both civil and criminal charges may result from an investigation by the federal government. Federal policy is designed to prevent relationships that purportedly “lead to excessive or unnecessary treatment,” drive up health care costs and inhibit free market competition. The kickback prohibition applies to all sources of referrals, even patients. For example, where the Medicare and Medicaid programs require patients to pay copays for services, you generally are required to collect that money from your patients. Routinely waiving these copays could implicate the AKS and you may not advertise that you will forgive copayments. However, providers are free to waive a copayment if the provider makes an individual determination that the patient cannot afford to pay or if reasonable collection efforts fail. In addition, providing free or discounted services to uninsured people is not prohibited. The beneficiary inducement statute (42 U.S.C. § 1320a-7a (a) (5)) also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services.

Is the federal government even active in investigating and prosecuting under the AKS?

Yes. The Office of the Inspector General, counsel for the Department of Health and Human Services (HHS), estimated in 2018 that for every $1 spent on investigating health care fraud, $4 is recouped. The government has investigated, prosecuted and settled claims with many types of providers and continues to do so. The government does not need to prove patient harm or financial loss to the programs to show that a physician violated the Anti-Kickback Statute. A physician can be guilty of violating the AKS even if the physician actually rendered a medically necessary service. Taking money or gifts from drug or device companies or DME suppliers is not justified by arguing that providers would have prescribed that drug or ordered that wheelchair even without a kickback. An example of unlawful activities comes from the Covidien case. A supplier of vein ablation products in California and Florida, Covidien recently settled its claims with the federal government that it offered or provided free to medical practices, or at discounted rates, practice development assistance, lunch-and-learns, dinners with physicians, and market development support, such as vein screening activities designed to recruit new patients to the practices — all provided free of charge or at discounted rates. This virtually uncompensated support, according to the Department of Justice, was designed to induce the use of certain items or services, leading to excessive and unnecessary treatments and driving up health care costs for everyone.

Are there any clear guidelines for physicians and other providers?

HHS has published guidelines for providers, such as “A Roadmap for New Physicians-Avoiding Medicare and Medicaid Fraud and Abuse,” which I routinely provide to new physicians, advanced-practice nurses and other providers. Failure to follow the guidelines can be costly. For example, the outcome of the Covidien investigation was a civil settlement agreement for violation of the AKS in the amount of $17,477,947, with additional payments in excess of $2 million by the company to the states of California and Florida for claims paid by their Medicaid programs.

How are violations of the AKS usually discovered?

Violations of the AKS are often discovered through “qui tam” actions brought by employees of the practice group or those with knowledge of its practices known as “whistleblowers” or “relators.” To avoid vulnerability to qui tam actions providers are advised to adopt and implement robust compliance policies, including training providers and other personnel regarding behavior that may constitute risk under a federal regulatory analysis. It is also advisable to have operating agreements of the practice’s legal entity and written agreements reviewed by counsel in order to shift legal liability where possible.

 

Published: 4/19/19; by Paula Burkes
Original article: https://newsok.com/article/5629122/medical-practice-support-can-be-costly-to-suppliers-others

/by
,

Attorney Mary Holloway Richard authors update to AHLA publication

Mary Holloway Richard, lent her expertise to an update of the American Health Lawyers Association‘s Institutional Review Boards publication.

In preparing the third edition, the AHLA recognized the need to update the previous edition based upon changes in statutes and regulations and to incorporate new guidance reflecting expertise and current, in-depth experience with clinical research and IRB’s.

An important addition is the new chapter 17 “IRB Compliance and Internal Audits” authored by Richard.

Richard has recognized expertise in regulatory requirements and risk management in clinical research based upon involvement with both researchers and the IRB process for many years in the largest health system in the state.

The chapter brings to life a clinical research compliance plan by including the key elements and sample policies, procedures and other forms for use by researchers and research facilities, she said.

Richard advises clients regularly about FDA, HHS and OHRP requirements and lectures and writes on related topics, including regulatory requirements of the General Data Protection Regulation applicable in clinical research performed in the European Union.

For more information on the latest edition of the publication, click here.

/by

GDPR in America: Businesses react to newly enforced EU Privacy Law

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses GDPR, a newly enforced EU privacy law, and what it means for businesses in America.

Q: What is the General Data Protection Regulation (GDPR)?

A: It’s a law regulating data protection and privacy for all individuals within the European Union (EU). It gives control to individuals over their personally identifiable information. It both standardizes the requirements throughout the EU and bolsters protections available to individuals amid well-publicized, costly data breaches in Europe. It’s a regulation rather than a directive, which means national governments within the EU don’t have to pass enabling legislation for these requirements to be effective. Rather, the regulation is directly binding on the members of the EU. The spirit of the General Data Protection Regulation also is embodied in recent legislation in the United Kingdom, providing consistency across Europe even though the U.K. withdrew from the EU effective in March. The regulation, passed two years ago, became effective May 22. Because of the length of time between passage and enforcement, there’s no transitional or grace period before compliance is required.

Q: How is this relevant to American businesses?

A: In certain circumstances, the GDPR also applies to organizations and other businesses based outside of the EU if they collect and/or process personally identifiable information located within the EU. For example, U.S. companies offering a website to market their products or services to individuals within the European Community or scientific concerns actively engaged in recruiting individuals within the European Community to be subjects in clinical trials are required to comply. It’s important for such commercial concerns to act quickly to determine if they are covered by the General Data Protection Regulation as processors of data or collectors of such data from individuals within the EU. Concerned about the potential burden of compliance on foreign businesses, some international websites have taken steps to block EU users on the effective date, thereby removing the need to comply and ensuring against potential liability under the regulation. USA Today’s international website redirected users to simplified sites limited in scope. Other U.S. newspapers with European editions made them temporarily unavailable to readers in the EU. In another example of responses by U.S. companies, Instapaper, a read-it-later app, temporarily shut off access to European users to allow sufficient time for compliance.

Q: What type of data is protected by the General Data Protection Regulation and how’s it protected?

A: Personally identifiable information is anything that allows a living person to be identified directly or indirectly. Such data elements include name, email and home addresses, medical information, bank or other financial information, computer IP address and photos. A data processing officer must be appointed by businesses involved in processing or collecting data who is similar to a compliance officer with special information technology proficiency in managing and securing personal and sensitive data as well as a local representative for the company. Individuals have the right to the portability (access) of their stored data, erasure of data in certain circumstances, the right to file complaints with the data processing authority and the right to contract automated decision-making made on a solely algorithmic basis. Data breaches must be reported in a manner similar to the Health Information Portability and Accountability Act of 1996 and its amendments (HIPAA).

Q: You mentioned HIPAA. Is informed consent required for American businesses engaged in business in Europe similar to that required for HIPAA?

A: Personally identifiable information may be lawfully processed under the General Data Protection Regulation with informed consent or with a legal basis for doing so which ranges from legitimate interests of the entity collecting the data or a third party performing a task under official authority in the public’s interest, in compliance with the controller’s legal obligation, in fulfillment of a contract with a data subject, and to protect vital interests of a data subject or another person. There are some similarities to the HIPAA informed consent and the various exceptions to the consent requirement including the requirements of clarity and the opportunity to withdraw consent. As with HIPAA, individuals must be apprised of their privacy rights and their ability to withdraw consent at any time under the General Data Protection Regulation.

Q: Are there exceptions or limitations to an individual’s right of access to information?

A: Limitations to disclosure and the individual’s right of access to protected data exist for overriding interests such as national security. Further, in recognition of the importance of providing health care across country boundaries and clinical research to fight disease, the General Data Protection Regulation doesn’t apply to statistical and scientific analyses. A recognition of the need to maintain the integrity of clinical research resulted in the limitation of the erasure right of the individual. The strengthened data protections of the General Data Protection Regulation are limited in the face of requirements of good science although companies engaging in clinical research, including patient recruitment in the EU, will need to evaluate their data compliance plans considering the requirements of the newly enforced law. In addition, the General Data Protection Regulation doesn’t apply to data related to employer-employee relationships.

Published: 7/20/18;

/by
, ,

Oklahoma Medicaid plans offer solution for high cost of prescription drugs

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses steps Oklahoma has taken to lower prescription drug costs for consumers.

Q: Oklahoma recently has been recognized by Secretary Alex Azar, of the U.S. Department of Health and Human Services, for innovations in its Medicaid prescription drug program designed to lower drug costs to the state. How was the state able to accomplish this feat?

A: Medicaid is a federal program that’s administered by the states. In Oklahoma, it’s administered by the Oklahoma Health Care Authority. So, while the state receives some federal funding, a good portion of Medicaid funds are supplied by the state. In order to reduce costs related to prescription drugs, Oklahoma applied to the Centers for Medicare & Medicaid Services (CMS) and was granted an amendment to the Oklahoma State Plan that facilitates prescription drug cost savings. The plan links the payment of a drug to its effectiveness and outcomes. This is essentially what we refer to as “value-based” prescription drug purchasing. CMS reports that “(t)he state plan amendment proposal submitted by Oklahoma will be the first state plan amendment permitting a state to pursue CMS-authorized supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers.” This program is part of the Trump administration’s “American Patients First” blueprint, designed to address rising drug prices.

Q: How will the amendment work in Oklahoma?

A: The amendment to the state plan, as approved by CMS, now allows Oklahoma to negotiate and enter into valued-based contracts with drug manufacturers. This means that, through identifying the most effective medications, the state can tailor its negotiations with manufacturers to drugs that have demonstrated the most success in treating patients, thereby achieving cost savings and efficiencies in treatment. Negotiating value-based contracts will supplement Oklahoma’s ability to control drug prices under its current participation in the Sovereign States Drug Consortium. The Consortium negotiates supplemental rebates on behalf of states. Oklahoma is free to accept or reject rebate offers.

Q: Are there other cost saving initiatives related to decreasing prescription drug costs?

A: Currently, certain drugs have a preferred status if they’re listed on the Medicaid State Supplemental Rebate Agreement. Almost every state Medicaid plan, including Oklahoma’s, gives the state the authority to negotiate supplemental rebate agreements with drug manufacturers. These agreements allow for rebates to be given to the state by manufacturers as least as large as those provided in the Medicaid national drug rebate agreement. Importantly, two other parts of the Trump administration’s plan to decrease drug costs include giving Medicare insurance plans greater ability to negotiate for the Medicare Program (Part B and prescription drugs) and to make drug prices transparent for consumers. The latter part of the president’s plan would require drugmakers to disclose list prices in public advertising.

 

Published: 7/10/18; by Paula Burkes
Original article: https://newsok.com/article/5600913/oklahoma-medicaid-plans-offer-solution-for-costly-prescription-drugs

/by
, ,

Finding the lawyer mentor to help you succeed in your career trajectory

“Forewarned is forearmed.” I adopted that as one of my guides. Nowhere is that more true than in the lawyer mentor selection process within AHLA.

I want to share some thoughts with you to make your selection more likely to lead to a meaningful mentor relationship to help you along your path in this broad, ever-changing field we have chosen.

I am passionate about many things, including mentoring and AHLA. While I mentor within my state and community, the focus there is often on facilitating connections for young lawyers looking for a job or a career change. Within AHLA, mentors additionally provide a safe place to discuss difficult issues – both legal and human relations – as well as inspiration and support to other lawyers. We have the opportunity to help other health lawyers along their career path, and to learn from those mentees.

Yet, while AHLA members may share similar passions and goals, that is not a strong basis for selection. Rather, there is a bit of magic to being selected. Obviously you need to be as transparent as possible about your goals, areas of interest (“Mentoring Topics”), and your member profile. As much information as you can share is important because you never know what it is that will draw a potential mentor to you. For example, in addition to substantive areas of health law of interest to me, I am interested in supporting young women balancing commitments to family, profession, and community. In reviewing recent mentee applications, I found that I connected with those who provided enough information so that I could connect with them., such as the young mother on the partnership track who still worked to contribute to her community and another who had moved from an in-house position to a private practice (as I did). Some of those who did not provide enough information in their profiles left me without a basis for connecting with them. I even suggested to some that they revise their profiles to tell their story and state their objectives more clearly.

In the spirit of wishing you the most satisfying, helpful, and inspiring mentor-mentee relationship, I will distill my thoughts down to the following messages of motivation:

Your story is interesting so tell enough of it – education, family, job path, current position. Let prospective mentors get to know you a bit.

Share your professional dreams, goals, objectives. Readers won’t know if they can be proper lawyer mentors without this information. Allow a prospective mentor to properly select you as his or her mentee based upon your objectives and common or complementary skill sets. You may also create a connection via disparate experiences and different skill sets, so pique the prospective mentor’s curiosity with sufficient information to determine if you two are a match.

If you want someone to provide feedback about a specific area, such as interfacing with the FBI or handling OIG investigations, or if you want your mentor to assist you in connecting within AHLA, be sure to mention those goals.

You must sell yourself truthfully, so don’t despair if it takes some time to connect with just the right mentor.

Finally, once connected to a Mentor, engage with that Mentor. AHLA recommends quarterly contact as a minimum. The responsibilities to create a meaningful relationship belong to both parties, as do the benefits of the relationship. Mentoring is a two-way street, and you will get out of it what you put into it, but it will be much less effective and satisfying – for both the mentor and mentee – if you fail to provide sufficient information upon which to base the relationship.

This Oklahoma healthcare law topic regarding mentoring was featured in the June 2018 issue of Connections, the official publication of the American Health Lawyers Association.

By Mary Holloway Richard

Mary H. Richard heads up the Health Care Practice Group at the law firm of Phillips Murrah, headquartered in Oklahoma City. Mary has a law degree from George Washington University and a master’s degree in public health administration from the Oklahoma Health Sciences Center. She began her career in ambulatory care, health services research, and health management consulting at the Texas Medical Center. She has practiced health law in private practice settings and as in-house counsel for the INTEGRIS Health system. While at INTEGRIS, she provided legal counsel on issues regarding behavioral health services, hospital operations, clinical research activities, and a variety of other topics in a number of facilities throughout the system. She is active in the AHLA and is a part of the AHLA Behavioral Task Force leadership. She served as subcommittee co-chair of the Providers/Clinicians subcommittee, Vice Chair of Publications, Vice Chair of Strategic Planning and Special Projects, and is currently Vice Chair of Membership. She continues to be active in the AHLA mentoring program by mentoring six young professionals and is an active mentor to lawyers in Oklahoma who are interested in health law. Mary is also a proud member if the Choctaw Nation of Oklahoma. Her grandfather was one of the first lawyers in Indian Territory.

/by