What is a PA Collaborative Agreement?
A collaborative agreement is defined as a written agreement between a supervising physician or podiatric physician and a CRNP. It contains the protocols, rules, and regulations that will be used by the CRNP in providing care to patients. By law, the CRNP may prescribe medications for a patient only in accordance with the terms of a written collaborative agreement with a physician or podiatric physician . In the absence of a written collaborative agreement, which must be filed with the appropriate licensing board, the CRNP is not authorized to prescribe medications. The collaborative agreement, much the same as an employment contract, is a contract between the supervising physician or podiatric physician and the CRNP. The board has promulgated specific requirements for the content of the collaborative agreement and these are set forth in Section (c) as discussed below.
Pennsylvania Prescriptive Authority CRNP
In Pennsylvania, a CRNP can prescribe most prescription drugs which are not designated as controlled substances so long as the prescription has been authorized by a supervisory physician through a PA collaborative agreement with the CRNP. The prescriptive authority of a CRNP may be broad, however, it is not unlimited. The CRNP may not prescribe these drugs:
PA law also prohibits a CRNP from prescribing in any of the following categories, unless the CRNP holds appropriate certification from a national certifying body approved by the Board of Nursing:
A CRNP may not make a medical diagnosis when prescribing drugs, defining "medical diagnosis" as an assessment of a disease or condition requiring a medical diagnosis or a medical determination concerning the cause of the disease or condition. According to the Board of Medicine and the Board of Nursing, however, "medical diagnosis" does not include an assessment of a patient’s injury, illness, symptom or complaint for purposes of assessing the safe and effective treatment of the injury, illness, symptom or complaint. This is a very significant difference between the CRNP and other allied health professionals, such as the PA or the optometrist, who have the ability to make an actual medical diagnosis when doing so is necessary to prescribing drugs.
Additionally, CRNPs may not consult with, supervise or collaborate with more than four CRNPs or CRNP interns who have prescriptive authority at one time. The services provided by a CRNP who is practicing on behalf of another CRNP who is unable to practice may not be counted against the limitations on prescriptive authority if the services provided are minor and the loss of the effected CRNP’s services is of limited duration. A CRNP may supervise a total of 12 CRNP interns who have not yet achieved prescriptive authorization at one time.
The Board of Nursing may, by regulation, limit the types of drugs which a CRNP may dispense or prescribe but has not yet done so. However, regulations have been proposed which would place limitations on the types of Schedule II drugs which may be prescribed by a CRNP without the cosignature of a supervising physician.
Collaboration Requirements
There are two procedural requirements for the valid collaboration agreement. First and foremost, the collaboration agreement must be in writing. Although it may be implied from practice patterns or prior agreements, an implied agreement is not sufficient. Second, the agreement must be signed by the collaborating physician. In order to be valid, the necessary signatures must be obtained prior to the CRNP prescribing from the new standing order or protocol. Once the agreement is signed, it must be maintained by the CRNP, and a copy must be maintained by the physician. In the event of an audit by the Department or the Board of Nursing, the Department and/or the Board of Nursing may require a copy of the collaborative agreement to be produced and will review the agreement as part of the audit process. Of course, there are other legal requirements that need to be satisfied for a CRNP to have prescriptive authority, but for purposes of determining whether the CRNP possesses valid prescriptive authority, satisfying the procedural requirements will suffice. We will discuss the other requirements for CRNP prescriptive authority in a later post.
Collaborative Agreement Duties and Responsibilities
The nurse practitioner or CRNP is the health care provider who is required to enter into a collaborative agreement with a physician in order to provide services in the Commonwealth and be able to prescribe schedule II-V controlled substances. The CRNP is responsible for executing their practice within the guidelines established by both law and any relevant regulations within a collaborative relationship with a physician.
The collaborating physician is the physician who is agreeing to provide supervision for the NP and is ultimately responsible for the patient’s care in this collaborative relationship. They can have up to four (4) active collaborative agreements with CRNPs covering no more than 3,600 clinical hours on average per year.
In order for a collaborative agreement to exist, the two professionals must have a written agreement that covers their roles and responsibilities, the frequency of communication, the degree of supervision required to provide services, management of the collaborating physician’s patients, situations during which the CRNP must refer back to the physician for care, criteria for amending the agreement, and methods for dispute resolution.
How to Form a Collaborative Agreement
The primary way for a CRNP to be able to write prescriptions for legend drugs in Pennsylvania is to establish a written collaborative agreement with a supervising physician. In order to be compliant, the following requirements must be satisfied:
The collaborative agreement must be in writing and signed in person by the healthcare practitioner and the physician. The CRNP may not write a prescription for a drug unless there is a signed collaborative agreement that is on file at the healthcare facility where CRNP provides patient care. The agreement should list the prescriptive authority and the specific drugs or drug categories covered by the collaborative agreement. If the agreement covers schedule II controlled drugs , then the prescriber’s federal Drug Enforcement Administration registration number and state license number are required on the agreement. If the prescriptive authority is limited to schedule III or IV controlled drugs, the prescriber’s federal and state registrations need not be on the collaborative agreement.
Furthermore, if a CRNP who has prescriptive authority writes a prescription for a drug that requires a collaborative agreement, the physician must be available and accessible at all times during patient care, either electronically or by telephone. The physician and the CRNP may not be in the same practice office setting, medical office building or other facility that contains multiple practices.
Legal and Regulatory Considerations
The legal implications of the collaborative agreement are significant for both the CRNP and the physician. If the relationship between the CRNP and the physician is not clear, the license of the physician (MD or DO) may be subject to disciplinary action. Even in the absence of discipline, if the entity or agency that pays for physician services interprets the relationship as that of employer/employee it may deny claims for payment of the CRNP’s services. Because the collaborative agreement is a voluntary and contractual relationship, it does not create an employment relationship. Employment creates certain tax, insurance and administrative obligations that must be observed by employers without regard to the compensation of the employee.
If the CRNP works in a facility that is not a fee-for-service practice, the collaborative agreement may need to be modified to comply with the applicable guidelines. Medicare and most other third-party reimbursement requires that the physician have availability in the office to be contacted about questions or issues relating to medical care provided by the CRNP. Availability in this context means that the physician will meet with the CRNP regularly to discuss these issues. The purpose of availability is to ensure that the physician is able to monitor the medical care provided by the CRNP.
The CRNP must be credibly qualified to offer services to patients to whom prescription drugs or drug regimens will be ordered or prescribed, and the types of drugs that may be prescribed must be restricted. In addition, on 2008, the U.S. Center for Medicare and Medicaid Services ("CMS") implemented a new rule regarding prescribing privileges and privileges to have personal supervision in hospitals. Since then, both the physician and CRNP must possess unrestricted and unchallenged prescribing privileges and privileges for personal supervision.
The physician must be qualified to oversee the CRNP’s provision of delegated patient care. A CRNP must demonstrate to his/her collaborating physician the capability of providing health care needs in a competent and safe manner. This also includes the introduction of new treatment therapies from a clinical trial or any findings of a newly discovered disease, disorder, impairment or condition, including neurological conditions.
For purposes of participating in Pennsylvania’s Workers’ Compensation system, a collaborative agreement must also adopt the procedures, guidelines, protocols and orders applicable to workers’ compensation patients to the extent they have not been otherwise addressed. In addition, the collaborative agreement must explain any relationships that exist between the CRNP and any medical service provider specifically related to workers’ compensation cases. The collaborative agreement should also clearly set forth any written care plans or treatment guidelines that the CRNP intends to follow when treating workers’ compensation patients.
There are specific provisions that must be included in the collaborative agreement to comply with Medicare and Medicaid regulations, including a provision requiring the acquisition and review of patient medical records, a provision requiring the supervision of CRNPs by the physician, and in the case of the office-based practice of medicine, the requirement for "availability." The collaborative agreement must also address the administrative obligations of the physician and CRNP. The physician must assign to the CRNP all or a portion of the physician’s available hours per week in the practice to provide direct patient care to patients in the practice who would otherwise be seen only by the physician if the CRNP were not available.
The DCNR and AOHN guidelines state that the collaborative agreement should be reviewed on a regular basis by both the CRNP and the collaborating physician. The revised collaborative agreement should be signed by the CRNP and physician.
Compliance with these guidelines is essential in order to ensure uninterrupted services to healthcare consumers.
Advantages and Disadvantages of Collaborative Agreements
The practice of forming collaborative agreements between physicians and CRNPs is common in many states. However, the 1 to 1 ratio between collaborating physicians and CRNPs is typically mandated by statuary law in other states so the model used in Pennsylvania for CRNP prescriptive authority is quite different from those of other states. It remains to be seen how new legislation will affect interested parties that wish to utilize Collaborative Agreements for this purpose.
There are several potential benefits for physicians who are willing to enter into a collaborative agreement with a CRNP. First, such agreements can increase their patient volume. In a busy practice, the physician may find it difficult to find time to treat all of his or her patients. An efficient CRNP can often handle many of these patients for the physician and allow the physician to focus on the more acute and/or complicated cases that require his or her immediate attention. The physician can also keep office expenses at a minimum while seeing patients, because the CRNP acts as both an ancillary provider and office manager at the same time.
Second, CRNPs can help a busy practice stay on schedule. Many physicians who practice in the fields of surgery or advanced care have trouble with scheduling in their practices. Many CRNPs can assist the physician in either performing minor procedures or performing follow-up visits, thereby freeing up the physician to perform surgeries or more complicated medical procedures. In many cases, all of the prescriptive authority of the CRNP is maintained by the collaborative physician. While this creates a burden on the collaborating physician because he/she must bear the burden of all of the prescriptions, it simultaneously benefits the physician because it allows him/her to maintain control over all prescriptions that are prescribed within his/her practice.
Quick access to a qualified health care provider who can manage a patient’s post surgical care or transitional follow-up care can also be of great benefit to a patient. A major hospital or delivery hospital will often have a transitional care program staffed by nurses or physician extenders. Many large medical facilities rely on CRNPs to supplement the practice of physician extenders who deliver care in these departments.
Despite the potential benefits to both the collaborating physician and CRNP, one of the greatest challenges to the success of a collaborative agreement is the limited time period during which the protocol may be carried out. The 720 hours per collaborative agreement are quickly used up, especially for those CRNPs who will participate in multiple collaborative agreements at any given time. In addition, each question or response must be immediately documented in the CRNP’s online patient record before the physician is available to answer questions at a later time. A common sense approach to evaluating a CRNP for a collaborative agreement would be to choose someone who is comfortable enough to ask appropriate questions of a physician without feel pressured to do so during a hectic office environment.
Finally, the most significant challenge to the effectiveness of a collaborative agreement is the question of coverage. The collaborating physician is essentially agreeing to act as a supervising physician for the agreement. This means that the collaborating physician must designate his/her PA to act as the covering physician who can assume responsibility on behalf the collaborating physician. The majority of physicians who are requested to enter into collaborative agreements are busy practitioners, therefore it can be difficult for the physician to designate the need for coverage to someone else within his/hier practice without burdening that person with the added responsibility of acting as a collaborative physician. A flexible coverage system will be needed to maximize the potential benefits of collaborative agreements.
Directions for the Future and Modifications
There are a number of ways in which the regulatory environment for CRNPCs in Pennsylvania may change in the future. The following are a few possible scenarios based on the current trends we’re seeing in regulation.
Potential for independent practice
At this time, it is unclear whether there will be a move toward allowing independent practice for CRNPs in the future. In some states, groups have been advocating for independent practice for the last several decades, without change. If we look at other advanced practice nursing roles, however, we see a slight difference. Both nurse anesthetists and clinical nurse midwives practice independently in all 50 states, and have done so since they emerged as specialties in the healthcare system. Figure 1 shows the differences in regulations for these roles as compared to CRNP prescriptive authority. As nurse practitioners (NPs) and CRNPs are indistinguishable from health care consumers, it is unclear how much support this change would gain. If and when regulation for CRNPs changes significantly, it will likely be preceded by changes for other advanced practice nursing roles.
Further reduction in business regulation
On the one hand, a further reduction in the requirements for CRNP business agreement compliance seems more likely than not, as there is ample evidence that this will cause no issues in patient safety. But on the other hand, because state agencies are typically not accountable to anyone but the governor, there is little reason for them to change their rules, aside from the fact that evidence proves that such rules are not required.
And perhaps here is where the greatest challenge lies. The barriers that prevent the reduction of state regulations may be those within the administration itself. There is a strong possibility that as a new governor is elected, he or she will replace many of the administrative secretaries and other individuals who oversee the actions of a particular bureau or board. Those individuals do not usually face term limits and are therefore not held accountable by the public. Given these factors , there is not much incentive for them to change regulations which are not proven to impact the safety of patients or other consumers. Such regulations are also costly and do not provide a corresponding return on investment.
Chronic Illness Care Management
One phenomenon we have seen in recent years is the rise of chronic illness care management and case management. As the definition of care expands from the primary care office alone to include the home, community and hospital, the potential for CRNPs to play a role in chronic illness management and care coordination expands. The most successful programs combine collaborative, community-based CRNPs with technology to ensure that patients receive care when and where they need it. We see this with the expansion of telemedicine, and patients and insurers should expect this trend to continue as the need for effective chronic and transitional care continues to rise.
Growth of intermediary organizations
The growth of intermediary organizations is something we are seeing across the country, and this trend does not show signs of slowing. We have already seen the reduction in the high costs of EMR systems and the proliferation of telemedicine companies across the country. This has made it far more accessible for providers to utilize technology to perform their duties.
In Pennsylvania, there are organizations providing many support services to groups of practitioners and hospitals, essentially acting as third-party middlemen between these groups and the payers. These services include contract management, billing and collections, credentialing, risk management and compliance. It is likely that as the pressure on physicians and hospitals to reduce costs rises, we will see an even greater proliferation of these types of organizations. In the not-so-distant future, intermediary organizations may provide multiple services in order to help providers focus more on patient care and reduce overhead costs. As such, payers may become more open to paying these organizations directly through a number of alternative payment models.
As competition in the healthcare market increases, the current wave of non-physician providers may be viewed as a way to drive costs down. This competition could actually aid in the reduction of restrictions on regulatory burdens. There is a strong trend toward lowering the burden of business agreements and collaboration which is quite likely to continue to rise.