Nearly four years later, DHMH proposed regulations to implement the statutory licensure requirement. Those regulations became final in July of this year, and took effect on August 23, 1999. As of that date, it became unlawful for anyone to establish or to operate a freestanding ambulatory care facility without a license.
The regulations contain general licensing requirements that apply to all freestanding ambulatory care facilities, as well as additional requirements applicable to each type of freestanding ambulatory care facility. The general licensing requirements outline minimum policies and procedures that each facility must develop and implement, including policies and procedures that describe "the provision of complete and partial charity care for indigent and Medicaid patients to promote access to all services regardless of an individual's ability to pay." Kidney dialysis centers and freestanding ambulatory surgical facilities are required to obtain Medicare certification as a condition of licensure.
In another example of delayed rulemaking, HCFA recently adopted new Safe Harbors for business practices that would be protected against Anti-Kickback penalties, including a Safe Harbor for ambulatory surgical centers owned by physicians or jointly owned by physicians and a hospital.
For further information about licensure requirements or Safe Harbors for freestanding ambulatory care facilities, contact Peter Parvis (410-244-7644, ppparvis@venable.com).