Deregulation Continues: CMS Proposes Reducing Medical History and Physical Examination (“H&P”) Requirements for ASCs and Acute-Care Hospitals
On September 20, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would “reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers” (“Proposed Rule”). One of the more significant proposals would eliminate the current comprehensive medical history and physical examination (“H&P”) requirements, allowing ASCs and acute-care hospitals (“Hospitals”) much more leeway and flexibility to establish policies and procedures that are more appropriate and tailored to their patients and the type of services being provided. It is important to note that the Proposed Rule only affects “if” and “how” H&Ps are conducted. CMS reaffirmed that when H&Ps are conducted, they must: (1) be completed by the physician performing the surgery or other qualified practitioner pre-surgery, and (2) any documentation related to such H&P must be placed in the patient’s medical record prior to the surgical procedure.
Currently, ASCs must: “Not more than 30 days before the date of the scheduled surgery, each patient must have an [H&P] completed by a physician . . . or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.” See 42 C.F.R. § 416.52. Citing stakeholder feedback and studies from the New England Journal of Medicine and other primary literature sources, CMS found that the H&P requirement “is inherently arbitrary and burdensome for the ASC patient population,” given the nature of the majority of the type of outpatient surgeries and the “extremely low risk of complications” of such surgeries.
CMS proposes to replace the ASC H&P requirements with “requirements that defer to the facility’s established policies for pre-surgical medical histories and physical examinations (including any associated testing) and the operating physician’s clinical judgment, to ensure patients receive the appropriate pre-surgical assessments that are tailored for the patient and the type of surgery being performed.” Under the Proposed Rule, an ASC’s H&P policy should: (1) identify patients that require an H&P prior to surgery; (2) propose time frames in which an H&P must be completed prior to surgery; (3) consider the age, diagnoses, number of surgeries, and known comorbidities for each patient and the planned level of anesthesia for the surgery to be performed; (4) follow nationally recognized standards of practice (“SOP”) and applicable state health and safety laws; and (5) adhere to any other factors the ASC deems necessary to meet the needs of its patient population.
Currently, Hospitals’ medical staff bylaws must require: “A[n] [H&P] be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.” See 42 C.F.R. §482.22(c) (5). Citing the similarities between the characteristics of patients treated by ASCs and Hospital ambulatory/outpatient surgery departments, CMS concluded that “[it] should propose a less burdensome option for the assessment of a patient prior to a [H]ospital outpatient/ambulatory surgery or procedure for specific patients and procedures.” However, because the Hospital H&P requirements apply to all Hospital patients, not just ambulatory/outpatient surgery patients as in ASCs, CMS proposed an exception to the current H&P requirements to mitigate the overbreadth issue. The proposed exception would:
require the medical staff bylaws to state that an assessment of the patient (in lieu of the requirement of paragraph (c)(5)(i) and (ii)) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies . . . specific patients as not requiring [an H&P], or any update to it, prior to specific surgical or procedural services.
Under the Proposed Rules, a Hospital H&P policy should: (1) identify specific outpatient surgical or procedural services in which a simplified H&P is allowed; (2) identify patients that require an H&P prior to surgery; (3) proposed time frames in which an H&P must be completed prior to surgery; (4) consider the age, diagnoses, number of surgeries, and known comorbidities for each patient and the planned level of anesthesia for the surgery to be performed; (5) follow nationally recognized standards of practice (“SOP”) and applicable state health and safety laws; and (6) any other factors the Hospital deems necessary to meet the needs of its patient population.
The Proposed Rule is a significant deregulatory step for CMS and consistent with the Trump Administration’s position on regulations. ASCs and Hospitals should welcome the changes in the proposed rules because they could, if finalized: increase utility, save ASC and Hospital resources, and allow ASCs and Hospitals more autonomy and flexibility to determine policies and procedures that best fit their patient populations and organizations. The entire Proposed Rule can be found here. The Comment Period closes on November 19, 2018, and comments can be submitted electronically or by mail.