DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Centers for Medicare & Medicaid Services 
7500 Security Boulevard, Mail Stop S2-26-12 
Baltimore, MD 21244-1850 
 
 
CMCS Informational Bulletin 
 
DATE:   January 17, 2017 
 
FROM:  Vikki Wachino, Director  
Center for Medicaid and CHIP Services (CMCS) 
 
SUBJECT:   State Flexibility to Facilitate Timely Access to Drug Therapy by Expanding 
the Scope of Pharmacy Practice using Collaborative Practice Agreements, 
Standing Orders or Other Predetermined Protocols. 
 
This guidance addresses flexibilities that states may have to facilitate timely access to specific 
drugs by expanding the scope of practice and services that can be provided by pharmacists, 
including dispensing drugs based on their own independently initiated prescriptions, 
collaborative practice agreements (CPA) with other licensed prescribing healthcare providers 
like physicians, standing orders issued by the state, or other predetermined protocols. These 
practices can facilitate easier access to medically necessary and time-sensitive drugs for 
Medicaid beneficiaries. 
 
Background 
 
Medicaid benefits in every state and the District of Columbia include prescribed drugs. In 
accordance with Section 1927(k)(2),(3) and (4) of the Social Security Act, in order to be covered 
under the Medicaid prescribed drug benefit, such drugs, including nonprescription and over-the-
counter (OTC) drugs, must be prescribed by an authorized licensed health practitioner prior to 
being dispensed by pharmacies. This practice is consistent with the requirements of other public 
and private third-party payers for prescription and nonprescription drugs. When an individual 
with Medicaid or third-party insurance requests drugs at a pharmacy without presenting a 
prescription, the pharmacist may either 1) advise the individual to contact their prescribing 
provider to obtain a prescription, or 2) contact the individuals provider to obtain a prescription. 
   
However, the need to contact a provider who has knowledge of the individuals medical 
circumstances may pose barriers to the initiation of drug therapy. The individual may not have 
established a relationship with a prescribing provider. The time required for individuals or 
pharmacists to contact prescribing providers for prescriptions could undermine access to, and the 
efficacy of, certain medications that require timely administration in order to be effective.  
 
Allowing Pharmacists to Dispense Drugs Prescribed Independently, or Under 
Collaborative Practice Agreements, Standing Orders, or Other Predetermined Protocols.  
 
Through laws and regulations, states establish sets of standards that dictate the scope of practice 
and services that may be provided by each type of licensed health practitioner in the state. The 
scope of practice for pharmacies and pharmacists are either authorized through legislation, or 
implemented by state Departments of Health and/or Boards of Pharmacy, or another governing   
 
CMCS Informational Bulletin  Page 2  
 
 
body authorized by the state, and in addition to drug dispensing, may enable pharmacists to 
provide a range of clinical services that include the initiation, modification and monitoring of a 
patients drug therapy. This scope of practice is typically tailored to meet state, jurisdiction or 
institution-specific public health needs related to specific diseases, conditions, epidemics, drugs 
or drug classes. In its definition of the authorized scope of practice for pharmacists, a state can 
specify that pharmacists can dispense certain drugs either 1) after independently prescribing 
them, or 2) after entering into collaborative practice agreements (CPA) under which the 
pharmacists operate under authority delegated by another licensed practitioner with prescribing 
authority, 3) under standing orders issued by the state, or 4) based on some other 
predetermined state authorized protocols. Forty-eight (48) states and Washington D.C. use one or 
more of these methods that, in effect, expand pharmacists scope of practice.1.  
 
States are implementing these approaches to help address a number of national public health 
challenges. For example, given the opioid epidemic, these approaches can help reduce the 
incidence of mortality and other complications from opioid overdoses by ensuring timely access 
to naloxone, the opioid overdose reversal drug. Naloxone is a drug indicated for the complete or 
partial reversal of narcotic depression, including respiratory depression induced by opioids that 
include natural and synthetic narcotics, propoxyphene, methadone and certain narcotic-
antagonist analgesics2, 3. The drug prevents or reverses the potential life-threatening effects of 
opioids, including respiratory depression, sedation, and hypotension, thereby allowing an opioid 
overdose victim to resume normal breathing. In cases of an opioid overdose emergency, 
naloxone is most effective with rapid onset of action, which requires it to be administered in a 
timely manner. In most states, naloxone can only be provided by prescription or medication 
order during the regular course of medical care, which typically starts after the ambulance first 
responders have arrived, or in the emergency room, at which point, precious time may have been 
lost. However, given the importance of timely naloxone administration, states can use their 
authority to define the scope of practice for pharmacists to include the ability to dispense the 
drug for individuals, including Medicaid beneficiaries, prior to overdose emergencies. This can 
help to ensure the drug is available in the community at the time of a suspected overdose, 
enabling the immediate initiation of this potentially life-saving drug treatment.  To help ensure 
that naloxone is on hand for life-threatening emergencies, forty (40) states4 authorize 
                                                 
1 National Alliance of State Pharmacy Associations (NASPA)/ National Association of Boards of Pharmacy 
(NABP) Convened Meeting on Statewide Protocols for Pharmacist Prescribing Meeting Notes, March 2016 
(Accessed on October 4, 2016) 
2 Naloxone hydrochloride FDA-approved drug label Information. Obtained from 
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76f7eee1-d524-43a4-a868-ffa9f29638a6 
3 Best Practices for Addressing Prescription Opioid Overdoses, Misuse and Addiction Obtained from 
https://www.medicaid.gov/federal-policy-guidance/downloads/cib-02-02-16.pdf  
4, 8 Alabama, Alaska, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, 
Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Nevada, New Hampshire, New 
Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South 
Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin 
authorize pharmacists to dispense naloxone by standing orders. California, Delaware, Massachusetts, New York and 
Oregon require pharmacists participate in naloxone administration programs in order to dispense the drug under   
 
CMCS Informational Bulletin  Page 3  
 
 
pharmacists to dispense naloxone under standing orders issued by licensed healthcare providers 
authorized by law to prescribe an opioid antagonist, or by the states top medical officials, for 
example the state physician general., or both. Five (5) of these states require pharmacists to 
participate in a naloxone administration training program.5 
 
When exercised, these flexibilities can also play an important role in facilitating the initiation of 
nicotine replacement therapy and other tobacco cessation treatment. Lung cancer is the leading 
cause of cancer death and the second most diagnosed cancer in both men and women in the 
United States. Although cigarette smoking is the number one cause of lung cancer, the disease 
can also be caused by using other types of tobacco such as pipes or cigars. In 2011, fourteen (14) 
percent of all cancer diagnoses and twenty-seven (27) percent of all cancer deaths were due to 
lung cancer. After increasing for decades, lung cancer rates are decreasing nationally, as fewer 
people smoke cigarettes.6 In California and New Mexico; the two states that have expanded their 
pharmacists scope of practice related to tobacco cessation drug therapy, pharmacists are able to 
initiate, modify and manage nicotine replacement and tobacco cessation drug therapy to assist 
patients interested in quitting cigarettes in the community setting without requiring them to 
contact their primary care providers for a prescription. This seamless process provides an 
improved patient experience, encourages adherence to the therapy, and increases the patients 
chances of overcoming nicotine dependence.   
 
These flexibilities are also instrumental to the prevention of influenza viral infections and 
epidemics by enabling pharmacists to administer flu-shots in community pharmacies. .  
Specifically, seventeen (17) states permit pharmacists to prescribe and administer flu shots 
independently.  The remaining thirty-three (33) states and the District of Columbia permit 
pharmacists to administer flu-shots based on either CPAs, standing orders, prescriptions from 
authorized prescribers, other protocols or a combination of some of these methods.  Individuals 
visit pharmacies requesting to receive a flu-shot, and ask the pharmacists to bill their third-party 
payers. The pharmacists determine the appropriate vaccine formulations, product and dosages for 
the specific individual based on their age, health status, health history and other health 
conditions, then initiate prescriptions independently or based on CPAs, standing orders or other 
protocols and submit the claims to the third-party payers. If covered and reimbursed by the third 
party, the pharmacists administer the vaccinations to the individual. If not covered, and therefore 
not reimbursed by the third party, the patient has the option of paying out-of-pocket for the 
vaccine. When covered, this process provides for seamless and timely delivery of care to 
patients, which is an important factor in encouraging the public to obtain a flu-shot.  
                                                 
standing orders according to Naloxone Overdose Prevention Laws  published on 
http://lawatlas.org/datasets/laws-regulating-administration-of-naloxone. Updated through July 1, 2016 (Accessed on 
December 5, 2016). 
 
6 Basic Information About Lung Cancer  https://www.cdc.gov/cancer/lung/basic_info/ (Accessed on December 
6, 2016)   
 
CMCS Informational Bulletin  Page 4  
 
 
These flexibilities can also be used to improve access to emergency contraception. Emergency 
contraception is a safe and effective method to prevent pregnancies7; however, as with naloxone 
its efficacy is contingent on the time of administration. While certain emergency contraception 
pills (ECPs) may be available over-the-counter, as with all over-the-counter medications, 
prescriptions for ECPs are required for Medicaid as well as third-party payer reimbursement.8  
Generally, authorized prescribers must be contacted for prescriptions prior to beneficiaries 
obtaining these drugs. However, similar to the process used to ensure timely access to flu 
vaccines and naloxone, nine states allow pharmacists to dispense and bill third-party payers like 
Medicaid for ECPs using prescriptions based on either standing orders, CPAs, or expanded scope 
of pharmacist practice.9  Like the other practices described in this bulletin, this is solely a state 
option, not a requirement. 
 
Conclusion  
 
CMCS recognizes that states continue to look for innovative tools to address pressing public 
health issues, such as the opioid epidemic or preventing influenza infections. State flexibilities in 
expanding the ability of pharmacists to prescribe, modify, or monitor drug therapy for certain 
medications may be effective at helping to address such issues by improving access to care. 
CMCS encourages states to consider using these methods to promote access particularly to those 
drugs that can help address priority public health issues.  
                                                 
7 Emergency Contraception - The Facts  https://www.hhs.gov/opa/sites/default/files/emergency-contraception-
fact-sheet.pdf (Accessed on January 4, 2017) 
8 FDA News release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358082.htm (Accessed 
on January 5, 2017) 
9 Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and Washington 
according to the Emergency Contraception State Laws published by the National conference of State Legislators 
on http://www.ncsl.org/research/health/emergency-contraception-state-laws.aspx  (Accessed on June 17, 2016)