Tag Archive for: oklahoma city law firm

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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.

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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

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The HIPAA Employee Rules Needed to Protect Your Company

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses how safeguarding patients’ electronic health information is an employment matter and how companies can enact HIPAA rules with their employees.

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

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Certificate of Need Laws Can Bridle Behavioral, Other Care

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 the 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 the 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 from 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 the 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

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Feds paid $60 million in Medicare improper payments last year

Q: In 2016 the federal government paid out $60 million in “improper payments” to Medicare and Medicare Advantage plans. What are improper payments?

A: The prohibition against improper payments applies to Medicare and to the Medicare Advantage plans which stand in the place of Parts A and B but offer more choices to patients in the private insurance market. Most are HMOs, PPOs, and private fee-for-service plans. “Improper payments” refers to both underpayments and overpayments. The most common payment problems are traced to insufficient documentation of the care provided. Other problems are no documentation, failure to establish medical necessity and incorrect coding. Regulators tell us that the objective is to understand the ordering practitioner’s reasoning in evaluating and diagnosing a patient, in considering the alternative course of action and in selecting a specific treatment plan with the patient. Just as physicians have been trained to document robust informed consent, they are now being called upon to document their thought processes as a way of demonstrating the legitimacy of the treatment.

Q: What action can the federal government take once an improper payment has been identified by the Center for Medicare and Medicaid Services (CMS)?

A: The CMS is part of the Department of Health and Human Services and it has an investigative arm known as the Office of the Inspector General (OIG), which is the most robust of all federal agencies’ legal and investigative arms. The OIG can investigate a provider and refer the matter to the Department of Justice to bring a criminal or civil action against the provider that can result in repayments, penalties, and even incarceration. Such actions also ultimately can result in exclusion from federal payment programs and even loss of the provider’s clinical license to practice. A demand for repayment can be based on an extrapolation of a statistical sample of a provider’s claims submission and payment history.

Q: How can providers avoid making claims that result in improper payments? Are there certain kinds of providers who are at the greatest risk for coding errors?

A: In the face of this regulatory environment, providers would do well to engage in periodic preventive spot audits of their medical records documentation, coding and billing activity. Billing regulations are increasingly complex and require advanced training not only of the practitioner but also of his or her staff, billing company and supporting professionals such as accountants and attorneys. Continuing education, coding seminars and the like are the order of the day for persons with these responsibilities.

Q: What’s the potential impact of these billing errors on patients and on providers?

A: Improper documentation can be a result of mistakes, faulty documentation or fraud. Some documentation shortcomings can be traced back to the provider’s original training or education. Others relate to the electronic records formatting, which some experts argue fosters copying responses rather than creating medical record entries for each patient. Ideally, eliminating unnecessary claims benefits the health care system financially and so ultimately benefits the patient. However, in my experience, “false claims” often represent a failure on the business side of a medical practice or facility operations in a situation where quality services were actually performed. But once characterized as an overpayment, the amount paid by the Medicare contractor must be returned despite the fact that quality services were provided.

From NewsOK / by Paula Burkes
Published: September 29, 2017
Click to see full story – Feds paid $60 million in ‘improper’ Medicare payments last year

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