One of the provisions of the Affordable Care Act (“ACA”) that has gotten a great deal of attention is Section 6402(a), which requires a person who receives an overpayment to report and return the funds within 60 days after the overpayment is identified (or the date any corresponding cost report is due, if applicable.) The provision is significant because the failure to report and return overpayments creates False Claims Act liability, exposure to Civil Monetary Penalties, and potentially exclusion from participation in the federal programs.
On February 16, 2012, CMS released a proposed rule (77 Federal Register 9179) to implement the requirements of Section 6402(a), and if finalized in its current form it will guide providers on what is required when information indicating a potential overpayment comes to light. While the ACA already creates the obligation to report and return overpayments, the proposed rule imposes additional burdens in an attempt to clarify and define key terms of the statute.
The most significant burden in the proposed rule is a new ten-year look-back period, which would require providers to report and return any overpayment that is identified within ten years from when it was received. CMS stated in the preamble to the rule that the ten-year period was chosen to “further our interest in ensuring that overpayments are timely returned to the Medicare Trust Fund.”
The proposed rule defines an “overpayment” just as the ACA: any funds received or retained under the Medicare program to which the person, after applicable reconciliation, is not entitled. This includes, but is not limited to, payments for non-covered services. An overpayment will be considered “identified” if the provider has actual knowledge of the existence of the overpayment or acts in “reckless disregard” or “deliberate ignorance” of the overpayment. “Reckless disregard” and “deliberate indifference” essentially mean that a provider cannot ignore information brought to his/her attention that a potential overpayment exists. The provider is thus required to make a “reasonable inquiry” to confirm whether or not an overpayment exists.
The definition of “identified” and the lack of guidance regarding “reasonable inquiry” introduce significant uncertainty. What is a “reasonable inquiry”? The preamble to the proposed rule seems to state that this means self-audits, compliance checks, or other research and suggests that such inquiry must be taken with “all deliberate speed.” When considered alongside the proposed ten-year look-back period, it is unclear whether CMS intends to obligate providers who recognize a problem to consider whether this same problem has occurred over the course of the last ten years with regard to similar claims. Is that enough information to trigger the obligation to investigate with all deliberate speed? If it is, this rule places a significant burden on providers to engage in extensive retrospective audits and generates substantial difficulties where information regarding ten-year-old claims may not be readily available.
The proposed rule contains other provisions, such as an explanation of the impact of the Anti-Kickback Statute and how the sixty-day reporting period is tolled when a provider submits a self-disclosure to either the OIG (Self-Disclosure Protocol) or to CMS (Self-Referral Disclosure Protocol).
Again, this rule is not final. The health care industry has an opportunity to comment and potentially impact the final rule’s requirements. Comments are due on April 16, 2012.
The proposed rule can be found at: http://www.regulations.gov/#!documentDetail;D=CMS_FRDOC_0001-0905
Friday, February 24, 2012
Thursday, February 2, 2012
New Regulation Imposes Strict Requirements on Medical Practitioners who Prescribe Controlled Substances for Treatment of Chronic Pain
On October 14th, we posted on the Delaware Health Law Blog that the Board of Medical Licensure and Discipline had proposed a rule regarding the use of controlled substances for the treatment of pain. A public hearing was held on November 1, 2011 without comment in opposition to the rule. On February 1st, Rule 32 was adopted as proposed and will go into effect on February 11, 2012. The Rule is designed to assist practitioners by providing them with the minimum requirements for meeting the necessary standard of care in prescribing controlled substances for the treatment of pain. In order to demonstrate that your practice has met the standard of care, you must be vigilant in documenting specific aspects of care and medical decision-making.
This new regulation is likely to change the way most medical practitioners treat chronic pain patients and it imposes significant documentation requirements.
What is Required
The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. The key to the standard of care is to document a diagnosis with unrelieved pain and the sound clinical judgment to prescribe controlled substances. Additional specific requirements are listed below.
Evaluation of Patient
A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The following must be documented in the evaluation:
• One or more recognized medical indications for the use of a controlled substance
• Etiology, the nature, and intensity of pain
• Current and past treatments for pain
• Underlying or coexisting diseases or conditions
• The effect of the pain on physical and psychological function
• History of substance abuse
Treatment Plan
A written treatment plan is required, and must outline the goals and objectives that will be used to determine treatment success. The plan should note all diagnostic evaluations and any planned alternative treatments. Importantly, the plan must note whether other treatment modalities or rehabilitation programs are necessary.
Informed Consent
You must discuss the risks and benefits of treatment with controlled substances with the patient and document that discussion, including the patient’s informed consent.
Pain Treatment Agreement
You must use a written treatment agreement only if the patient is at “high risk” for medication abuse or has a history of substance abuse. The agreement must include required medication level screenings upon request, the number and frequency of prescription refills, the reasons drug therapy will be discontinued, and the requirement that the patient receive prescriptions from one physician and one pharmacy, where possible.
Periodic Review
The course of drug therapy must be periodically reviewed and documented, including any new information about the etiology of the pain and the patient’s state of health. A periodic review must include whether the treatment should be continued or modified, whether the patient’s pain has improved, and whether the patient has an increased level of function or improved quality of life. If not, it should be noted that the practice has considered the appropriateness of continued drug therapy or alternative modalities. A periodic review must also consider all objective evidence of improved or diminished function, including information from family members or other caretakers.
Consultation
During the course of treatment, the practitioner must refer the patient as necessary for additional evaluation and treatment in order to meet the goals and objectives of treatment. “The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients.” Importantly, the rule states that “practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients.”
Records must be maintained in an accessible manner. The record should also include documentation appropriate for each visit’s level of care, including interim history, vital signs, an assessment of progress, and the continued medication plan.
With the final rule becoming effective in ten days, it is important make sure that new documentation meet these standards. Notes used for initial and follow-up visits should be scrutinized to ensure that each of these new requirements is achieved in order to meet the these regulatory requirements.
This new regulation is likely to change the way most medical practitioners treat chronic pain patients and it imposes significant documentation requirements.
What is Required
The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. The key to the standard of care is to document a diagnosis with unrelieved pain and the sound clinical judgment to prescribe controlled substances. Additional specific requirements are listed below.
Evaluation of Patient
A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The following must be documented in the evaluation:
• One or more recognized medical indications for the use of a controlled substance
• Etiology, the nature, and intensity of pain
• Current and past treatments for pain
• Underlying or coexisting diseases or conditions
• The effect of the pain on physical and psychological function
• History of substance abuse
Treatment Plan
A written treatment plan is required, and must outline the goals and objectives that will be used to determine treatment success. The plan should note all diagnostic evaluations and any planned alternative treatments. Importantly, the plan must note whether other treatment modalities or rehabilitation programs are necessary.
Informed Consent
You must discuss the risks and benefits of treatment with controlled substances with the patient and document that discussion, including the patient’s informed consent.
Pain Treatment Agreement
You must use a written treatment agreement only if the patient is at “high risk” for medication abuse or has a history of substance abuse. The agreement must include required medication level screenings upon request, the number and frequency of prescription refills, the reasons drug therapy will be discontinued, and the requirement that the patient receive prescriptions from one physician and one pharmacy, where possible.
Periodic Review
The course of drug therapy must be periodically reviewed and documented, including any new information about the etiology of the pain and the patient’s state of health. A periodic review must include whether the treatment should be continued or modified, whether the patient’s pain has improved, and whether the patient has an increased level of function or improved quality of life. If not, it should be noted that the practice has considered the appropriateness of continued drug therapy or alternative modalities. A periodic review must also consider all objective evidence of improved or diminished function, including information from family members or other caretakers.
Consultation
During the course of treatment, the practitioner must refer the patient as necessary for additional evaluation and treatment in order to meet the goals and objectives of treatment. “The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients.” Importantly, the rule states that “practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients.”
Records must be maintained in an accessible manner. The record should also include documentation appropriate for each visit’s level of care, including interim history, vital signs, an assessment of progress, and the continued medication plan.
With the final rule becoming effective in ten days, it is important make sure that new documentation meet these standards. Notes used for initial and follow-up visits should be scrutinized to ensure that each of these new requirements is achieved in order to meet the these regulatory requirements.
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