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Phillips Murrah PPE donation to OU Medicine follow-up

As part of Phillips Murrah’s efforts to assist in the Oklahoma City community’s response to the COVID-19 pandemic, our Firm once again partnered with NPR radio station KGOU. In addition to supporting KGOU’s ongoing work, Phillips Murrah raised $3000 for OU Medicine to assist in acquiring personal protective equipment (PPE) for front-line medical workers, as part of May’s #GivingTuesdayNow pledge drive.

On Wednesday, our Firm presented the donation to Anne Clouse, Chief Development Officer for OU Medicine. Due to COVID-19-related restrictions, Phillips Murrah Director Catherine L. Campbell and Healthcare practice leader Mary Holloway Richard presented a six-foot-wide check, designed with appropriate social distancing in mind.

Phillips Murrah OU Medicine PPF Check Presentation

Phillips Murrah Director Catherine L. Campbell (l) and Healthcare practice leader Mary Holloway Richard (r) presented a six-foot check to OU Medicine, designed with appropriate social distancing in mind.

“We are deeply grateful to Phillips Murrah for their generous gift to support OU Medicine’s COVID-19 response,” said Clouse. “Their donation will help support our healthcare workers taking care of patients on the frontline. What a kind a thoughtful gesture.”

“Phillips Murrah has long had a strong relationship with healthcare facilities and providers throughout our state,” said Richard, who represents institutional and non-institutional providers of health services. “We are proud to support the heroic efforts of OU Medicine and those on the front line ministering to all Oklahomans.”

“There is a certain element of good humor related to this giant, social-distancing presentation check, which Cathy and Mary safely presented to Anne in a parking lot on the downtown OU Medicine complex.” said Dave Rhea, Phillips Murrah Marketing Director. “However, supporting OU Medicine as they battle this virus is a very serious matter, and we are grateful to be able to help.”

#GivingTuesdayNow was a global day of giving and unity as an emergency response to the unprecedented need caused by COVID-19.

Promotional graphic for KGOU GivingTuesNow 2

RELATED LINKS:

#GivingTuesdayNow: Phillips Murrah partners with KGOU to support OU Medicine PPE
Phillips Murrah partners with KGOU and Regional Food Bank to provide 20,000 meals

Keep up with our ongoing COVID-19 resources, guidance and updates at our RESOURCE CENTER.

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Oklahoma Governor Announcement: Healthcare occupational licenses extended during the emergency

By Phillips Murrah attorney Mary Holloway Richard

Announcement for all Licensed Healthcare Providers regarding Expiration of Licenses

Oklahoma Opioid Decision by Phillips Murrah healthcare attorney Mary Holloway

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

On March 17, 2020, Governor Stitt issued Amended Executive Order 220-7 which provided additional responses to the current pandemic.  The Order applies to all 77 counties and positions state agencies and departments to respond to the emergency with new hires and purchases as necessary.  One portion of the order focuses on the providers in the front lines—physicians and nurses.  While there is much for health care providers to worry about—office closings, staff, patient access to providers, and safety—providers will likely not be thinking about the status of license applications or the need to renew them.  This executive order offers a grace period by providing the following guidance to providers with those state licensure issues:

Any medical professional who holds a license, certificate, or other permit issued by any state that is a party to the Emergency Management Compact evidencing the meeting of qualifications for the practice of certain medical services, as more particularly described below, shall be deemed licensed to practice in Oklahoma so long as this Order shall be in effect, subject to the following conditions:

    1. This shall only apply to Medical (MD) and Allied Licenses issued by the Board of Medical Licensure and Supervision, Licenses issued by State Board of Osteopathic Examiners, and Licenses and Certificates issued by the Board of Nursing, all three shall collectively be referred to as “Boards”;
    2. Any medical professional intending to practice in Oklahoma pursuant to this Order, hereinafter referred to as “Applicant,” shall first apply with and receive approval from appropriate Board;
    3. It is the responsibility of each Board to verify the license status of any applicant and, upon verification of good standing, shall issue a temporary license to practice within this State; and
    4. Any applicant licensed under this Order shall be subject to the oversight and jurisdiction of the licensing Board, which includes the ability of the Board to revoke said license and to initiate any administrative or civil proceeding related to any alleged misconduct of applicant.

All occupational licensed of this type shall be extended during the emergency and shall expire fourteen (14) days following the withdrawal or termination of Amended Executive Order 2002-07.

In addition, this Executive Order, supports The Centers for Medicare and Medicaid Services’ (CMS) Section 1135 Waiver in eliminating the current requirement that a preexisting patient relationship exist in order for treatment to continue via telehealth.

Medicare Reimbursement Actions by the Government: Relief for Providers?

This article was originally published in the American Bar Association’s Health eSource newsletter in February 2020.


Oklahoma Opioid Decision by Phillips Murrah healthcare attorney Mary Holloway

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.

By Mary Holloway Richard, Phillips Murrah, and
Anna Stewart Whites, Attorney at Law, Frankfort, KY

The tension between the government’s need to ensure appropriate use of Medicare funds and the need of providers to receive reasonable compensation for services to Medicare beneficiaries is an ongoing issue.  Providers are subject to demands for repayment or recoupment of compensation paid to providers based upon claims filed.  Providers are also pressed to keep up with the continually developing arsenal of vast data mining, increasingly restrictive federal reimbursement policies, and oversight tools, including a plethora of audit options available to the Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) programs that can lead to penalties and mandatory exclusion.  Locating the applicable guidance — statutes, regulations, guidelines, reimbursement policies — can be challenging, with the information upon which CMS actions are based sometimes emanating from data gathered across the country, which allows for identification of trends to be pursued by the regulators.

The focus of this article is to explore the tools available to counsel for providers seeking to place appropriate limits on CMS in connection with statutory and regulatory limits on HHS rulemaking authority as interpreted by recent case law.

Proper Rulemaking as a Limit to Regulatory Authority

Providers who have received payment under the CMS fee schedules may, even years later (1) be faced with demands by CMS for repayment of amounts received due to an after-the-fact reduction in the fees payable to the provider, or (2) experience a downward adjustment in payments.1  These changes by CMS, both prospective and retrospective, are frequently transmitted via electronic manuals or by local or national coverage determinations (LCDs or NCDs).

Providers argue that the retrospective changes by fiat can be likened to ex post facto laws penalizing the provider for actions occurring before the regulation, policy or change in interpretation of the law existed.  When a government entity or agency determines that such a change is necessary, and when those changes are substantive or can adversely impact providers or patients, an opportunity for all affected parties to comment is advisable to support wise decision-making within the government’s scope of authority, and to facilitate smooth transitions within the industry.2  The existing structured rulemaking process offers providers and other interested parties the opportunity to comment on the proposed change prior to its implementation, thereby facilitating the avoidance of bad rulemaking or rulemaking with unintended consequences.

The Rulemaking Process:  An Overview

The rulemaking process is formal and includes the notice-and-comment period so that public awareness and input are parts of the making of any enforceable regulatory change.3  Under the Social Security Act, a notice-and-comment period is required for a “rule, requirement or statement of policy” that establishes or changes a “substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits.”4 This requirement is stricter than the more common notice-and-comment requirements of the Administrative Procedures Act (APA). The APA employs different nomenclature and holds that no notice-and-comment period is required where the change is merely an “interpretive rule” or “general statement of policy.”  That exception had been relied upon by agencies to change rules via policy manual updates or internal regulatory interpretations.5

Informal rulemaking under the APA requires development of a proposed rule and a published notice of the proposed rule or changes to an existing rule.  Following that, there is a comment period of at least 30 days.  Members of the public, including but not limited to those impacted by the change, have the opportunity to comment on the proposal. Codification of the final rule may take place only after the comment period has passed and the agency has made any final revisions to the rule.6 Typically, rule and regulation changes have a future, rather than retroactive, effective date.  Where the change to a law or regulation is “substantive,” formal rulemaking under the APA requires an additional opportunity for an agency hearing on the proposal before it can be made effective.

Historically, providers faced with recoupment demands from a federal payor had little choice but to accede to the payor’s demands within a specified, limited timeframe.  Providers could argue against such recoupment or denial, but such arguments in reality were limited to proving that the recoupment demand was in error.. The provider was thus placed in a defensive posture and required to operate from the premise that the recoupment request was correct, but for an obvious calculation or medical necessity oversight by the payor during its review.8

From the agency perspective, however, rulemaking takes significant time and effort and can be administratively debilitating.  It requires publication of the proposed changes, a lengthy comment period (often as much as several months long), opportunity for live comments as well as written comments, and then an analysis of the comments by the agency and publication of the agency’s responses to the comments.  If the comments result in an amendment to the policy, the rulemaking process may have to begin again to allow comment on those amendments newly proposed or on the resolution of issues raised during the comment period.  Because of the complexity of that rulemaking, agencies may choose to draft minor changes instead, and implement those via an announcement to providers/patients, thereby eliminating any delay in implementation or any requirement that those affected be allowed to speak.  Implementing minor changes is a necessary way to keep policies and regulations current, and is an acceptable part of the agency’s process.  Over time, however, there may be a blurring of the applicable procedures, where an agency implements a substantive change informally for an item that required the complete rulemaking process, particularly under the Medicare Act.  Providers have begun to pay more attention to the correct application of the rulemaking process and to challenge agencies ignoring required rulemaking.

Judicial Interpretation of Rulemaking Requirements Related to Healthcare

In Clarian Health West, LLC v. Hargan,9 the Court required adherence to the rulemaking process before a recoupment of payments could be enforced.  Under Part A of the Medicare program, hospitals are compensated prospectively based on the estimated likely cost of patient care.10 The hospitals may also receive supplemental or “outlier” payments.11 The regulatory changes enacted by HHS in 2003, which included notice-and-comment rule making, altered the way such “outlier payments” are calculated.12  The Court found that an agency decision is arbitrary and unenforceable as such where the agency “has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.”13

Two recent cases, Azar v. Allina Health Services14 and Polansky v. Executive Health Resources, Inc.,15 have provided validation for that argument, finding that absent the required rulemaking process and an opportunity for providers to comment on and be aware of the effect of the changes to the law, recoupment of funds properly paid exceeds CMS authority.

Provider Litigation to Enforce Rulemaking

In Azar v. Allina Health Services, the United States Supreme Court held that the decision to retroactively reduce Medicare disproportionate share hospital (DSH) payments according to a newly revised formula and practice must be vacated due to HHS’s failure to provide an opportunity for notice and comment in the context of revised payment rules.16 The DSH payment is calculated based upon a Medicare Fraction which establishes a proportion of low income patients provided services at the hospital for a certain time period and is the basis for the hospital’s final reimbursement adjustments.

By way of explanation, a DSH payment is a sum awarded a hospital pursuant to 42 C.F.R. 412.106.  Under Section 1886(d) (5) (F) of the Medicare Act, hospital DSH payments are calculated by the formula:

  • DSH Patient Percent = (Medicare SSI Days / Total Medicare Days) + (Medicaid, Non-Medicare Days / Total Patient Days)17

A new CMS rate calculation affected the way the applicable payments were made, and was therefore considered by the Court to be a ‟substantive legal standard” under the Medicare Act requiring notice-and-comment rulemaking prior to enforcement.18  The Court found that HHS had promulgated a retroactive Medicare rate calculation methodology and that this was not a change that could be enacted without opportunity for comment and discussion.As explained by the Court of Appeals for the D.C. Circuit, in 2004 HHS decreed that Medicare Part C patients would now be included in DSH calculations along with patients entitled to Medicare Part A benefits, and this change would have been applied prospectively for all Medicare Fraction calculations from 2005 onward. However, this change was successfully challenged and vacated by the D.C. Circuit.19 In response, in 2013 HHS promulgated the same rule to be applied prospectively from 2014. This left fiscal year 2012 at issue, and in 2014 HHS posted the Medicare Fraction on the CMS website, including Part C patients and Part A patients.20

CMS clarified that the 2012 determination that Medicare Part C days would be included in the calculations, thereby lowering the DSH calculation by including Medicare Advantage subscribers who generally represented higher income, resulting in a reduction of the DSH payments to hospitals.21

The proposed change underwent notice and comment in 2013 and eventually was adopted as a valid way to calculate those payments prospectively, beginning in 2014.  Rather than simply implementing the changed standard from 2014 onward, CMS looked back at earlier years and claimed that the change should apply retroactively.  There was no notice and comment period in 2012 on that change.  Following the changes, CMS used this ability to look back and demanded recoupment from provider hospitals, applying the changed law or interpretation of the law retroactively to 2012.

A group of  hospitals  challenged the changes made without notice and the opportunity to comment and sought to stop the recoupment, which represented billions of dollars.22  They argued that absent such timely rulemaking procedures, the change should not apply to years prior to 2014. HHS’s response was that it was not required to hold a notice-and-comment period for the new rule, since it was only advising the public on an existing interpretation of the law.  HHS relied on the less stringent standards of the APA23 to permit the recoupment.

The DC Circuit Court ruled in favor of HHS, and the hospitals appealed to the United States Court of Appeals for the District of Columbia, which reversed the lower court ruling and held that the new payment schedule amounted to a “statement of policy” that required the notice-and-comment period specified by the Social Security Act.24

The Supreme Court, quoting the Social Security Act, held that “[n]o rule, requirement, or other statement of policy (other than an NCD) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under this title shall take effect unless it is promulgated by the Secretary by regulation.…”25 “Substantive rules” refer to the Supreme Court phrase “substantive legal standard” as encompassing more than just the “substantive rules” that already require notice and comment under the APA.26 The Supreme Court noted in particular that the many manuals that provide guidance to participants in the Medicare program might contain substantive legal standards that require notice and comment, and that its decision applied broadly across those fields.27

The Allina ruling established that substantive changes to the law should not be applied retroactively to time periods in which there has been no rulemaking process.  Providers faced with any retroactive application of a change in the law that occurred after a payment to the provider which was valid at the time of payment could now claim that absent rulemaking at that time, the change should only be prospectively applied.

That doctrine was expanded in Polansky v. Executive Health Resources, Inc.,28 where the provider faced a False Claims Act (FCA) action based upon allegations that the provider’s billing was fraudulent for failure to comply with Medicare reimbursement guidelines. The provider argued that the Medicare criteria being applied had not gone through appropriate rulemaking prior to implementation.  The Court agreed, holding that Medicare reimbursement criteria must be established through notice-and-comment rulemaking to provide the basis for enforcement actions under the FCA. Because the reimbursement policy at issue had been established solely in the 1989 edition of the Medicare Hospital Manual and not via the rulemaking process including questions and comments, the court found that it “cannot withstand scrutiny under Allina’s interpretation of the Medicare Act.”29

The Court based its findings in part on Bowen v. Michigan Academy of Physicians,30 which held that a provider demanding administrative or judicial review of a recoupment of a Medicare Part B claim or payment must show that the matter is reviewable by challenging the method by which the claim was determined under 42 U.S.C.A. § 1395ff(b)(1)(C) (Supp.1990).  While courts may not “improperly impose on agencies an obligation beyond the `maximum procedural requirements’ specified by [statute or regulation],” the rulemaking standards must have applied to the creation of the statute or regulation.31  The District Court in Polansky relied upon the Allina decision to grant summary judgment in favor of the defendant, holding that the method by which a change is implemented may be challenged by an affected party where the agency failed to comply with the process required.32  The provider must show first that this is a matter to which the rulemaking standard applies, and secondly, that the method used by the agency was flawed in that it did not use the correct standard, before being allowed to attack the change or any related financial impact created by the change.33

The Allina and Polansky decisions establish an additional strategy for providers to defend enforcement actions that are part of a recoupment or recalculation, rather than attempting to prove that the government’s audit determinations or interpretations are in error. This, in effect, places the burden of defense back on CMS (or another governmental agency or payor) by requiring it to prove that the law or regulation was properly created in compliance with required rulemaking procedures.  Importantly, these decisions offer that, where providers did not have opportunity to comment on or object to implementation of a rule or regulation, they should not be found to have either had notice of it or be bound by its terms.

In response to Allina, the Department of Justice (DOJ) provided notice of DOJ policy in a memorandum to U.S. Attorneys from former Associate Attorney General Rachel Brand dated January 25, 2018. Known as the Brand Memo, it announced that “Department litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law in affirmative civil enforcement (ACE) cases.”34 The effect of the Brand Memo is to place agencies on notice that they may not rely upon sub-regulatory guidance to re-frame, expand, or enforce requirements established by statute or regulation.35  Specifically, the Brand Memo prohibits coercing regulated parties from taking or refraining from taking actions beyond the requirements of applicable statute or “lawful regulation.”36 The Brand Memo further pointedly provides that “the Department may not use its enforcement authority to effectively convert agency guidance documents into binding rules.”37

A new internal memorandum from HHS dated October 31, 2019 is instructive. That Memo says that it’s important for CMS to conform its guidance documents to the rulemaking obligations set forth in Allina.  For instance, HHS personnel are discouraged from basing enforcement actions on guidance documents, specifically the Internet-only manuals, that are not “closely tied to statutory or regulatory standards.”38  This Memo suggests to counsel for providers a few new tools when dealing with Medicare payment issues, including the limits of the impact of formerly formidable sub-regulatory or “non-regulatory” guidance, the amelioration of LCDs as the single basis for enforcement actions and judicial support for these limitations.

Conclusion

Recoupment and reimbursement demands, audits, exclusions, prosecutions and targeting by CMS, its contractors or other federal and state agencies are substantive, significant matters.  Adherence to the regulatory protections, including the notice and opportunity to provide input, allows all affected parties to have an understanding of the law or regulation and to be prepared for its impact.  The Allina case and its progeny are likely to benefit providers and patients alike as the country continues to grapple with healthcare reform.

  1. 42 U.S.C. § 1886(d)(5)(F); 42 C.F.R. § 412.106.
  2. See discussion below comparing the rulemaking requirements of the Medicare Act, 42 U.S.C. § 1395(h), which was passed as an amendment to the Social Security Act, 5 U.S.C. Chapter 5, §§ 551-559.
  3. See generally, https://www.federalregister.gov/uploads/2011/01/the_rulemaking_process.pdf, “A Guide to the Rulemaking Process” (last accessed Jan. 24, 2020).
  4. 5 U.S.C. § 1395hh(a)(2)  (emphasis added).
  5. See, e.g., acus.gov/research-projects/agency-guidance-through-interpretive-rules, “Agency Guidance Through Interpretive Rules” (Administrative Conference of the United States) Adopted June 13, 2019 (last accessed Jan. 19, 2020).
  6. 5 U.S.C. §§ 551-559.
  7. 5 U.S.C. § 553.
  8. See, e.g., “Tricare Recoupment Steps Outline”(Guidance provided to Tricare Beneficiaries), https://tricare.mil/Resources/Recoupment?p=1 (last accessed Jan. 15, 2020).
  9. 878 F3d. 346 (D.C. Cir. 2017).
  10. 49 Fed. Reg. 234 (Jan. 3, 1984); 42 U.S.C. § 1395ww(d)(2), “Prospective Payment for Medicare Inpatient Hospital Services.”
  11. 42 U.S.C. § 1395ww(d)(5)(A)(ii); See also Dist. Hosp. Partners, L.P. v. Burwell, 786 F.3d 46,  49 (D.C. Cir. 2015).
  12. See Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient and Long-Term Care Hospital Prospective Payment Systems Final Rule.  Fed. Reg. June 9, 2003 at 34493-515; https://www.ncbi.nlm.nih.gov/pubmed/12795306 (last accessed Dec. 27, 2019).
  13. See Hawaii Helicopter Operators Ass’n v. F.A.A, 51 F.3d 212, 214-15 (9th Cir.1995). See also n. 1 supra and accompanying text.
  14. 863 F.3d 937 (D.C. Cir. 2017), aff’d, 139 S.Ct. 1804 (2019).
  15. 2019 WL 5790061 (E.D. Pa. Nov. 5, 2019).
  16. 587 U.S. ___, 139 S.Ct. 1804 (2019), 42 U.S.C. §§ 1395 ww(d)(5)(k)(I); 42 C.F.R. § 412.106; cms.gov/Medicare/Medicare.Fee.For.Service.Payment /Acute InpatientPPS/dsh (last accessed Jan. 15, 2020).  See S.Ct. at 1309 quoting Petition for Cert; “So counting makes the fraction smaller and reduces hospitals’ payments considerably–by between $3 and $4 billion over a 9-year period, according to the government.”
  17. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInPatientPPS/dsh. Hospitals rely on DSH payments, as calculated annually, for a significant part of the yearly budget and income. The change in the method in which HHS was calculating those payments, applied retroactively, reduced the sum HHS found should have been paid each hospital in 2012 and 2013, resulting in a CMS demand for recoupment (paying back) of those funds to Medicare. There is an alternate special exception method for large urban hospitals that can demonstrate that more than 30 percent of their total net inpatient care revenues come from state and local governments for indigent care (other than Medicare or Medicaid). Because Medicaid monies are funds designated to serve a specific group in accordance with CMS payment guidelines, CMS is permitted up to 10 years to recoup funds which it believes were paid in error.
  18. Allina at 1810-1815.
  19. Allina Health Services v. Sebelius, 746 F.3d 1102, 1107-9 (D.C. Cir. 2014), as quoted in Allina Health Services v. Sebelius, 863 F.3d 937 (D.C. Ct.App. 2017).
  20. Allina at 1810.
  21. Part A Benefits refers to inpatient benefits (42 U.S.C. § 1395ww(9)(5)(F)(vi)(I). Part C Benefits refer to Medicare Advantage beneficiaries, who generally have more financial resources. Including Part C patients in the DSH calculation lowers hospital payments markedly. See Northeast Hospital Corp. v. Sebelius, 657 F.3d 1, 5 (D.C. Cir. 2011).
  22. See n. 17 and accompanying material.
  23. 42 U.S.C. Chapter 5, §§ 551 – 559. See Allina at 1813.  See also Perez v. Mortgage Bankers Ass’n, 575 U.S. 92, 95 (discussion of “interpretive rules” to which the APA notice and comment rulemaking requirements do not apply.)
  24. See Allina Health Servs. v. Price, 863 F.3d 937, 949 (D.C. 2017).
  25. 42 U.S.C. § 1395hh(a)(2) (emphasis added).
  26. See Allina Health, 139 S. Ct. at 1814.
  27. Id. At 1816.
  28. No. 12-4239, 2019 WL 5790061 (E.D. Pa. Nov. 5, 2019).
  29. Polansky at 7. See generally Allina at 1816. (discussion of CMS Provider Manual).
  30. 476 U.S. 667, 106 S.Ct. 2133, 90 L.Ed.2d 623 (1986).
  31. See Perez v. Mortg. Bankers Ass’n, 135 S.Ct. 1206, 191 L.Ed.2d 186 (2015).
  32. ___ F.Supp.3d___, 13 (2019); 2019 WL 579006 (at 12-13).
  33. Id. at 16.
  34. https://www.justice.gov/opa/press-release/file/1028756/download . See also Executive Order, https://www.whitehouse.gov/presidential-actions/executive-orders-promoting-rule-law-improved-agency-documents/.
  35. See Attorney General Memo on the Prohibition on Improper Guidance Documents, https://www.justice.gov/opa/press-release/file/1012271/download (last accessed Dec. 27, 2019).
  36. Brand Memo at Page 1.
  37. Id. at Page 2. The Brand Memo has been incorporated into the Justice Manual, the guidebook for DOJ attorneys. See https://www.justice.gov/jm/1-20000-limitation-use-guidance-documents-litigation (last accessed Dec. 27, 2019).
  38.  https://fcablog.sidley.com/wp-content/uploads/2019/11/1222000-1222453-allina-memo-cms.pdf.

About the Authors

Mary Holloway Richard represents both institutional and non-institutional providers of health services. Her career has included work at hospitals, outpatient clinics, behavioral health facilities and rehabilitation facilities and clinics. She has significant experience in health services contracting, reimbursement audits and appeals, OIG investigations, and regulatory and corporate matters. She lectures and has written on numerous healthcare topics including nonprofit operations, telehealth and behavioral health law, confidentiality and criminal justice reform. She was the driving force behind the first Oklahoma Women’s Law Manual as well as a contributor and editor.  She is currently a member of the faculty of the Oklahoma City University School of Law teaching an introduction to Healthcare Law and Behavioral Health Law. She has been in the leadership of the Behavioral Health Task Force of the American Hospital Association since its inception and is currently Vice Chair. She is Chair of the Oklahoma Bar Association’s Health Law Section. She may be reached at mhrichard@phillipsmurrah.com.

Anna Whites is the owner of Anna Whites Law Office and a graduate of Centre College and the University of Kentucky College of Law.  Her practice concentrates on health law, with a focus on laboratories, rural hospitals and behavioral health.  She advises providers on reimbursement, compliance and transactional issues.  Ms. Whites works with the Kentucky State Legislature and advocates in Kentucky and nationally to advance policies on prompt payment, uniform provider credentialing, telehealth advances and laws providing broad coverage to vulnerable populations. She is the Co-Chair of the Rural Health Subcommittee of AHLA’s Behavioral Health Task Force and speaks and writes for HCCA, ABA and AHLA on behavioral and compliance health law topics. She may be reached at annawhites@aol.com.

Summary of Landmark Johnson & Johnson Oklahoma Opioid Decision

The following summary of the Oklahoma Johnson & Johnson opioid decision is also published at Lexology.com.

Oklahoma Opioid Decision by Phillips Murrah healthcare attorney Mary Holloway

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

The decision in the non-jury trial, Oklahoma ex rel. Mike Hunter, Attorney General of Oklahoma v. Purdue Pharma L.P. et al was filed on August 26, 2019.  The trial, which lasted for thirty-three days, focused on the State’s sole claim against the defendants for public nuisance under state statute, during which forty-two witnesses were called by the parties and 874 exhibits were submitted into evidence, along with 225 additional court exhibits.

In the first such decision in the United States among a plethora of cases filed across the nation, the Court held that the State had met its burden of proof that the defendant, Johnson & Johnson, was the cause-in-fact of the extensively described injuries and that the harm suffered was the kind recognized by the state law. Purdue and Teva Pharmaceuticals settled prior to trial. The court found no intervening causes to defeat a finding of direct and proximate cause.

Testimony ran the gamut of describing the development of opioids in the 1950s and research and development that occurred from the 1990s until recent years, and it focused on what the Court considered intentionally misleading marketing information and activities. It is noteworthy that the Court included in its findings that there was no opioid epidemic in Oklahoma through the mid-1990s, according to the state Commissioner of Mental Health.

The Court found that “Defendants, acting in concert with others, embarked on a major campaign in which they used branded and unbranded marketing to disseminate the messages that pain was being undertreated and ‘there was a low risk of abuse and a low danger’…designed to reach Oklahoma doctors through multiple means and at multiple times over the course of the doctor’s professional education and career” in the state.  The defendants were found to have deceptively marketed the concepts of “undertreatment” and “pseudoaddiction” in the effort to avoid the “addiction ditch,” to increase the volume of prescriptions and increase use by state physicians.

An Abatement Plan was relied upon to represent the cost of addiction treatment included in the: assessment and treatment at all levels for addicted individuals; supplementary treatment; public medication and disposal programs; screening; Brief Intervention and Referral to Treatment (SBIRT) for all primary care practices and emergency departments; universal screening; pain management program for state Medicaid members; education; naloxone treatment and education; law enforcement and provider licensure agency investigation activities; and perinatal preventive services.

The total yearly costs for remediation as described to the Court for 2019 is $572,102,028.  While State witnesses testified that the abatement Plan will require twenty years, the Court found that “…the State did not present sufficient evidence of the amount of time and costs necessary, beyond year one, to abate the Opioid Crisis.” Oklahoma ex rel. v. Purdue Pharma L.P. et al at 41.

In a news release, counsel for Johnson & Johnson stated that it is confident that it has strong grounds for an appeal of Oklahoma’s opioid decision. This decision is expected to influence the settlement talks taking place in Ohio currently related to thousands of pending lawsuits against twenty-two opioid manufacturers and distributors, including Purdue.

Phillips Murrah announces 48 attorneys named to 2020 Best Lawyers list

Phillips Murrah is proud to announce that 48 of our attorneys have been named to The Best Lawyers in America© 2020 list in Oklahoma City.

2020 Best Lawyers – Lawyers of the Year

Douglas A. Branch – Venture Capital Law

Elizabeth K. Brown – Business Organizations (including LLCs and Partnerships)

Susan E. Bryant – Securities Regulation

Michael D. Carter – Workers’ Compensation Law – Employers

Nicholle Jones Edwards – Family Law

Sally A. Hasenfratz – Land Use and Zoning Law

Dawn M. Rahme – Commercial Transactions / UCC Law

Mary Holloway Richard – Health Care Law

Jim A. Roth – Natural Resources Law

G. Calvin Sharpe – Medical Malpractice Law – Defendants

 

The Best Lawyers in America 2020

Jennifer Ivester Berry – Commercial Finance Law; Commercial Transactions / UCC Law; Real Estate Law

Douglas A. Branch – Securities / Capital Markets Law; Venture Capital Law

Elizabeth K. Brown – Business Organizations (including LLCs and Partnerships); Litigation – Trusts and Estates; Litigation and Controversy – Tax; Real Estate Law; Tax Law; Trusts and Estates

Susan E. Bryant – Securities Regulation

John M. Bunting – Commercial Litigation; Insurance Law

Catherine L. Campbell – Commercial Litigation; Litigation – Labor and Employment

A. Michelle Campney – Commercial Litigation

Michael D. Carter – Labor Law – Management; Litigation – Labor and Employment; Workers’ Compensation Law – Employers

Rodney L. Cook – Commercial Litigation; Insurance Law

Cody J. Cooper – Commercial Litigation

Bobby Dolatabadi – Corporate Law; Mergers and Acquisitions Law

Jason A. Dunn – Commercial Litigation

Joshua L. Edwards – Real Estate Law

Marc Edwards – Administrative / Regulatory Law; Commercial Litigation; Government Relations Practice

Nicholle Jones Edwards – Family Law; Family Law Arbitration

Juston R. Givens – Commercial Litigation; Insurance Law

Mark E. Golman – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

Lauren Barghols Hanna – Employment Law – Management; Litigation – Labor and Employment; Water Law

Sally A. Hasenfratz – Commercial Transactions / UCC Law; Construction Law; Land Use and Zoning Law; Real Estate Law

Terry L. Hawkins – Public Finance Law

Heather L. Hintz – Commercial Litigation

Patrick L. Hullum – Commercial Litigation

Clayton D. Ketter – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Litigation – Bankruptcy

Timothy D. Kline – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Commercial Transactions / UCC Law; Litigation – Bankruptcy

Fred A. Leibrock – Commercial Litigation; Insurance Law; Litigation – Antitrust; Litigation – ERISA; Litigation – Real Estate

Candace Williams Lisle – Commercial Litigation; Financial Services Regulation Law

Mark Lovelace – Banking and Finance Law; Business Organizations (including LLCs and Partnerships); Commercial Transactions / UCC Law

Byrona J. Maule – Litigation – Labor and Employment

Melvin R. McVay, Jr. – Banking and Finance Law; Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Financial Services Regulation Law; Litigation – Banking and Finance; Litigation – Bankruptcy; Litigation – Real Estate

Andrew S. Mildren – Administrative / Regulatory Law; Government Relations Practice; Real Estate Law

Jennifer L. Miller – Commercial Litigation

Cindy H. Murray – Real Estate Law

Robert O. O’Bannon – Business Organizations (including LLCs and Partnerships); Private Funds / Hedge Funds Law; Tax Law

Martin G. Ozinga – Commercial Litigation; Information Technology Law; Technology Law

Donald A. Pape – Banking and Finance Law; Financial Services Regulation Law

Michael R. Perri – Commercial Litigation; Energy Law; Natural Resources Law; Oil and Gas Law

William S. Price – Government Relations Practice

Dawn M. Rahme – Commercial Transactions / UCC Law; Litigation and Controversy – Tax; Tax Law; Trusts and Estates

Mary Holloway Richard – Health Care Law

Jim A. Roth – Energy Law; Energy Regulatory Law; Environmental Law; Government Relations Practice; Natural Resources Law

G. Calvin Sharpe – Insurance Law; Medical Malpractice Law – Defendants; Personal Injury Litigation – Defendants; Product Liability Litigation – Defendants

Robert N. Sheets – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Litigation – Bankruptcy; Litigation – Land Use and Zoning; Litigation – Real Estate

Ellen K. Spiropoulos – Corporate Law; Mergers and Acquisitions Law

D. Craig Story – Business Organizations (including LLCs and Partnerships)

Amy D. White – Commercial Litigation; Product Liability Litigation – Defendants

Lyndon W. Whitmire – Commercial Litigation; Product Liability Litigation – Defendants

Thomas G. Wolfe – Bet-the-Company Litigation; Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Oil and Gas Law; Product Liability Litigation – Defendants

Raymond E. Zschiesche – Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Product Liability Litigation – Defendants

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.

Mary Holloway

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.

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

Data breaches still HIPAA compliance concern for healthcare providers

cyber breach artworkHIPAA concerns, established in 1996 and evolving ever since, continue to be a very real compliance concern for healthcare providers. As an example, last year HHS collected $28.7 million from providers of healthcare services and payors for responses to HIPAA data breaches that HHS considered inadequate.

According to Modern Healthcare, this is $5.2 million over the prior high for settlement and penalties reported in 2016.  The data for 2018 may be skewed by the $16 million settlement by Anthem for a breach involving approximately 79 million people. That breach occurred in 2015, and the settlement was record-setting for the Office of Civil Rights.

Changes being discussed by HHS include the possibility of sharing a percentage of civil monetary penalties or monetary settlements with affected individuals; revisions to HIPAA rules that facilitate the additional information demanded by coordinated care, outcome-focused care and value-based payments; and reconciliation of behavioral health care’s 42 CFR Part 2 rules with HIPAA.


Mary Holloway Richard portrait

Mary Holloway Richard

If you are concerned about how this issue affects your business or practice, contact Mary Holloway Richard, who represents and counsels clients on issues including healthcare compliance, health services contracting, reimbursement audits and appeals, OIG investigations, and regulatory and corporate matters. 

Mary can be reached at 405.552.2403 or at mhrichard@phillipsmurrah.com.

Click here to view Mary’s Attorney Profile page.

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.

Phillips Murrah announces 44 attorneys named to 2019 Best Lawyers list

Phillips Murrah is proud to announce that 44 of our attorneys have been named to The Best Lawyers in America© 2019 list in Oklahoma City.

2019 Best Lawyers – Lawyers of the Year

Douglas A. Branch – Venture Capital Law

Susan E. Bryant – Securities Regulation

Terry L. Hawkins – Public Finance Law

Michael R. Perri – Natural Resources Law

Thomas G. Wolfe – Product Liability Litigation – Defendants

 

The Best Lawyers in America 2019

Jennifer Ivester Berry – Commercial Transactions / UCC Law; Real Estate Law

Douglas A. Branch – Securities / Capital Markets Law; Venture Capital Law

Elizabeth K. Brown – Business Organizations (including LLCs and Partnerships); Litigation – Trusts and Estates; Litigation and Controversy – Tax; Tax Law; Trusts and Estates

Susan E. Bryant – Securities Regulation

John M. Bunting – Insurance Law

Catherine L. Campbell – Commercial Litigation

Michael D. Carter – Labor Law – Management; Workers’ Compensation Law – Employers

Rodney L. Cook – Commercial Litigation; Insurance Law

Bobby Dolatabadi – Corporate Law; Mergers and Acquisitions Law

Jason A. Dunn – Commercial Litigation

Joshua L. Edwards – Real Estate Law

Marc Edwards – Administrative / Regulatory Law; Commercial Litigation; Government Relations Practice

Nicholle Jones Edwards – Family Law

Juston R. Givens – Commercial Litigation

Mark E. Golman – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

Sally A. Hasenfratz – Commercial Transactions / UCC Law; Construction Law; Land Use and Zoning Law; Real Estate Law

Terry L. Hawkins – Public Finance Law

Heather L. Hintz – Commercial Litigation

Patrick L. Hullum – Commercial Litigation

Clayton D. Ketter – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation

Timothy D. Kline – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Commercial Transactions / UCC Law; Litigation – Bankruptcy

Fred A. Leibrock – Commercial Litigation; Insurance Law; Litigation – Antitrust; Litigation – ERISA; Litigation – Real Estate

Candace Williams Lisle – Commercial Litigation

Mark Lovelace – Banking and Finance Law; Business Organizations (including LLCs and Partnerships); Commercial Transactions / UCC Law

Melvin R. McVay, Jr. – Banking and Finance Law; Commercial Litigation; Litigation – Banking and Finance; Litigation – Bankruptcy; Litigation – Real Estate

Andrew S. Mildren – Administrative / Regulatory Law; Government Relations Practice; Real Estate Law

Jennifer L. Miller – Commercial Litigation

Cindy H. Murray – Real Estate Law

Robert O. O’Bannon – Business Organizations (including LLCs and Partnerships); Tax Law

Martin G. Ozinga – Commercial Litigation; Technology Law

Donald A. Pape – Banking and Finance Law

Michael R. Perri – Commercial Litigation; Energy Law; Natural Resources Law; Oil and Gas Law

William S. Price – Government Relations Practice

Dawn M. Rahme – Commercial Transactions / UCC Law; Litigation and Controversy – Tax; Tax Law; Trusts and Estates

Mary Holloway Richard – Health Care Law

Jim A. Roth – Energy Law; Energy Regulatory Law; Environmental Law; Government Relations Practice; Natural Resources Law

G. Calvin Sharpe – Medical Malpractice Law – Defendants; Personal Injury Litigation – Defendants; Product Liability Litigation – Defendants

Robert N. Sheets – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Litigation; Litigation – Bankruptcy; Litigation – Land Use and Zoning; Litigation – Real Estate

Ellen K. Spiropoulos – Corporate Law; Mergers and Acquisitions Law

D. Craig Story – Business Organizations (including LLCs and Partnerships)

Amy D. White – Commercial Litigation; Product Liability Litigation – Defendants

Lyndon W. Whitmire – Commercial Litigation; Product Liability Litigation – Defendants

Thomas G. Wolfe – Bet-the-Company Litigation; Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Oil and Gas Law; Product Liability Litigation – Defendants

Raymond E. Zschiesche – Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Product Liability Litigation – Defendants

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)?

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.

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 Paula Burkes
Original article: https://newsok.com/article/5601938/qa-with-mary-holloway-richard-u.s.-businesses-react-to-newly-enforced-eu-privacy-law

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.

oklahoma city health care attorney mary richard

Mary Holloway Richard

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.

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.

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.

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. 

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.

oklahoma city health care attorney mary richard

Mary Richard is recognized as one of the 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.

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

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?

Mary Richard is recognized as one of the 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.

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

Click to see Mary Holloway Richard’s attorney profile

Phillips Murrah announces 37 attorneys named to 2018 Best Lawyers list

Phillips Murrah is proud to announce that 37 of our attorneys have been named to The Best Lawyers in America© 2018 list in Oklahoma City.

The Best Lawyers in America 2018

Jennifer Ivester Berry – Commercial Transactions / UCC Law; Real Estate Law

Douglas A. Branch – Securities / Capital Markets Law; Venture Capital Law

Elizabeth K. Brown – Litigation – Trusts and Estates; Litigation and Controversy – Tax; Tax Law; Trusts and Estates

Michael D. Carter – Workers’ Compensation Law – Employers

Rodney L. Cook – Insurance Law

Bobby Dolatabadi – Corporate Law; Mergers and Acquisitions Law

Jason A. Dunn – Commercial Litigation

Joshua L. Edwards – Real Estate Law

Marc Edwards – Administrative / Regulatory Law; Commercial Litigation; Government Relations Practice

Nicholle Jones Edwards – Family Law

Shannon K. Emmons – Commercial Litigation; Employment Law – Management; Employment Law – Individuals

Juston R. Givens – Commercial Litigation

Sally A. Hasenfratz – Commercial Transactions / UCC Law; Construction Law; Land Use and Zoning Law; Real Estate Law

Terry L. Hawkins – Public Finance Law

Heather L. Hintz – Commercial Litigation

Timothy D. Kline – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law; Commercial Transactions / UCC Law; Litigation – Bankruptcy

Fred A. Leibrock – Commercial Litigation; Insurance Law; Litigation – Antitrust; Litigation – ERISA; Litigation – Real Estate

Candace Williams Lisle – Commercial Litigation

Mark Lovelace – Banking and Finance Law; Business Organizations (including LLCs and Partnerships); Commercial Transactions / UCC Law

Melvin R. McVay, Jr. – Banking and Finance Law; Commercial Litigation; Litigation – Banking and Finance; Litigation – Bankruptcy; Litigation – Real Estate

Andrew S. Mildren – Administrative / Regulatory Law; Government Relations Practice

Jennifer L. Miller – Commercial Litigation

Cindy H. Murray – Real Estate Law

Robert O. O’Bannon – Business Organizations (including LLCs and Partnerships); Tax Law

Martin G. Ozinga – Commercial Litigation

Donald A. Pape – Banking and Finance Law

Michael R. Perri – Commercial Litigation; Energy Law; Natural Resources Law; Oil and Gas Law

William S. Price – Government Relations Practice

Dawn M. Rahme – Commercial Transactions / UCC Law; Litigation and Controversy – Tax; Tax Law; Trusts and Estates

Mary Holloway Richard – Health Care Law

Jim A. Roth – Energy Law; Energy Regulatory Law; Environmental Law; Government Relations Practice; Natural Resources Law

G. Calvin Sharpe – Medical Malpractice Law – Defendants; Personal Injury Litigation – Defendants

Robert N. Sheets – Commercial Litigation; Litigation – Land Use and Zoning; Litigation – Real Estate

Ellen K. Spiropoulos – Corporate Law

Lyndon W. Whitmire – Commercial Litigation; Product Liability Litigation – Defendants

Thomas G. Wolfe – Bet-the-Company Litigation; Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Product Liability Litigation – Defendants

Raymond E. Zschiesche – Commercial Litigation; Mass Tort Litigation / Class Actions – Defendants; Product Liability Litigation – Defendants

Mary Holloway Richard sourced in article investigating hospital merger

Mary Holloway 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.

Mary Holloway Richard, Phillips Murrah Of Counsel Attorney and leader of the Firm’s Health Care Practice, was quoted in a Journal Record article by Sarah Terry-Cobo regarding an attempted merger by OU Medical System and how best to financially achieve that mission.

Read Richard’s comments from the article below:

OKLAHOMA CITY – When it comes to complicated relationships, sometimes it just takes the right partner. After a failed hospital merger was announced Monday, OU Medical System could still find its better half.

But making that match probably won’t be easy, said industry observers. Health care attorney Mary Holloway Richard said a potential partner needs the business expertise as well as the financial backing to purchase a large teaching hospital.

Richard said teaching hospitals have historically had higher costs than non-academic hospitals.

A potential partner has to evaluate the economic feasibility, regardless of whether parties are considering an outright acquisition or a joint venture, she said.

“Will it fit in with your overall business model?” Richard said. “(A teaching hospital) is a complex system, so how you incorporate that complex system into an existing system requires mastery of both the business model and the financial feasibility, as well as recognition of the compliance issues at play.”

Read the full article at the Journal Record.

50 Making a Difference profile: Mary H. Richard, J.D.

From The Journal Record / by Jessica Mitchell
Published: November 3, 2016
Click to see full story – 50 Making a Difference profile: Mary H. Richard, J.D.

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.

For Mary Richard, the main thing is to keep the main thing the main thing.

“Life will do everything in its power to distract you and sway you from your path,” Richard said. “It is vital to have courage, foresight and conviction to take risks and embrace change – and for the next generation to see you live your life in this way.”

Richard, who has a master’s in public health and a law degree, took 10 years off from her successful legal career to raise her three children – Katherine, Andrew and Claire. When they were grown, she returned to full-time practice.

“Re-entering the workforce took some courage,” she said. “Regulations were nearly unrecognizable from the beginning of my career, technological advances meant playing in a different league, and the issues facing health care providers had become increasingly more important.”

Richard tackled the challenges to continue her dedication to health care law and to expand her practice to include mental health issues. Today, Richard is an attorney of counsel for Phillips Murrah PC and adjunct law professor at Oklahoma City University.

“Some of the most fulfilling work I do combines helping families, patients and their providers navigate the labyrinth of regulations surrounding mental health with the requisite skill and empathy,” Richard said. “For me, this has become more essential as mental health law has become more arcane.”

Richard’s dedication to the broader community is as obvious as was her dedication to her young family when the children were growing up, said U.S. District Judge Stephen P. Friot.

“Mary has recommitted herself to the practice of law with a level of energy and dedication that would be admirable in a 30-year old lawyer. The short of the matter is that Mary no longer has anything to prove, as a professional, a wife, a mother or a humanitarian, but she keeps on proving it.”

Richard has served in various leadership positions with the Mental Health Association Oklahoma, Oklahoma Health Lawyers Association and Oklahoma Bar Association Health Law Section and has been instrumental in establishing a webcast series on vulnerable populations that has focused on the mentally ill, the elderly, children and education for the disabled.

“Through my law practice, community service and adjunct professorship, I have had the opportunity to help correct, in some small measure, our state’s failures to provide adequate services to the mentally ill and those suffering from substance abuse disorders,” Richard said. “I believe strongly in educating lawyers, law students and families about the significant and increasingly complex legal issues facing mental health patients, their families, governmental units and health service providers.”

She and her husband, Dr. James M. Richard, live in Oklahoma City.

Attorneys present at PLICO Healthcare Summit

Mary Holloway Richard

Mary Holloway Richard, Renee M. Brown, and Candace Williams Lisle at the PLICO EXPLORE Healthcare Summit on August 11, 2016.

Phillips Murrah attorneys Mary Holloway Richard and Candace Williams Lisle spoke on audits in the health care industry at the PLICO EXPLORE Healthcare Summit in Norman, OK on August 11.

They presented “Driving Success: Using Internal and Payor Audits to your Benefit” with Renee M. Brown, CMIS, ACS-EM, CHA and covered:

  • regulatory reviews
  • federal health care (Medicare) contractors and oversight
  • appeals
  • external audits
  • False Claims Act
  • Medicaid
  • compliance plans, and
  • commercial payors.

For more information about the PLICO EXPLORE Healthcare Summit, click here.

Journal Record names three attorneys Woman of the Year

woty-web-logo-2016The Journal Record will honor Phillips Murrah directors Sally A. Hasenfratz, Dawn M. Rahme, and attorney Mary Holloway Richard as those named on the 2016 Fifty Making A Difference list.

Judge Jane P. Wiseman will be the keynote speaker at the 2016 Journal Record Woman of the Year gala set for Nov. 2 at the National Cowboy & Western Heritage Museum.

The Fifty Making A Difference list spotlights female business and community leaders, and honorees are chosen from nominations received across the state.

For more information, visit the Journal Record’s website.

Phillips Murrah attorney named to Mental Health Association Oklahoma’s Advisory Council

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.

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.

A new opportunity for Phillips Murrah Attorney Mary Holloway Richard will help her continue her work of increasing visibility of mental health issues in Oklahoma.

Richard has joined Mental Health Association Oklahoma’s Advisory Council based in Tulsa, Oklahoma.

Partnered with the Homeless Alliance, Mental Health Association Oklahoma has a variety of programs including youth wellness screenings, support groups and legal services. These programs focus on housing, education, advocacy, support, and recovery to those affected by mental disorders.

To learn more about Mental Health Association Oklahoma and the programs they provide, visit their website here.

Attorney teaches Behavioral Health Law course at OCU

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.

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.

Phillips Murrah Attorney Mary Holloway Richard is teaching Behavioral Health Law at the Oklahoma City University School of Law this Spring semester.

The course will cover a broad spectrum of behavior health topics including: basic mental illness diagnoses, licensure laws related to behavioral health providers of all types, reimbursement and financing issues, liability concepts related to the dangerous patient, consent and release of information, social and community responses to mental illness and substance abuse disorders and current policy and regulatory developments in the field, Richard said.

In conjunction with the American Health Lawyers Association’s Behavioral Health Task Force of which she is Vice Chair, Richard plans to bring in speakers from across the state and give the class better exposure to the subject matter, to the larger context of the healthcare industry and to people who work in the field, she said.

This class follows Richard’s Fall course which was a survey and introductory course to Health Law.

Phillips Murrah attorneys support i2E 2015 BrewFest

Attorneys Monica Ybarra, Dawn Rahme, and Erica Halley at Brewfest

Attorneys Monica Ybarra, Dawn Rahme, and Erica Halley at Brewfest.

Hundreds of patrons filled the Chickasaw Bricktown Ballpark on Nov. 5 to support i2E’s (Innovation to Enterprise) annual OKBio BrewFest.

“The intellectual activity surrounding the annual i2E BrewFest channels the exciting physical changes in downtown Oklahoma City, the Oklahoma Health Center, Bricktown, Deep Deuce and the state,” Attorney Mary Holloway Richard said. “Where else can you find entrepreneurs mingling to discuss their business plans and dreams with one another and with support professionals like the Phillips Murrah team that supports technical businesses as they establish themselves and expand?”

“From conversations with a graduate student physiologist focusing on lessening the impact of retinitis pigmentosa to discussions with an OCU Botany professor and a young distiller known for his marketing genius who is expanding into new markets—all this on a beautiful fall evening at the ballpark.  Helping clients achieve their business goals in research, health care, product development is a exciting as it gets.”

Lauren Branch and her husband Phillips Murrah Director Doug Branch.

Lauren Branch and her husband Phillips Murrah Director Doug Branch at Brewfest.

The event featured samples from 23 of Oklahoma’s local craft beer, wine and spirits producers.

“OKBio BrewFest is an annual fall event to shine a spotlight on bio in Oklahoma and provide support for OKBio, which among other things provides BIO International scholarships to Oklahomans every year,” said i2E President Scott Meacham in an article about BrewFest.

Other event sponsors include Crowe & Dunlevy, Foundation HealthCare, Greater Oklahoma City Chamber, Oklahoma Gazette, Hall Estill, Caisson Biotech, Hit Design, VWR International, McAfee & Taft, Dunlap Codding, and Woodland & Associates.

Read more about BrewFest here.

Attorney Mary Holloway Richard moderates webcast for OBA

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.

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.

Phillips Murrah Health Care Attorney Mary Holloway Richard hosted a webcast October 28 for the Health Law Section of the Oklahoma Bar Association.

“The presentation is entitled ‘Representing Vulnerable Populations: Behavioral Health Patients and Families,’ Richard said. “The webcast covers psychiatric diagnoses, emergency detention and involuntary admissions, confidentiality of information and other topics which will be useful to attorneys across the state called upon to represent behavioral health patients and their families.”

Richard served as moderator and presenter along with Judge Don Andrews, District Judge Oklahoma County formerly assigned to the Mental Health docket; Dr. Britta Ostermeyer, chairman Department of Psychiatry at the University of Oklahoma College of Medicine; and Dewayne Moore, general counsel of the Oklahoma Department of Mental Health and Substance Abuse Services.

The presentation was offered for Continuing Legal Education credit and will be made available by the OBA here.

 

Attorney Mary Holloway Richard sourced in CARE Act article

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.

Phillips Murrah Attorney Mary Holloway Richard was featured as a source in a Journal Record article by Sarah Terry-Cobo.

The article, titled “Complex prognosis: Hospital group, AARP disagree on CARE Act,” focuses on the 2014 Oklahoma Caregiver Advise, Record, Enable Act and the protections it adds.

From the article:

Mary Holloway Richard, a health care attorney at Phillips Murrah, said the CARE Act doesn’t provide anything fundamentally different for elderly patients than laws in place before it was passed. Though the caregiver designation is different than a legal power of attorney, the patient still must sign a written release before the hospital can give out information to another person, she said.

“You could achieve the same thing if you got a release-from-patient for my best friend or my cousin, and in the discharge note you explain the care plan, and the patient gives you the release,” Richard said.

Read the rest of the Journal Record article here.

 

PM attorney Mary Richard appointed vice chair of AHLA Behavioral Health Task Force

Mary Holloway Richard, Of Counsel to Phillips Murrah’s Healthcare Practice Group, has been appointed Vice Chair of the American Health Lawyers Association’s Behavioral Health Task Force.

AHLA-logo-bigRichard was formerly a co-chair of the Providers and Clinicians Committee of the Behavioral Health Task Force.

She has represented both institutional and non-institutional providers of health services, as well as patients and their families.  Her career has included work at hospitals, outpatient clinics, behavioral health facilities and rehabilitation facilities and clinics.

Richard will be participating in a panel discussion entitled “Hot Topics in Behavioral Health” at the AHLA Annual Meeting in Washington, D.C. in June, 2015.

The Behavior Health Task Force was established by the nationwide professional organization to provide education for attorneys about the legal issues that arise in the provision of services to behavioral health patients and to alcohol and drug treatment providers and patients.

NewsOK Q&A: Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

From NewsOK / by Paula Burkes
Published: May 1, 2015
Click to see full story – Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

Click to see Mary Holloway Richard’s attorney profile

Phillips Murrah’s Mary Holloway Richard provides medical providers tips for minimizing risk and damages related to health information breaches.

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.

Q: What do you recommend to hospitals, physicians and other providers to minimize the risk of a breach of confidential patient information and to lessen the degree of harm in the event of a breach?

A: I recommend creation in advance of a response process to enable a rapid, sensible response. The goals in such a plan (“Incident Response Plan” or “IRP”) are to demonstrate compliance with HIPAA (Health Insurance Portability and Accountability Act) and HITECH (Health Information Technology for Economic and Clinical Health) regulations and to mitigate any harm that may result from the breach.

Q: What specific steps should be taken to prepare for a breach?

A: The first step is to create an IRP that includes all appropriate parties and to appoint someone in the practice or facility who is knowledgeable about HIPAA and HITECH requirements. The second step is to make certain that the process created is a quick, sensible one. In addition, information technology (IT) components, such as encryption throughout the process, are imperative. The safe harbor provision of the breach notification rule establishes a certain standard of encryption and relieves the provider from breach notification responsibilities if the protected patient information has been properly encrypted. Most breaches result from lost IT assets such as phones, laptops and iPads. Fourth, the IRP must be supported by sufficient employee and staff training. I also recommend that you adequately document that this training took place. Finally, insurance should be in place to provide for risk transfer as needed. Cyberliability is a continually developing area along with a range of products that foresee types of breaches and predict costs that may be incurred.

Q: How do such losses occur?

A: Along with loss of IT assets, misdirected faxes, disposal of nonshredded records, inappropriate disposal or destruction of paper, such as placing material in a dumpster without shredding and mailing patient information to incorrect address. Intentional loss or compromise of data can occur through a combination of IT and social engineering, such as where a person is tricked into clicking on a hyperlink or revealing a password. This occurs with Spear phishing or false emails inserting malware in a system and is very difficult to control. In the case of Cryptolocker, the perpetrator makes a threat and requires payment to restore prevention. This also is called ransomware and can make the system and information completely inaccessible to everyone in your organization, effectively stymieing patient care and business operations.

Resolution of the “sustainable growth rate” issue

By Mary Holloway Richard.  View her attorney profile here.


medicare

Senate Passes the bill repealing Medicare’s sustainable growth rate (“SGR”) formula just in time to avoid the looming cuts (21%) to physician payments.

(See HERE our ongoing coverage leading up to this.)

Congressional members are purportedly patting themselves on the back as the bill goes to the President who has given assurances that he will sign it.

In the past weeks we have discussed possible amendments, but none of the amendments are included in the final legislation approved by the Senate.  The bill extends the Children’s Health Insurance Program (“CHIP”) for two years.  The bill also provides physician incentives sure to impact both reimbursement and physician contracting include incentives to shift more patients to risk-based payment models.  For physicians who are successful in this effort, as interpreted by CMS, the reimbursement will increase in 2019.

Approximately one-third of the cost of this package is offset by financial cuts to providers and increased costs to wealthier Medicare patients.  The bill also includes additional funding for community health centers and a six-month delay in the enforcement of the payment policy for short inpatient stays known as the “two midnights” rule.

Mary Holloway Richard is recognized as one of the 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.

(UPDATE) What does all of the talk in the media about the “SGR” mean for physicians?

By Mary Holloway Richard. View her attorney profile here.


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.

(Updated 4/14/15)

What does all of the talk in the media about the “SGR” mean for physicians?

One of the important issues identified in the health care industry “crisis” and reform is the cost of providing services.  Focus has been on shifting payment from charges for visits and procedures to reimbursement according to certain metrics such as outcome and quality.  In addition, a ceiling on physician reimbursement has been much debated.  The Affordable Care Act (“ACA”) included the Medicare sustainable growth rate (“SGR”) formula for doing just that, although the SGR was actually created as part of the 1997 deficit reduction law designed to contain federal spending  by tying physician payments to an economic metric or growth target.

On Tuesday, March 24, 2015, Democrats and Republicans revealed the result of their negotiation and cooperation to offer an alternative to Medicare’s SGR formula.  The proposal calls for repeal of the SGR formula.  House Speaker John Boehner (R-OH) and Minority Leader Nancy Pelosi (D-CA) have arrived at this compromise to strengthen the financial picture for Medicare and to end the continuing threat of payment cuts to physicians.  According to the Association of American Medical Colleges, although medical school applications are up slightly since 2011, the United States faces a physician shortage of between 46,000 and 90,000 by 2015.  www.aamc.org/newsroom/aamcstat/,a=427828.  The economic incentives to the professional are an integral component in stabilizing the health care system in this country.  The House overwhelmingly approved the proposal on Thursday, March 26, 2015.

What does the SGR mean to physicians?  There is still great divergence between the Boehner (repeal Washington’s most famous gimmick) and Pelosi (Medicare payments for doctor services to seniors facilitating continuation of physician-patient relationship) perspectives.

What does the bipartisan proposal mean to physicians?  This will halt the cut that was to be implemented on April 1, 2015.  When the ACA was signed five years ago, that seemed like a long time away but was nonetheless worrisome.  It puts in place a 21.2% reduction in Medicare payments making it virtually impossible for many providers to support the operations of their practices or clinics.

This proposal is very similar to the one proposed in 2014 , and it includes a system of rewarding physicians based upon quality standards rather than output or number of services provided and fosters a focus on coordination of care, prevention and quality and key cost containment strategies.  All of these elements are part of a new accountability that is the cornerstone for allowing payment increases for doctors for the next five years during this period of transition.  In addition, if approved by the Senate, the bipartisan proposal would extend the Children’s Health Insurance Program (“CHIP”) with full funding through September 30, 2017.  It also provides for $7.2 billion funding for community health centers.  The cost of the House package is $200 billion

On Friday, March 27, 2015, the Senate adjourned without approving the Doc fix.  It apparently will take up the issue upon its return in mid-April.  In the meantime, CMS is poised to delay processing provider claims as of April 1, 2015, when the 21.2% cut was to go into effect.  However, CMS is warning that the cut will go into effect if the Senate fails to pass an SGR fix by April 15.  One complication may exist in the form of legislation introduced by a bipartisan Senate team, Senators Cardin (D-MD) and Collins (R-ME), to permanently repeal the caps on how much the program spends on rehabilitation therapy.  This unresolved issue may arise as an amendment to the legislation to be considered after the break and provides a reminder of how single issues or senators can ultimately frustrate the passage of legislation that has support from both parties.  Others in the Senate are critical that spending cuts will offset only a portion of the costs.  Conservatives have characterized this element of the plan as irresponsible.  The AARP is focused on increased costs to Medicare beneficiaries and will continue to lobby for changes to lower these costs.

Democrats may want amendments to extend the CHIP program four years, to remove the Hyde Amendment (abortion-related language), and to repeal the Medicare therapy cap.  Any amendments would, of course, send the legislation back through the House, and this appears to be an unattractive alternative to all concerned because of the remarkable support for this resolution from both parties.  A perhaps more significant complication is presented by the report issued last week by the Office of the Actuary of the Centers for Medicare and Medicaid Services (CMS) indicating that physician payments in which the 0.5% increases in Medicare payments over the next four years would come to a halt in 2020.  In that year a two-tiered system is phased in which is designed to encourage physicians to shift greater numbers of patients into risk-based models.  For physicians continuing to work within the traditional payment system, but who are scoring well on the quality metrics, remuneration will be awarded from a separate appropriation.  After 2024, the alternative payment track would increase annually by 0.75% which will be three times greater than the rates of other physicians. CMS is predicting that 2024 is the time when there will be a shortfall and payments will lag behind inflation.

On the one hand, Congress is fed up with required annual intervention for the past seventeen years to avoid scheduled cuts to physicians.  On the other hand, Congress is forced to rely on estimates to predict costs which places the federal government at risk of future payments not keeping up with the either the chosen formulae or with inflation.

(UPDATE) A look at the controversial Affordable Care Act on its fifth anniversary

By Mary Holloway Richard. View her attorney profile here.


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.

(Updated 4/7/15)
President Obama has taken the occasion of the fifth anniversary of the signing of the Affordable Care Act (“ACA”) to characterize continued activities on the Hill to repeal it as renegade special interest activities. The ACA continues to be a subject of debate both in terms of its accomplishments—how many are newly covered and how much will be saved—and in terms of its public support.

While the Associated Press reported on March 23, 2015, that public support was down 5% since its passage, as one who daily writes and advises health care clients on matters related to the ACA, I can say with certainty that the depth and breadth of increased regulation spawned by the ACA are changing the nature of the system.

Those changes include responsive movement toward integrated health systems, mergers and affiliations; transition from quantity- to quality-based reimbursement; the relaxation of HIPAA standards in some respects and its tightening in others in the context of EHR transformation; and increased direct and indirect costs to employers as a result of new responsibilities.

Nearly fifty changes have been made to the ACA as of March 2, 2015, and this suggests a continuing need for providers, employers and business owners to remain informed and responsive to the moving regulatory compliance target.

On Monday, March 30 the Supreme Court rejected a new challenge to the Affordable Care Act (“ACA”)  that targeted the Independent Payment Advisory Board (“IPAB”), a 15-member government panel which has been characterized as a “death panel” because of its intended role in cutting Medicare costs.   The IPAB was to convene when the target growth rate for Medicare (3.03%) is exceeded.  However, the growth rate is 1.15% according to CMS, and so the administration has not nominated any panel members.  In declining to take up the case, the Supreme Court left undisturbed the 9th US Circuit Court of Appeals in San Francisco dismissal of the lawsuit. The proponents of the ACA are calling this a win.  Coons v. Lew, No. 14-525.   Certiorari was denied by the United States Supreme Court on March 30, 2015.