In its 2014 final rule on hospital outpatient payments, CMS ended its delay of the direct supervision requirement for critical access hospitals. Beginning next year, the agency will require on-site, around-the-clock supervision by a physician or non-physician practitioner (such as a nurse practitioner) at these facilities for outpatient therapeutic services.
Direct vs. general supervision requirements
The direct supervision requirement, which CMS instated in 2009, requires "direct supervision" for the provision of certain "hospital outpatient therapeutic services," which include everything from infusion, to vaccinations, to inserting a catheter.
Until this year, thanks to lobbying by the American Hospital Association and others, CMS has delayed the requirement for CAHs and facilities under 100 beds, allowing for "general supervision" — care that is provided under the overall direction or control of a physician, who may or may not be physically onsite — instead. Beginning Jan. 1, these hospitals will be required to comply with direct supervision requirements, something many of these facilities say will be challenging (due to financial constraints and provider shortages) and could inhibit access the healthcare services.
Will direct supervision limit access?
With the most powerful hospital lobby against the change, it's hard to understand why CMS implemented the supervision requirement. According to the AHA, it "remains concerned that these hospitals will have difficulty implementing CMS's supervision requirements." If hospitals are unable to meet the requirements, they will have to cease offering those affected services, greatly reducing healthcare access throughout some of the most rural hospitals in America.
According to a statement this summer by Sen. Jerry Moran (R-Kan.), "CMS' policy does not take into account the realities of rural health care. Many Kansas hospitals, and other rural hospitals across the country, find these supervision requirements impossible to meet — jeopardizing continued access to these important health care services…Small and rural hospitals, where medical workforce shortages are most severe, need reasonable flexibility to appropriately staff their facilities so they can continue to provide a full range of services to their communities."
The AHA says the direction supervision requirement is "clinically unecessary," "difficult to implement for hospitals and CAHs," and could "create patient access problems if hospitals were forced to discontinue or limit the hours of certain outpatient services."
Additionally the AHA contends the requirement is at odds with CAHs' Medicare Conditions of Participation. "Direct supervision is not a requirement of the Medicare hospital CoPs and, in fact, the rules contradict the CoPs for CAHs. One CAH CoP requires a physician or NPP to be available by phone, but not necessarily physically present on the CAH campus. In order to ensure access to hospital emergency care in these otherwise underserved areas, another CAH CoP has long required only that a physician or NPP be able to arrive within 30 minutes of a request from the staff in the facility. Therefore, CAHs may meet the CoPs yet be non-compliant with direct supervision regulations."
Why the requirement?
Given that the AHA explicitly calls the requirement "clinically unnecessary," I was interested to know CMS' rationale for enacting it.
I reached out to a CMS spokesperson and was provided the following explanation, which is generally attributable to CMS:
"The requirement for direct supervision stems from a longstanding statutory provision that therapeutic services furnished to hospital outpatients are furnished 'incident to' physicians’ services. That is, as a condition of Medicare payment, an appropriate physician or non-physician practitioner must be involved in the care and this is reflected in the direct supervision standard. In addition to the payment rule, there is a safety and quality of care concern. Most hospital outpatient therapeutic services must be furnished directly (are not delegable), or require an appropriate physician or non-physician practitioner nearby who is able to direct the services and intervene if necessary. We implemented the non-enforcement instruction in 2010 to allow time to establish an independent advisory review entity composed of the various stakeholders that could make recommendations to CMS for exceptions to this general rule. The independent review process has been in place since 2012 and exceptions have been established, so we believe we should reinstate enforcement of the supervision rules."
CMS' first rationale seems, to me, a technicality. And, while I understand the concern around quality, I haven't seem any research suggesting that outpatient care provided when physicians are onsite is of significantly higher quality than when the care is provided under general supervision. (I didn't yet do exhaustive research, however, so if studies like this exist, I'd love for a reader to point me in the right direction.)
Why it matters for rural America
The issue of direct vs. general supervision is of particular interest to me because I grew up in a very small town, home to its own critical access hospital, Memorial Hospital. The hospital is a major institution in our community, despite its small size. I recently heard from friends that it stopped offering obstetric services, likely because the volume wasn't high enough to cover the costs of continuing the service line. Women in the community now travel around 30 miles to another critical access facility to give birth; the closest non CAH hospital is at least 45 minutes away. This is certainly not convenient, but childbirth isn't something most women go through more than a few times in their lives.
Imagine, though, you were a patient with cancer undergoing chemotherapy multiple times a week — 45 minutes each way, three or four times a week, would make for a lot of driving. If a patient couldn't drive herself, the driver certainly couldn't be someone with a 9-5 job.
Luckily, my hometown hospital has a healthy medical staff, and I imagine it will be able to meet the challenges that direct supervision creates for small facilities. However, I certainly worry about other CAHs. Rural communities are special places with tight-knit connections and a powerful sense of community. However, many people living in rural communities are less wealthy, and less healthy, than those living in more metropolitan areas. If anything, they need policy that leads to more access to care, not policy that threatens it. Can the cancer patient afford the cost of driving 270+ miles a week for dialysis? What happens if she can't?
Small towns aren't the most attractive places for physicians, many who have trained in urban areas who are used to communities with more people and more things to do. HHS has certainly created many programs and policies to improve access to care for rural communities, and that should be lauded, but the recent decision to plow ahead with direct supervision requirements seems contrary to many of its other programs to protect rural healthcare in America.
Will the direct supervision requirement impact your hospital? Share your story with us; contact me at ldunn@beckershealthcare.com.