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Lifting a Regulatory Burden Could Create Dangerous Consequences

Cheryl Clark, for HealthLeaders Media, November 17, 2011

When the Centers for Medicare & Medicaid Services last month proposed a rule to relax some Medicare conditions of participation for hospitals seeking federal reimbursement, we heard that leaders of acute care facilities jumped for joy.

Instead of dishing out tons of new regulatory paperwork, the payers in chief were finally deleting some that were thought to be unnecessary. In doing so, CMS officials said, they would be saving hospitals an estimated $942 million a year and allowing providers to spend more time at the bedside. 

This announcement "is welcome news for hospitals and patients, providing much-needed regulatory relief to a health system choked with paperwork," the American Hospital Association's President and CEO, Rich Umbdenstock said in a statement.

That’s all well and good... except for one thing.

The 76-page CMS proposal seeks to eliminate one requirement that could cause more in time and harm – in headaches and adverse events, not to mention true disasters and damage to family relationships – than it prevents.

The agency proposes to allow hospitalized patients, or their caregivers, or 'support' persons, the ability to administer some medications themselves, eliminating the requirement that a hospital employee (i.e. a nurse) perform those functions.

Here's the language of the proposed rule: "We also propose additional revisions at proposed §482.23(c)(6) that would allow hospitals the flexibility to develop and implement policies and procedures for a patient and his or her caregivers/support persons to administer specific medications (non-controlled drugs and biologicals).

"This proposal would be consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers, and selected non-prescription medications, such as lotions and rewetting eye drops. These proposed changes would apply to the self-administration of both hospital-issued medications and the patient’s own medications brought into the hospital."

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1 comments on "Lifting a Regulatory Burden Could Create Dangerous Consequences"


Mark Dominesey (11/30/2011 at 8:32 AM)
There clearly two very important sides to this issue. One issue is the patient is trusted to administer the medication (or have someone else administer it for them) while they are out of the hospital, and allowing them to continue that practice can help alleviate some of their anxiety and promote a sense of partial independence. The other issue is that now the hosptal and the clinicians may be required to take responsibility for something that they did not do, or have little control over. The article takes a negative tone for allowing patient administered medications after it does a wonderful job of laying out how clinicians and hospitals can alleviate some culpability. The CMS guidelines appear to be vague enough to allow the hospitals some flexibility in creating policies (in consultation with their Risk Management Dept) that will delineate when this pratice should be allowed and when it should not be. Patient and caregiver education is key to this practice and patient education was not mentioned in the article. Yes, there are very real possibilities of patient harm if certain medications are administered more than what is therapeutically efficacious, but hospitals can craft policies and procedures to mitigate those risks. At no time should patient self-administration be implemented to alleviate some burden on clinicians or for clinician convenience, but only as a vehicle to promote patient independence and wellness. I am in favor of this proposal by CMS. Patient self-administration does occur now, though not widespread, in many hospitals, with a properly [INVALID]d physician order and patient education. Many medications are not suitable for this proposal and it would behoove the hospitals to include such language in their ploicies and procedures along with assistance from their pharmacy staff.