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May 26, 2000

WEEKLY UPDATE for May 26, 2000

***LEGISLATIVE UPDATE
Patient Protections—Conference Committee
Quality Health Care Coalition Act (HR 1304)
Cardiac Arrest Survival Act (HR 2498)

***REGULATORY UPDATE
OIG Issues Proposed Anti-kickback Safe Harbor for Ambulance Restocking
HCFA Moving Forward to Allow Nurse Anesthetists to Work without Physician Supervision

LEGISLATIVE UPDATE

Patient Protections—Conference Committee

A compromise on the outstanding contentious issues – liability, the right to sue and scope – continues to elude conferees. Informal meetings with Conference Chairman Nickels (R-OK) failed to break the ongoing impasse. This week, House Speaker Hastert (R-IL) met with Senate Majority Leader Lott (R-MS) in an attempt to smooth the way for compromise. The meeting was said to have been cordial but did not result in a plan to move the bill. On Tuesday, Conference Democrats sent a proposal to Chairman Nickles, which they hoped would "jump-start" the stalled negotiations. The proposal clarified the Democrats position on employer liability, scope and an appeals process. Chairman Nickles called the proposal a "non offer."

In addition to the three issues, post-stabilization remains a discussion item. ACEP understands that many of the conferees have questioned the logic of the tentative agreement described in previous reports. Since an overall agreement has not yet been reached, there is still time to convey your concern to your Representative and Senators.

CALL OR VISIT YOUR LEGISLATORS

The House and Senate will be in recess until June 6. Since many Members will return home, we encourage members of the 911 Network to contact their legislators. Continued pressure from constituents can help break the logjam during the current recess. Tell your legislators that the "three-hour limit must go." Although we need to reach out to all legislators, we must target the following Republican members of the Conference:

House of Representatives--

Reps. Bill Archer (R-TX), Mike Bilirakis (R-FL), Tom Bliley (R-VA), John Boehner (R-OH), Dan Burton (R-IN), Ernie Fletcher (R-KY), Porter Goss (R-FL), Nancy Johnson (R-CT), Jim McCrery (R-LA), Joe Scarborough (R-FL), John Shadegg (R-AZ), Jim Talent (R-MO), Bill Thomas (R-CA).

Senate--

Sens. Mike Enzi (R-WY), Bill Frist (R-TN), Phil Gramm (R-TX), Judd Gregg (R-NH), Tim Hutchinson (R-AR), Jim Jeffords (R-VT), Don Nickles (R-OK), John Ashcroft (R-MO), Chuck Hagel (R-NE), Rod Grams (R-MN), Spencer Abraham (R-MI), Bill Roth (R-DE), Jon Kyl (R-AZ), John McCain (R-AZ), Rick Santorum (R-PA).

Quality Health Care Coalition Act (HR 1304)

The Campbell bill (HR 1304) was schedule to go to the House Rules Committee on Wednesday May 23rd and to the House floor for a vote on Thursday May 24th. On Wednesday, 86 members of the Republican caucus voted to pull the bill and it was subsequently pulled from the schedule without notice or explanation. The Republican leadership staff indicates that the bill may be taken up in June when the House returns from Memorial Day recess. The outcome of the bill in the House remains unclear.

Cardiac Arrest Survival Act a.k.a. CASA (HR 2498)

The CASA bill (HR 2498) calls on the Secretary of the US Department of Health and Human Services to establish guidelines for the placement of automated defibrillators in federal buildings. The bill also establishes Good Samaritan protections for individuals using the devices from civil liability. H.R. 2498 cleared the House on a 415-2 vote on Tuesday night. The bill now goes to the Senate.

REGULATORY UPDATE

OIG Issues Proposed Anti-kickback Safe Harbor for Ambulance Restocking

The Office of Inspector General (OIG) published a proposed rule on May 22 that would establish a safe harbor to the anti-kickback statute for ambulance restocking. The safe harbor would protect certain arrangements involving hospitals that replenish drugs and medical supplies used by ambulance providers when transporting emergency patients to hospitals. Comments on the proposed safe harbor must be submitted to the OIG by July 21.

Over the past two and a half years, there has been some confusion regarding the applicability of the anti-kickback statute to ambulance restocking. The OIG issued an advisory opinion in late 1997, stating that an ambulance restocking arrangement potentially violated the anti-kickback statute. In 1998, the OIG issued three advisory opinions approving ambulance restocking arrangements. The OIG stated that the facts of those opinions differed significantly from the facts of the 1997 case. In proposing to establish a safe harbor for ambulance restocking, the OIG stated that these arrangements serve a significant public interest by providing a means of ensuring that ambulances are fully stocked with current medications, sanitary linens and other supplies that are compatible with equipment used in local emergency departments.

Under the proposed rule, safe harbor protection would be established for ambulance restocking arrangements that meet the conditions in one or two categories. Both categories pertain only to emergency ambulance services – the safe harbor would not protect ambulance restocking following routine ambulance transports.

The first new proposed safe harbor would protect ambulance restocking where an ambulance provider pays the hospital fair market value for the replenished drugs or supplies used for the transport of an emergency patient.

The second category would protect arrangements where a hospital contemporaneously restocks drugs and supplies used during the transport of an emergency patient, even if restocking is for free or reduced prices. The OIG proposed seven criteria to be met to qualify for this safe harbor:

• Hospitals must restock on an equal basis for all ambulance providers who bring emergency patients to the receiving facility.
• Restocking arrangements must be part of a comprehensive and coordinated effort to improve the EMS delivery system in the relevant service area; must be open to all emergency ambulance providers and hospitals in the area; and must be implemented with and monitored by a regional EMS Council or equivalent.
• The restocking arrangements must be in writing.
• The hospital must not bill any federal health care program or beneficiary for the restocked drugs or supplies or write off the cost of the drugs or supplies as bad debt.
• Ambulance providers may not bill any federal health care program or beneficiary separately for the replenished drugs or supplies.
• The hospital and ambulance supplier must maintain records of the restocked drugs and supplies and make the records available to the Secretary of the Department of Health and Human Services upon request.
• The hospital and ambulance supplier must otherwise comply with all federal, state, and local laws regulating emergency medical care and the provision of drugs and medical supplies, including laws relating to the handling of controlled substances.

The proposed safe harbors are available on the OIG's web site at: http://www.dhhs.gov/progorg/oig/oigreg/ambulancepr.pdf.

HCFA Moving Forward to Allow Nurse Anesthetists to Work without Physician Supervision

In a recent letter from HCFA Administrator Nancy-Ann Min DeParle to Senator Arlen Spector (R-PA), HCFA indicated that it is moving forward with plans to allow Medicare payment for nurse anesthetists who work without immediate supervision of anesthesiologists. The letter stated that HCFA is planning to finalize the policy, proposed in December 1997, by June. The letter stated, "We propose the change because the clinical evidence supports that anesthesia outcomes have improved substantially in recent years such that anesthesia is a relatively safe procedure." The American Society of Anesthesiologists (ASA) is continuing its effort to persuade the agency not to make this policy change. ACEP has signed on to letters supporting ASA.