1. Direct Supervision of Hospital Outpatient Therapeutic Services CAH Perspective and Concerns
Todd Schaffer, MD
Carrington Health Center
Carrington, North Dakota
Catholic Health Initiatives
Carrington Health Center is a 25-bed critical access hospital located in Carrington, ND. Our hospital is part of Catholic Health Initiatives, a national, not-for-profit, faith-based health care system operating in 19 states. I speak today on behalf of Carrington Health Center but my views reflect the concerns of all 21 critical access hospitals in our system.

2. Issues
CMS has directed that certain hospital outpatient therapeutic procedures require direct supervision until “medically stable” and then general supervision can occur with explicit documentation of when that stability occurs.
Carrington Health Center is requesting a change from Direct Supervision to General Supervision for specific items listed below with details on the following slides:
Observation stays
IV therapies including hydration
Subcutaneous therapies

3. Observation Stays
HCPCS code G0378: Hospital observation service per hour
HCPCS Code G0379: Direct admission of patient for hospital observation care
Complexity: always lower than acute stays.
Acuity: the higher acuity patients would already be screened out and admitted or transferred to an acute care setting. Protocols for patient treatment are identical in both an Observation Stay and an Acute Care setting.
Observation admissions are for much less severe patients who are not stable to be treated as an outpatient but certainly much more stable than an acutely ill patient. Physician wants to monitor and rule out specifics related to the diagnosis to determine if patient needs to be either admitted to an acute setting or can safely be discharged home.
Examples include: chest pain-rule out acute coronary syndrome, Transient Ischemia Attacks, gastroenteritis etc.
ALL patients will have been thoroughly worked up (and monitored) in the clinic or ER prior to admission to observation-the most unstable period that the patient would present. Typically a patient is monitored and receives specific laboratory tests or other diagnostic tests to assist with an accurate diagnosis. The physician or NPP would have written orders that are carried out by either nursing or other departments. There is not a need for a physician or NPP to be on site to ensure the orders are being carried out and patient quality of care is not compromised because a physician or NPP is not on –site. For example in the case of gastroenteritis, the patient would receive IV hydration therapy and possibly IV medications to decrease nausea, vomiting, or diarrhea but the medication and IV hydration are low risk, low adverse reaction therapies.

4. Observation Stays
Probability of unexpected or adverse patient events: much less than an acute care patient that has higher acuity. The sickest patients that are considered high acuity will have been placed into an acute care setting.
Expectation of rapid clinical change: very low as typically an observation patient does not have multiple complex issues or the patient would be in an acute care setting.
Recent changes affecting patient safety: virtual healthcare availability, smart pumps, electronic diagnostic interpretations, scanners for EKGs/labs, etc. that allow for rapid diagnosis.
Clinical context care delivered: exactly the same as a much sicker and more unstable acute care patients.
Innovative virtual care is changing and improving health care delivery, particularly in rural hospitals. Using a virtual physician or ARNP rather than an onsite physician can increase the quality and safety of care.

5. Intravenous Infusions, Hydration
HCPCS Code 96360: Intravenous infusion, hydration; initial, 31 minutes to 1 hour
HCPCS Code 96361: Intravenous infusion, hydration; each additional hour
Complexity: very low.
Acuity: the higher acuity patients would already be screened out and admitted or transferred to an acute care setting. Protocols for patient treatment are identical in both an Observation Stay and an Acute Care setting for patients using the same fluids.

6. Intravenous Infusions, Hydration
Probability of adverse event: very low as hydration therapy does not include any medication.
Expectations of rapid clinical change: minimal to see decline in a patient. Most common rapid clinical change would be seen in the pediatric and elderly population where IV hydration can lead to dramatic improvement in a short period of time in this population that is dehydrated.

7. Intravenous Infusion for Therapy, Prophylaxis, or Diagnosis
HCPCS code 96365: specific substances or drug, initial, up to 1 hour HCPCS Code 96366: Each additional hour in addition to HCPCS Code 96367: Additional sequential infusion, up to 1 hour in addition to initial HCPCS Code 96368: Concurrent infusion in addition to primary procedure

8. Intravenous Infusion of Medications
Complexity: very low. Smart pump technology has largely taken human error out of rate calculations in particular for complex medications. Single dose vials of medications are used that eliminates the need to draw specific doses of medication out of a multi dose vial where errors are more prone to occur.
Acuity: higher acuity patients would already be screened out and admitted or transferred to an acute care setting. Protocols for patient treatment are identical in both an Observation Stay and an Acute Care setting for patients who are administered the same medications.
Probability of adverse event: very low, depending on the medication. There is also a triple check system in place as the physician, NPP, Pharmacist, and Nurse all check for allergies.
Expectations of rapid clinical change: if a patient receives treatment in an outpatient setting it would be very low otherwise the patient would be admitted to the acute care setting.
Rocephin would be a typical antibiotic that requires IV infusion that is not a complicated medication requiring rigorous dosing regimens while Dopamine would be an example of a complicated medication that is dosing specific to weight of patient where a smart pump has built in parameters via an internal computer device that would prevent this medication of being either under or over dosed or delivered.

9. Intravenous Infusions of Medications
Recent changes in technology: smart pump technology; telepharmacy allowing 24/7 pharmacy coverage provides high quality patient care.
Clinical context in which the service is delivered: treatment is designed for the patient that does not require the same treatment as a higher acuity or sicker and more unstable acute care patient, but still requires a higher level treatment than oral medications can provide.
Smart pump technology: IV pump that has a “computer” in it that has an internal list of all medications that a nurse can administer that a nurse uses to choose a specific medication. For high complexity medications (example heart medications such as dopamine) there are limits built in that prevent a medication from being infused either too quickly or too slow. This is an additional assurance that gives high quality patient care.
Telepharmacy allows access to a pharmacist 24 hours per day; 7 days per week. Once the physician or NPP orders a medication, a nurse cannot infuse that medication unless the orders have been verified and approved by a pharmacist from the remote site.

10. Therapeutic, Prophylactic, or Diagnostic Injections
HCPCS Code 96372: Specify substance or drug; subcutaneous or intramuscular HCPCS Code 96374: Specify substance or drug for intravenous push, single or initial substance/drug HCPCS Code 96375: Specify substance or drug; each additional sequential intravenous push of a new substance/drug in addition to the primary procedure HCPCS Code 96376: Specify substance or drug; each additional sequential intravenous push of the same substance/drug provided in a facility

11. Therapeutic, Prophylactic, or Diagnostic Injections
Complexity: subcutaneous and intramuscular injections are a basic nursing service taught early on in nursing school.
Acuity: The higher acuity patients would already be screened out and admitted or transferred to an acute care setting. Protocols for patient treatment are identical in both an Observation Stay and an Acute Care setting for identical injections.
Probability of unexpected outcomes: very low but depends on the drug being administered.
Probability of unexpected outcomes: Nursing is familiar with medication side affects and have been trained to respond to situations such as adverse reactions including anaphylactic reactions.
Reemphasize that the protocols that a nurse follows in our hospital in the case of an unanticipated reaction are the same in the acute setting and the outpatient setting.

12. Therapeutic, Prophylactic, or Diagnostic Injections
Expectation for rapid clinical change: if a patient receives treatment in an outpatient setting it would be very low otherwise the patient would be admitted to the acute care setting .
Recent changes in technology: smart pumps, medications that are ordered in prefilled single dose syringes such as Lovenox, and the use of telepharmacy to verify all medications delivered to the patient.
Clinical context delivered: higher acuity patients would already be screened out and admitted or transferred to an acute care setting.

13. Protocols
CMS has stated that RNs do not have sufficient training to supervise and that protocols “do not give all possibilities for changes.”
Specific protocols exist for the HCPCS codes listed in this presentation.
Carrington Health Center protocols indicate the RN is to “stop” the infusion and contact the provider if a nurse encounters an issue. This ensures a fast response and quick treatment if required. A physician or NPP is always contacted at that point and if the infusion must be stopped a physician or NPP is required to come on site and examine the patient and recommend further treatments if required.
RNs practice within the scope of their licensure with the expectation that they must supervise other nursing staff and be responsible for all care given to a patient that includes using the five rules of medication administration.
Emergencies (most severe would be anaphylaxis) are handled with predetermined medications/anaphylaxis protocols and anaphylaxis kits that are readily available in the outpatient settings.
The higher acuity patients would already be screened out and admitted or transferred to an acute care.
The higher acuity patients are typically a “sicker” patient that would be more susceptible to adverse events.

14. Recommendation:
Allow general supervision for all HCPCS codes in this presentation, rather than direct supervision switching to general supervision once “stable.”

15. Consequences if direct supervision, rather than general supervision, is required for these HCPCS codes in CAHs:
Inability for patients to receive care locally for simple outpatient procedures
Loss of physicians in rural areas already struggling to obtain physicians to cover direct supervision.
Greatly increased costs to Medicare if patient is admitted to acute care facility for less complex services
Crippling of rural health care delivery

16. Questions?