Tag: Substance abuse

Combatting the Opioid Crisis

By Andy Cole, Class of 2018

Florida Governor Rick Scott announced on September 26, 2017, plans to introduce legislation that would limit opioid prescriptions to only three days unless a set of very strict standards are met. If the standards are met, then a seven day supply would be permitted. Currently, this bill has not been filed in the House or Senate, but a similar seven day limit bill has been filed.
This legislation follows President Donald Trump declaring the opioid epidemic as a national emergency and many other states and pharmaceutical retailers taking similar stances. Less than a week before Gov. Scott’s announcement, pharmaceutical retailer CVS announced that beginning next February it will limit opioid prescriptions to seven days for patients who are new to pain therapy. Additionally, the Pharmaceutical Research and Manufacturers of America has announced its support for a seven day limit on opioid prescriptions with exceptions for certain conditions such as cancer.
It is unclear if this legislation will pass as it is currently planned. If so, it will be the strictest opioid limitations in the country. Many states have passed seven day limits for first time opioid patients.
In Massachusetts, Governor Charlie Baker proposed a similar 72 hour limit on opioids for first time users. This proposal was met with much criticism from many doctors and advocacy groups who called the proposal “draconian.” The final product of the bill had overwhelming support from both parties. Baker, a Republican, signed the final bill after it passed unanimously through the Democrat controlled legislature.
Many state legislatures have found it hard to balance the need for doctors to maintain discretion and to curb a national crisis. Many doctors and organizations are calling for tighter restrictions that prevent overprescribing of opioids to patients who do not need the medication.
Dr. Steven Stanos, president of American Academy of Pain Medicine, said the academy “supports any initiative that would help limit the effects of over prescribing medications or leading to excessive unused medicines that could lead to harm to a patient or family members or their community.”
The trend of states seeking to regulate the amounts of opioids doctors are allowed to prescribe will continue to grow until the epidemic can be helmed. As many states look to begin drafting their legislative initiatives for 2018 and many politicians prepare for midterm elections, combating opioid addictions will undoubtedly be a bipartisan effort.
There is a possibility that many states will push for law similar to the law enacted in Massachusetts, which requires practitioners to take more steps to combat opioid misuse. The first point of the law is to limit opioid prescriptions to seven days for any new opioid prescription. This applies to all opiates Schedule II through Schedule VI. There are exceptions to this limit. Physicians can prescribe for more than seven days if the prescription is designed for the treatment of substance use disorder or opioid dependence, for inpatient prescriptions, for pain related to an acute medical condition, for chronic pain management, for pain associated with a cancer diagnoses, or for palliative care.
If a first time opiate prescription is being written for greater than a seven-day supply pursuant to an exception, the prescriber must document in the medical record the specific exception for which the opiate is being prescribed; and provide brief information about the actual condition or treatment that necessitates more than seven days; and indicate whether there were known and available non-opiate alternatives. The state has added an additional requirement for prescribing opioids to minors under the age of eighteen. For minors, the prescriber must also document that there was a discussion with the parent/guardian of the known risks with the specific prescription and why it is necessary for that condition/treatment. Additionally, prescribers must document in the medical record each and every time an outpatient opioid prescription is being issued to anyone.
This law moves beyond the prescription limit and also requires prescribers to check the Prescription Monitoring Program every time he or she schedules a Schedule II or III narcotic. The law also requires prescribers to complete training in pain management and addiction. In addition, it requires prescribers and patients to enter into a written pain management treatment agreement for prescriptions for extended-release long-acting opioids.
Finally, this law also places a new burden on pharmacists. If a patient requests a partially filled opioid prescription, the pharmacist must notify the prescriber within seven days. Then the prescriber is responsible for discussing with the patient the quantity of the prescription and the option to partial fill.
From an attorney’s point of view, it is important to make sure your client is aware of all of these changes and their new obligations under the law. While Tennessee has not enacted this type of law yet, combatting the opioid crisis in the state will be high on the legislative agenda for the next few years. A piece of legislation similar to this is bound to be at least be discussed by lawmakers as a potential route to take. At the moment it is difficult to tell how difficult it will be to monitor providers who may abuse the system.

SAMHSA Final Rule Updates the 42 C.F.R. Part 2 Substance Abuse Confidentiality Requirements

By Will Blackford, Class of 2017

After four decades of anticipation, the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published on January 18 a Final Rule modernizing the laws governing how providers share data about individuals with a substance use disorder (“SUD”). The affected regulations, known as 42 C.F.R. Part 2 (“Part 2”), were updated to meet the demands of the electronic age. The Final Rule is meant to facilitate broader data delivery and electronic exchange while safeguarding the privacy of the patient information.

Revisions to Part 2 under the Final Rule include:

  • Consent. Rather than requiring the identification of a specific information recipient, patients are now allowed, in certain circumstances, to consent to a “general disclosure” to intermediate entities (e.g., “my current and future treating providers”).
  • Disclosure. Any patient who opts for this general designation consent may request in writing (paper or electronic) a list of entities to which their information has been disclosed (“List of Disclosures”), and the disclosing entity named on the general consent form must respond within 30 days with a brief description of each disclosure made within the past two years.
  • Description. All patient consent forms are required to include an explicit description of the amount and kind of information that may be disclosed.
  • Scope. The applicability of restrictions on disclosures under Part 2 is expanded to include individuals or entities receiving patient records from “other lawful holders of patient identifying information.”
  • Security. Part 2’s security requirements now apply to both electronic and paper records, as well as require Part 2 programs and “other lawful holders” to have formal security policies and procedures in place.
  • Exclusions. Simply providing screening, brief intervention, or referral to treatment, within the scope of general healthcare, does not subject a provider to classification as a Part 2 program.
  • Qualified Service Organizations. The definition of a Qualified Service Organization (“QSO”) is expanded to include an entity that provides population health management (“PHM”) services to a Part 2 program; however, disclosures under QSO agreements are limited to specific offices or units that actually carry out PHM and such agreements may not be used to circumvent patient consent.
  • Re-disclosure. As a clarification, the prohibition on re-disclosure under Part 2 now applies only to information that would identify a patient as having been diagnosed, treated, or referred for a SUD, unless the patient expressly authorizes such disclosure.
  • Other Disclosures. The Final Rule also relaxes requirements in specific areas, such as disclosure without consent for certain scientific research, medical emergencies, and audits or evaluations.
  • Payment and Operations Disclosures. Due to commenter concerns, SAMHSA issued, alongside the Final Rule, a Supplemental Notice of Proposed Rulemaking (“SNPRM”) to seek comment on disclosures to contractors for payment and operations facilitations, as well as disclosures for Medicare, Medicaid, and other federal program audits or evaluations.


Although the Final Rule was scheduled to go into effect on February 17, 2017, President Trump’s 60-day hold on all rules published in the Federal Register that are not yet effective will likely delay the effective date until at least March 21, 2017. But even with the delay, those providers subject to Part 2 have a very limited timeframe to thoroughly review the new provisions and implement necessary changes.

Specifically, Part 2 providers should implement or update security procedures to address both paper and electronic records. Security measures should also clarify internal policies for creating, maintaining, transferring, destroying, and de-identifying such records. Should providers choose to utilize the new general designation consents for disclosures, there will need to be adequate recordkeeping processes in place to ensure compliance with any List of Disclosure requests. Additionally, providers working with QSO vendors should review relevant contractual documentation to confirm that such vendors are correctly categorized as a QSO under the new definition.

Stay tuned as we continue to monitor the implementation of this Final Rule and analyze its legal consequences.