COLORADO PODIATRY BOARD POLICIES
TABLE OF CONTENTS Disciplinary Process ................................................................................................................. 2 10-1
Protocol 30-Day Letters (Section 12-32-108.3(2), C.R.S.) .................................................... 2
10-2
Release of Investigatory Information to Other State Licensing Boards ..................................... 2
10-3
Retention of Letters of Concern.................................................................................. 3
10-4
Release of Active Complaint Information to Other State Boards ............................................ 3
10-5
Disciplinary Actions Taken by Other State Podiatry Boards or Governmental Agencies Against a Lapsed or Inactive Colorado Podiatrist .......................................................................... 3
10-6
Anonymous Complaints ............................................................................................ 3
10-7
Investigative Subpoena Enforcement ............................................................................ 4
10-8
Delegation of Authority to Enforcement Program Manager, Program Director, and Section Director .. 4
10-9
Eligibility to Serve as a Practice Monitor........................................................................ 5
10-10
Process for Handling Complaints Involving Board of Podiatry ................................................ 5
10-11
Scope of Investigation (Section 12-32-108.3, C.R.S.) ......................................................... 6
10-12
Public Disciplinary Documents (Section 12-32-108.3, C.R.S.) ................................................ 6
10-13
Practice Monitoring Compliance Policy.......................................................................... 7
10-14.
Fining Schedule for Violations fo the Podiatric Practice Act and Board Rules ............................. 7
Licensing Process .................................................................................................................... 8 20-1
Release of Information from Application Files ................................................................. 8
20-2
Licenses Issued Within Four Months of Renewal/Expiration Date ........................................... 8
20-4
Administrative Approval of Applications ........................................................................ 9
20-5
Purging Incomplete Applications ................................................................................. 9
Miscellaneous 9 30-1
Sale of Products in Podiatrists’ Offices.......................................................................... 9 Position ................................................................................................. 10
30-2
Guidelines Pertaining to the Release and Retention of Medical Records ................................. 10 Medical Records Release.............................................................................. 11 Retention and Protection of Medical Records ..................................................... 11
30-3
Policy for Prescribing and Dispensing Opioids ................................................................ 12
Amended September 4, 2015
1
COLORADO PODIATRY BOARD POLICIES DISCIPLINARY PROCESS 10-1
Protocol 30-Day Letters (Section 12-32-108.3(2), C.R.S.) Date Issued: 03/07/03; Revised: 07/01/10
PURPOSE: To authorize staff to initiate 30-day letters for specific types of complaints and reports. POLICY: It is the policy of the Colorado Podiatry Board (“Board”) that upon receipt of a report or other notification from one of the entities generally described below; staff shall establish a numbered complaint file and shall issue a 30 day letter to the involved podiatrist. In the event the written notification from the reporting entity does not include a substantive account of the potential unprofessional conduct issues, Podiatry Board staff shall correspond with the reporting entity and request additional information for review by the Board. Upon receipt of the 30-day letter response the original information that was received, the response and any other information that has been collected will be forwarded to the Board for review in the standard manner. This Policy shall apply to complaints, reports or notifications forwarded to the Board by or on behalf of the following organizations:
10-2
•
Hospitals/HMOs;
•
Professional Review Committees;
•
Other DORA agencies;
•
Other government agencies (e.g., Department of Corrections, Department of Health, Department of Public Safety, Department of Social Services, US Drug Enforcement Administration, US Department of Health and Human Services, US Department of Justice, the Department of Defense or its component services, the Veterans Administration, other law enforcement agencies);
•
Another state podiatry board;
•
Podiatrists;
•
Podiatric specialty societies;
•
Miscellaneous sources with generally accepted credibility (e.g., allied health providers, residency directors, criminal or civil cases involving potential podiatry practice act violations);
•
Malpractice reports which involve a patient death, a wrong site surgery, or a settlement amount totaling $100,000 or more;
•
Signed complaints addressing issues within the Board’s jurisdiction.
Release of Investigatory Information to Other State Licensing Boards Date Issued: 03/07/03
PURPOSE: To allow staff to transmit confidential investigatory materials to other state licensing boards upon request. POLICY: It is the policy of the Colorado Podiatry Board that staff may advise other state podiatry boards regarding a podiatrist’s complaint history and complaints currently under investigation. Upon request from another state licensing board, staff may transmit information from the investigatory file which is normally considered to be confidential pursuant to C.R.S. 12-32-108.3(12). Prior to transmittal of this information, Board staff will consult with the Attorney General’s Office to ensure that no information is being released which must be kept confidential by law, such as peer review information and letters of concern.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 10-3
Retention of Letters of Concern Date Issued: 03/07/03
PURPOSE: To designate a specific retention period for the above mentioned case files. POLICY: It is the policy of the Colorado Podiatry Board that complaint files in which a letter of concern has been issued to the podiatrist will be retained in the Board’s files for a period of 5 years. After 5 years from the date of the letter of concern, the file will be treated as a standard dismissed case and disposed of in the customary fashion. If the podiatrist has other active cases pending at the end of the five year retention period, the letter of concern may be kept for a longer period of time at the discretion of the Board staff.
10-4
Release of Active Complaint Information to Other State Boards Date Issued: 03/07/03
PURPOSE: To authorize staff to release active complaint information to other state licensing boards. POLICY: It is the policy of the Colorado Podiatry Board that Board staff shall release information to other state podiatry boards regarding complaints currently under investigation. It shall be the Policy of the Board that upon receipt of a request for verification of licensure status, the Colorado Board will notify the other state podiatry board if there is a case currently under investigation. It shall be the responsibility of the inquiring board to request further documentation of the nature of the complaint, if that information is desired.
10-5
Disciplinary Actions Taken by Other State Podiatry Boards or Governmental Agencies Against a Lapsed or Inactive Colorado Podiatrist Date Issued: 03/07/03
PURPOSE: To clarify action to be taken by Board staff when disciplinary reports are received. POLICY: It is the policy of the Colorado Podiatry Board that no investigation will be undertaken in those instances when a report of disciplinary action is received from another state licensing board or governmental agency involving a podiatrist who holds a Colorado license that is either lapsed or inactive. At such time as the Colorado podiatrist chooses to apply for reinstatement or reactivation of the Colorado license, it shall be the policy of the Board to inquire with the original reporting entity and/or with the Healthcare Integrity & Practitioner DataBank (HIPDB) as to the podiatrist’s disciplinary history. Normal procedures will be followed to obtain information regarding the nature and extent of the action taken. This information shall be presented to the Board in the customary fashion. Exceptions to this policy may occur at the discretion of the Board when the conduct at issue is such that immediate action is warranted.
10-6
Anonymous Complaints Date Issued: 03/07/03
PURPOSE: To clarify the Board’s position regarding consideration of anonymous complaints. POLICY: It is the policy of the Colorado Podiatry Board to discourage anonymous complaints. Further, the Board will not automatically investigate anonymous complaints. Rather, they will be subject to review on a case-by-case basis.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 10-7
Investigative Subpoena Enforcement Date Issued: 03/07/03
PURPOSE: To clarify who has the authority to request subpoena enforcement. POLICY: When in the course of investigation of a complaint, a subpoena needs to be enforced pursuant to the podiatry practice act or the Administrative Procedure Act, the Podiatry Board specifically authorizes the Program Director to refer such matters directly to the Office of the Attorney General for enforcement.
10-8
Delegation of Authority to Enforcement Program Manager, Program Director, and Section Director Date Issued: 03/07/03 Date Revised: 07/01/10
PURPOSE: To clarify the authority that has been delegated to the Deputy Director, Program Director or designee. POLICY: The Colorado Podiatry Board delegates the following duties to the Deputy Director, Program Director or designee: 1.
Forward directly to the Office of Investigations, without a 30-day request for response being sent by Board staff to the respondent in the case for complaints: a) b) c) d) e) f) g)
with allegations of unlicensed practice. with allegations related to fraudulent or substandard recordkeeping or billing issues. with allegations involving drugs or alcohol. with allegations of sexual misconduct. with allegations relating to infection control. with allegations relating to practice beyond the statutory or customary scope of practice. where it is apparent to the Deputy Director, Program Director or designee that an immediate investigation is needed.
2.
Initiate complaints against licensees currently under Stipulation or other Final Agency Action if, in the opinion of the Deputy Director, Program Director, or designee the licensee has failed to comply with any of the terms of the Stipulation or other Final Agency Action.
3.
Sign Suspension Orders as required by the Child Support Enforcement Program.
4.
Suspend and reinstate the licenses of practitioners who are in violation and subsequently in compliance of the Child Support Enforcement Act as notified by the Colorado Department of Human Services.
5.
Perform initial review of complaints relating to the practice of persons under the Board’s jurisdiction and issue 30-day letters relating to the complaints.
6.
Initiate complaints on behalf of the Board.
7.
Sign Letters of Concern, Letters of Admonition, Show Cause Orders, Cease and Desist Orders, Stipulations and Final Agency Orders and other formal actions authorized by the Board.
8.
Approve termination of stipulations where the respondent has completed the terms and conditions agreed upon. Any requests for early termination of probation or practice monitoring must be reviewed and approved by the Board.
9.
Sign and issue subpoenas and/or orders of inspection and otherwise gather information in order to assist the Board in carrying out its duties.
10. Preliminary review and approval of applications. 11. Coordinate and conduct public rulemaking hearings.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 12. Issue Letters of Concern to licensees found to be practicing on an expired license for less than one year. 13. Perform additional delegated duties as set forth in other Board policies.
10-9
Eligibility to Serve as a Practice Monitor Date Issued: 03/07/03
PURPOSE: To clarify when a podiatrist is not eligible to serve as a practice monitor for a podiatrist under probation with the Board. POLICY: It is the policy of the Colorado Podiatry Board that a podiatrist who has been disciplined by the Board or a podiatrist against whom a formal complaint has been filed by the Attorney General's Office, is not eligible to serve as a practice monitor for another podiatrist under probation or under other disciplinary sanctions with the Board. In these instances, Board staff will notify the podiatrist under probation or under other disciplinary sanctions that a new practice monitor must be nominated in a timely fashion.
10-10
Process for Handling Complaints Involving Board of Podiatry Date Issued: 03/07/03 Date(s) Revised: 08/28/09
PURPOSE: To provide written notice regarding the process by which specific types of complaints against current Board members, licensees who have served on the Board within the past five years, or licensees who have an ongoing formal relationship with the Board will be handled. The purpose of this policy is to assure the integrity of the disciplinary process and prevent any appearance of bias or preferential treatment. POLICY: It is the policy of the Board of Podiatry that any signed complaint received by the Board against a current licensee who is a member of the Board or one who has served on the Board within the past five years, or a licensee who has an ongoing formal relationship with the Board will be handled as follows: •
If the complaint alleges a violation of the Practice Act, the complaint will be sent to the Office of Investigations within the Division of Registrations for a formal investigation.
•
If the complaint alleges substandard practice, the Office of Investigations will also have the case reviewed by an independent consultant selected by the Office of Investigations.
•
If the complaint alleges boundary violations, allegations of substance abuse or allegations of a physical or mental impairment, the licensee will be required to undergo evaluation by the designated peer assistance provider to the Board or a qualified healthcare professional selected by the Office of Investigations.
Upon completion of the investigation and/or evaluation, the report will be referred to the Board for appropriate action. If the complaint is against a current board member, he or she shall recuse from all discussions regarding the complaint and physically leave the meeting room during these discussions. All other customary procedures for the handling of a complaint by the Board will apply. These include but are not limited to issuance of a 30-day letter, notification to the licensee and complainant of Board decisions, and the confidentiality of the complaint and investigation as provided by the Practice Act. Anonymous complaints filed against a current licensee who is a member of the Board or one who has served on the Board within the past five years, or a licensee who has an ongoing formal relationship with the Board will be evaluated by the Board in accordance with the Board’s policy regarding anonymous complaints.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 10-11
Scope of Investigation (Section 12-32-108.3, C.R.S.) Date Issued: 03/07/03
PURPOSE: To provide guidance to the Board's investigators regarding expanding the scope of an investigation. POLICY: It is the policy of the Colorado Podiatry Board to allow an investigator to expand the scope of an investigation when warranted. Such expansion may include, but not be limited to, investigation of the care provided to patients other than those originally referred for investigation or the investigation of other possible podiatry practice act violations which were not known to the Board at the time the case was referred for investigation. Should the investigator feel that expansion of the scope of an investigation is warranted, the investigator must notify the Board's Program Director. Should the Program Director have any concerns regarding the expansion of the investigation, the matter will be brought to the appropriate inquiry panel for consideration.
10-12
Public Disciplinary Documents (Section 12-32-108.3, C.R.S.) Date Issued: 06/06/03
PURPOSE: To put podiatrists, Board staff and the public on notice as to those documents which the Board considers to be a matter of public record pursuant to 12-32-108.3(12), C.R.S. POLICY: It is the policy of the Colorado Podiatry Board that the following documents pertaining to the disciplinary process are a matter of public record: 1.
Letters of Admonition
2.
Stipulations between the Board and a podiatrist
3.
Orders of Summary Suspension
4.
Stipulations for Interim Cessation of Practice
5.
Notices of Charges or Formal Complaints filed by the Attorney General’s Office with the Division of Administration Hearings on behalf of the Board
6.
Final Board Orders
7.
All pleadings, initial decisions or orders, including any attachments, filed or created in relation to a hearing held pursuant to the podiatry practice act or the Administrative Procedure Act shall be open to public inspection. Matters sealed by order of an Administrative Law Judge or the Board shall not be open to public inspection.
8.
All material contained in the record of an appellate proceeding following a hearing held pursuant to the podiatry practice act or the Administrative Procedure Act shall be open to public inspection unless sealed.
The following documents are also considered to be a matter of public record even though they are not considered to be a disciplinary action: 1.
Licensing Agreements between the Board and podiatrists
2.
Stipulations which are non-disciplinary in nature
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 10-13
Practice Monitoring Compliance Policy Date Issued: 09/14/2007 (proposed)
PURPOSE: To provide guidance to Board staff and to licensees practicing pursuant to a Stipulation or Final Board Order requiring practice monitoring as to how the practice monitoring provisions are enforced. POLICY: It is the policy of the Colorado Podiatry Board that Board staff is to promptly notify a licensee whose practice monitoring report is late that the licensee must come into compliance with the terms of the Stipulation or Final Board Order within 14 days. If the licensee does not come into compliance, the Board will determine whether imposition of a suspension pursuant to Section 24-4-104(4), C.R.S., is warranted. Non-compliance issues will be reported by Board staff to the Office of the Attorney General as appropriate. The Board may determine that additional disciplinary proceedings are warranted due to a licensee’s noncompliance with a Stipulation or Final Board Order. Practice monitors whose reports are not timely and complete pursuant to the terms of the Stipulation or Final Board Order on at least two occasions shall be deemed to have failed to perform their duties as a practice monitor and may be terminated as the practice monitor at the discretion of the Enforcement Program Manager or Program Director. If the podiatrist is terminated as the licensee’s practice monitor, the licensee shall be instructed to nominate a new practice monitor within thirty days of the date of notification. A licensee’s probationary period shall be tolled pursuant to the terms of the licensee’s Stipulation or Final Board Order.
10-14.
FINING SCHEDULE FOR VIOLATIONS OF THE PODIATRIC PRACTICE ACT AND BOARD RULES Date Issued: 9/4/2015
Pursuant to section 12-32-108.3(20), C.R.S. any person violating any provision of the Podiatric Practice Act or Board Rules may be fined, not to exceed $5,000, per violation. The Board will impose fines including, but not limited to the following violations: 1.
Substandard Record Keeping a. Up to $250 for the 1st violation b. Up to $500 for the 2nd violation c. Up to $1,000 for the 3rd or subsequent violation
2.
Failure a. b. c.
3.
Practicing on an Expired or Inactive License a. 0-12 months: $500 b. 1-2 years: $1,000 c. 2 or more years: $5,000
4.
Failure a. b. c.
5.
Failure to Keep Premises Clean and Sanitary a. Up to $1,000 for each violation
6.
Administering, Distributing, Dispensing, and Prescribing Outside of a doctor patient relationship a. Up to a $1,000 for each violation
7.
to Provide Records Up to $250 for the 1st violation Up to $500 for the 2nd violation Up to $1,000 for the 3rd or subsequent violation
to Appropriately Supervise Personnel Up to $250 for the 1st violation Up to $500 for the 2nd violation Up to $1,000 for the 3rd or subsequent violation
Failure to Respond to a Board Complaint a. Up to $500 for the 1st violation b. Up to $1,000 for the 2nd or subsequent violation
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 8.
Violation of the Pharmacy Act a. Up to a $1,000 for each violation
9.
Other Violations a. Up to a $1,000 for each violation
LICENSING PROCESS 20-1
Release of Information from Application Files Date Issued: 03/07/2003
PURPOSE: To provide staff with necessary guidance with regard to information contained in an application file which can be released to the applicant or to the general public. POLICY: It is the policy of the Colorado Podiatry Board that upon written request from an applicant for a copy of their application file, the entire file shall be provided with the exception of the following: 1.
letters of reference including, but not limited to, letters from residency programs whether the applicant had satisfactorily completed the program; and
2.
any other information in the file normally considered confidential (i.e., attorney-client privileged memos from the Attorney General’s Office).
It is the policy of the Colorado Podiatry Board that upon written request from an inquiring party, other than the applicant, for a copy of a podiatrist’s application file, the entire application will be provided with the exception of the following:
20-2
1.
letters of reference including, but not limited to, letters from residency programs indicating whether the applicant had satisfactorily completed the program;
2.
transcripts;
3.
examination scores,
4.
medical or psychological records concerning the applicant and
5.
any other information in the file normally considered confidential (i.e., attorney-client privileged memos from the Attorney General’s Office).
Licenses Issued Within Four Months of Renewal/Expiration Date Date Issued: 03/07/2003
PURPOSE: The purpose of this policy is to provide staff with guidance regarding the initial expiration date for a podiatric license issued within four (4) months of a renewal/expiration date. POLICY: It is the policy of the Colorado Podiatry Board that the expiration date will be extended into the next renewal period for all applicants receiving licensure within 4 months of the current renewal/expiration date.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES 20-4
Administrative Approval of Applications Date Issued: 03/07/2003
PURPOSE: To allow staff the authority to administratively approve applicants possessing the required credentials necessary for licensure and to process the licensure of these applicants into the database on a timely basis. POLICY: The Colorado Podiatry Board delegates to the Program Director or his/her designee, the authority to license podiatrist applicants who successfully meet all requirements. Applications will be presented to the Board for review when there is uncertainty if requirements are met. At each meeting, the Board will be asked to ratify a list of the applicants administratively licensed since the previous meeting.
20-5
Purging Incomplete Applications Date Issued: 03/07/2003
PURPOSE: To provide staff with guidance regarding the length of time an application will remain open and active. POLICY: Incomplete applications for licensure will be held open and active for one year from the date of receipt by the Board. Failure to complete the application within that time period, unless the Board has required additional information or activities which will take longer than the one year to complete, will result in the application being purged and the application fee being forfeited.
MISCELLANEOUS 30-1
Sale of Products in Podiatrists’ Offices Date Issued: 09/09/2011
PURPOSE: See policy statement introduction. POLICY: On September 9, 2011, the Colorado Podiatry Board adopted the following policy statement concerning the sale of products in podiatrists' offices. Colorado Podiatry Board Policy Statement Concerning the Sale of Products in Podiatrists' Offices It is the position of the Colorado Podiatry Board ("Board") that Podiatrists who sell products, including shoes and prescription medications, to their patients from their practice office potentially creates a financial conflict of interest. Any activity that creates a conflict of interest casts doubt on the podiatrist's ability to fulfill fiduciary obligations and undermines the patient's trust. In-office sales transactions risk exploiting the inherent imbalance of power in the patient-podiatrist relationship. In many cases, patients lack the expertise and independent judgment to make a proper determination about their need for the product and have no alternative reliable source of information. They may feel compelled to buy an item because they wish to secure the doctor's favor, or because they have placed implicit trust in their doctor's judgment and believe that he or she is acting in their best interest. Because of the risk of patient exploitation, podiatrists should take steps to minimize financial conflicts of interest. One mechanism to limit the conflict of interest is to take the element of financial gain out of the transaction. Many podiatrists distribute health-related products to their patients free of charge. In other cases, podiatrists sell health-related products to their patients at cost, in order to make useful products readily available to their patients. An "at cost" sale refers to the sale of products at a price that covers the reasonable expense of obtaining, storing, and dispensing the products. Another mechanism to minimize conflict of interest is to limit the appropriateness of sales to those circumstances that serve the immediate and pressing needs of patients. One of the most important safeguards to limit conflicts of interest is disclosure. Podiatrists selling health related products should disclose to the patient their financial arrangements with the manufacturer or the supplier of the product.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES In-office sales of podiatric-related products that offer a unique benefit to patient health and are available only through podiatrists raises particular concerns. Since patients would be unable to purchase an equivalent product elsewhere, podiatrists would have a monopoly on the market. Exclusive arrangements such as these force patients either to purchase the product from their podiatrist or to forego the recommended treatment. If a podiatrist strongly believes that a patient needs the product that is available only through podiatrist-distributorship, then podiatrists should encourage manufacturers to make the products accessible through alternative existing structures such as pharmacies. POSITION 1.
30-2
Podiatrists should not sell non-health-related goods from their offices or other treatment settings, with one exception. Podiatrists may sell non-health-related goods from their offices for the benefit of community organizations provided that: a)
the goods in question are low-cost;
b)
the podiatrist takes no share in profit from their sale;
c)
such sales are not a regular part of the podiatrist's business;
d)
sales are conducted in a dignified manner; and
e)
sales are conducted in such a way as to assure that patients are not pressured into making purchases.
2.
Podiatrists who sell health-related products from their offices should not sell any health-related product which does not provide a reasonable potential for therapeutic gain in a patient's medical condition.
3.
Podiatrists should not participate in exclusive distributorships of health-related products in which the products are available only through podiatrists' offices, and for which product there is no comparable alternative available at a local pharmacy or health-products store.
4.
Podiatrists who sell health-related products from their offices should follow these guidelines to limit their conflicts of interest, minimize the risk of brand endorsement, and ensure a focus on benefits to patients: a)
Podiatrists may distribute health-related products to their patients free of charge or at a reasonable price, in order to make useful products readily available to their patients.
b)
Podiatrists should disclose the nature of their financial arrangement with a manufacturer or supplier to sell health-related products. Disclosure also includes informing patients about the availability of a product or other essentially equivalent products elsewhere.
c)
Podiatrists should, upon request, provide patients with understandable literature that relies on scientific standards in addressing the validity of the health-related product.
Guidelines Pertaining to the Release and Retention of Medical Records Date Issued: 09/07/2012
PURPOSE: To provide guidelines to podiatrists and podiatry offices with respect to the Colorado Podiatry Board’s expectations regarding patient record release and retention. The Colorado Podiatry Board (“Board”) has adopted the attached guidelines pertaining to the release and retention of medical records.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES MEDICAL RECORDS RELEASE 1.
Colorado statute (25-1-802 C.R.S.) makes clear that records shall be available to the patient upon submission of a written authorization/request. There are no exceptions for circumstances such as the patient's failure to pay an outstanding bill for clinical services, failure to follow treatment instructions, or failure to return for follow-up care.
2.
The statute does make an exception for psychiatric or psychological illnesses. (See §25-1-802 C.R.S.) Therefore, not all provisions of this policy apply to requests for copies of medical records related to psychiatric or psychological illnesses.
3.
Disclosure of information concerning drug or alcohol problems may be restricted by the Federal confidentiality statute (42 C.F.R. Part 2) in some instances. The statute defines specific consent requirements such as purpose of disclosure, limitation of information released, right to revocation, expiration date of release, and signature of patient.
4.
A valid request for release of records must be in writing. It should clearly identify the patient and be signed and dated by the patient or the patient's authorized representative.
5.
The Board has concluded that except where medical urgency otherwise requires a more prompt response, thirty days is "reasonable notice" when records have been requested.
6.
Podiatrists may charge a reasonable fee for copying of records and may ask for payment in advance. The Board notes that the Colorado Department of Public Health and Environment (CDPHE) has published rules setting forth reasonable costs for copies of medical records in licensed facilities. The Board considers these rules to be reasonable guidelines for podiatrists providing copies of medical records. It is customary when a patient is transferring care for podiatrists to provide copies of records to another podiatrist's office free of charge.
7.
Items such as x-rays and electrocardiograms, which may not at the time of the request be physically in the medical record, are nonetheless considered part of the medical record. If these are specifically requested, then they must be copied and provided to the patient. The podiatrist may charge the requesting party the cost of copying these records in advance.
8.
In those instances where a patient cannot, or chooses not to, pay the fee for copying of medical records identified in paragraphs 6 and 7 above, the podiatrist at a minimum must make the records available to the patient for inspection or otherwise provide access to the records.
9.
Unless a summary of the case has already been prepared and is part of the medical record (e.g. a hospital summary at the time of discharge), a podiatrist is not obligated to provide one.
10. This policy does not supercede state and federal law. A podiatrist must provide patient records in compliance with state and federal law. 11. The Board advises podiatrists to consult with their professional liability insurance carrier regarding any guidelines it may have for record release. RETENTION AND PROTECTION OF MEDICAL RECORDS 1.
Each licensed podiatrist should develop a written plan to ensure the security of patient medical records. The plan should address at least the following: a)
The storage and proper disposal, if appropriate, of patient medical records;
b)
The disposition of patient medical records in the event the licensee dies, retires or otherwise ceases to practice or provide medical care to patients; and
c)
The method by which patients may access or obtain their medical records promptly if any of the events described in paragraph b of this subsection occurs.
Amended September 4, 2015
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COLORADO PODIATRY BOARD POLICIES
30-3
2.
A licensee should inform each patient, in writing, of the method by which the patient may access or obtain his or her medical records if an event described in paragraph b of subsection 1 of this section occurs. If a medical practice is composed of multiple licensees, one notification may be provided to patients on behalf of all licensees within the medical practice.
3.
The Board recommends retaining all patient records for a minimum of 7 years after the last date of treatment, or 7 years after the patient reaches age 18 - whichever occurs later.
4.
At the time of discontinuation of practice, patients should be notified and instructed to submit a written authorization/release if they wish their records transferred to another podiatrist. Records should be retained after discontinuation of practice using the guidelines above. a)
The Board recommends sending letters to patients seen in the last 3 years notifying them of discontinuance of practice;
b)
The podiatrist may want to place a notice in the newspaper announcing discontinuance of practice;
c)
If all records are being transferred to another podiatrist, patients should be notified as above.
5.
In the event of a podiatrist's death, the estate should retain the records utilizing the guidelines above.
6.
In case of litigation or Board investigation, records must be retained until resolution of the matter.
7.
When records are destroyed, it should be done in a manner that maintains patient confidentiality.
8.
The Board advises podiatrists to consult with their professional liability insurance carrier regarding any guidelines it may have for record retention.
Policy for Prescribing and Dispensing Opioids Date Effective: 09/05/2014 This policy begins on page 13.
Amended September 4, 2015
12
Policy for Prescribing and Dispensing Opioids Colorado Dental Board, Colorado Medical Board, State Board of Nursing, and State Board of Pharmacy In collaboration with the Nurse-Physician Advisory Task Force for Colorado Healthcare
Policy for Prescribing and Dispensing Opioids
PREAMBLE Prescribing and dispensing medication for the appropriate treatment of pain is a priority for Colorado healthcare providers. However, in 2013 the misuse and abuse of prescription opioids became a public health epidemic in the United States in general, and Colorado in particular, leading to drug addiction, death from overdose, and increased costs to society. In order to address this crisis, the Colorado Dental Board, Colorado Medical Board, State Board of Nursing, State Board of Pharmacy, and the Nurse-Physician Advisory Task Force for Colorado Healthcare collaborated to identify opportunities and provide meaningful guidance to prescribers and dispensers in Colorado. The Boards recognize that reversing the trend of opioid misuse and abuse requires coordinated efforts to increase public awareness, take-back events for safe disposal, addiction treatment and recovery options, and enforcement, among others. The Boards and the practitioners they license are one part of a multi-pronged solution. The Boards recognize the complexities faced by prescribers in the appropriate management of pain.1 The demands on practitioners considering opioid prescribing differ depending on patient diagnosis, practice settings, and/or conditions. Importantly, long-term therapies addressing cancer-related treatment, palliative and/or hospice care involve different considerations from short-term therapies appropriate for acute or chronic non-cancer pain. Pain and addiction specialists play an important role in healthcare and the communities they serve to compassionately and safely care for patients. Many of the tools and practices referenced in this policy were developed by such specialists. The need for therapeutic care of pain in Colorado patients exceeds the supply of specialists in the state. However, other types of providers can successfully treat many painful conditions and achieve the function and relief the patient seeks. Accordingly, this policy is intended to educate prescribers and dispensers broadly by providing useful tools that may be utilized at the point-of-care to support clinical decision making. The Boards further recognize that decreasing opioid misuse and abuse in Colorado should be addressed by collaborative and constructive policies aimed at improving prescriber education and practice, decreasing diversion, and establishing the same guidelines for all opioid prescribers and dispensers. This includes opioid therapies for both acute and chronic non-cancer pain, 2 because the Boards find that treatment for pain often does not fall clearly into one category or another.
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“Boards” as used in this policy means the Boards overseeing prescribing and dispensing of opioids and involved in the drafting of this policy: the Colorado Medical Board, State Board of Nursing, Colorado Dental Board, and the State Board of Pharmacy. 2 Pain is categorized by a number of descriptors ranging from duration, impact, or physiological response, among others. For the purpose of this policy, the term "chronic, non-cancer pain" is utilized to refer to pain that lasts longer than 90 days and is non-terminal. It does not include conditions such as cancer, scleroderma, multiple sclerosis, muscular dystrophy, or rheumatoid arthritis.
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Policy for Prescribing and Dispensing Opioids
Diversion and “doctor shopping” accounts for 40% of drug overdose deaths.3 To address the dual issues of access to appropriate pain management and opioid-related adverse outcomes, prescribers have dual obligations: to manage pain and improve function while reducing problems resulting from misuse and abuse of prescription opioids in the patient and community. Pharmacists share a corresponding responsibility with the prescriber to assure that a prescription order is valid in all respects and is appropriate for the patient and condition being treated. Therefore, the Boards have agreed to the following guidelines regarding opioid prescriptions in Colorado. Providers prescribing and/or dispensing opioids should: ● Follow the same guidelines ● Use the Colorado Prescription Drug Monitoring Program (PDMP) ● Be informed about evidence-based practices for opioid use in healthcare and risk mitigation ● Educate patients on appropriate use, storage and disposal of opioids, risks and the potential for diversion ● Collaborate within the integrated healthcare team to decrease over-prescribing, misuse and abuse of opioids. Opioid prescribers and dispensers must conform to the regulations set forth by the respective licensing board and other laws. To this end, we, the Boards regulating the prescribers and dispensers in Colorado, have developed this joint policy incorporating the guidelines above. This policy provides guidelines, and does not set a standard of care for prescribers and dispensers. This policy represents the Boards’ current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Boards or the public. Prescribers may use an alternative approach if the approach satisfies the requirements of the applicable statutes, regulations, and standard of care. The Boards will refer to current clinical practice guidelines and expert review in approaching cases involving the management of pain. 4
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Paulozzi, L., Baldwin, G., Franklin, G., Ghiya, N., & Popovic, T. (2012). CDC Grand Rounds: Prescription drug overdoses — a U.S. epidemic. Center for Disease Control and Prevention, Morbidity and Mortality Weekly Report (MMWR), 61(01), 10-13. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm 4 A “policy” is adopted by a board to provide guidance to licensees regarding the board’s position on various subjects. Policies are unlike statutes or rules in that they are not law. Conversely, “board rules” have the force of law and set forth requirements to which licensees must adhere.
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Policy for Prescribing and Dispensing Opioids
Table of Contents BEFORE PRESCRIBING OR DISPENSING ...................................................................................................... 1 WHEN PRESCRIBING OR DISPENSING ........................................................................................................ 2 PRESCRIBING AND DISPENSING FOR ADVANCED DOSAGE, FORMULATION OR DURATION .................................... 4 PATIENT EDUCATION ............................................................................................................................ 5 DISCONTINUING OPIOID THERAPY ........................................................................................................... 5
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Policy for Prescribing and Dispensing Opioids
BEFORE PRESCRIBING OR DISPENSING Develop and maintain competence Prescribers, including prescribers who dispense, must maintain competence to assess and treat pain to improve function. This includes understanding current, evidencedbased practices and using other resources and tools related to opioid prescribing and dispensing. In some clinical situations consultation with a specialist is appropriate. Pharmacists must maintain competence in the appropriateness of therapy. See the Appendix for a list of resources and tools for developing and maintaining competence.
Utilize safeguards for the initiation of pain management The decision to prescribe or dispense opioid medication for outpatient use may be made only after a proper diagnosis and complete evaluation which should include a risk assessment, pain assessment, and review of relevant PDMP data. These safeguards apply to acute and chronic, non-cancer pain but not to palliative end-of-life care. Not all pain requires opioid treatment. Prescribers should not prescribe opioids when non-opioid medication is both effective and appropriate for the level of pain.
1. Diagnose Prescribers should establish a diagnosis and legitimate medical purpose appropriate for opioid therapy through a history, physical exam, and/or laboratory, imaging or other studies. A bona fide provider-patient relationship must exist.
2. Assess Risk Prescribers should conduct a risk assessment prior to prescribing opioids for outpatient use and again before increasing dosage or duration. Risk assessment is defined as identification of factors that may lead to adverse outcomes and may include: ● Patient and family history of substance use (drugs including alcohol and marijuana) ● Patient medication history (among other reasons, this is taken to avoid unsafe combinations of opioids with sedative-hypnotics, benzodiazepines, barbiturates, muscle relaxants or to determine other drug-drug interactions) ● Mental health/psychological conditions and history ● Abuse history including physical, emotional or sexual ● Health conditions that could aggravate adverse reactions (including COPD, CHF, sleep apnea, elderly, or history of renal or hepatic dysfunction) ● Prescribers and dispensers should observe the patient for any aberrant drugrelated behavior and follow-up appropriately when aberrant drug-related behavior is presented. See the Appendix for a description of such behaviors. 1
Policy for Prescribing and Dispensing Opioids
See the Appendix for additional resources related to assessment, including resources for alcohol and substance use screening and guidelines for treating patients with risk factors. If the assessment identifies risk factors, prescribers should exercise greater caution before prescribing opioids as detailed in subsequent sections, consider conducting a drug test or consulting a specialist and put in place additional safeguards as part of the treatment plan.
3. Assess Pain An appropriate pain assessment should include an evaluation of the patient’s pain for the: ● Nature and intensity ● Type ● Pattern/frequency ● Duration ● Past and current treatments ● Underlying or co-morbid disorders or conditions ● Impact on physical and psychological functioning
4. Review PDMP Prescribers and dispensers should utilize the Prescription Drug Monitoring Program (PDMP) prior to prescribing or dispensing opioids.
Collaborate with the healthcare team Prescribers and dispensers should collaborate within the healthcare team to prevent under-prescribing, over-prescribing, misuse and abuse of opioids. See the Appendix for additional resources.
WHEN PRESCRIBING OR DISPENSING Verify a provider-patient relationship A bona fide provider-patient relationship must exist. The prescriber or dispenser should verify the patient’s identification prior to prescribing or dispensing opioids to a new or unknown patient. For pharmacists, this includes exercising judgment and conducting research if appropriate (such as use of the PDMP or communication with the prescriber or relevant pharmacies) when the prescription order is: ● For a new or unknown patient 2
Policy for Prescribing and Dispensing Opioids
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For a weekend or late day prescription Issued far from the location of the pharmacy or patient’s residential address Denied by another pharmacist.
Additional Safeguards Ensure the dose, quantity, and refills for prescription opioids are appropriate to improve the function and condition of the patient, at the lowest effective dose and quantity, in order to avoid over-prescribing opioids. Factors that have been associated with adverse outcomes include: 1) opioid doses greater than 120 mg morphine equivalents per day 2) certain formulations and 3) treatment exceeding 90 days. Additional safeguards have been found to reduce these risks.
Dosage Opioid doses >120 mg morphine equivalents per day is a dosage that the Boards agree is more likely dangerous for the average adult (chances for unintended death are higher) over which prescribers should use clinical judgment, put in place additional safeguards for the treatment plan (such as utilizing a treatment agreement), consult a specialist or refer the patient; and dispensers should be more cautious.5 Benzodiazepines are known to potentiate the effects of opioids and may increase the risk of adverse outcomes. See the Appendix for additional resources on dose calculators
Formulation In addition to noting and responding to this dosage marker, prescribers and dispensers must use clinical judgment regardless of dose, especially when: The prescription is considered an outlier to what is normally prescribed, or Transdermal, extended relief or long-acting preparation is prescribed.
Duration Treatment exceeding 90 days should be re-evaluated as opioids may no longer be as effective. One way to distinguish pain is as either acute (that lasting less than 90 days) or chronic (that lasting 90 days or greater). Management of each presents its own unique challenges. The overwhelming majority of prescribers treat patients with acute pain; in fact the pain for these patients lasts considerably less than 90 days.
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Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92.
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If a prescriber extends short-term treatment, and results in exceeding 90 days, prescribers should re-conduct the risk and pain assessments, review the PDMP and undertake the additional safeguards.
PRESCRIBING AND DISPENSING FOR ADVANCED DOSAGE, FORMULATION OR DURATION Tools and Trials Prior to issuing prescriptions that are outliers to the dosage, formulation and duration guidelines described above (for chronic, non-cancer pain), prescribers should determine whether the patient improves functionally on opioids, which could include an opioid trial, and whether the pain relief improves his/her ability to comply with the overall pain management program.
Monitoring The prescribing and dispensing of opioids for chronic pain must be monitored on an ongoing basis, such as: assessing for improved function rechecking the PDMP, and random drug screening according to the prescriber’s clinical assessment. These monitoring tools and others should be documented in a treatment agreement signed by the patient, described more below. Prescribers should not increase an initial opioid dosage without rechecking the PDMP.
Treatment Agreements Prescribers should utilize treatment agreements (also commonly referred to as a plan or contract) and should ensure the patient understands the terms of the agreement. This may be accomplished by having the patient review and sign the treatment agreement. A treatment agreement often includes information about proper: ● Goals of treatment ● Patient education (proper use, risks of addiction, alternatives) ● Controls (single prescriber, single pharmacy for refills) ● Random drug testing and restrictions on alcohol use ● Storage, disposal, and diversion precautions (including detailed precautions related to adolescents and/or children and visitors to the home). ● Process and reasons for changing/discontinuing the treatment plan; communicating reduction or increase of symptoms; and referring to a specialist. See the Appendix for resources on sample agreements.
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Policy for Prescribing and Dispensing Opioids
PATIENT EDUCATION Prescribers should educate patients regardless of the dosage, formulation and duration of opioid therapy on proper use, risks of addiction, alternatives, storage, and disposal of opioids and the potential for diversion (see the Appendix for resources on disposal). Risks may include but are not limited to: overdose, misuse, diversion, addiction, physical dependence and tolerance, interactions with other medications or substances, and death. Pharmacists should offer to review information with the patient about risks, disposal, and other applicable topics. Providers should educate patients about the risks and benefits of medications that exceed the dosage, formulation and duration guidelines indicated above which may place them at increased risk for long-term dependence and unintended adverse drug effects. Patients who have a previous history of substance use disorder (including alcohol) are at elevated risk. When alerted to these risk factors, patients can make more informed decisions about their healthcare treatment. For example, some patients have reduced or forgone opioids when alerted to the risk factors. If a decision is made to continue with opioid therapy, a satisfactory response to treatment would be indicated by a reduced level of pain, increased level of function and/or improved quality of life. The use of an interdisciplinary team and family members may be considered as a part of the treatment plan and ongoing monitoring.
DISCONTINUING OPIOID THERAPY The prescriber should consider discontinuing opioid therapy when: ● The underlying painful condition is resolved; ● Intolerable side effects emerge; ● The analgesic effect is inadequate; ● The patient’s quality of life fails to improve; ● Functioning deteriorates; or ● There is aberrant medication use. The prescriber discontinuing opioid therapy should employ a safe, structured tapering regimen through the prescriber or an addiction or pain specialist. There is a risk of patients turning to street drugs or alcohol abuse if tapering is not done with appropriate supports. Prescribers of opioids should be familiar with treatment options for opioid addiction. See the Appendix for tips on tapering.
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Policy for Prescribing and Dispensing Opioids
APPENDIX PDMP Colorado Prescription Drug Monitoring Program (PDMP): http://www.hidinc.com/copdmp
Preventing diversion through appropriate disposal In order to prevent diversion, providers should provide information regarding appropriate disposal, including the following: ● Secure unused prescription opioids until such time they can be safely disposed. Specifically, ensure that prescription opioids are not readily accessible to other family members (including adolescents and/or children) or visitors to the home. ● Take-back events are preferable to flushing prescriptions down the toilet or throwing them in the trash. Only some medications may be flushed down the toilet. See the FDA’s guidelines for a list of medications that may be flushed: www.fda.gov ● Utilize take-back events and permanent drop box locations ● Utilize DEA disposal guidelines if take-back or drop boxes are unavailable. Those guidelines include: ● Take the drugs out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter; then put them in a sealable bag, empty can, or other container to prevent the medication from leaking out of a garbage bag; ● Before throwing out a medicine container, tell the patient to scratch out all identifying information on the prescription label to protect their identity and personal health information; and ● Educate patients that prescriptions are patient specific. Patients may not share prescription opioids with friends, family or others and may pose serious health risks, including death. ● Use activated charcoal absorption technologies to inactivate unused medications or used fentanyl patches.
Record keeping Prescribers who treat patients with opioids should maintain accurate and complete medical records according to the requirements set forth by their licensing board.
Discontinuing/tapering opioid therapy Weaning from opioids can be done safely by slowly tapering the opioid dose and taking into account several factors related to risk, symptom, and alternatives. Opioid Taper Plan and Calculator: “Interagency Guidelines on Opioid Dosing for Chronic Non-Cancer Pain” State of Appendix Page 1
Policy for Prescribing and Dispensing Opioids
Washington Agency Medical Directors Group. 2010 Online: www.agencymeddirectors.wa.gov Withdrawal Symptoms Assessment: “Clinical Opiate Withdrawal Scale” The National Alliance for Advocates for Buprenorphine Treatment. Online at: www.naabt.org
Aberrant drug-related behavior Prescribers and dispensers should use clinical judgment when aberrant drug-related behaviors are observed. Such behavior should be reported to the proper authorities and/or healthcare team as appropriate. Aberrant drug-related behaviors broadly range from mildly problematic (such as hoarding medications to have an extra dose during times of more severe pain) to felonious acts (such as selling medication). These are any medication-related behaviors that depart from strict adherence to a prescribed therapeutic plan of care. Prescribers and dispensers should observe, monitor and take precautionary measures when a patient presents aberrant drug-related behaviors such as: ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Requesting early and/or repeated refills Presents at or from an emergency department seeking high quantities of a prescription Denied by other prescribers or dispensers Presents what is suspected to be a forged, altered or counterfeit prescription. Forging prescriptions Stealing or borrowing drugs Frequently losing prescriptions Aggressive demand for opioids Injecting oral/topical opioids Unsanctioned use of opioids Unsanctioned dose escalation Concurrent use of illicit drugs Failing a drug screen Getting opioids from multiple prescribers Recurring emergency department visits for chronic pain management*
Prescribers and dispensers should be alert for subjective behaviors such as being nervous, overly talkative, agitated, emotionally volatile, and evasive, as these may be signs of a psychological condition that may be considered in a treatment plan or could suggest drug misuse.** *“Interagency Guidelines on Opioid Dosing for Chronic Non-Cancer Pain” State of Washington Agency Medical Directors Group. 2010 Online: http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf **Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain. Sunrise River Press, North Branch, MN 2007.
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Policy for Prescribing and Dispensing Opioids
Practitioner Considerations Healthcare team: Consider that the patient may be receiving opioids from another prescriber. Contact the patient’s healthcare team when appropriate which may include the following: ● Physician ● Specialist (pain, addiction, etc.) ● Dentist ● Advanced Practice Nurse (APN) ● Physician assistant ● Pharmacists ● Area emergency rooms ● Surrounding (within 5 miles) or historical pharmacies Authorities: ● If the prescriber or dispenser suspects illegal activity, the matter should be referred to the Drug Enforcement Agency (DEA) and local law enforcement. ● If a prescriber or dispenser suspect illegal activity on behalf of another prescriber or dispenser, at a minimum, the matter should be reported to the appropriate licensing board. Prescribers and dispensers should be aware that: ● There is no legal obligation to prescribe or dispense a prescription; and, ● Colorado law strongly encourages prescribers and dispensers of opiate antagonists “to educate persons receiving the opiate antagonist on the use of an opiate antagonist for overdose, including but not limited to instructions concerning risk factors for overdose, recognition of overdose, calling emergency medical services, rescue breathing and administration of an opiate antagonist.” (Section 18-1-712(3)(b), C.R.S.)
Additional Resources and Tools Establishing and maintaining competence: Tenney, Lili and Lee Newman. “The Opioid Crisis: Guidelines and Tools for Improving Pain Management” Center for Worker Health and Environment, Colorado School of Public Health. Functional and pain assessment: “Functional Assessment” Colorado Division of Workers Compensation Patient agreements: “Screener and Opioid Assessment for Patients with Pain - Revised (SOAPP - R)” PainEDU.org Online at: www.painedu.org Pain tool kit: Various resources for assessing and managing pain including risk assessments, patient Appendix Page 3
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agreements, dose and conversion calculators among others. Center for Worker Health and Environment, Colorado School of Public Health. Online at: http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/maperc/ online/Pages/Pain-Management-CME.aspx Substance use screening and brief counseling: SBIRT Colorado www.ImprovingHealthColorado.org Drug abuse resources: Substance Abuse and Mental Health Services Administration: www.samhsa.gov NIH National Institute on Drug Abuse: www.drugabuse.gov or www.nida.nih.gov
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