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Maryland Limits on Opioid Prescriptions.

June 30, 2017 by  
Filed under Regulatory Issues | Privacy

(June 30, 2017):  In March 2016, the Centers for Disease Control and Prevention (CDC) published “CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016” [1] in an effort to address the seemingly ever-increasing deaths that have been attributed to opioid-related overdose. A number of states have passed legislation or enacted regulatory provisions designed to better safeguard patients from abuse and the public from illegal diversion.

For instance, Indiana,[2] Ohio[3] and Kentucky,[4] have all taken action to better ensure that physicians, nurse practitioners and physician assistants with qualified to prescribe opioids do in a manner that will protect patients from abuse and the public from illegal diversion.  Many of the requirements put in place by these states track one or more of the recommendations set out in the CDC’s March 2016 guideline.  The State of Maryland is merely the latest jurisdiction to take action in this regard.  This article examines the approach that the Maryland legislative has taken and discusses the collateral impact that opioid prescribing practices can have on a provider’s license and financial health.

I.  Purpose of Maryland’s Legislation “The Prescriber Limits of 2017”:

 On May 25, 2017, Maryland Governor Larry Hogan, signed-off on The Prescriber Limits of 2017.”  The legislation was enacted as an emergency measure and was found to be needed for the immediate preservation of the public’s health and safety. As an emergency measure, it was passed by a “yea” and “nay” vote supported by three-fifths of all the members elected to the each of the two Houses of the General Assembly.

The statute’s requirements are codified in several sections of the Code of Maryland, Article – Health Occupations.  Several amendments were made to Section 1-223. As the Preamble to the legislation notes:

“The rise in overdose deaths is attributable to the surge of opioid dependence that has emerged in Maryland over the past two decades, stemming from a dramatic increase in the number of opioid medications prescribed by the medical community and the influx of cheap, potent heroin and fentanyl

II. Guidelines a Health Care Provider Must Follow When Prescribing an Opioid for Pain:

As set out under Section 1-223(B), a Maryland health care provider must base pain treatment decisions based on his / her clinical judgement.  The health care provider must prescribe:

 (1) The lowest effective dose of an opioid, and

(2) a quantity that is no greater than the quantity needed for the expected duration of pain severe enough to require an opioid that is a controlled dangerous substance unless the opioid is prescribed to treat:[5]

A substance-related disorder;

Pain associated with a cancer diagnosis;

Pain experienced while the patient is receiving end-of-life, hospice or palliative care services; or

Chronic pain.

Section 1-223(c) requires that the dosage, quantity and duration of an opioid prescribed under Section 1-223(B) SHALL “be based on evidence-based clinical guideline for prescribing controlled substances that is appropriate” for:

(1) The health care service delivery setting for the patient;

The type of health care services required by the patient; and

The age and health status of the patient.”

As Section 1-223(D) notes, if a prescribing health care provider violates one of the requirements set out under Section 1-223(B), the violation constitutes grounds for disciplinary action and the responsible Maryland Health Occupational Board[6] can take action against a licensee.

The prescriber is required to carefully document in the patient’s medical record the reasons(s) why a drug other than an opiate was not appropriate in the care and treatment of a particular patient.  Additionally, the prescriber must document that the patient is receiving palliative care or that the decision is based on the prescriber’s professional judgment that the exemption is reasonable and appropriate.

An interesting component of the law’s requirement is that a prescriber is required, if requested by a patient, the patient’s legal representative or guardian, to issue an opioid prescription for a lesser amount that the prescriber initially intended to prescribe.  The prescriber must also document in the patient’s medical records that such a request was made and who made it.

III. Maryland Licensing Boards are Authorized to Discipline Physicians, Nurse Practitioners, Physician Assistants, Podiatrists and Dentists Who Violate “The Prescriber Limits of 2017.”

As the Preamble to the legislation notes, state licensing boards play an important role in the education and supervision of licensees under their jurisdiction who prescribe opioids and other controlled substances.  It was the intent of the General Assembly that the:

“. . . State Board of Dental Examiners, State Board of Nursing, State Board of Physicians, and State Board of Podiatric Medical Examiners shall work to educate practitioners to ensure that the residents of Maryland are aware of the risks associated with the use of opioid drugs, including the risks of dependence, addiction, and overdose, and the dangers of taking an opioid drug with alcohol, benzodiazepines, and other depressants;”

  • Amendments to the Authority of the Maryland Board of Dentistry.

The amendments made to Section 4-315(a) modified the list of reasons that the Board may “deny a general license to practice dentistry, a limited license to practice dentistry, or a teacher’s license to practice dentistry to any applicant, reprimand any licensed dentist, place any licensed dentist on probation, or suspend or revoke the license of any licensed dentist.”  Under the legislation, these actions may now also be taken if an applicant or licensed dentist:

            . . .

(33) Fails to comply with any Board order; [or]

(34) Willfully and without legal justification, fails to cooperate with a lawful investigation conducted by the Board; OR

(35) Fails to comply with § 1-223 of this Article.

  • Amendments to the Authority of the Maryland Board of Nursing.

The amendments made to Section 8-316(a) modified the list of reasons that the Board may “deny a license or grant a license, including a license subject to a reprimand, probation, or suspension, to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke the license of a licensee. . .”  Under the legislation, these actions may now also be taken if an applicant or licensed nurse:

(34) When acting in a supervisory position, directs another nurse to delegate a nursing task to an individual when that nurse reasonably believes:

  • . . .

(ii) The patient’s condition does not allow delegation of the nursing task; [or]

(35) Has misappropriated the property of a patient or a facility; OR

(36) Fails to comply with the opioid prescribing limitation established under §1–223 of this article.

  • Amendments to the Authority of the Maryland Board of Medicine.

Consistent with the amendments made to Section 14-404(a), subject to the hearing provisions of §14-405 of this subtitle:

. . .a disciplinary panel, on the affirmative vote of a majority of the quorum of the disciplinary panel, may reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the licensee:

(41) Performs a cosmetic surgical procedure in an office or a facility that is not:

(ii) Certified to participate in the Medicare program, as enacted by Title XVIII of the Social Security Act; [or]

(42) Fails to submit to a criminal history records check under § 14–308.1 of this title; OR

(43) Fails to comply with the opioid prescribing limitation established under § 1–223 of this article.

  • Amendments to the Authority of the Maryland Board of Podiatric Medical Examiners.

Amendments were made to Section 16-313 to bring provisions governing applicants and licensed podiatrists into alignment with the requirements of “The Prescriber Limits of 2017.”  Amendments made include:

Subject to the hearing provisions of § 16–313 of this subtitle, the Board, on the affirmative vote of a majority of its members then serving, may deny a license or a limited license to any applicant, reprimand any licensee or holder of a limited license, impose an administrative monetary penalty not exceeding $50,000 on any licensee or holder of a limited license, place any licensee or holder of a limited license on probation, or suspend or revoke a license or a limited license if the applicant, licensee, or holder:

 (8) Prescribes or distributes a controlled dangerous substance to any other person in violation of the law, including in violation under §1–223 of this article;

IV.  Conclusion:

Physicians, nurse practitioners and physician assistants authorized to prescribe opioids and other controlled substances, need to review both the CDC guidance and any state requirements that have been issued to protect both patients and the public from abuse and diversion.  Prescriptions for opioids are continuously monitored by a variety of law enforcement agencies and government program integrity contractors. In addition to the Drug Enforcement Agency[10] (DEA), your prescribing and billing practices are actively being assessed by Medicare, Medicaid and private payor auditors and investigators.  You should monitor and audit your practices as part of your overall Compliance Program. To the extent that your prescribing and / or billing practices are different from those of your peers, there is a significant likelihood in today’s enforcement environment that you will be audited.

Should you receive an audit request from a ZPIC or UPIC, we strongly recommend that you contract a qualified health lawyer to advise you regarding the records submission and appeals process.  This initial level of the audit is a provider’s best opportunity to present his / her arguments in support of payment in a positive light.

Robert W. Liles represents licensed health care providers in connection with opioid prescribing complaints.Robert W. Liles is Managing Partner at the health law firm, Liles Parker, PLLC.  With offices in Washingtonn, DC, Houston, TX, McAllen, TX and Baton Rouge, LA, our attorneys represent pain management physicians and practices around the country in connection with Medicare / Medicaid audits, Compliance Plan reviews and state peer review actions.  Should you have any questions, please call us for a free consultation.  Robert can be reached at: 1 (800) 475-1906.  

[1] Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49. http://dx.doi.org/10.15585/mmwr.rr6501e1.

[2] A copy of Senate Enrolled Act No. 226 (SEA 226), amended the Indiana Code and established “Chapter 9.7. Prescribing and Dispensing Opioids.”  A copy of the legislation can be found at:  https://iga.in.gov/legislative/2017/bills/senate/226#document-b9523207

[3]State of Ohio, Board of Pharmacy.  “FAQ: New Limits on Prescription Opiates for Acute Pain, Updated 4/3/2017.” http://www.pharmacy.ohio.gov/Documents/Pubs/Special/ControlledSubstances/New%20Limits%20on%20Prescription%20Opiates%20for%20Acute%20Pain%20-%20Frequently%20Asked%20Questions.pdf

[4] See Kentucky House Bill 333 http://www.lrc.ky.gov/recorddocuments/bill/17RS/HB333/bill.pdf

[5] Although Maryland’s statute does not provide dosage recommendations, prescribers may wish to consider the recommendations made by the CDC in its March 2016 guidance.  As Recommendation #6 provides:

Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

[6] The State Board of Dental Examiners, State Board of Nursing, State Board of Physicians, and State Board of Podiatric Medical Examiners.

[7] HHS OIG. “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns” (OEI-02-16-00290)(Page 4). 6/21/2016. https://oig.hhs.gov/oei/reports/oei-02-16-00290.pdf

[8] Lembke A, Chen J. Use of Opioid Agonist Therapy for Medicare Patients in 2013. JAMA Psychiatry. 2016; 73(9): 990-992.

[9] Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated with opioid abuse in managed care and Medicaid patients in the United States: a comparison of two recently published studies. Journal of Pain & Palliative Care Pharmacotherapy. 2010 Sep; 24(3): 251-8.

[10] DEA is an agency of the U.S. Department of Justice. A link to the agency’s diversion program description is: https://www.deadiversion.usdoj.gov/

 

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Indiana Prescribing Guidelines–Eff. July 1, 2017.

(June 29, 2017):  Deaths resulting from a drug overdose have grown considerably in recent years.  The results of a study published in “Morbidity and Mortality Weekly Report”  by the Centers for Disease Control and Prevention (CDC) found that 63.1% of the overdose-related deaths in 2015 involved opioids. Notably, this was a significant increase from the 60.9% figure recorded in 2014.[1] The CDC has noted that overdoses from prescription opioids have been a “driving problem” contributing to this problem.[2]  In an effort to further address the opioid overdose crisis, in March 2016, the CDC published “CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016.” [3] Many states have also taken affirmative steps to ensure that their licensed prescribers of opioids are taking additional steps to safeguard both their patients and the public (from the illegal diversion of prescription drugs). Indiana has recently passed legislation in this regard.  This article examines the actions that the State of Indiana has recently taken to protect the citizens of its state from opioid-related drug death.

I. Recent Legislative Action Taken in Indiana to Address Opioid Prescribing Practices:

On April 26, 2017, Indiana Governor Eric Holcomb signed Senate Enrolled Act 226 (SEA 226) into law.  Notably, this legislation followed similar restrictive measures taken in neighboring Ohio[4] and Kentucky[5] to require that their state professional licensing boards act to ensure that licensees qualified to prescribe opioids were doing so in a manner that is consistent with the CDC’s March 2016 guideline.

II. Overview of Indiana’s Prescriber Requirements:

The provisions of SEA 226 have been codified as a new chapter to the Indiana Code and is effective on July 1, 2017.  The new chapter is Chapter 9.7 Prescribing and Dispensing of Opioids.   As Sec. 1 of Chapter 9.7 provides, the term “prescriber” refers to a practitioner who maintains an Indiana controlled substance registration AND a federal Drug Enforcement Administration registration.

Except as provided under Sec. 2(b), an Indiana qualified prescriber may only issue a prescription for an opioid if the following requirements under Sec. 2(a) are met:

“(1) If the prescription is for an adult who is being prescribed an opioid for the first time by the prescriber, the initial prescription may not exceed a seven (7) day supply.

(2) If the prescription is for a child who is less than eighteen (18) years of age, the prescription may not exceed a seven (7) day supply.”

Notably, the restrictions set out under Sec. 2(a) above do not apply if one of the following circumstances outlined under Sec. 2(b)(1) or (2) is met:

“(1) The prescriber is issuing the prescription for the treatment or provision of any of the following:

(A) Cancer.
(B) Palliative care.
(C) Medication-assisted treatment for a substance use disorder.
(D) A condition that is adopted by rule by the medical licensing board under IC 25-22.5-13-8 to be necessary to be exempted from subsection (a).

(2) If, in the professional judgment of a prescriber, a patient requires more than the prescription limitations specified in subsection (a).”

As the code provisions further reflect, an Indiana prescriber must take care whenever issuing a prescription under the exceptions discussed above in Sec. 2(b)(1) and Sec. 2(b)(2).  Under the provisions of Sec.2(c), if a prescriber:

“(1) determines that a drug other than an opioid is not appropriate; and

(2) uses an exemption specified in subsection (b)(1)(B) or (b)(2) and issues a prescription for a patient that exceeds the limitations set forth in subsection (a);”

The prescriber is required to carefully document in the patient’s medical record the reasons(s) why a drug other than an opiate was not appropriate in the care and treatment of a particular patient.  Additionally, the prescriber must document that the patient is receiving palliative care or that the decision is based on the prescriber’s professional judgment that the exemption is reasonable and appropriate.

An interesting component of the law’s requirement is that a prescriber is required, if requested by a patient, the patient’s legal representative or guardian, to issue an opioid prescription for a lesser amount that the prescriber initially intended to prescribe.  The prescriber must also document in the patient’s medical records that such a request was made and who made it.

III. Conclusion:

Physicians, nurse practitioners and physician assistants authorized to prescribe controlled substances (especially opioids) need to review both the CDC guidance and any state requirements that have been issued to protect both patients and the public from abuse and diversion.  Your prescribing practices are continuously being monitored by Medicare, Medicaid and private payors.  You should monitor and audit your practices as part of your overall Compliance Program. To the extent that your prescribing practices are different from those of your peers, there is a significant likelihood in today’s enforcement environment that you will be audited.

Should you receive an audit request from a NBI MEDIC, UPIC or ZPIC we strongly recommend that you contract a qualified health lawyer to advise you regarding the records submission and appeals process.  This initial level of the audit is a provider’s best opportunity to present his / her arguments in support of payment in a positive light.

Robert W. Liles is Managing Partner at the health law firm, Liles Parker, PLLC.  With offices in Washington, DC, Houston, TX, and Baton Rouge, LA, our attorneys represent pain management physicians and practices around the country in connection with Medicare / Medicaid audits, Compliance Plan reviews and state peer review actions.  Should you have any questions, please call us for a free consultation.  Robert can be reached at: 1 (800) 475-1906.  

[1] Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016. DOI: http://dx.doi.org/10.15585/mmwr.mm6550e1

[2].https://www.cdc.gov/drugoverdose/epidemic/index.html

[3] Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65:1-49. http://dx.doi.org/10.15585/mmwr.rr6501e1.

[4]State of Ohio, Board of Pharmacy.  “FAQ: New Limits on Prescription Opiates for Acute Pain, Updated 4/3/2017.” http://www.pharmacy.ohio.gov/Documents/Pubs/Special/ControlledSubstances/New%20Limits%20on%20Prescription%20Opiates%20for%20Acute%20Pain%20-%20Frequently%20Asked%20Questions.pdf

[5] See Kentucky House Bill 333 http://www.lrc.ky.gov/recorddocuments/bill/17RS/HB333/bill.pdf

[6] HHS OIG. “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns” (OEI-02-16-00290)(Page 4). 6/21/2016. https://oig.hhs.gov/oei/reports/oei-02-16-00290.pdf

[7] Lembke A, Chen J. Use of Opioid Agonist Therapy for Medicare Patients in 2013. JAMA Psychiatry. 2016; 73(9): 990-992.

[8] Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated with opioid abuse in managed care and Medicaid patients in the United States: a comparison of two recently published studies. Journal of Pain & Palliative Care Pharmacotherapy. 2010 Sep; 24(3): 251-8.

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Opioid Prescribing Practices & NBI MEDIC / UPIC / ZPIC and Board Actions.

June 29, 2017 by  
Filed under Regulatory Issues | Privacy

(June 29, 2017):  It has been estimated that from 1999 to 2014, more than 165,000 persons died from an overdose of opioid medications in the United States.  Researchers also noted that during this same time period, sales of opioids increased in proportion to the rise in deaths resulting from an opioid-related overdose.  In an effort to better protect patients from opioid abuse and the public from illegal opioid diversion, state and federal agencies have ramped up their audit and investigation efforts of physician, nurse practitioner, physician assistant, podiatrist and dentist opioid prescribing practices.  The Centers for Disease Control and Prevention (CDC) has taken a central role in establishing recommendations and guidance on the ordering of opioids by qualified prescribers when treating patients who suffer from chronic pain. In March 2016, the CDC published The CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.”  As the document reflects, the CDC expressly intended for the guidance to:

  • Help ensure that clinicians and patients consider safer and more effective treatment;

  • Improve patient outcomes such as reduced pain and improved function, and

  • Reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs.

Over the past year, a number of state legislatures and professional licensing boards have followed-up with their own restrictions and / or guidance on the parameters to be observed when when writing a prescription for opioids or other controlled substances.  This article looks back at the CDC guidelines and examines the primary recommendations made by the agency.

I.  Overview of the CDC’s Recommendations When Prescribing Opioids:

Although voluntary, the CDC guidance notes that a qualified health care provider’s decision to prescribe opioids should take a number of factors into account.  A summary of the CDC’s recommendations are set out below:

Determining When to Initiate or Continue Opioids for Chronic Pain.

Recommendation #1: Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

Recommendation #2: Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

Recommendation #3: Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation.

Recommendation #4: When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

Recommendation #5: When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ?50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ?90 MME/day or carefully justify a decision to titrate dosage to ?90 MME/day.

Recommendation #6: Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

Recommendation #7: Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing Risk and Addressing Harms of Opioid Use.

Recommendation #8: Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (?50 MME/day), or concurrent benzodiazepine use, are present.

Recommendation #9: Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

Recommendation #10: When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

Recommendation #11: Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

Recommendation #12: Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

II. Purpose of the CDC Prescribing Guidelines:

Importantly, the March 2016 guidance issued by the CDC was not intended to serve as a restrictive set of guidelines that would prevent a prescribing physician from exercising his or her independent medical judgement.  As the Director for the CDC’s National Center Injury Prevention and Control wrote in response to the concerns of a patient suffering from pain:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain.  It helps physicians assess how to safely maintain or discontinue opioid use in patients who are currently on an opioid treatment plan.  Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.  The Guideline is not a rule, regulation or law.  It is not intended to deny access to opioid pain medication as an option for pain management.  It is not intended to take away physician discretion and decision-making. . . .

Furthermore, CDC encourages physicians to continue to use their clinical judgement and base their treatment on what they know about their patients.  It is the ultimate goal of the Guidelines to ensure people who need them have access to opioids, while reducing opioid related deaths.” (emphasis added).

III.  State Efforts to Address Opioid Abuse and Diversion:

Many state legislatures and / or state licensing boards have taken affirmative steps to incorporate one or more of the CDC’s recommendations into their laws and regulations.  For instance, legislation addressing the opioid epidemic was signed into law by the Governor of Massachusetts at about the same time that the CDC’s guidance was formally published.  On March 14, 2016, Governor Charlie Baker signed An Act Relative to Substance Use Treatment, Education and Prevention.  A number of additional states (Ohio, Kentucky and Indiana) have also action to better ensure that physicians, nurse practitioners and physician assistants qualified to prescribe opioids do so in a manner that will protect patients from abuse and the public from illegal diversion.  Most recently, on May 25, 2017, Maryland Governor Larry Hogan, signed-off on The Prescriber Limits of 2017.”  The legislation was enacted as an emergency measure and was found to be needed for the immediate preservation of the public’s health and safety.  While all of these statutes are consistent with the overall purpose and goals of the CDC Mach 2016 guidelines, each of them address prescriber limits on opioids and other controlled substances in a different fashion.  Moreover, a number of other states have similar legislation that is still pending.  It is therefore essential that you carefully monitor the rules in your state, both at the legislative and at the licensing board level, to ensure that your prescribing practices are consistent with applicable standards of care and stay within the four corners of law.

IV. Medicare and Medicaid Patient Considerations:

It is important to keep in mind that deaths due to prescription opioid overdoses have been disproportionately high in elderly and financially disadvantaged populations. Last June, the Office of Inspector General (OIG), issued its report “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns.”  As the report details, in 2015, 1 in 3 Medicare beneficiaries received a prescription for a commonly abused opioid.  Additionally, OIG found that these Medicare beneficiaries received prescriptions for an average of five commonly abused opioids during 2015.[6]  Moreover, the Medicare population has one of the highest and fastest growing rates of diagnosed opioid use disorder.  One researcher found that more than 6 out of every 1000 Medicare beneficiaries suffer from this condition.[7]  Unfortunately, the Medicaid population is even worse, at 8.7 per 1000 beneficiaries.  The prevalence of opioid use disorder among Medicaid patients is more than 10 times higher than that of populations covered by private insurance.[8]

V. The Collateral Impact of Opioid Misuse on Medicare and Medicaid Program Integrity Audits:

Over the last year, we have seen a significant increase in the number of Medicare and Medicaid audits of pain management physicians and practices by program integrity contractors working for the Centers for Medicare and Medicaid Services (CMS).  On the Medicare side, these audits have been dominated by Zone Program Integrity Contractors (ZPICs) and the National Benefit Integrity Medicare Drug Integrity Contractor (NBI MEDIC) responsible for performing data analyses to identify questionable physician prescribing practices.

On the Medicaid side, these audits have typically been conducted by the Medicaid Integrity Contractor (MIC) handling a particular state. In some jurisdictions, where the contractor consolidation process has progressed, pain management professionals have received audit letter from a Unified Program Integrity Contractor (UPIC).  UPICs are intended to replace and consolidate the various Medicare and Medicaid program integrity contractors into a single contracting entity.

CMS is actively utilizing its program integrity contractors to identify opioid prescription practices of physicians, nurse practitioners and physician assistants that appear to be different from those of their peers OR appear to be contrary to the best practices outlined in CDC’s guidance. Please keep in mind – once an audit is initiated, every aspect of the care and treatment provided will be subject to review.  Even though a physician’s prescribing habits may have been the impetus for an audit, once medical records are submitted for review, the program integrity contractor will examine multiple aspects of the care in its determination of whether the services at issue were medically necessary and qualify for coverage and payment.

As a final point, it is important to remember pursuant to Chapter 4 of the Medicare Program Integrity Manual, Section 4.18.2, that if a ZPIC or UPIC determines that a Medicare provider engaged in “unethical or improper practices,” it is REQUIRED to also make a referral’s to the provider’s state licensure authority, medical boards and professional societies so that these organizations can review the practices and decide whether disciplinary action is required.

VI. Opioid Prescriber Practices are Leading to Sanctions Licensure Board:

To be clear, the government’s interest in opioid and controlled substance prescribing practices isn’t new.  A cursory look at the list of administrative sanctions taken by almost any state’s Medical Board and / or Dental Board will confirm that pain medications have been, and will likely continue to be, a significant problem.  Unfortunately, the number of opioid-related complaint referrals has risen over the last six months due to the rise in NBI MEDIC and ZPIC audits of provider care, treatment and prescribing practices. Nevertheless, prescribing practices of Federal and state regulators are carefully monitoring the opioid prescribing practices of qualified physicians, nurse practitioners, physician assistants, podiatrists and dentists in their respective jurisdiction. Despite the fact that the CDC March 2016 guidance is “voluntary,” we recommend that pain management professionals review their prescribing practices and verify whether their particular practices are consistent with the recommendations set out in the CDC’s March 2016 guidance.  Additionally, you should ensure that your opioid prescribing practices also comply with any requirements established by your state legislature and any state licensing authorities.

Health Lawyer Robert Liles Represents Physicians and Nurse Practitioners in State Board Opioid Prescriber Cases.Robert W. Liles is Managing Partner at the health law firm, Liles Parker, PLLC.  With offices in Washington, DC, Houston, TX, McAllen, TX and Baton Rouge, LA, our attorneys represent pain management physicians and practices around the country in connection with Medicare / Medicaid audits, Compliance Plan reviews and state peer review actions.  Should you have any questions, please call us for a free consultation.  Robert can be reached at: 1 (800) 475-1906.  

 

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Cell Tower Ground Lease Renewals and Purchases

September 15, 2015 by  
Filed under Regulatory Issues | Privacy

Cell-Phone-TowerA landowner/ground lessor considering a renewal or easement buyout of his cell tower lease is making a MAJOR financial decision. As a businessman (or woman), you understand that. You may also realize that information about what’s “market rent” or “market price” is hard to come by.

Your operator is likely one of the big three public tower companies, American Tower, Crown Castle or SBA Communications (Big Three) – well capitalized and extremely sophisticated in dealing with ground leases. Of course, your lessee is trying to make the best deal for itself.

What’s market? What is a fair or good deal for you the landowner? How can negotiations be positioned to your advantage? In a pinch, what might your lessee ACTUALLY BE WILLING TO PAY to secure your land for the long-term? In addition to price, what terms of a renewal lease are most important to the landowner?

Because data is not readily available about the current market, a landowner should seek industry insight. Andrew C. Lynch, a business attorney at Liles Parker PLLC, has years of experience in the cell tower industry, access to industry data and sources (for all states in the U.S.), and a specialized focus on ground lease renewals. By virtue of years of working collaboratively with clients, Mr. Lynch offers insight and strategic approaches that can position your renewal or buyout negotiations to your advantage.

            To make an informed decision, a landowner should consider:

  • The rental stream that the cell tower on your land generates for its Big Three operator
  • What rents the Big Three have recently paid for ground lease renewals (ie. rent comparables) – the magnitude of price increases may surprise you
  • What amounts have the Big Three paid for lease or easement purchases – you might be pleasantly surprised
  • Whether the cell tower on your property might be relocated or de-commissioned
  • Industry standards for annual rent increases (escalators)
  • Tower industry economics
  • The value of the tower asset to your lessee – generally speaking, a very healthy multiple of net tower cash flow
  • The Big Three’s ROI (return on investment) model and its impact on ground lease renewals or purchases
  • Ground lease aggregators – a competitive threat to which the Big Three are responding
  • The corporate priority of the Big Three to securing tower sites for the long term and the substantial capital being allocated to that effort
  • Other key lease terms and conditions for a ground lease renewal

The landscape has changed dramatically in the tower industry since your cell tower was put in service. Your land is substantially more valuable to the tower operator than it was many years ago. The wireless industry has taken flight and your Big Three lessee and its dominant customers – AT&T, Verizon, Sprint, etc. – want to retain access to the tower and cellular antennas elevated thereon.

Third-party investment groups may have contacted you about purchasing your ground lease or an easement. These investors are also experienced and sophisticated in the cell tower industry and generally well capitalized. They represent A COMPETITIVE THREAT and the Big Three have responded. For each of the Big Three, securing its ground leases for the long-term, either by renewal or purchase, is a major corporate priority.

The result – IT’S A SELLER’S MARKET for an astute and informed landowner/ground lessor. If you arm yourself with INFORMATION AND A GOOD ADVISOR, you won’t be taken advantage of and can secure a fair and advantageous deal for yourself. And now is a good time, even if your ground lease has years to run.

Of course, if you are like most lessors, you appreciate the ultra dependable rent check that arrives every month — you don’t want to overplay your hand and jeopardize the income stream. We can help you understand and navigate the ample room that you now have to maximize the present value income from your tower site.

Lynch_AndyContact Andy Lynch at 202-298-8750 (office) or 703-447-4959 (mobile) for a no-obligation, free telephone consultation about your ground lease renewal or buyout. Or email Mr. Lynch at alynch@lilesparker.com. Or if you prefer, have your local attorney or advisor contact Mr. Lynch.

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Cloud Storage Providers & BAAs – Where is Your Data?

In a recent webinar presentation, I was asked whether I believed one of the many file sharing services that are available, was adequately encrypted. After investigating some of the particulars, the answer to that question was “yes”, but the answer raised more questions as to what else the Cloud Service Provider (CSP) may or may not have done to secure and protect the health care provider’s electronic Protected Health Information (ePHI) from loss, misuse, unauthorized access, disclosure, alteration and destruction. This paper addresses some of those issues.

Presently, there are no uniform CSP industry standards or best practices in place on how to best secure ePHI, and as some states like Texas additionally require, confidential information Encryption at the 256-bit banking level meets standards referenced in the HIPAA Technology Safeguards Rule , but this is not the only risk with CSPs. Knowing where your data will be stored is vital to HIPAA breach security and to modifying your BAA to best prevent any unauthorized access, transfers or use of ePHI.

I. Where are the CSP’s Servers Located?

This is a critical question. Frequently, CSP services require their new clients to sign off on the CSP’s Business Associate Agreement (BAA), before cloud services can begin. On the surface, this seems like a good idea and is even a convenience for the health care provider, but is it really? Each Covered Entity health care provider and each Business Associate Cloud Service Provider has a separate and overlapping duty under the HIPAA Final Omnibus Rule as modified by the HITECH Act, to maintain a BAA. This means both entities have their own BAA and can request the other entity to sign it. You may choose to sign and use the CSP’s BAA and abide solely by its terms, but the CSP’s BAA language will control.

Why is this important? The CSP’s BAA is written from their own point of view. The CSP’s primary interest is flexibility to move large amounts of data from location to location as needed to maximize efficient use of space. This is, after all, what they are selling. The CSP considers things like data overflow, backup data, and emergency rollovers in the event of equipment or power failure, fire, earthquake and the like. To accommodate these factors the, CSPs often scatter their servers geographically to multiple locations. Some may even be beyond the borders of the continental United States. They might also subcontract their cloud storage services to other CSPs overseas. Both scenarios create a problem for the health care provider.

Once your ePHI leaves the borders of the United States, you lose control over it and remember that if a breach occurs that the Health and Human Services Department’s Office of Inspector General (HHS-OIG) deems preventable, you could be liable for up to $50,000 per incident in Civil Monetary Penalties. You could also find yourself without a remedy. If the service contract is enforceable in Bangladesh for instance, you could have a contract in hand but no way to enforce it. American law might not apply or in some countries like India, it could take 25 years for your case to reach a judge.

II. Using the BAA to Control the Location and Means of Storing Your ePHI

A. Using your BAA – The health care provider’s primary interest is to maintain control over its patients’ ePHI as much as possible, and that means specifying in your own BAA that your data shall not be received, transmitted, backed up or stored on any server not located within the borders of the continental United States, or it if should be transferred overseas by accident, mistake or negligence, that the CSP must notify you and recover, remove, delete or destroy the information (at your option), within a reasonable length of time such as 48 hours (a weekend). Rather than trying to force the CSP to change their own BAA agreement to incorporate your needs and concerns (an unlikely task), it is simpler to rely on your own right to a BAA and modify it accordingly for a reciprocal signature.

B. Document Refusal by the CSP – If finding another provider is not a practical alternative for you, and you’ve already signed the CSP’s BAA, you can try and get them to modify their own BAA or use your own BAA in a reciprocal signing. Should the CSP refuse to modify their own BAA agreement to accommodate your concerns, which is most likely, or if the CSP verbally agrees then refuses to sign off on the changes, or refuses to sign your version of the BAA, then you should document that refusal by saving the CSP’s e-mail response, fax response, or send them an e-mail memorandum describing the time, date, persons engaged in the conversation, and content of the telephone conversation as you understood it. Include a written opportunity for them to make any additions or changes the memo if they disagree with the content. This is your proof to HHS and your State’s Medicaid enforcement agency, (HHSC in Texas), that you anticipated the issue and affirmatively tried to put policies, procedures or contract provisions in place to prevent this potential breach issue, but the business associate refused to comply. In the event of a server location related breach, this puts the burden of proof and fault back on the CSP as responsible party and helps insulate you from possible Civil Monetary Penalties in the event of such a breach. Because of changes in BAA law by the Omnibus Rule, Covered Entities are now responsible for breach actions by their Business Associates, so this is even more important than it was previously.

III. Additional Liability for HIPAA violations under the ACA

When the Affordable Care Act was passed more than 4 years ago on March 23, 2010, it mandated that every health care provider shall have and maintain a compliance plan. Even though the Secretary of Health and Human Services, Sylvia Mathews Burwell, has not yet set a final deadline date for most providers to have a plan in place, the mandate is well established and could be set at any time. While the date is not certain, the outcome is. Compliance Plans are now mandatory, and inevitable. Every health care service provider should be actively working to get their plan updated now. Health Care Service Providers should understand that the Office of Inspector General is already enforcing the compliance plan mandate in HIPAA breach situations, by charging the provider knew or reasonably should have known of the breach risk and failed to have effective policies and procedures in place to prevent it.

IV. Conclusion

As a covered entity and health care services provider the burden is on you to anticipate problems with business associates you do business with and plan for these problems as best you can. For these reasons, it’s imperative to read all of your contracts carefully. This holds true for your Medicare and Medicaid provider agreement and it holds true for your private payor insurance carriers. If you have a health care related legal issue, administrative appeal or compliance problem, please contact Liles Parker for a free consultation at 1 (800) 475-1906

Pecore, RichardRichard Pecore, Esq., serves as an Associate at Liles Parker, Attorneys & Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with Medicare audits by RACs, ZPICs and other CMS-engaged specialty contractors.  The firm also represents health care providers and medical billers in regulatory compliance reviews, HIPAA Omnibus Rule risk assessments, privacy breach matters, and State Medical Board inquiries.  For a free consultation, call Robert at:  1 (800) 475-1906

Ismail Cropped 14Attorney Ismail Laher focuses on solving complex issues for Health Care Providers. Mr. Laher assists clients to better understand their option strategically on on a a wide variety of issues in civil and criminal proceedings, complex civil litigation, compliance audits & reviews, practice management and strategic client counseling. He also serves in the role of General Counsel on an as needed basis. Mr. Laher is a graduate of Harvard Business School and Georgetown Law  and was previously an associate attorney with Jones Day law firm in their Washington, DC office.  Mr. Laher focuses his practice on regulatory compliance oversight, practice management and strategic client counseling. He can be reached directly at 202-596-7863 or at ext 111 at the office 202-298-8750.

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OIG Proposes New Anti-Kickback Law Safe Harbors

(November 10, 2014): The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently published a Proposed Rule that would amend the safe harbor regulations under the Federal Anti-Kickback statute[1] (“AKS”) as well as add new safe harbors. The Proposed Rule would also establish new exceptions to the Civil Monetary Penalty (“CMP”) statute related to the beneficiary inducement CMP.[2] OIG will accept comments on the Proposed Rule by mail or electronically until December 2, 2014 at 5 p.m. (Eastern).

I.  The Anti-Kickback Statute and Safe Harbor Regulations:

The AKS provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs. The types of remuneration covered specifically include, but are not limited to, kickbacks, bribes, and rebates, whether made directly or indirectly, overtly or covertly, in cash or in kind. Additionally, prohibited conduct includes not only the payment of remuneration intended to induce or reward referrals of patients, but also the payment of remuneration intended to induce or reward the purchasing, leasing, or ordering of, or arranging for or recommending the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by any Federal health care program.

Due to the broad reach of the statute, interested parties expressed concern that some relatively innocuous commercial arrangements would be covered by the statute. This could, in turn, potentially subject entities to unwarranted criminal prosecution. As a result, Congress drafted certain “Safe Harbor” provisions. These regulations describe various payment and business practices that, although they potentially implicate the Federal AKS, are not treated as offenses under the statute.

II.  Changes to the Anti-Kickback Statute:

The Proposed Rule would modify certain existing safe harbors under the AKS as well as add new safe harbors that provide new protections or codify certain existing statutory protections. These changes include:

      • A technical correction to existing safe harbor for referral services;
      • Protection for certain cost-sharing waivers, including pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries and waivers for state- or municipality-owned emergency ambulance services;
      • Protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
      • Protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
      • Protection for free or discounted local transportation services that meet specified criteria.

III.  Changes to the Beneficiary Inducement CMP:

The Beneficiary Inducement CMP statute generally prohibits any person or entity from offering remuneration to a Medicare or Medicaid beneficiary if that remuneration is likely to influence the beneficiary’s selection of a provider. The Proposed Rule would also amend and narrow the definition of “remuneration” to include certain exceptions for the following:

  • Copayment reductions for certain hospital outpatient department services
  • Certain remuneration that poses a low risk of harm and promotes access to care;
  • Coupons, rebates, or other retailer reward programs that meet specified requirements;
  • Certain remuneration to financially needy individuals; an
  • Copayment waivers for the first fill of generic drugs.

OIG also proposes to codify the gainsharing CMP[3]. The gainsharing CMP prohibits a hospital from knowingly paying, either directly or indirectly, a physician to induce the physician to reduce or limit the services provided to Medicare or Medicaid beneficiaries under the physician’s direct care. The Proposed Rule would narrow the prohibition in light of today’s health care landscape, which focuses on “accountability for providing high quality care at lower costs.”

IV.  Conclusion:

Health care providers should be interested in the Proposed Rule and make comments as necessary. The Proposed Rule makes pertinent changes to the AKS Safe Harbors and CMP laws that should give providers greater leeway to enter into beneficiary arrangements without fear that they will be subject to criminal penalties under the statutes. In a sense, the Proposed Rule follows OIG’s ongoing efforts to adopt regulations that promote lower costs and greater health care services while protecting patients and federal health care programs from fraud and abuse.

As a provider, if you have any questions about the current regulations found within the Anti-Kickback Statute or the proposed changes, please do not hesitate to give us a call today. We would be more than happy to assist you so that you remain compliant with all federal and statute regulations regarding potentially fraudulent activity.

Saltaformaggio, RobertRobert Saltaformaggio, Esq., serves as an Associate at Liles Parker, Attorneys & Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with Medicare audits by RACs, ZPICs and other CMS-engaged specialty contractors.  The firm also represents health care providers in HIPAA Omnibus Rule risk assessments, privacy breach matters, State Medical Board inquiries and regulatory compliance reviews.  For a free consultation, call Robert at:  1 (800) 475-1906

[1] 42 U.S.C. § 1320a-7b(b).

[2] 42 U.S.C. § 1320a-7a.

[3] 1128A(b)(1) of the Social Security Act.

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The Dangers of Keeping Medical Records in the “Cloud”

Overworked tired doctor at computer(July 3, 2014): The growing trend of storing all kinds of data in the cloud comes with benefits and risks. However, when it comes to storing medical records in to the cloud, patient privacy becomes a special concern.

I.          Benefits

With a properly implemented cloud storage system, hospitals can share information far more efficiently. Prescriptions and test results are immediately available between hospital departments and floors that previously had ineffective communication networks. This way, tasks can be processed more quickly and performance and overall patient health are improved.

Another benefit of storing medical records in the cloud is that doctors are not tied to their offices to look up patient information, as they can pull up medical records remotely. Also, when a patient moves to a new doctor, their files can be transferred with far less hassle. Finally, cloud computing has proven cost effective for patients and healthcare providers, as the patients do not have to pay twice for the same test when they go to different doctors and medical offices.

II.        Risks

While storing medical records digitally on the cloud may offer great promise for increasing the efficiency of the health care system, the cloud is not necessarily as secure as other forms of storage. Data security and privacy of health information are major obstacles. If a medical provider loses control of patient data, privacy could be endangered.

The basic rules for how the American medical industry handles private data are in the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). Many argue however that just because something is HIPAA and HITECH compliant does not necessarily mean it is secure.

Hackers

The headline for a year-long Washington Post examination released in December 2012 called the health care sector “vulnerable to hackers.” A computer scientist and technical director of the Information Security Institute at Johns Hopkins University, was quoted as saying, “I have never seen an industry with more gaping security holes.”

In 2012, Eastern European hackers broke into Utah’s state health records database, gaining access to personal information on 780,000 patients including some 280,000 social security numbers.

Human Error

Like so many other problems, medical privacy in the cloud often comes down to human error. Encrypted data is only safe if the required passwords are well protected, and that requires well-trained and conscientious employees. There have been several instances where employees maliciously stole data before leaving a company or absent-mindedly put data at risk by storing files on mobile devices that become lost or stolen. A couple of years ago, a contractor for a University hospital lost a laptop with medical records of more than 34,000 patients. Last fall, a stolen unencrypted laptop from a California hospital exposed medical records of 250,000 patients.

Physicians and their staff are not the only ones who could be at fault. Employees of other companies using the same cloud service could also make a mistake, cause a data breech, or even intentionally steal or sell information stored on the cloud. A virus or other malicious program could potentially spread from one client’s office to the cloud server, and from there to other offices.

Finally, if a medical provider closes his practice, medical records stored on the cloud could be lost or at risk. If the provider does not keep a local backup, vital information may be compromised.

III.       Conclusion

It is critically important for health care providers choosing to store medical records in the cloud to implement policies and training requirements to protect the privacy of patients. Providers should go beyond the requirements of HIPAA and HITECH to ensure adequate measures are taken to avoid being hacked, to prevent and fix human errors, and to keep up with technological advancements and threats.

Robert W. Liles

Robert W. Liles, Esq., serves as Managing Partner at Liles Parker, Attorneys & Counselors at Law.  Liles Parker attorneys represent health care providers around the country in connection with both regulatory and transactional legal projects. For a free consultation, call Robert at (800) 475-1906.

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Liles Parker Attorney has Article Titled “Individual Liability in Medicare Overpayment Cases” Published in Law Journal.

Will the government seek to "pierce the corporate veil"?

Will the government seek to “pierce the corporate veil”?

(October 16, 2013):  A recent article by Liles Parker attorney David P. Parker in the Health Law & Policy Brief,  a law journal publication of American University’s Washington School of Law, examines an issue that is becoming more important to health care providers each day.  The article, titled:  “Individual Liability for Medicare Overpayment Claims” carefully examines whether an owner of a health care practice, home health agency or DME company, can be held to be personally liable for alleged overpayments owed by the health care entity.

The article examines several of the primary issues which typically arise when a health care entity seeks bankruptcy relief while allegedly owing Medicare a significant overpayment. As the article discusses, it is becoming more common for the government to attempt and “pierce the corporate veil,” in an effort to collect the overpayment debt from one or more of the owners of the bankrupt company. As the article reflects, this area of the law is highly complex and it can be quite difficult to project how hard the government will attempt to collect seek an outstanding overpayment.  A copy of Mr. Parker’s analysis can be found on the Law School’s website.

David P. Parker serves as Co-Managing Partner at the health law boutique firm Liles Parker.  David counsels health care provider and suppliers on a full range of health care transactional projects. He also represents health care providers in State Medical Board proceedings. For a free consultation, call David today at: 1 (800) 475-1906.

 

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A Recent False Claims Act Case Being Brought Against an Individual Physician has Resulted in a Record Recovery for the Government.

False Claims Act cases against physicians and other solo providers are increasing.(February 12, 2013):  The civil False Claims Act is the primary civil enforcement tool used by the U.S. Department of Justice.  As discussed below, the False Claims Act is an extraordinarily useful statute for government prosecutors, both in terms of ease of use and in terms of the damages which may be recovered by the government.

I.   Overview of the False Claims Act:

As set out below, the civil False Claims Act imposes civil monetary penalties and will expose a person to civil liability under the circumstances below:

Sec. 3729.  False claims 

(a) Liability for Certain Acts—any person who: 

(1) Knowingly presents, or causes to be presented, to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval; 

(2) Knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government; 

(3) Conspires to defraud the Government by getting a false or fraudulent claim allowed or paid; 

(4) Has possession, custody, or control of property or money used, or to be used, by the Government and, intending to defraud the Government or willfully to conceal the property, delivers, or causes to be delivered, less property than the amount for which the person receives a certificate or receipt; 

(5)  Authorized to make or deliver a document certifying receipt of property used, or to be used, by the Government and, intending to defraud the Government, makes or delivers the receipt without completely knowing that the information on the receipt is true; 

(6) Knowingly buys, or receives as a pledge of an obligation or debt, public property from an officer or employee of the Government, or a member of the Armed Forces, who lawfully may not sell or pledge the property; or 

(7) Knowingly makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the Government, 

. . . is liable to the United States Government…  

II.    What is Not Covered Under the False Claims Act:

            It is essential to keep in mind that the civil False Claims Act does not cover mistakes, accidents, or mere negligence.  Unfortunately, the line separating a billing “mistake” from a non-intentional wrongful billing, which could give rise to an action under the False Claims Act, is not always easy to discern.  In an effort to provide additional guidance to DOJ attorneys on the judicial use of the False Claims Act, guidance setting out a number of factors to be considered when pursuing a False Claims Act case.

III.   Damages Under the Civil False Claims Act:

            A “person” (which would covers individuals, physician practices, home health agencies, hospice agencies, third-party billing companies, ambulance companies, hospitals, skilled nursing facilities and other health care providers)   found to have violated this statute is liable for civil penalties in an amount between $5,500 and not more than $11,000 per false claim, as well as up to three times the amount of damages sustained by the government.

IV.   What is the Involvement of the U.S. Department of Justice?

            While attorneys in DOJ’s Civil Division in Washington, D.C. are likely to be involved in most of the larger, more complex cases under the False Claims Act, it is important to remember that a “Civil Health Care Fraud Coordinator” has been appointed in each of the 94 U.S. Attorney’s Offices around the country. Assistant U.S. Attorneys are highly trained and experienced in handling False Claims Act cases and will readily file a case against a health care provider in the event that improper conduct can be shown.

V.  Whistleblower or “Qui Tam” Provisions of the False Claims Act:

          One of the most unique elements of the False Claims Act is that it authorizes private parties having direct knowledge of fraudulent conduct to bring a civil suit against the violator on behalf of the government.  These civil suits are known as qui tam actions, and the private parties who initiate such actions are called “relators.”  Relators may share in any monies recovered as a result of their qui tam action.[1]

            A qui tam action is initiated when a relator files a complaint – along with supporting documentation – “under seal” in federal court.  When a case is filed under seal, it means that all records associated with the whistleblower are maintained on a non-public docket by the Clerk of the Court.  A copy of the complaint is given to the judge assigned to the case.  The relator’s attorney also serves a copy of the complaint on the Attorney General in Washington, D.C. and on the U.S. Attorney in the federal judicial district in which the case was filed.[2]  Initially, the government will have 60 days to evaluate whether to proceed against the defendant.  In almost all cases, the government will seek an extension to allow it an opportunity to investigate the allegations.  After showing “good cause” for an extension, most federal courts will readily grant the request for an extension.  It is not at all uncommon for a qui tam to remain under seal for over a year (and often much longer) while the government reviews the allegations.  The seal is important for several reasons:

  • The government can quietly investigate the allegations without the defendant knowing that their company is under investigation.
  • The mere existence of a government investigation can be devastating on the public’s view of a company.  Moreover, if a company is publicly-traded, the publicity surrounding a government investigation can severely affect the price of a company’s stock—despite the fact that the allegations at issue have not been investigated or proven at this point in the process. 

After concluding its evaluation, the government may elect to proceed with the complaint and intervene in the case or it may decline to intervene.  If the government decides to intervene in the action, then the relator has the right to remain a party to the action.  If the government decides not to intervene in the case, the qui tam relator may elect to proceed on his or her own against the defendant.  Notably, the government always retains the ability to intervene in the case at a later time.  From a practical standpoint, if the government decides not to intervene in a case, in all likelihood the relator will seek to dismiss the suit.  Unlike the government, the relator’s ability to investigate a False Claims Act case is quite limited, both in terms of resources and in terms of investigative tools.  As a result, the government’s decision to decline to intervene severely impacts a relator’s ability to move forward with the case.

            The government often asks the court to partially lift the seal solely for the purpose of advising the defendant of the existence of the case and to seek their cooperation in resolving the allegations.

             Should the government choose not, to intervene, it will often ask that the Court remove the seal to the case.  Once the seal is removed, the case (and its allegations) will be part of the public record.  In cases where the government chooses to intervene, the case is often kept under seal until a settlement is worked out with the defendant.

            There are a number of limitations placed on the filing of qui tam cases.  Two of the more commonly seen limitations include:

  • When the government has already initiated an action against a party for the same allegations that would form the basis of a qui tam suit; or

  • When the action is based on publicly-disclosed information[3] that was contained in an official hearing, report, investigation, audit, or information disseminated by the news media. 

VI.  Record Recoveries in 2012 Under the False Claims Act:

            In recent years, False Claims Act recoveries resulting from whistleblower suits have exceeded most observers’ expectations.  Issues related to the False Claims Act should be at the top of the list of ongoing concerns for most health care Compliance Officers.  The potential damages a provider may face for violations of the False Claims Act cannot be understated.

             In Fiscal Year 2012, the U.S. Department of Justice secured settlements and judgments in civil False Claims Act of $4.9 billion.  Notably, this includes a “record recovery for a single year” by more than $1.7 billion.  Over the last four years, $13.3 billion has been recoveries.  Notably, this represents more than a third of the total recoveries achieved since the False Claims Act was amended over 26 years ago.[4]

VII.  Are Physicians Being Targeted Under the False Claims Act:

         While large pharmaceutical, durable medical equipment and hospital chain cases continue to dominate the press, physicians, dentists and other solo health care providers are increasingly finding themselves and their practices subject to whistleblower suits under the False Claims Act by former employees, competitors and others who believe that false claims are being submitted to the government for payment.

          Notably, a recent whistleblower case pursued by the U.S. Department of Justice against an individual physician (a dermatologist) resulted in a $26.1 million settlement.  In this case, the physician was alleged to have accepted kickbacks from a pathology laboratory.  The physician was also accused of billing Medicare for medically unnecessary services. The whistleblower reportedly collected $4 million as part of the settlement.

VIII.  How Can You Prevent a False Claim Act from Being Filed Against You?

         Ultimately, your ability to avoid the filing of a False Claims Act case against you or your practice rests on your ability to comply with state and federal laws, regulations and rules governing the provision, coding and billing of health care services. Without a doubt, the single most important step you can take in this regard is to develop, implement and adhere to the provisions and guidelines set out in an effective Compliance Plan.  While most hospitals and other institutional providers have had Compliance Plans in place for many years, very few physicians have taken this necessary preventative step.

          Will a Compliance Plan prevent you from having a False Claims Act case brought against you or your practice?  No, not necessarily.  Instead, you should look at a Compliance Plan as being akin to a flu shot.  Just because you have received a flu shot does not mean that you will never catch the flu.  However, if you do come down with the flu, chances are that it won’t be as serious and it might otherwise have.  All of us make mistakes, and physicians are not immune to this risk.  Nevertheless, having an effective Compliance Plan in place is likely to greatly assist you in your efforts to stay within the four corners of the law.

Robert W. Liles is a health care attorney experienced in handling prepayment reviews and audits.Robert W. Liles serves as Managing Partner at Liles Parker.  Robert and other attorneys at Liles Parker have extensive experience working on False Claims Act matters and case.  For a free consultation, please call Robert at:  1 (800) 475-1906.   

 


[1] Whistleblowers (also known as “Relators”) can receive between 15% and 25% of any recovery in a qui tam action where the government has intervened in the case.  In a non-intervened case, a relator may recover up to 30%.  Consequently, there is a tremendous financial incentive to file and pursue these types of actions.

[2] The relator must also serve a “disclosure statement” on DOJ (normally, it is provided to the U.S. Attorney’s Office) which sets out the evidence that the relator has in support of the allegations set out in his/her Complaint.  This statement is not filed with the Complaint and is not given to the defendant.

[3] This rule is known as the “public disclosure bar.” The Affordable Care Act modifies this rule in several respects.  First, a qui tam action will not be dismissed under the public disclosure rule if the government opposes dismissal.  Second, fraud disclosed in private legal actions will not activate the public disclosure bar; the government must have been a party to the action in order for the public disclosure rule to apply.  Third, information obtained from state proceedings or hearings likewise will not qualify under the public disclosure bar.  Finally, the public disclosure bar will not operate where the relator was the “original source” (e.g., has independent knowledge) of the fraud or false claim allegation.

[4] http://www.justice.gov/opa/pr/2012/December/12-ag-1439.html

 

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What is Civil Fraud?

November 29, 2012 by  
Filed under Regulatory Issues | Privacy

(November 29, 2012):  Civil fraud cases are complex and can have substantial effects on your business and on your personal assets.

Definition of Civil Fraud

Merriam-Webster defines fraud as:

a: deceit, trickery; specifically : intentional perversion of truth in order to induce another to part with something of value or to surrender a legal right

b : an act of deceiving or misrepresenting:

Civil Fraud Houston AttorneyFraud is founded upon a misrepresentation of past or present fact. Courts have defined fraud as trickery, deceit, intentional misrepresentation, concealment, or nondisclosure for the purpose of inducing another to part with something of value. It also includes false representation of a matter of fact by words or conduct or by the concealment of what should have been disclosed that deceives or is intended to deceive another so he shall act upon it to his legal injury. See In re E.P., 185 S.W.3d 908 (Tex. App. Austin 2006).

Elements of Civil Fraud

The elements or actions that are common to most legal definitions of fraud are:

  1. There was a material representation made that was false;
  2. The person who made the representation knew the representation was false or made it recklessly as a positive assertion without any knowledge of its truth;
  3. The person who made the representation intended to induce another to act upon the representation; and
  4. The person to whom the material representation was made actually and justifiably relied on the representation, which caused the injury. See Ernst & Young, L.L.P. v. Pac. Mut. Life Ins. Co., 51 S.W.3d 573, 577 (Tex. 2001)

However, courts have broadly defined the elements of civil fraud in various situations and there is no single definition that covers civil fraud entirely.  There are laws passed by the legislature that define fraud.  Courts of law have provided common law definitions of fraud. There are actions for negligent misrepresentation, a cause of action which is similar to fraud. Fraud by itself is not a fact but rather a conclusion that is reached after the facts of the relationship or transaction complained of have been reviewed.

The above comments on fraud are not inclusive and there are exceptions and other considerations to review to determine if civil fraud has occurred.  Whenever you feel you have suffered a legal wrong because someone has misrepresented a fact to you, it is recommended you take action and consult with an attorney to determine if you have a valid claim.

Experienced Houston AttorneyLeonard Schneider and other Liles Parker attorneys have extensive experience in business litigation, civil fraud matters, contract review and drafting. Call 1 (800) 475-1906 today for a free consultation.

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