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Attorney Mary Holloway Richard authors update to AHLA publication

Mary Holloway

Mary Richard is recognized as one of pioneers in healthcare law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families.

Mary Holloway Richard, Phillips Murrah Healthcare Law Attorney, 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.

Q&A: Medical Marijuana and the Construction Industry

Sam Newton

Samuel D. Newton is an attorney practicing in Construction, Health Care, and Oil and Gas Law.

In this article, attorney Samuel D. Newton discusses procedures Oklahoma construction industry employers need to develop with the legalization of medical marijuana.

With the passage of State Question 788 and the decision by the Governor not to call a special session, many of the ancillary questions regarding the impact of medical marijuana will remain unanswered until the next legislative session in 2019. But, in jobs where safety is key, such as construction, employers will need to develop procedures now to ensure that they are complying with safety rules and regulations as well as not stepping on an employee’s rights.

Q: How does the passage of State Question 788, medical marijuana, affect my safe work site and drug free policies?

A: The provisions of State Question 788 provide that an employer can take action against an employee who uses or possesses medical marijuana at the place of employment or during work hours. Thus, a contractor’s safe work site policy that prohibits the use of drugs or alcohol on the job is allowable under the law. However, unless an employer can show an imminent risk of losing a monetary or licensing benefit under federal law or regulation, an employer cannot refuse to hire, terminate, or otherwise discriminate against an employee simply because the employee has a medical marijuana card.

Q: If one of my employees with a medical marijuana card is “high” on the job can I still terminate him or her?

A: Maybe. Contractors will need to carefully differentiate between being impaired at work (ie, under the influence of marijuana and its attendant effects) and testing positive for marijuana although the employee may not be impaired. Unlike alcohol, scientific research has not been able to put a specific number on the THC levels (the compound in marijuana that makes one “high”) that impairs a person’s ability to drive or work safely—and THC may appear in a blood or urine screen well after it is consumed. So, unless the legislature choses a legal level of THC, the key will likely be whether, based on an objective observation, the employee was able to safely function.

Q: My company is working on federal projects, how can I mesh the state law requirements and federal law requirements?

A: Federal law still considers marijuana to be a Schedule I Narcotic under the Controlled Substances Act. Thus it is against federal law to consume or possess marijuana, medical or not. Additionally, most, if not all, federal projects are subject to the federal Drug Free Workplace Act which requires employers to have a drug free work place policy prohibiting the unlawful possession or use of drugs in the workplace and make an ongoing good faith effort to maintain a drug free workplace. These policies include requiring the employee to report to the employer and the employer to report to the contracting agency any workplace criminal drug conviction. However, the distinctions are fine and the interplay between federal law and the imminent risk of losing federal contracts or licensing has yet to be defined by Oklahoma or Federal courts and not by the federal or state government.

NewsOK Q&A: Oklahoma Medicaid plans offer solution for costly prescription drugs

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

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

NewsOK Q&A: For health care providers, safeguarding patients’ electronic health information is also an employment matter

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses how safeguarding patients’ electronic health information is an employment matter with the Oklahoman newspaper.

Q: In preparation for an employee or other members of a health care company’s workforce quitting, what preventive steps can be taken to ensure that patients’ health information is protected?

A: Two particular measures are critical to health care providers, in their role as employers, to protect the private patient information. Those are preparation and training. First, advance preparation is essential. Administrative, technical and physical safeguards are mandated by HIPAA (the Health Insurance Portability and Accountability Act) and its amendments, and just as we recommend with regard to all types of health care compliance and regulations, a compliance plan should be in place to provide security for protected health information electronically maintained. The person responsible for a health care practice or company’s IT should perform periodic risk assessments, and sufficient access termination procedures should also be in place. Second, an important part of prevention is proper training. Just as we recommend preparation to respond to identity theft, employers must identify the individuals responsible for safeguarding electronically maintained protected health information and responding to a breach, and provide them with appropriate training. Since health care is such a labor-intensive industry, a high rate of personnel turnover requires proportionate re-training and monitoring of employees regarding compliance with privacy and other regulatory requirements.

Q: You mentioned termination procedures — what procedures provide effective deterrents to unauthorized use or access to electronically maintained protected health information in such situations?

A: As a part of an overall separation procedure, there are some critical checkpoints along the way. Health care providers/employers are advised to standardize the process and create a checklist of steps to be taken when an individual leaves. Document that these steps have been taken, including the return of any company equipment. Next, if the company or practice is large enough to have departments, it is important to quickly alert the department or staff members responsible for changing access to electronically maintained protected health information, deactivating or deleting user accounts and monitoring access. Also, after these and other important steps are carried out, I recommend a post-termination audit to verify that all necessary steps to cut off access to electronically maintained protected health information have been taken.

Q: What steps must be taken to terminate access to electronically maintained protected health information?

A: Such steps, in addition to terminating user accounts and reclaiming computers, laptops, iPads and cellphones, should include terminating access to the physical space, which may require changing locks, access codes, and authorized individuals lists. Obviously, keys, fobs, ID badges, card keys and other items by which the former employee gained access to the physician space must be reclaimed or reprogrammed so that access by the former employee or other former member of your company’s workforce to secure areas with electronically maintained protected health information is no longer possible. For all former employees, and particularly for those with remote access, deactivation of any remote accounts and accessibility should reach all levels of access so that portals, web access and email services are no longer accessible.

 

Published: 5/9/18; by Paula Burkes
Original article: http://newsok.com/for-health-care-providers-safeguarding-patients-electronic-health-information-is-also-an-employment-matter/article/5593919

Phillips Murrah healthcare attorneys to address nation’s opioid epidemic

Oklahoma healthcare attorneys Mary Holloway Richard and Samuel D. Newton

Phillips Murrah attorneys Mary Holloway Richard and Samuel D. Newton

Phillips Murrah Healthcare attorneys Mary Holloway Richard and Samuel D. Newton will be featured presenters for a program exploring the opioid epidemic in Oklahoma and across the country.

“Our purpose is to provide information to the attendees about different policies and programs across the country, which is extraordinarily helpful in tailoring responses that will be effective in our state and in explaining policies and programs to everyone they impact,” Richard said.

The program will be presented for Continuing Legal Education (CLE) credit by the Oklahoma Bar Association Health Law Section at noon on April 11 via live webcast.

“This program has been designed for policy makers, attorneys, healthcare professionals, regulators, law enforcement, patients and their families and community advocates,” Richard said.

Participants can expect the program to cover the statutes, regulations and policies being implemented to combat this epidemic by making services more available, detecting abuse and misuse within the healthcare system, and supporting enforcement and remedial processes, according to the Oklahoma Bar Association.

“The opioid epidemic touches every quadrant of our society with high costs to addicted individual and their families and presenting an unsustainable financial drain on our local communities, state and nation,” Richard said. “The presenters offer information about the depth and breadth of this problem in Oklahoma, responses from across the nation, and the programs that are in place in Oklahoma.”

Those interested may click here for more information and to register for this program.

Mary Holloway Richard is a healthcare lawyer who has written extensively in this area and has published a review of state programs across the nation.

Samuel D. Newton is an attorney who represents healthcare providers and practitioners with a special focus on long term care and licensure.

Click here for more information about Phillips Murrah’s Healthcare Law practice. 

Avoiding construction contract litigation

Gavel to Gavel appears in The Journal Record. This column was originally published in The Journal Record on February 15, 2018.


Samuel D. Newton is an attorney practicing in Oil and Gas, Construction, and Health Care Law.

By Phillips Murrah Attorney Samuel D. Newton

Oklahoma heavy civil and oil and gas construction will likely increase in the near term due to increased activity in the oil and gas fields and President Trump’s proposed $1.5 trillion investment in infrastructure.

Often seen as a heavily litigious industry, construction projects don’t have to end in litigation if contracts are carefully drafted and parties enforce the provisions during the course of the project. Here are some points to consider when drafting and/or reviewing.

Know your deadlines. Most construction contracts impose liquidated damages in the event of delay. While substantial/final completion is likely non-negotiable, (sub)contractors should raise, and try to draft around, any potential milestone concerns during negotiations to prevent the assessment of liquidated damages or exercise of the contract default provisions. Additionally, all parties need to be aware of the timeline for making claims or submitting change orders. Both are often waived under the contract if the proponent of the claim/change doesn’t submit the appropriate notice to the appropriate person in the requisite period of time.

Know the payment scheme. Payments are also often a litigious issue in construction. All parties should be aware of lien and, if applicable, bond claim rights, as they vary based on who the contracting entity is and where the project is located. Additionally, “pay if paid” and “pay when paid” clauses should not be confused. “Pay if paid” clauses shift the risk for nonpayment to lower tiers if payment is not received from higher tiers. “Pay when paid” generally only acts to give the (sub)contractor time to pay after it receives payment. Case law suggests that “pay if paid” clauses would need to be explicit to be enforceable in Oklahoma, though no cases directly examine the clause.

Know your contracting partners. Conduct due diligence to ensure that those you are contracting with – at each tier – have the skills and financial stability to complete the project. Consider including (or modifying) clauses that allow suspension and/or termination of the contract, if the representations and warranties you relied on when deciding to enter into the contract were untrue or grossly overstated.

Know your contract. Finally, don’t simply sign the contract and put it in a drawer. All parties should know the provisions and educate their employees about provisions relevant to their scope of work.

Samuel D. Newton practices construction and oil & gas law at Phillips Murrah P.C.

NewsOK Q&A: Certificate of need laws can bridle behavioral, other care

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of pioneers in Oklahoma healthcare law. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses Oklahoma’s Certificate of Need laws with the Daily Oklahoman newspaper.

Q: What are Certificate of Need (CON) laws and what is the status of CON in Oklahoma?

A: The history of CON laws is an interesting one. Federal law required CON for facilities that received federal funds to construct facilities. By 1978, unique CON statutes were passed in 36 states. Although the federal mandate was repealed in 1987, many states still have CON laws in place. The CON system was intended by Congress as one mechanism for controlling healthcare costs by controlling development. The idea was that unnecessary beds or services would drive up the costs and miss system efficiencies and economies of scale. Development was broadly defined to include activities ranging from new development, acquisitions, mergers, management agreements, leases, stock purchases and changes in ownership via foreclosure. The Oklahoma legislature repealed CON laws in all areas except for psychiatric and chemical dependency services and long-term care.

Q: What are current requirements for developing long-term care and behavioral health services in Oklahoma under these statutory schemes?

A: For long-term care, the Oklahoma law provides for development of long-term care services in a “ … planned orderly economical manner consistent with and appropriate to services needed by people in various (parts of Oklahoma) ….” Development must match or reflect the need demonstrated in the CON application as evaluated by the state Department of Health. The statutes also enumerate the powers of the Department of Health with regard to long-term care facilities, and services. The law applies to long-term care facilities including nursing homes, specialized facilities such as long-term acute care and skilled nursing facilities and the nursing component of continuity of care and life care communities. For psychiatric and chemical dependency service facilities, the process is outlined in the statutes and includes application requirements, findings by the state Board of Health, providing bases for the board’s decision, the opportunity for appeal of the board’s decision and an explanation of potential penalties for failure to comply.

Q: Some writers and consultants in the healthcare industry contend that these laws no longer serve the purposes for which they were created by legislatures or fail to achieve the ostensible objectives. Is this fair criticism?

A: All segments of the healthcare industry are highly regulated. There is a good argument to be made that business decisions in the healthcare space are guided by reimbursement, the impact of effectiveness and outcome metrics, and classic business principles such as market share and that, while the original ideas supporting the CON effort may have been sound, the system now provides an additional hurdle and expenses in two areas of significant needs in our state — services to the elderly and others requiring long-term care and to those suffering with behavioral health diagnoses. More specifically, Oklahoma’s CON rules apply only to hospitals so that development for treatment facilities not considered “hospitals” by the Oklahoma Department of Health are not covered by the CON procedures and limitations. The result is that addiction treatment facilities providing services, including beds, only require approval of the Oklahoma Department of Mental Health and Substance Abuse Services, which does not have its own CON process and can be developed without hindrance.

Q: Is there interest among Oklahoma lawmakers to repeal the last vestiges of CON law in Oklahoma?

A: Although this issue has come up in the last several years, it has not been successful. No such legislation was proposed in the first regular session of this legislative term, which ended in May. In terms of the status of CON laws in the nation, as of 2016, 14 states had discontinued their certificate of need requirements and 34 continued with some remnant of the CON system.

Published: 10/12/17; by Paula Burkes
Original article: http://newsok.com/qa-with-mary-holloway-richard-certificate-of-need-laws-can-bridle-behavioral-other-care/article/5567643

Office Visit: Therapists need liability protection

By Mary Holloway Richard, Of Counsel for Phillips Murrah. This column was originally published in The Journal Record on January 18, 2017.


Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families.

Office Visit: Therapists need liability protection

Behavioral health is a unique subset of health care law. I long have been privileged to see firsthand the challenges in working as a therapist while successfully avoiding liability and regulatory land mines, and I am empathetic with patients and families.

I believe it is important to provide protection from liability for therapists and to eschew expansion to predicting dangerousness of patients as the standard of care to which they are held. Therapists must adhere to standards of care that, when breached, result in liability to a patient for harm caused by that breach. Forty years ago the therapist’s burden was expanded to encompass a duty to warn third parties under certain circumstances in Tarasoff v. Regents of Univ. of California.

Recently the Washington Supreme Court decided Volk v. DeMeerleer, expanding liability of mental health professionals to unidentified individuals. As in Tarasoff, reactions among states can range from adopting to rejecting the rule in response. Such decisions are framed in reliance on laws in other states, scholarly articles and treatises, such as the creation of post-Tarasoff California statutory immunity for the therapist’s duty to warn third parties.

The Washington Supreme Court ruled in Volk that a psychiatrist could be liable for homicides even though the victims were not identified as targets of violence. The decision expands the scope of liability beyond the professional’s traditional duty to create a duty to identified third parties and may also result in expanding the rule from mental health professionals to other providers.

It is true that the Volk case concerned the murders of a young mother and her son as well as the suicide of the patient who killed them, and we are all too familiar with the facts of Columbine and Newtown. And society must protect these individuals. We must balance the need to protect our communities from violence with the need to protect our providers from the reprehensible burden of liability for predicting violent propensities.

The Washington Supreme Court stated that whether the patient’s violent actions were foreseeable should have been resolved by a jury and created instability concerning professional liability. It remains to be seen if this holding reflects a national trend of expanding the scope of liability for mental health and other health care professionals.

Mary Richard is a health care attorney with Phillips Murrah and a member of the Behavioral Health Task Force of the American Health Lawyers Association.

Health care industry leaders need to understand history of regulations

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

Mary Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

By Mary Holloway Richard, JD, MPH

On March 10th, the industry magazine, Modern Healthcare, posted news hot off the presses that a physician, Dr. Benjamin Chu of Kaiser, has been selected to be the CEO of Memorial Hermann Hospital in Houston.

As I read this, I couldn’t help but remember my first job out of graduate school—the lowest level administrator at Hermann Hospital in Houston at the Texas Medical Center.  I was responsible for ambulatory care at a time when layoffs in the emergency department and the outpatient clinics were required.  It was quite literally a baptism by fire.

I had come to that position from graduate school where I studied about the needs of the health care system—continuity, quality, cost effectiveness.  This likely sounds familiar to you if you are involved in health care in any capacity.  During my final semesters in graduate school, I interned at the Old University Hospital in what developed into the session in which the legislature refused to, once again, bail the hospital out in meeting its payroll. That unfortunately also sounds familiar.

In the classes I teach at OCU law school, I remind my students, who are largely enthralled with the idea of a health care law practice, of the importance of understanding the language and limitations of the pervasive regulations, but also their history.  It is important to have the context within which to place the regulations, statutes and case law that impact our providers.

Similarly, I advise clients to look forward, to be proactive in their compliance efforts.  It will be interesting to observe physician leadership in the Memorial system.

You can read more articles by Mary Holloway Richard here.