Posts Tagged civil

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases.  In this article, I discuss the consequences physicians and other medical professionals potentially face as a result of a “pill mill” investigation.

CRIMINAL PROSECUTION

A litany of criminal charges can be heaped on medical professionals at the conclusion of a “pill mill” investigation. Exactly what charges the government pursues will obviously depend on the facts and circumstances of each particular case. One charge that will inevitably be included in every “pill mill” indictment is an alleged violation of the Controlled Substances Act (“CSA”). The CSA governs the distribution and dispensing of various listed drugs, including narcotics, that are prescribed by physicians and other licensed medical providers. To issue a controlled substance, a physician must be licensed to practice by a state authority and must have a DEA registration number.

Under the CSA, controlled substances are placed into one of five “schedules” based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and their likelihood of causing dependence when abused. Most opioids are Schedule II drugs because they have acceptable medical uses and but a high potential for abuse.

To be convicted under the CSA, the government must prove that (1) the defendant physician knowingly and intentionally distributed or dispensed a controlled substance, and (2) did so “for no legitimate medical purpose and outside the usual course of professional practice.” Determining whether a physician has illegally prescribed drugs under this standard is never simple and will necessarily involve a “battle of the experts.”

A criminal conviction for violating the CSA may result in a vast array of prison sentences under the federal Sentencing Guidelines, a set of advisory sentencing rules that establish a uniform policy for individuals convicted of felony crimes in federal court. The exact range may vary significantly from case-to-case, depending primarily on the type and quantity of controlled substances involved. And these ranges can be staggeringly severe. In a recent “pill mill” case in Mobile, Ala., the physicians each faced a guidelines range of imprisonment of 30 to 240 years, although the court sentenced them well below that range (20 and 21 years, respectively) – as it had the discretion to do. In addition to applicable guidelines ranges in each case, the CSA provides for statutorily “enhanced” sentences in certain circumstances. For instance, if the government proves that a patient’s death resulted from the distribution of a Schedule II controlled substance, the convicted physician will face a sentence of no less than 20 years and up to life in prison.

SEIZURE AND FORFEITURE

In almost every “pill mill” case, the government will attempt to seize (take possession of) and forfeit (take ownership of) bank accounts, business assets, and personal assets of the targeted medical professional based on a theory that they are “proceeds” of the alleged “pill mill” operation or somehow “facilitated” the purported criminal enterprise. For example, following the physicians’ convictions in the case mentioned above, the government forfeited their bank accounts, investment and retirement accounts, college fund accounts, houses, beach-fount condominiums, and 20-plus luxury automobiles.

CIVIL LIABILITY

On top of criminal prosecution, a “pill mill” investigation could result in a civil lawsuit by the government against the targeted physician or medical professional, to the extent they have billed a federal health care program. For instance, the government might bring a direct suit under the False Claims Act (“FCA”), alleging that the physician made false diagnoses, prescribed drugs for non-covered indications, or prescribed excessive or “medically unnecessary” drugs for Medicare or Medicaid patients. Likewise, the government may join in a “qui tam” suit, which is initiated by a “whistleblower” – such as a current or former employee of the practice – claiming the targeted physician or practice has violated the FCA and other laws.

ADMINISTRATIVE PROCEEDINGS

In addition to facing criminal prosecution, the loss of asserts, and civil liability, physicians investigated or charged in a “pill mill” case can be subject to a number of administrative sanctions. The DEA, in particular, has a range of administrative actions it can take, such as: issuing a letter of admonition to the registrant providing notice of a violation of the applicable law/regulations; requiring the registrant to enter into a memorandum of understanding agreeing to take certain corrective steps to stave off revocation of the registration; or, for the most serious alleged violations, pursuing a show cause order to appear before an administrative law judge, during which the DEA will advocate for revocation of the registration.

Like the DEA, state professional boards (such as medical and pharmacy boards) have disciplinary authority and can sanction practitioners for professional violations, such prohibiting a physician from prescribing specific schedules of drugs, suspending a physician’s medical and/or dispensing license, or revoking the license.

Further, the Centers for Medicare & Medicaid Services (“CMS”) may limit, suspend, or revoke a provider’s Medicare billing privileges for, among other things, noncompliance with Medicare enrolment requirements, a felony conviction related to controlled substances, or a pattern of improper prescribing practices. Likewise, state Medicaid agencies can impose various administrative sanctions against providers, including outright exclusion from the program.

CONCLUSION

The consequences physicians and other medical professionals face as a result of a “pill mill” investigation are varied and potentially severe. Given that, pain management practitioners should be acutely aware of any signs that they are under investigation, including, among other things, receiving a government subpoena or civil investigative demand or learning that the practice’s employees or patients have been interviewed by investigating agents. Upon receiving the slightest hint of an investigation, practitioners should act quickly in obtaining legal counsel to conduct an internal investigation, determine the practice’s potential exposure, and intervene on the practice’s behalf in the hopes of warding off further government scrutiny.

For more information on these issues, please contact Burr & Forman’s Health Care team. Burr & Forman is an official partner with the Medical Association.

Posted in: Opioid

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What If No One Was On Call [at the Legislature]?

What If No One Was On Call [at the Legislature]?

2018 Recap of the Regular Session of the Alabama Legislature

In times of illness, injury and emergency, patients depend on their physicians. But what if no one was on call? Public health would be in jeopardy.  However, the same holds true for the Legislature. During the 2018 session alone, if the Medical Association had not been on call advocating for you and your patients, unnecessary and costly standards of care would have been written into law, lawsuit opportunities against physicians would have increased and poorly thought out “solutions” to the drug abuse epidemic ─ that could’ve made the problem worse ─ would have become law. Keep reading to find out more.

Moving Medicine Forward

The 2018 Legislative Session is over, but continued success in the legislative arena takes constant vigilance. Click here to download our 2018 Agenda.

If no one was on call…increased state funding for upgrading the Prescription Drug Monitoring Program (PDMP) would not have occurred. Working with the Governor’s Opioid Task Force, the Medical Association proposed increased funding for the PDMP, to allow it to be an effective tool for physicians. As a result, the Task Force made the request its number one recommendation to the Governor and the 2019 budget for the Alabama Department of Public Health (the PDMP administrator) has a $1 million increase for making a long-overdue upgrade to the user-friendliness of the drug database.

If no one was on call…legislation helping veterans at-risk for drug abuse get the care they need and also leverage technology to combat the drug abuse epidemic would not have occurred. Through enactment of SB 200, the prescription information of VA patients will be shared between the VA and non-VA physicians and pharmacists who are outside the VA system, the same kind of information sharing of prescription data that exists for almost all other patients. Passage of SB 200 also establishes a mechanism for vetting requests for release of completely de-identified PDMP information that can be used to spot drug abuse trends and help state officials better allocate resources in combatting this epidemic. The proposals that resulted in the drafting of SB 200 originated with a recommendation from the Governor’s Opioid Task Force, one the Medical Association supported.

If no one was on call…the concerns of physicians regarding the current state of affairs surrounding the Maintenance of Certification program would not have been heard. A formal recommendation from the Medical Association’s MOC Study Committee resulted in the enactment of SJR 62 by Senators Tim Melson, M.D., Larry Stutts, M.D., and the entire Alabama Senate. The resolution was signed by Gov. Kay Ivey. SJR 62 vocalizes Alabama physicians’ frustrations with MOC and urges the American Board of Medical Specialties to honor its commitment to help reduce the burden and cost of MOC. Pursuit of a legislative resolution was just one of several recommendations from the Association’s MOC Study Committee this year.

If no one was on call…the Board of Medical Scholarship Awards could have seen its funding reduced but instead, the program retained its funding level of $1.4 million for 2019. The BMSA grants medical school loans to medical students and accepts as payment for the loan that student’s locating to a rural area to practice medicine. The BMSA is a critical tool for recruiting medical students to commit to practice in rural areas. As well, the economic footprint of every physician is at least $1 million, which improves both community health and local economies.

If no one was on call…Medicaid cuts could have been severe, possibly reducing access for patients within an already fragile system in which less than 20 percent of Alabama physicians participate. The 2019 budget has sufficient funds available for Medicaid without scheduled cuts to physicians. However, increasing Medicaid reimbursements to Medicare levels could further increase access to care for Medicaid patients and remains a Medical Association priority.

Beating Back the Lawsuit Industry

While Alabama’s medical liability laws have fostered fairness in the courtroom and improved the legal climate, each year personal injury attorneys seek to undo parts of the very law that helps keep “jackpot justice” and frivolous suits in check.

If no one was on call…bill language that could have pulled physicians into new lawsuits targeting opioid drug makers and opioid wholesale drug distributors could have been included in the final version of the legislation, whose subject matter was originally limited to placing new criminal penalties on unlawful possession, distribution and trafficking of Fentanyl. After the liability language was added on the House floor, a committee of the House and Senate removed the new cause of action language that could have affected physicians. Additionally, an unsuccessful attempt was made to amend this same bill to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of prescription drugs. The final bill that passed contained neither of these elements that would have been problematic for physicians.

If no one was on call…physicians and medical practices could have been forced to provide warranty and replacement coverage for “assistive medical devices.” As originally drafted in the bill, the term “assistive medical devices” was broadly defined to include any device that improves a person’s quality of life including those implanted, sold or furnished by physicians and medical practices like joint or cochlear implants, pacemakers, hearing aids, etc. However, the Medical Association successfully sought an amendment to remove physicians, their staff and medical practices from having any new warranty or assistive device replacement responsibility under the act, and the final version doesn’t expand liability on doctors.

If no one was on call…legislation granting nurse practitioners and nurse midwives new signature authority outside of a collaborative practice and for some items prohibited under federal law – thereby significantly expanding liability for collaborating physicians – could have become law. The Medical Association successfully sought to ensure that all new signature authority granted to CRNPs and CNMs was subject to an active collaborative agreement and all additional forms or authorizations granted were consistent with federal law, protecting collaborating physicians from new liability exposure. The final bill was favorably amended with this language.

If no one was on call…physicians could have been held legally responsible for others’ mistakes including individuals following or failing to follow DNR orders on minors. The language of the final bill does not expand liability for physicians.

Protecting Public Health and Access to Quality Care

Every session, various pieces of legislation aimed at improving the health of Alabamians are proposed. At the same time however, many bills are also introduced that endanger public health and safety, like those where the Legislature attempts to set standards for medical care, which force physicians and their staffs to adhere to non-medically established criteria, wasting health care dollars, wasting patients’ and physicians’ time and exposing physicians to new liability concerns.

If no one was on callcollaborative practice in Alabama between nurse practitioners, nurse midwives and physicians could have been abolished. The legislation did not pass. Read the joint statement on the bill from the Medical Association and allied medical specialties here. The bill may return next session.

If no one was on call…legislation to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of controlled substances (and making violations a Class B Felony) could have become law. The Medical Association sought changes to the bill to require prosecutors to have to prove beyond a reasonable doubt that a physician knowingly or intentionally prescribed controlled substances for other than a legitimate medical purpose and outside the usual course of his or her professional practice, and also to ensure sufficient qualifications for expert witnesses. The sponsor however – arguing that expert witness testimony for prosecuting a physician should not be required – asked the bill not be passed and instead “indefinitely postponed it,” killing the bill for the 2018 session. The bill will return next session.

If no one was on callmarriage and family therapists could have been allowed unprecedented authority to diagnose and treat mental illnesses without restriction. The legislation would also have deleted numerous prohibitions in current law including prescribing drugs, using electroconvulsive therapy, admitting to a hospital and treating inpatients without medical supervision, among other things. The Medical Association offered a substitute bill that (1) ensures all diagnoses and treatment plans made by MFTs are within the MFT treatment context; (2) ensures MFTs cannot practice outside the boundaries of MFT services; (3) prohibits MFTs from practicing medicine; and, (4) ensures all the current prohibitions in state law regarding prescribing of drugs, electroconvulsive therapy and inpatient treatment remain intact. The final bill that is now law contains all of these elements.

If no one was on call…legislation creating a new state board with unprecedented authority over medical imaging could have passed. The legislation would have required x-ray operators, magnetic resonance technologists, nuclear medicine technologists, radiation therapists, radiographers and radiologist assistants to acquire a new license from a new state board, a board granted total control over the scope of practice for each licensee. Quality and access to care concerns abounded with this legislation that many saw as unnecessary. The legislation did not pass, but is likely to return next session.

If no one was on call…proposals to move the PDMP away from the Alabama Department of Public Health and instead under the authority of some other state agency or even to a private non-profit organization could have been successful. In working with the Governor’s Opioid Task Force, the Medical Association stressed the Health Department was the proper home for the PDMP and the Task Force did not recommend that the PDMP be moved elsewhere.

If no one was on call…legislation to place new requirements on and increase civil liability exposure on referring physicians under the Women’s Right to Know Act could have become law. The legislation aimed to provide a woman seeking an abortion with notice that she can change her mind at any time and be entitled to a full refund for not going through with the abortion. The Medical Association sought to fix a longstanding problem that places information-provision requirements on referring physicians under the Women’s Right to Know law. While the Association’s language was adopted, the bill failed to pass. The bill is expected to return next session.

If no one was on call…state law could have been changed to require mandatory PDMP checks on every prescription. Attempts to change this are expected in 2019.

If no one was on call…law enforcement could have been granted unfettered access to the prescriptions records of all Alabamians. Attempts to change this are expected in 2019.

Other Bills of Interest

Rural physician tax credits…legislation to increase rural physician tax credits and thereby increase access to care for rural Alabamians did not pass but will be reintroduced next session.

Infectious Disease Elimination…legislation to establish infectious disease elimination pilot programs to mitigate the spread of certain diseases failed to garner enough support to pass this session.

Data breach notification…relating to consumer protection, is known as the “data breach bill.” In the event of a data breach by a HIPAA-covered entity, as long as the entity follows HIPAA guidelines for data breaches and notifies the attorney general if the breach affects more than 1,000 people, the HIPAA-covered entity is exempt from any penalties. Now, only North Dakota lacks a “data breach” notification statute. The bill was signed by the Governor.

School-based vaccine program…a Senate Joint Resolution urging the State Department of Education and the Alabama Department of Public Health to encourage all schools to participate in a school-based vaccine program passed in 2018. The Medical Association, Alabama Academy of Pediatrics and Alabama Academy of Family Physicians issued a joint statement in opposition to the resolution.

While we remain committed to increasing vaccine rates in Alabama for the very reasons outlined in the “Whereases” of the resolution, we are very concerned about the potential disruption that a widespread school-based program could bring to local practices and the likelihood of detrimental effects of adolescents not visiting the doctor-their medical home–during the critical teen years,” the joint statement from the medical societies reads.

While Gov. Ivey did not sign the resolution, it was ratified under state law without her signature.

Workers comp…legislation to penalize an individual from obtaining workers comp benefits by fraudulent means was introduced this session. The Medical Association successfully sought an amendment to require notice to the physician of termination of a worker’s benefits and to ensure continued payment of claims submitted by a physician until that notice is received. The bill failed to see any action this session.

Genital mutilation…legislation criminalizing the genital mutilation of a minor female was introduced this session. The Medical Association successfully sought an amendment to exclude emergency situations and procedures. The bill died in the Senate during the last days of the session. It is expected to return next year.

If the Medical Association was not on call at the Legislature, countless bills expanding doctors’ liability, placing standards of care into state law, lowering the quality of care provided and diminishing the practice of medicine could have passed. At the same time, positive strides in public health – like new funding for a much-needed PDMP upgrade, better data-sharing with VA facilities and the resolution on MOC – would not have occurred. The Medical Association is Alabama physicians’ greatest resource in advocating for the practice of medicine and the patients they serve.

Questions? For more information contact Niko Corley at ncorley@alamedical.org

Posted in: Advocacy

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What You Need to Know About Section 1557: The ACA Nondiscrimination Provisions

What You Need to Know About Section 1557: The ACA Nondiscrimination Provisions

The Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities. Section 1557 builds on long-standing Federal civil rights laws: Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973 and the Age Discrimination Act of 1975. Individuals may either file a complaint with the Office of Civil Rights (OCR) or the law creates a private cause of action.

Who must comply?

Physicians receiving financial assistance from HHS (except solely Medicare Part B).

When?

By October 16, 2016

What must be done?

Post notices, taglines, and take steps to provide meaningful access to individuals with limited English proficiency. This may mean you need to enter into a contract with a call center.

What does Section 1557 require?

By October 16, 2016, all covered entities must post notice and taglines in the top 15 languages in conspicuously visible font size for individuals with limited English proficiency (LEP). The rules require language assistance for persons with LEP. A provider may not require an individual with LEP to provide his or her own interpreter. The Office of Civil Rights website contains sample notices, statements and taglines in multiple languages. (See link below). The rules require using a “qualified translator” when translating written content. The rule itself is lengthy and specific. Any physicians, hospitals or entities receiving any financial assistance with HHS, including Medicare Parts A, C & D; Medicaid grants; loans; subsidies; meaningful use payments; payments for research offered through NIH; payments for any health program administered by HHS; etc. must comply. If a physician’s only financial assistance from HHS is to receive Part B, he or she is not covered. If a physician or entity is principally engaged in health care then all of the operations are covered minus certain limited exceptions.

Covered entities must offer a qualified interpreter to an individual with LEP when oral interpretation is a reasonable step to provide meaningful access. The interpreter need not be licensed under state law, but must have relevant proficiency. Simply having above average familiarity with speaking or understanding the relevant foreign language does not necessarily qualify him or her as an interpreter. HHS has regulations that apply to covered entities choosing to provide interpreters through remote video. See 45 C.F.R. § 92.201(f)

What are the basics?

  1. Do not discriminate on the basis of race, color, national origin, sex, age, or disability. Treat men and women equally in healthcare and treat individuals consistent with gender identity. Provide language assistance. Provide auxiliary aids to those with disabilities. Make newly constructed or altered facilities accessible to those with disabilities.
  2. Sign a form with HHS that you will comply – HHS-690 Form.
  3. Entities with 15 or more employees must appoint a compliance coordinator and establish a grievance coordinator.
  4. “Taglines” and statements must be included on “significant” documents and communications. HHS is working on guidance as to what is a “significant” publication. Information on services or treatment, or the administration of drugs, is considered significant.
  5. Post notices of nondiscrimination. A sample notice is available from the link set forth below.
  6. The entity must take reasonable steps to provide meaningful access to LEP persons.

What is a tagline?

All covered entities must post short statements written in non-English informing individuals that language assistance services are available free of charge. These taglines should be posted in the top 15 languages spoken by LEP persons in that state. (See list below). The entity should post the taglines in physical locations with interaction with the public, websites and other significant communications. The top two languages should be posted in small sized publications.

Is there guidance?

OCR has translated a sample notice of nondiscrimination and the taglines for use by covered entities into 64 languages: www.hhs.gov/civil-rights/for-individuals/section-1557/translated-resources/index.html

HHS has provided a training guide (http://www.hhs.gov/sites/default/files/section1557-presenters-guide.pdf and http://www.hhs.gov/sites/default/files/section1557-training-slides.pdf).

What are the current top 15 languages for Alabama?

  • Spanish — 75,000
  • Chinese — 5,405
  • Korean — 4,554
  • Vietnamese — 3,708
  • Arabic — 1,440
  • German — 1,411
  • French — 1,278
  • Gujarati — 888
  • Tagalog — 856
  • Hindi — 818
  • Laotian — 681
  • Russian — 586
  • Portuguese — 516
  • Turkish — 505
  • Japanese — 484

http://www.hhs.gov/sites/default/files/resources-for-covered-entities-top-15-languages-list.pdf

Posted in: Legal Watch

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