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Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Sometimes, Alabama is No. 1. In 2012, Alabama was the highest per capita painkiller prescribing state, with an average of 143 prescriptions written per 100 people — almost three times the rate of the lowest prescribing state.1 Alabama has been home to other No. 1s, too. In 2012, Dr. Shelinder Aggarwal, a former Huntsville-area pain doctor, was the top Medicare prescriber of prescription painkillers in the United States, until he was sentenced to 15 years in prison, had to pay back some $9.5 million in fraudulently billed claims, and surrendered his medical license in the wake of an examination by the Board of Medical Examiners.2

Many aspects of Aggarwal’s practice, which was described in the charging documents against him as a “pill mill,” are almost beyond belief. Aggarwal was seeing 80 to 145 patients in his office each day in 2012. Alabama pharmacies filled about 110,013 prescriptions (12,313,984 pills) in calendar year 2012 for controlled substances prescribed by Aggarwal. That equates to 423 prescriptions and 144 patients per day, assuming Aggarwal worked a five-day work week and wrote about three prescriptions per patient.3

Exactly how Aggarwal was able to prescribe controlled substances in such volumes is no less shocking. According to charging documents, initial visits entailed little more than a superficial physical exam and a urine drug test and lasted only five minutes. Follow-up visits could last as little as two minutes. Aggarwal allegedly did not retrieve a patient’s medical history, nor did he treat his patients with anything other than controlled substances. He was known to ask patients what medications they wanted, and he even wrote prescriptions for controlled substances to patients who admitted to using illegal drugs, or whose drug screen showed illegal drugs in their system.4

Aggarwal’s example, perhaps, is on the extreme end of the spectrum, but it highlights the gravity of the “opioid epidemic” Alabama and the United States are facing right now. Every physician has a role to play combating these opioid problems, and there are tools out there to help.

Prescription Drug Monitoring Program

The Alabama Prescription Drug Monitoring Program, or PDMP, is designed to “promote the public health and welfare by detecting diversion, abuse and misuse of prescription medications classified as controlled substances under the Alabama Uniform Controlled Substances Act.”5 Under the authorizing act and implementing regulations for the PDMP, any dispenser of Class II, III, IV or V controlled substances must report the dispensing of these drugs to the PDMP.6 Therefore, in most cases, you should be able to see any controlled substance (e.g. opioids) that have been dispensed to a patient if you check the PDMP. Although the PDMP authorizing act does not require prescribers to check the PDMP, they are allowed to access PDMP
information for a current or prospective patient,7 and their applicable licensure board may impose requirements to check the PDMP by regulation. Prescribers and dispensers should consult the PDMP and may suggest other health providers also consult the PDMP if there is information that may be important to the other health provider. Note: Neither the PDMP report nor any information from the PDMP report should be disclosed — that’s why you should suggest the other health provider consult the PDMP if you have a concern, rather than revealing information directly from the report.8

BME Risk and Mitigation Strategies Rule

The PDMP statute does not require prescribers to consult the PDMP, but certain licensure boards do. For instance, the BME recently finalized a new rule on risk and mitigation strategies (RMS) for prescribing physicians.9 The new rule requires prescribers to check the PDMP at frequencies that vary based on the morphine milligram equivalency (MME) of medications they are prescribing: (1) upon each prescription for controlled substances greater than 90 MME; (2) at least twice each year for controlled substances between 30 and 90 MME; and (3) consistent with “good clinical practice” for controlled substances less than 30 MME. Additionally, physicians are required to document the use of RMS in the patient’s medical record. Physicians should take care to adequately document appropriate RMS without running afoul of the PDMP prohibition on disclosing the PDMP report or the information contained therein. This can be a difficult task to fulfill when you can’t keep a copy of the PDMP report in the patient’s medical record.10 A simple notation in the patient’s medical record that you have checked the PDMP and that there are no contraindicated prescriptions likely would suffice.

The new RMS rule sets forth other RMS, including pill counts, urine drug screenings, patient education, and others, some of which are described below from the CDC. Physicians should note that failure to fulfill their obligations under this rule could lead to adverse licensure actions.11

CDC Guidelines for Prescribing Opioids for Chronic Pain

The Centers for Disease Control and Prevention, after a rigorous period of research, consultation and public comment, has also issued opioid prescribing guidelines for primary care physicians treating patients with chronic pain.12 Below is a brief description of the guidelines:

  • Consider nonpharmacologic therapy; only prescribe opioids if risks outweigh benefits;
  • Establish treatment goals;
  • Discuss known risks and benefits of opioid therapy with patients, as well as clinician responsibilities for managing therapy;
  • Consider prescribing immediate-release, rather than extended-release opioids;
  • Prescribe the lowest-effective dosage;
  • For short-term (acute) pain, prescribe the lowest-effective dose and only in the quantity needed for the expected duration of pain severe enough to require opioids;
  • Evaluate risk factors for opioid-related harms and implement a risk mitigation plan;
  • Review the PDMP for harmful quantities or combinations of controlled substances;
  • Conduct urine drug testing before starting opioid therapy;
  • Avoid prescribing opioids and benzodiazepines concurrently, if possible;
  • Offer evidence-based treatment for patients with opioid-use disorder.

A full report listing methods, clinical evidence, and a full discussion of the above recommendations are available from the CDC (see link in footnote 12 below for reference).

These are just a few tools to help you help your patients and mitigate the opioid epidemic. Let’s not win anymore No. 1s of the kind described above for the State of Alabama.

References

1 Prescribing Data, Centers for Disease Control and Prevention (Dec. 20, 2016), https://www.cdc.gov/drugoverdose/data/prescribing.html; Leonard J. Paulozzi, MD et al., Vital Signs: Variation Among States in Prescribing Opioid Pain Relievers and Benzodiazepines—United States, 2012, CDC: Morbidity and Mortality Weekly Report (July 4, 2014), available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w.

2 Huntsville Pill Mill Doctor Sentenced to 15 Years in Prison for Illegal Prescribing and Health Care Fraud, Department of Justice: U.S. Attorney’s Office, Northern District of Alabama (February 7, 2017), available at https://www.justice.gov/usao-ndal/pr/huntsville-pill-mill-doctor-sentenced-15-years-prison-illegal-prescribing-and-health.

3 United States v. Shelinder Aggarwal, Information Against Shelinder Aggarwal, Sept. 22, 2016.

4 Id.

5 Alabama Department of Public Health: Prescription Drug Monitoring Program Home (June 23, 2017), http://www.alabamapublichealth.gov/pdmp/index.html.

6 Ala. Code § 20-2-213 (1975); Ala. Admin. Code r. 420-7-2-.12 (Nov. 24, 2014).

7 Ala. Code § 20-2-214(2) (1975); Ala. Admin. Code r. 420-7-2-.13 (Nov. 24, 2014).

8 See Ala. Code §§ 20-2-215 to 20-2-216 (1975) (making records and information in the PDMP privileged and confidential and creating a Class A Misdemeanor for individuals who intentionally make an unauthorized disclosure of information from the PDMP); see also FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

9 See Ala. Admin. Code r. 540-X-4-.09 (March 9, 2017).

10 See FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

11 Ala. Admin. Code r. 540-X-4-.09(8) (March 9, 2017).

12 Deborah Dowell, MD et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, CDC: Morbidity and Mortality Weekly Report (March 18, 2016), available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm#suggestedcitation.

 

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C., is a Bronze Partner with the Medical Association.

Posted in: Legal Watch

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Medical Association’s 2018 State and Federal Agendas

Medical Association’s 2018 State and Federal Agendas

The Medical Association Board of Censors has met and approved the Association’s 2018 State and Federal Agendas. These agendas were developed with guidance from the House of Delegates and input from individual physicians. As the Alabama Legislature and U.S. Congress begin their work for 2018, additional items affecting physicians, medical practices and patients may be added to this list.

Download the Medical Association’s 2018 State and Federal Agendas (PDF)

 

2018 STATE AGENDA

 

The Medical Association supports:

  • Ensuring legislation “first do[es] no harm”
  • Extending the Medicaid payment bump for primary care to all specialties of medicine
  • Eliminating the health insurance-coverage gap for the working poor
  • Ensuring fair payment for patient care and reducing administrative burdens on physicians and medical practices
  • Strengthening existing tort reforms and ensuring liability system stability
  • Empowering patients and their doctors in making medical decisions
  • Continued physician compounding, dispensing of drugs
  • The same standards and reimbursements for telehealth and face-to-face visits
  • Training, education and licensing transparency of all individuals involved in patient care
  • Continued self-regulation of medicine over all areas of patient care
  • Increased state funding to upgrade the Prescription Drug Monitoring Program to a useful tool for physician monitoring patients at risk for drug interactions and overdose potential
  • Using data analytics to combat the drug abuse epidemic by strengthening research capabilities of pre-approved, de-identified prescription information
  • Maintaining the Alabama Department of Public Health as the repository for PDMP information to ensure continuity for prescribers and dispensers and security for patients
  • Standard opioid education in medical school so the physicians of tomorrow are prepared to face the realities and responsibilities of opioid prescribing

 

The Medical Association opposes:

  • The radical Patient Compensation System legislation
  • Legislation/initiatives increasing lawsuits against physicians
  • Non-physicians setting standards for medical care delivery
  • Tax increases disproportionately affecting physicians
  • Expanding access to the Prescription Drug Monitoring Program (PDMP) for law enforcement
  • Statutory requirements for mandatory PDMP checks
  • Further expansion of Maintenance of Certification (MOC) requirements
  • Changes to workers’ compensation laws negatively affecting treatment of injured workers and medical practices
  • Any scope of practice expansions that endanger patients or reduces quality of care
  • Biologic substitution legislation that allows lower standards in Alabama than those set by the FDA that doesn’t provide immediate notifications to patients and their physicians when a biologic is substituted, and that increases administrative burdens on physicians and medical practices

 

2018 FEDERAL AGENDA

 

The Medical Association supports:

  • Meaningful tort reforms that maintain existing state protections
  • Reducing administrative and regulatory burdens on physicians and medical practices
  • Repeal of the Affordable Care Act and replacement with a system that:
    • Includes meaningful tort reforms that maintain existing state protections
    • Preserves employer-based health insurance
    • Protects coverage for patients with pre-existing conditions
    • Protects coverage for dependents under age 26
    • With proper oversight, allows the sale of health insurance across state lines
    • Allows for deducting individual health insurance expenses on tax returns
    • Increases allowed contributions to health savings accounts
    • Ensures access for vulnerable populations
    • Ensures universal, catastrophic coverage
    • Does not increase uncompensated care
    • Does not require adherence with insurance requirements until insurance reimbursement begins
    • Reduces administrative and regulatory burdens
  • Overhauling federal fraud and abuse programs
  • Reforming the RAC program
  • Prescription drug abuse education, prevention and treatment initiatives
  • Allowing patient private contracting in Medicare
  • Expanding veterans’ access to non-VA physicians
  • Reducing escalating prescription drug costs
  • A patient-centered MACRA framework, including non-punitive and flexible implementation of new MIPS, PQRS and MU requirements
  • Congressional reauthorization of CHIP (Children’s Health Insurance Program) at the current enhanced funding level
  • Better interstate PDMP connectivity
  • Eliminating “pain” as the fifth vital sign
  • Repealing the “language interpreters” rule
  • Requiring all VA facilities, methadone clinics and suboxone clinics to input prescription data into state PDMPs where they are located

 

The Medical Association opposes:

  • Non-physicians setting standards for medical care delivery
  • Publication of Medicare physician payment data
  • National medical licensure that supersedes state licensure
  • Legislation/initiatives increasing lawsuits against physicians

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