Hydrocodone combination products Schedule II Oct 6, 2014

On Aug 22, 2014, the US Drug Enforcement Administration (DEA) published a final rule in the Federal Register reclassifying drugs that contain hydrocodone combinations from Schedule III to Schedule II.  The change will take effect Oct 6, 2014.

What does the new rule mean for physicians?

  • Prohibits physicians from delegating to advance practice nurses (APNs) and physician assistants (PAs) authority to prescribe these drugs outside of a hospital or hospice setting.  Accordingly, delegated prescriptive authority agreements you have with APNs or PAs may need to be updated.  
  • Prevents physicians from calling in prescriptions for these medications to pharmacies (except in emergencies, in which case oral transmission must be followed up with written prescription within 7 days- see Texas Health and Safety Code, Ch. 481 Controlled Substances Act. Sect 481.074. PRESCRIPTIONS); 
  • Physicians must use the official prescription pads from Texas Department of Public Safety (DPS) for written prescriptions;
  • Prohibits refills of prescriptions for these drugs; and
  • Physicians may issue prescriptions for Schedule II drugs for a maximum 90-day period.*   

What do I need to consider when writing new prescriptions for Schedule II drugs?  Physicians may want to ask:  

  • As a prescription requires a medically valid purpose, does the patient at the time of the prescription request have a valid medical condition requiring a prescription (or multiple prescriptions in order to provide up to a 90-day supply of a Schedule II drug as allowed under state and federal law)?
  • How will I, the physician, prove (document) that the patient has a current medically valid condition requiring a prescription (or multiple prescriptions in order to provide up to a 90-day supply)? 
  • What are the established medical standards for writing a prescription for this patient and this patient's medical condition?  Would writing a prescription (or multiple prescriptions to provide up to a 90-day supply) meet those standards? Is it appropriate for me, using sound medical judgment, to write such prescriptions or multiple prescriptions? 

Physicians with questions may find it beneficial to visit with their risk manager at their professional liability carrier as well as refer to Texas Medical Board rules regarding prescribing and pain management.  

If I write a prescription for a hydrocodone combination product on Oct 5, 2014 (while it is still a Schedule III drug) and specify refills, will pharmacies honor those written under the Oct 5, 2014 prescription, or must I rewrite the prescription as a Schedule II drug with no refills? 

Prescriptions for hydrocodone combination products (HCPs) that are issued before Oct 6, 2014 and that have authorized refills, may be dispensed in accordance with DEA rules until April 8, 2015.  Both DPS and the Texas State Board of Pharmacy have indicated that refills authorized on prescriptions dispensed prior to Oct 6, 2014 can be honored. However, at this time, TMA is aware of only one drug-store chain, HEB, that is prepared to do so. 

Will health plans and pharmacy benefit managers (PBMs) honor refills of prescriptions issued before Oct. 6, 2014?

There have been concerns that health plans and PBMs may not honor the refills.  TMA has received verification from Blue Cross and Blue Shield of Texas and from Cigna that they will honor the refills until April 8, 2015.  Patients on home delivery of a HCP through Cigna may need to convert to monthly prescriptions before April 8, 2015.  Patients receiving their medications via mail order will receive a notice that they need to contact their physician prior to the next refill cycle.  UnitedHealthcare is reviewing its policy at this time.  TMA has not received a response from Humana or Aetna.  We will update this answer when we receive additional information.

How do I order the Official Prescription Program pads?

Forms may be ordered from DPS using the official order form for prescription pads for practitioners.  APNs and PAs (hospital setting or hospice only) must use this official order form. Pads of 100 forms cost $9.  DPS now offers online ordering. The standard time frame for fulfillment is 30 days, however, the DPS has diverted additional personnel to process orders and is fulfilling orders in 15-20 days, on average.  In addition to online ordering/payment, the order form and payment in the form of a check or money order can be mailed to DPS:

Texas Prescription Program
PO Box 15888
Austin, TX  78761-5888

Physicians needing assistance may contact the Regulatory Services Division at (512) 424-7293 or visit the customer contact center and then select "Texas Prescription Program" from the drop-down menu.

How do I modify my controlled substance registration with the DPS if my current registration does not indicate that I have authority to prescribe Schedule II drugs?  

Physicians can use this modification form and either fax it to the DPS at (512) 424-5799 or mail it to:

Controlled Substances Registrations MSC-0438

PO Box 4087

Austin, TX 78773-0438

APNs and PAs (hospital setting or hospice only) must use this modification form

Do federal and state laws allow for e-prescribing of Schedule II drugs?

Yes, e-prescribing of controlled substances (EPCS) is legal.  However, physicians need to use an EPCS-certified e-prescribing vendor and ensure the pharmacy in receipt of the EPCS is able to receive the prescription.  Currently, EPCS in Texas is in the very early stages and still fairly rare. 

Check which e-prescribing vendors are certified for EPCS.  Check which pharmacies are able to receive EPCS

For more information about e-prescribing of controlled substances, see A Necessary Pain: e-Prescribing of  Controlled Substances is Worth It from the July 2014 issue of Texas Medicine magazine.

Can residents in a medical residency program in Texas write prescriptions for Schedule II drugs?

According to DPS, the physician-in-training (PIT) must contact their permit office, staff coordinator, or department in charge of approving its PIT prescribing authority.  The medical training institution will provide to the DPS' Texas Prescription Program a letter or list on company letterhead (or via electronic document) the names of authorized PITs along with the Texas Medical Board PIT permit numbers.  As a validation, the Texas Medical Board provides the Texas Prescription Program a monthly electronic file exchange with all current PIT permit holders.  

Do I need official prescription pads for each of my office locations? 

As long as the DEA/DPS numbers are correct, to use the prescription pad for a different address, please line through the address/phone number printed on the Rx form and write the correct address. 

Can I use another physician's pad?

No, the forms are not transferable. 

For more information:

American Medical Association FAQs (pdf) 

DPS FAQs on Hydrocodone Combination Products Reclassification

*Texas Administrative Code , Title 37, Part 1, Ch 13, Subchapter D, Rule §13.72, Prescriptions: 
http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=37&pt=1&ch=13&rl=72  

Texas Health and Safety Code, Ch 481 Controlled Substances Act, Sec 481.074. PRESCRIPTIONS
 http://www.statutes.legis.state.tx.us/Docs/HS/htm/HS.481.htm#481.074

Texas Health and Safety Code, Ch 481 Controlled Substances Act, Sec 481.075. OFFICIAL PRESCRIPTION PROGRAM.
http://www.statutes.legis.state.tx.us/Docs/HS/htm/HS.481.htm#481.075

Texas Medical Board - Delegation FAQs:

http://www.tmb.state.tx.us/page/renewal-Other-Delegation-FAQs

Texas Medical Board - Prescriptive Authority Agreements
http://www.tmb.state.tx.us/page/prescriptive-delegation

 

NOTICE: The Texas Medical Association provides this information with the express understanding that 1) no attorney-client relationship exists, 2) neither TMA nor its attorneys are engaged in providing legal advice and 3) that the information is of a general character.  This is not a substitute for the advice of an attorney.  While every effort is made to ensure that content is complete, accurate, and timely, TMA cannot guarantee the accuracy and totality of the information contained in this publication and assumes no legal responsibility for loss or damages resulting from the use of this content.  You should not rely on this information when dealing with personal legal matters; rather legal advice from retained legal counsel should be sought.