Posts Tagged epidemic

Study: Is the Opioid Crisis Response Overlooking Women?

Study: Is the Opioid Crisis Response Overlooking Women?

CONNECTICUT Women’s Health Research at Yale is calling on a government committee to revise its report on a coordinated response to the opioid epidemic so that it reflects the unique needs of women.

In a commentary published in the peer-reviewed journal Biology of Sex Differences, WHRY Director Carolyn M. Mazure, Ph.D., and Jill Becker, Ph.D., chair of the Biopsychology Area of the University of Michigan Psychology Department, detailed the laboratory, clinical and epidemiological evidence showing the need for the report to endorse and encourage the research of sex and gender differences. They argued such data is necessary to generate gender-based interventions that more fully address the opioid epidemic.

“All data must be reported by sex and gender so that gender-specific treatment and prevention strategies derived from this research are provided to practitioners and the public,” the authors said. “We encourage biomedical researchers and clinical care providers, as well as the public, to insist that a successful response to the opioid crisis should highlight the importance of understanding sex and gender differences in the current opioid epidemic.”

Mazure and Becker noted that the draft report of the White House National Science and Technology Council’s Fast-Track Action Committee (FTAC) created to respond to the opioid crisis does include important concerns about maternal and neonatal exposure to opioids. But they said the draft, released in October, overlooks significant and growing data on sex and gender differences in opioid use disorder (OUD). For example, they wrote that women are more likely than men to be prescribed and use opioid analgesics, and females and males experience pain and the effects of opioids differently.

In addition, women more quickly develop addictions after first using addictive substances, and women are more likely than men to relapse after a quit attempt.

The authors also described how women with opioid addiction are more likely than men to have experienced early trauma and have been diagnosed with depression. And women with opioid addiction suffer greater functional impairment in their lives, impacting their ability to work, secure steady housing, and — because women are more often family caretakers — avoid negative effects on children.

“Our experimental models will not begin to yield the desired information until they employ appropriate models that include both females and males, and our clinical and epidemiological investigations will not uncover needed data until both women and men are studied,” the authors said. “A successful response to the opioid crisis will only be found when scientists, practitioners and the public incorporate the essential importance of understanding sex and gender differences into the solution for OUD.”

Posted in: Opioid

Leave a Comment (0) →

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

Leave a Comment (0) →

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

Leave a Comment (0) →