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Two-Minute Primer on Electronic Prescription of Controlled Substances

Posted by admin on September 14, 2018

The contents of a recent Drug Enforcement Administration policy statement on electronic prescriptions for controlled substances sound simple enough—you can use a mobile device for EPCS if it meets the latest Federal Information Processing Standards security requirements (FIPS 140-2), and you can use it as a “hard token” if it is separate from the device used to create the EPCS. But what does that mean? Are there any more limitations?

The Controlled Substances Act regulates drugs and other substances that have a potential for abuse and psychological and physical dependence, i.e., “controlled substances.” Controlled substances are organized into five schedules. Schedule I drugs have a high risk of abuse and no current accepted medical uses in the United States. Drugs in Schedules II through IV have currently accepted medical uses, but they also have a high potential for abuse. Drugs in Schedule II can only be issued pursuant to a written prescription, whereas drugs in Schedules III and IV may be issued pursuant to written or oral prescriptions.[1] The written prescription may be an electronic one, if it satisfies certain requirements.

An EPCS may be created with input and data entry from the DEA registrant (the prescribing practitioner) or his or her agent, provided that only the registrant can actually sign the prescription using the EPCS application.[2] To sign the application, however, the registrant has to complete a two-factor authentication process while at the same time viewing certain information about the EPCS (date of issuance; full name of patient; drug name; dosage strength and form, quantity prescribed, and directions for use; number of refills authorized; earliest date on which a pharmacy may fill each prescription; name, address and DEA number of the registrant)[3] and a statement of acknowledgement[4] regarding the EPCS, as prescribed by regulation. The provider’s completion of the two-factor authentication process in the EPCS application is the equivalent of signing a hard-copy paper prescription.[5]

The two-factor authentication process includes the use of two of the following authentication factors: (1) something only the practitioner knows (e.g., a password or response to a challenge question); (2) biometric data (e.g., a fingerprint or iris scan); or (3) a device, known as a hard token, which is separate from the computer or other device used to access the EPCS application (i.e., the hard token could be your phone, as long as you are not electronically prescribing the EPCS through an EPCS application on your phone).[6] The hard token is subject to FIPS 140-2 Security Level 1 requirements,[7] and the system used to validate biometric data must comply with other regulatory requirements,[8] all of which are beyond the scope of this article and beyond this author’s expertise.[9] Whichever factors are used in the two-factor authentication process, the prescribing practitioner/registrant must not share the authentication factors with any other person or allow it to be used to electronically sign an EPCS.[10] Additionally, if a practitioner/registrant loses his or her hard token (if applicable), he must notify the appropriate access control managers for the EPCS application (either in his/her individual practice or through an institutional provider such as a hospital) within one business day of the discovery, or he or she may be held responsible for any controlled substances written using his or her two-factor authentication credential.[11]

In addition to the requirements above and the responsibilities the practitioner normally has when issuing paper or oral prescriptions for controlled substances, there are more practitioner responsibilities when it comes to EPCS.[12] To the extent an EPCS is not successfully delivered, the practitioner must ensure that any paper or oral prescription issued as a replacement for a failed EPCS indicates that the prescription was originally transmitted electronically to a particular pharmacy and that the transmission failed. The practitioner must also exercise certain reasonable precautions to ensure that the EPCS application complies with all applicable regulatory requirements, especially if the practitioner is on notice that the EPCS system may not meet all the requirements.[13]

An exhaustive discussion of all the applicable requirements for EPCS is beyond the scope of this article. However, practitioners should be thinking about the vendors they are using for their EPCS system, the system’s capabilities and process control limitations, and the information security or physical safeguards they must maintain to ensure their two-factor authentication credentials are secure. In addition, it should be noted that EPCS are subject to other laws, such as the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which generally requires a practitioner to conduct at least one in-person medical examination for a patient if they are prescribing controlled substances for the patient.[14]

From a process standpoint, EPCS may be easier to work with, but it implicates substantial compliance concerns with a variety of laws. Practitioners should carefully consider the volume of legal and regulatory requirements applicable to EPCS and ensure their operations conform to all applicable requirements.

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C. is an official partner with the Medical Association.

Resources

[1] Drugs in Schedule V may only be distributed or dispensed for medical purposes, but are not grouped in with either Schedule II or Schedules III and IV for purposes of the prescription requirements. See 31 U.S.C. § 829.

[2] 21 C.F.R. § 1311.135.

[3] 21 C.F.R. § 1311.120(b)(9).

[4] “By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.” 21 C.F.R. § 1311.140(a)(3).

[5] 21 C.F.R. § 1311.140(a)(5).

[6] 21 C.F.R. § 1311.115.

[7] Incorporated by reference in 21 C.F.R. § 1311.08.

[8] See 21 C.F.R. § 1311.116.

[9] This author suggests consulting with information technology experts in order to verify applications meet regulatory requirements, or at least include in agreements with vendors that the service they are providing complies with the applicable regulatory requirements.

[10] 21 C.F.R. § 1311.102(a).

[11] 21 C.F.R. § 1311.102(b).

[12] See 21 C.F.R. § 1311.102.

[13] 21 C.F.R. § 1311.102.

[14] See 21 U.S.C. § 829(e).

Tags: control, dea, electronic, prescription, substance

Posted in: Legal Watch

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Study: Doctors Reduced Opioid Prescriptions after Learning a Patient Overdosed

Posted by admin on August 10, 2018

Will clinicians become more careful in prescribing opioids if they are made of aware of the risks of these drugs first-hand? That was one of the core questions researchers set out to explore in a new study published in the August 2018 issue of Science. In doing so, they found that many clinicians do not learn of the deaths of those patients who overdose as they just disappear from their practice, outcomes unknown.

This disconnect from the personal experience of losing a patient due to fatal overdose, related to a prescription for opioids to relieve pain, makes the problem of the nation’s opioid crisis seem remote – statistics happening elsewhere. While the epidemic continues to exert its outsized impact, opioid prescription-writing levels have not responded with adequate risk-benefit analysis by prescribers tasked with caring for patients with complaints around pain.

“Clinicians may never know a patient they prescribed opioids to suffered a fatal overdose,” explained lead author Jason Doctor. “What we wanted to evaluate is whether closing that information gap will make them more judicious prescribers.” Doctor is the Director of Health Informatics at the USC Schaeffer Center for Health Policy & Economics and Associate Professor at the Price School of Public Policy.

The study leverages behavioral insights and psychology to give prescribers personal experience with the risk associated with opioids and finds that when a clinician learns one of their patients had suffered a fatal overdose they reduced the number of opioids prescribed by almost 10 percent in the following three months.

Doctor and his colleagues conducted a randomized trial between July 2015 and June 2016 of 861 clinicians who had prescribed to 170 patients who subsequently suffered a fatal overdose involving prescription opioids. Half the clinicians, who all practiced in San Diego County, were randomly selected to receive a letter from the county medical examiner notifying them that a patient they had prescribed opioids to in the past twelve months had a fatal overdose. The letter, which was supportive in tone, also provided information from the Centers for Disease Control and Prevention on safe prescribing guidelines, nudging clinicians toward better prescribing habits.

In the three months after receiving the letter, prescribing decreased by 9.7 percent compared to the control group who didn’t receive a letter. Furthermore, clinicians who received the letter were 7 percent less likely to start a new patient on opioids and less likely to prescribe higher doses.

The results are particularly exciting given that numerous, more traditional state regulations which often involve mandated limits on opioids have not been shown to have much impact. The authors point to numerous reasons why this study showed more promising results including its simplicity, that the letters still allows clinicians to decide when they will prescribe opioid analgesics and that it provides an important missing piece of clinical information to them.

This intervention is easily scalable nationwide as existing state and national resources already track the information necessary around overdose deaths associated with prescription and illicit drugs.

“Interventions that use behavioral insights to nudge clinicians to correct course are powerful, low-cost tools because they maintain the autonomy of the physician to ultimately decide the best course of care for their patient,” said Doctor. “In this case, we know opioids, though beneficial to some patients with certain conditions, come with high risks that the doctor may not fully grasp when observing patients in the clinic. Providing information about the harm that would otherwise go unseen by them gives physicians a clearer picture.”

###

Co-authors include Andy Nguyen, Roneet Lev, Jonathan Lucas, Tara Knight, Henu Zhao, and Michael Menchine. Funding for the study was provided by the California Health Care Foundation and the National Institute on Aging at the National Institutes of Health (R21-AG057395-01).

The Leonard D. Schaeffer Center for Health Policy & Economics, one of the nation’s leading health policy centers, aims to measurably improve value in health through evidence-based policy solutions, research and educational excellence, and private and public sector engagement. The Center is a unique collaboration between the USC School of Pharmacy and the Sol Price School of Public Policy at the University of Southern California (USC).

Tags: death, opioid, overdose, patient, prescribe, prescription

Posted in: Opioid

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Reducing Opioid Prescriptions for One Operation Can Have a Spillover Effect to Other Procedures

Posted by admin on July 27, 2018

Study results show revised recommendations resulted in about 17 fewer pills being dispensed per patient for four major operations.

CHICAGO – To curb the use of opioids after major elective operations and prevent these pain relievers from falling into the wrong hands, surgeons at the University of Michigan developed prescribing recommendations based on published medical evidence for one operation, gallbladder removal, and then discovered a spillover effect that led them to prescribe roughly 10,000 fewer pills for other major operations, according to study results appearing as an “article in press” on the website of the Journal of the American College of Surgeons ahead of print.

“We changed how many opioids we dispense or prescribe to patients after laparoscopic cholecystectomy, which is performed for gallbladder removal,” said lead study author Michael Englesbe, MD, FACS, a transplant surgeon in the department of surgery, University of Michigan Health System, Ann Arbor. “As an unintended spillover consequence, the change had a significant impact on how we prescribe for other procedures.”

The study noted that surgeons have been known to overprescribe opioids after operations, resulting in leftover pills that can sometimes be diverted for illegal use. Dr. Englesbe and coauthors set out to determine if prescribing guidelines for one specific operation would have an impact on reducing opioids prescribed for other surgical procedures.

In a previous study, * Dr. Englesbe and coauthors described their recommendations for opioids after minimally invasive gallbladder removal: 15 tablets of hydrocodone/ acetaminophen 5/325 mg or 10 tablets of oxycodone 5 mg; along with encouraging the use of non-opioid pain medications such as acetaminophen or ibuprofen. They found that after implementing the recommendation, opioid prescriptions also declined significantly for four other types of major operations—thyroidectomy or parathyroidectomy (removal of all or part of the thyroid gland), and laparoscopic, or minimally invasive, appendectomy (surgical removal of the appendix), inguinal hernia repair, and sleeve gastrectomy (a weight-loss operation in which a portion of the stomach is removed).

The study involved reviews of 1,158 patient charts, 558 who had operations before the opioid recommendations were implemented and 600 over 10 months afterward to compare surgeons’ prescribing behavior. For sleeve gastrectomy, the most extensive operation, the average prescription after surgery went from around 89 pills before the recommendations to around 58 afterward, about a 35 percent reduction. The reductions for the other operations were more significant: about 43 percent for hernia repair (37 pills before to 21 after); and 50 percent or more for appendectomy (35 to 17 pills) and thyroidectomy/parathyroidectomy (16 to 8 pills). The prescriptions were measured in oral morphine equivalents, with 100 OMEs equal to about 20 pills of hydrocodone/acetaminophen 5/325 mg.

Dr. Englesbe explained why the researchers chose these four operations: “These procedures are not usually performed to treat pain, so there is an expectation that patients will have the procedure and essentially recover relatively quickly; and they are relatively straightforward elective operations that are commonly done across Michigan and throughout the United States.”

Despite the reduction in prescribing, patients requested refills after only minimally invasive appendectomy. Prescriptions for non-opioid analgesics also increased significantly for two procedures. For the four procedures across the entire study population, the revised recommendations resulted in roughly 10,000 fewer pills entering the community. On average, that equals about 17 fewer pills per patient.

“These findings are relevant to any surgeon,” Dr. Englesbe said. “Every surgeon, no matter what specialty or procedure they do, dentists included, needs to be thoughtful about how they prescribe opioids and be realistic that overprescribing can really have some devastating complications.”

Since the original recommendations for opioids after gallbladder removal, the Michigan Surgical Quality Collaborative and Opioid Prescribing Engagement Network have developed recommendations for 17 other procedures, including three types of hysterectomy, breast biopsy, and mastectomy. The recommendations are reviewed quarterly and updated as needed, Dr. Englesbe said, and will soon include some dental procedures. The recommendations are available at https://opioidprescribing.info.

“Some patients do not do well with opioids, and we as providers need to be very thoughtful while we give the best pain care possible but at the same time also make sure it’s the safest pain care,” Dr. Englesbe said.

Dr. Englesbe’s coauthors are Ryan Howard, MD, and Jay Lee, MD, of the department of surgery, Michigan Medicine, Ann Arbor; Mitchell Alameddine, BS, and Michael Klueh, BS, of the University of Michigan Medical School, Ann Arbor; Chad Brummett, MD, of the department of anesthesia, University of Michigan Health System; and Jennifer Waljee, MD, MS, MPH, FACS, of the section of plastic surgery, department of surgery, University of Michigan Health System.

“FACS” designates that a surgeon is a Fellow of the American College of Surgeons.

Citation: Spillover Effect of Evidence-Based Opioid Prescribing after Surgery. Journal of the American College of Surgeons. Available at: https://www.journalacs.org/article/S1072-7515(18)30436-8/fulltext.
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* Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in opioid prescribing through evidence-based prescribing guidelines. JAMA Surg. 2018;153:285-287.

Tags: opioid, prescription, surgery

Posted in: Opioid

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Trump Administration Releases Drug Pricing Blueprint

Posted by admin on May 18, 2018

On May 11, The Trump Administration released “American Patients First,” the President’s blueprint to lower drug prices and reduce out-of-pocket costs, along with a request for information. The Blueprint was framed as advancing four specific goals:

Reducing list prices;
Improving government’s ability to negotiate better prices;
Encouraging competition through rapid entry to market of generics and biosimilars; and
Lowering patient out-of-pocket expenses.

The Blueprint proposes a broad number of changes to prescription drug programs in several federal health care programs – such as Medicare, Medicaid and other safety net programs – as well as Food and Drug Administration policies that should impact commercial and federal health care program access to affordable prescription drugs.

While some of these proposals can be undertaken through immediate regulatory or subregulatory actions, others are still on the drawing boards at the U.S. Department of Health and Human Services and some will require congressional action to implement. The Blueprint proposes a select number of programmatic and design changes, yet the Administration is seeking feedback for a large number of lingering questions.

Initial review appears to show an increased access to lower-cost alternative generics. But closer review is needed on proposed changes to the Medicare Part D Prescription Drug Benefit Program and the Part B drug reimbursement methods to alleviate concerns the changes may limit patient access to medically necessary alternative brand or specialty treatments and result in additional administrative burdens on physicians and patients. The proposal may also eliminate the requirement that Part D plans include a minimum of two drugs proven to be effective in each therapeutic category or pharmacologic class, if available.

The Medical Association will be closely monitoring the Administration’s “American Patients First” Blueprint and will keep our members updated on any new developments as they become available.

Tags: benefit, biosimilar, blueprint, drug, FDA, generic, Medicare, medication, prescription

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Successful Take Back Alabama Week Ends with Opioid Summit

Posted by admin on April 20, 2018

REVISED APRIL 27, 2018 ─ The Medical Association’s Take Back Alabama Week kicked off this week with a press conference at Walgreens in Birmingham on Monday, April 23. Representatives from AmerisourceBergen, Blue Cross and Blue Shield of Alabama, Pfizer, Prime Therapeutics and Walgreens joined Attorney General Steve Marshall and Birmingham physician Gregory Ayers to announce the installation of 13 new safe medication disposal kiosks in select Walgreens locations in Alabama.

“Once they are in the consumers’ hands, many of these medications are not all used,” Dr. Ayers said during the press conference. “A patient may use only a few pills out of a prescription, and then many of these medications are left over that just sit unused in a medicine cabinet…unsecured in most cases. These medications need to be disposed of safely so they don’t get into the hands of those who don’t need them. These kiosks offer a very safe avenue for disposal.”

The kiosks allow individuals to safely and conveniently dispose of unwanted, unused or expired medications, including controlled substances and over-the-counter medications at no cost. They are available during regular pharmacy hours.

The week ended with Take Back Alabama’s parent program, Smart & Safe Alabama, exhibiting at the Annual Opioid Crisis in Alabama: From Silos to Solutions to further spread the word about the new medication disposal kiosks as well as raising awareness for prescription drug safety.

Check out some of the news coverage, compliments of WIAT:

APRIL 20, 2018 ─ According to the Alabama Department of Public Health, 749 Alabama residents died in 2016 due to drug overdose, which includes prescription drug overdose. This number is up from 726 in 2015…and this is why the Medical Association of the State of Alabama created Take Back Alabama Week. In an unprecedented partnership, the Medical Association reached out to Walgreens, Blue Cross Blue Shield of Alabama and Pfizer to form a strategic alliance for education about and safe disposal of prescription medications.

Take Back Alabama Week is April 23-28, and kicks off Monday, April 23, with a media event at Walgreens located at 4700 Highway 280 in Birmingham. The event is the perfect opportunity to spread the word about the availability of safe medication disposal kiosks in 13 Walgreens locations across Alabama. Attorney General Steve Marshall and Birmingham physician Gregory Ayers will join representatives from Blue Cross and Blue Shield of Alabama and Pfizer to kick off the campaign.

“While Alabama has beaten the national average from 2013 to 2017 in the percentage of reduction in opioid prescriptions, we still lead the nation in the total number of opioid prescriptions on a per capita basis,” said Medical Association Executive Director Mark Jackson. “That’s why joining forces with Blue Cross Blue Shield of Alabama, Walgreens and Pfizer is so important. We are waging an information campaign to educate Alabamians not only of the dangers of the misuse of opioids and other prescription medications but also that there are alternatives to opioids. It begins with an open and honest conversation with your physician to find the best treatment plan for each patient.”

DISPOSAL LOCATIONS

Visit the following Walgreens locations to safely dispose of your unused medications:

7155 US Highway 431
Albertville, AL 35950

1815 9th Avenue N.
Bessemer, AL 35020

101 Green Springs Highway
Birmingham, AL 35209

4700 Highway 280
Birmingham, AL 35242

9325 Parkway E.
Birmingham, AL 35215

2940 W. Main Street
Dothan, AL 36305

900 Rucker Boulevard
Enterprise, AL 36330

2 Greeno Road S.
Fairhope, AL 36532

1801 Montgomery Highway S.
Hoover, AL 35244

7813 Highway 72 W
Madison, AL 35758

3948 Airport Boulevard
Mobile, AL 36608

6680 Atlanta Highway
Montgomery, AL 36117

2515 Crawford Road
Phenix City, AL 36867

Walgreens at these locations have drop boxes in which residents may safely deposit unused prescriptions and over-the-counter medications…no questions asked. These boxes are locked, and there is no danger of your medications getting into the hands of someone who could accidentally overdose or misuse them.

For more information, log on to www.SmartAndSafeAL.org/takeback.

Tags: aware, drug, opioid, prescription

Posted in: Smart and Safe

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The New Department of Justice Initiative: Aggressively Investigating and Prosecuting Opioid-Related Cases

Posted by admin on January 4, 2018

Before joining Burr & Forman, LLP, I was a federal prosecutor for a little over a decade specializing in health care fraud and general white collar matters. In that role, I was the member of a prosecution team that secured guilty verdicts earlier this year against two pain management doctors in Mobile, Ala., following a protracted jury trial. The doctors were convicted of a litany of federal crimes arising from their operation of a pain management clinic, including, among others, violations of the Controlled Substances Act and the Anti-Kickback Statute. The doctors received substantial prison sentences of 20 and 21 years, respectively, and forfeited virtually all of their assets (including bank accounts, houses and cars) to the government.

The doctors in this case were convicted of running what the government calls a “pill mill,” a pain management clinic that allegedly prescribes narcotics for illegitimate purposes. Pain management professionals should be aware this is just one example of what will likely be an onslaught of “pill mill” and other opioid-related prosecutions by the Department of Justice (DOJ) during the current administration. In fact, just a few months after the convictions in the Mobile case, Attorney General Jeff Sessions announced a nationwide takedown of 120 doctors, pharmacists and nurses – dubbed “Operation Pilluted” – who were charged with various federal crimes related to their alleged “unlawful distribution of opioids and other prescription narcotics.” In announcing the takedown, Sessions noted the DOJ would continue to “aggressively pursue corrupt medical professionals,” and “the Department’s work is not finished. In fact, it is just beginning.”

On the heels of that announcement, in August of this year, Sessions heralded a new DOJ pilot program called the “Opioid Fraud and Abuse Detection Unit.” According to Sessions, the unit “will focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to the opioid epidemic.” Sessions warned, “If you are a doctor illegally prescribing opioids or a pharmacist letting these pills walk out the door and onto our streets based on prescriptions you know were obtained under false pretenses, we are coming after you.” Sessions explained the DOJ would be appointing a special federal prosecutor in 12 select districts across the country whose sole purpose will be to prosecute “pill mill” and other opioid-related cases.

One of the districts, which has received one of the special “pill mill” prosecutors, is the Northern District of Alabama, in Birmingham. The U.S. Attorney for that district, Jay Town, separately confirmed the new prosecutor will spend “100 percent of their time working these types of cases…What we’re going after is the medical providers who are operating outside the boundaries of the law and the medical practice.” Echoing the Attorney General’s statements, Town vowed, “We’re going to rid the Northern District of these pill mills.”

Note “pill mills” are not the only opioid-related cases on the DOJ’s radar. In fact, it is also concentrating on the “diversion” of opioids in hospital settings. Such “diversion” schemes include, for instance, the theft of opioids from a hospital “Pxyis” machine (a device hospitals utilize to regulate the dispensing of controlled substances) by nurses, or the forgery or fraudulent creation of opioid prescriptions by hospital personnel.

In sum, the DOJ has fired a warning shot that physicians, pharmacists and other medical professionals involved in the treatment of patients will be under intense scrutiny for the foreseeable future. This is especially true for physicians who operate pain management clinics. These doctors should, in general, prescribe opioids reasonably and carefully in the context of each patient’s presentation and thoroughly document their treatment.

To that end, doctors should, among other things: maintain a thorough intake procedure, which requires the patient to give a detailed medical history and provide previous diagnostic studies; have the patient sign, if applicable, an “opioid treatment agreement” requiring the patient to abide by certain opioid use guidelines; perform exhaustive physical examinations during the initial visit and at regular intervals during the patient’s treatment (which should be carefully documented); consider alternatives to opioid treatment, such as non-narcotics drugs, physical therapy and surgery (and, where applicable, carefully document why alternative treatments would be ineffective); prescribe the lowest dosage and quantity of opioids possible to treat the patient’s condition; closely monitor for signs of diversion and addiction by regularly ordering urine drug screens and reviewing the patient’s prescription drug monitoring data; and have regular independent audits conducted by a billing consultant or another pain management specialist to ensure compliance with all regulations and laws. Implementing these practices should help doctors avoid government scrutiny as part of the DOJ’s new initiative to crack down on alleged “pill mill” operations.

Adam Overstreet is counsel at Burr & Forman, LLP. Prior to joining Burr, Adam practiced with the U.S. Attorney’s office and gained extensive experience with health care fraud matters. Burr & Forman, LLP, is a partner with the Medical Association. Please read other articles from Burr & Forman, LLP, here.

Tags: abuse, advocacy, burr, diversion, forman, fraud, legal, mill, opioid, pill, prescription, pxysis

Posted in: Legal Watch

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Medical Association’s 2018 State and Federal Agendas

Posted by admin on December 13, 2017

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

Tags: adph, agenda, bump, burden, certification, CHIP, compensation, drug, educate, federal, legislative, liability, license, licensure, MACRA, maintenance, Medicaid, MIPS, MOC, monitor, MU, opioid, PDMP, PQRS, prescription, reimburse, specialty, state, telehealth, train

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CVS Pharmacy, Others to Limit Prescriptions for Opioids

Posted by admin on September 29, 2017

Beginning in February 2018, CVS Pharmacy will limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply, which adheres to the Centers for Disease Control and Prevention’s guidelines for prescribing opioids. This limit involves capping daily low-dosages and requires patients to receive versions of the medication that give pain-relief for a short period of time rather than a long duration. However, pharma companies seem to be following in the pharmacy’s footsteps as well.

According to the CVS plan, for a patient to receive an opioid prescription for longer than seven days, the patient would need to complete a pre-authorization for the medication — obtained after the pharmacy benefit manager consults with the prescribing doctor — and will have to pay for them out of pocket. The plan also includes in-store pharmacy training and awareness programs on opioid safety and addiction prevention, along with 750 in-store medical disposal units.

While the seven-day quantity limit on opioid prescriptions is intended for CVS Caremark’s PBM clients and applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, CVS is not the first — and will not the be last — to place limitations on opioid prescriptions. Earlier this week during a meeting of President Trump’s opioid commission, the Pharmaceutical Research and Manufacturers of America announced support to limit the supply of opioids to seven days for acute pain management. PhRMA is a trade organization representing more than three dozen pharma companies, including AstraZeneca, Bayer, Allergan, Bristol-Myer Squibb, Eli Lilly, Johnson & Johnson, Merck, Pfizer, Teva, Novartis, GlaxoSmithKline, and Purdue Pharma.

In August, OptumRx announced the initial results of its Opioid Risk Management program, which is also reducing opioid use. The program places maximum fill limits on opioid therapy regardless of whether the patient is new to opioids or a chronic user. Results include:

82 percent decrease in prescriptions above the CDC guideline recommended dose of 50 mg morphine equivalent dose (MED) per day for first-fill acute prescriptions;
65 percent decrease in prescriptions for first-fill acute opioid treatment written above the maximum seven-day supply;
68 percent decrease in prescriptions for current chronic opioid utilizers issues for >90 mg MED; and
14 percent reduction in average dose across all opioid prescriptions.

Tags: opioid, pharmacy, prescription

Posted in: Opioid

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Congress Squares Off Over Drug Pricing and a Controversial Drug Discount Program

Posted by admin on July 21, 2017

House Democrats are calling foul on Republican assertions that cuts to a little-known discount drug program will eventually reduce skyrocketing drug prices. At a hearing Tuesday, Rep. Diana DeGette (D-Colo.) said high drug prices should be investigated separately from the focus on oversight of the drug discount program, known as 340B.

“I think we need an investigation, a robust investigation, and a series of hearings that explore in-depth the reasons for the exorbitant cost of drugs and why the prices continue to rise,” DeGette said.

Last week, Health and Human Services Secretary Tom Price proposed steep cuts in what Medicare reimburses some hospitals for outpatient drugs under the 340B program. In a release, Price said such cuts would be “a significant step toward fulfilling President [Donald] Trump’s promise to address rising drug prices.”

DeGette countered Tuesday that the proposal “would do nothing” to address high drug prices and said making that connection “seems more like fantasy than reality.”

Also on Tuesday, there were other hints at Trump administration efforts to address drug pricing. Food and Drug Administration Commissioner Scott Gottlieb talked in a public meeting about lowering drug prices on a different front — saying that the agency needs to increase generic-drug competition.

Trump routinely criticized high drug prices on the campaign trail last year and promised to take action during his presidency. In June, a leaked draft of an executive order on drug prices, first reported by The New York Times, spoke of facilitating more drug competition but also targeted the 340B program. That strategy immediately drew criticism from Sen. Al Franken (D-Minn.), who said scaling back the program would drive up what hospital patients pay for drugs and force Americans “to choose between health and other basic life necessities, like putting food on the table and a roof overhead for the family.”

The federal 340B program requires pharmaceutical manufacturers to provide outpatient drugs at a significant discount to hospitals and clinics that serve a largely low-income population.

After buying the discounted drugs, the hospitals and clinics can bill Medicare or other insurers at their regular rate, pocketing the difference.

About 40 percent of hospitals nationwide participate in the program and, as House members pointed out Tuesday, the program has grown dramatically in recent years to become a significant force in the pharmaceutical marketplace. The Medicare Payment Advisory Commission estimated that hospitals and other participating entities spent more than $7 billion to buy 340B drugs in 2013, three times the amount spent in 2005.

Advocates of the program say the discounts — and the money hospitals make on payments from Medicare — are necessary to combat skyrocketing drug prices.

But federal reports in recent years from the Medicare advisory board, as well as the Government Accountability Office and the Office of Inspector General, have raised concerns about oversight and abuse of the 340B program.

Rep. Joe Barton (R-Texas) noted “this is a difficult hearing” because while the program was created with good intent, its complexity makes it challenging to understand. For example, hospitals and clinics aren’t required to pass any discounts they receive on to patients — they can direct the money to their general fund.

Looking at his colleagues, Barton said: “We all support the program but it has grown topsy-turvy. We need to put the best minds on this.”

Republican lawmakers are not the only ones raising concerns about 340B oversight. The Pharmaceutical Research and Manufacturers of America, which represents drugmakers, advocates ensuring hospitals are “good stewards” of the money they gain from the program’s discounts.

Peggy Tighe, who represents hospitals in the 340B program as a principal at the D.C. law firm Powers, said “PhRMA has done a particularly good job of getting the attention of the administration. … They haven’t let up on 340B.”

The rule that Price proposed last week would cut what hospitals are paid for drugs from the Medicare Part B program, which covers outpatient drugs including those delivered through infusion.

Currently, Medicare pays hospitals an average sales price plus 6 percent for most of the Part B drugs they purchase. The administration’s proposal is to cut that to average sales price minus 22.5 percent.

340B Health, a coalition that represents hospitals, immediately responded to the proposal saying the cuts would be “devastating” to hospitals and would “lead to cuts in patient services.”

sjtribble@kff.org | @SJTribble | Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing are supported in part by the Laura and John Arnold Foundation.

Tags: cost, drug, medicine, prescription

Posted in: Advocacy

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Opioid Prescribing Still High and Varies Widely Throughout U.S.

Posted by admin on July 14, 2017

Opioid prescribing in the United States peaked in 2010 and then decreased each year through 2015, but remains at high levels and varies from county to county in the U.S., according to the latest Vital Signs report by the Centers for Disease Control and Prevention (CDC).

Six times more opioids per resident were dispensed in 2015 in the highest-prescribing counties than in the lowest-prescribing counties. This wide variation suggests inconsistent prescribing practices among health care providers, and that patients receive different care depending on where they live.

“The amount of opioids prescribed in the U.S. is still too high, with too many opioid prescriptions for too many days at too high a dosage,” said Anne Schuchat, M.D., acting director of the Centers for Disease Control and Prevention. “Health care providers have an important role in offering safer and more effective pain management while reducing risks of opioid addiction and overdose.”

CDC researchers analyzed changes in annual prescribing measures from 2006 to 2015 and found that while there have been declines in opioids prescribed, more can be done to improve prescribing practices. For example, between 2006 and 2015 opioids prescribed peaked in 2010 at 782 morphine milligram equivalents (MME) per person and decreased to 640 MME in 2015. (MME is the amount of opioids in milligrams, accounting for differences in opioid drug type and strength.)

Daily MME per prescription remained stable from 2006 to 2010 and then decreased 17 percent from 2010 to 2015 (from 58 MME to 48). However, the average days’ supply per prescription increased 33 percent from 13 days in 2006 to almost 18 days in 2015. Opioids prescribed per capita in 2015 was still approximately three times as high as in 1999.

County-level opioid prescribing patterns vary

For this Vital Signs report, CDC analyzed retail prescription data from QuintilesIMS to assess opioid prescribing in the United States from 2006 to 2015, including rates, amounts, dosages, and durations prescribed. CDC examined county-level prescribing patterns for the years 2010 and 2015.

County-level factors associated with higher amounts of opioids prescribed include:

A greater percentage of non-Hispanic white residents.
A greater prevalence of diabetes and arthritis.
Micropolitan areas (non-metro small cities and big towns).
Higher unemployment.

“While some variation in opioid prescribing is expected and linked to factors such as the prevalence of painful conditions, differences in these characteristics explain only a fraction of the wide variation in opioid prescribing across the United States,” said Deborah Dowell, M.D., M.P.H., chief medical officer in the Division of Unintentional Injury Prevention at CDC’s National Center for Injury Prevention and Control. “This variation highlights the need for healthcare providers to consider evidence-based guidance when prescribing opioids.”

Ensuring access to safer, more effective pain treatment

In 2016, CDC published the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings. These recommendations focus on the use of opioids in treating chronic pain (pain lasting longer than three months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care. The Guideline includes recommendations such as:

Use opioids only when benefits are likely to outweigh risks.
Start with the lowest effective dose of immediate-release opioids.
Reassess benefits and risks when considering dose increases.

Health care providers should also use state-based prescription drug monitoring programs (PDMPs), which help identify patients at risk of addiction or overdose.

The Guideline can also be used by health systems, states, and insurers to help ensure appropriate prescribing and improve care for all people. Tools and resources are available to help providers and patients discuss the risks and benefits of opioid therapy for chronic pain to improve the safety and effectiveness of pain treatment and to reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death. For more information about preventing opioid overdose: www.cdc.gov/drugoverdose.

Vital Signs is a CDC report that typically appears on the first Tuesday of the month as part of the CDC journal Morbidity and Mortality Weekly Report. The report provides the latest data and information on key health indicators, such as cancer prevention, obesity, tobacco use, motor vehicle injury prevention, prescription drug overdose, HIV/AIDS, alcohol use, health care-associated infections, cardiovascular health, teen pregnancy, and food safety.

For information about the Medical Association’s prescription drug abuse awareness program, visit Smart & Safe.

Tags: chronic, opioid, pain, PDMP, prescribe, prescription

Posted in: Smart and Safe

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