Archive for March, 2009
OIG Tightens Self-Disclosure Protocol Protection
The Department of Health and Human Services Office of Inspector General released an Open Letter to Health Care Providers on March 24, 2009 to refine the provider Self-Disclosure Protocol (SDP). Two important comments are included. First, only disclosures that include a colorable anti-kickback statute violation will be accepted. Second, a health care provider accepted in the SDP program can expect a minimum of a $50,000 judgment.
For background, SDP was described in an earlier open letter as designed to:
…Encourage the healthcare provider community to help ensure the integrity of the Federal health care programs by voluntarily disclosing self-discovered evidence of potential fraud…. to disclose improper arrangements under the physician self-referral (Stark) law (42 D.S.C.§ 1395nn) and committed to settling liability under OIG’s authorities generally for an amount near the lower end of the damages continuum.
Looking at Civil Monetary Penalties (CMP) by the OIG, the minimum penalty requirements doesn’t appear to have significant impact. Of the 10 judgments noted in the past year, just four are identified as self-disclosure. The penalties averaged $348,700. Though the only one less than $100K was a $21,000 self-disclosure participant.
But the “colorable anti-kickback” requirement could. While the OIG carefully states that this shouldn’t be construed as a change in the government’s interest in enforcing physician self-referral, it’s difficult not to.
The change makes sense. In effect, the OIG is saying, “Help us identify and focus on the serious fraud cases, and we’ll all benefit from a greater return on our regulation investment.”
Add comment March 25, 2009
The New Standards
In a step to rationalize healthcare representative credential requirements, a joint best practices team across Advamed, AACN, AHRMM, AORN, HIRA, HMMC, IMDA, IPPS, IHAC and MDMA have released their recommendations on appropriate credentials for Health Care Industry Representatives in Clinical Areas.
The document reflects what Vendormate health care clients typically require for reps in patient care or clinical areas:
1. Immunization Records – the commonly requested MMR, HepB, and TB test
2. Training — product competency, HIPAA policies, Code of conduct/ethics, OSHA/Bloodborne pathogens
3. Hospital/Department Orientation
4. Background verification — drug screen (as applicable), criminal background check, sexual offender registry, and sanction screens
5. Statement of Insurance Liability letter
The standards emphasize the importance of the representative’s privacy and generally state that the healthcare system should accept attestations of the representative’s employer that these standards have been met.
Combining privacy with relevancy, the standards also counsel against collecting SSNs, drivers license information, personal credit checks, and resumes.
In general, most of our customers’ programs already meet these recommendations. None collect the personal information of SSNs, drivers licenses, credit checks, and resumes.
A few nuances we would recommend:
Record the expirations of immunizations. The status of “current” is what is essential here. A document that is collected one time at the start of a relationship does not reflect changes that occur over time. A simple notation of “expiration date” can help both the health system and the representative stay on top of this potential exposure.
Sanction checks need to be done more frequently. CMS has pushed state level bodies to check at least monthly, and the rate of recidivism is relatively high. Of all checks, this should certainly be done by someone other than the rep or the employer. However, privacy can be protected even here. Basic information such as name, county, and state of residence is generally enough to clear any sanction list match question. Vendormate counsels its customers that any additional information is required to reconcile a potential match be collected only on an as needed basis and with the full awareness of the potentially matching person.
The recommendations clearly reflect that these are for reps in “clinical areas.” Clinical reps are only one part of the supply chain approach to vendor credentialing. In addition to the clinical rep, the healthcare system will still want to define standards for its vendor companies — the company’s financial strength, the company’s sanction list standing, etc.
Add comment March 18, 2009
Who’s the Guy in the Black Hat?
There was a time when clothing colors made statements. Good guys wore white hats. Bad guys wore black. Serious business men wore white shirts. No one attending the wedding would wear black because black was the color of mourning, and only the bride wore white. (In the U.S. at least. Of course in Asia, white is commonly a mourning color.) In some hospitals, vendor reps are required to wear black scrubs.
But color alone isn’t enough to tell who’s who. Oh, remnants of these practices still hold. And color-coded scrubs give an at-a-glance clue as to which group an individual belongs to, but that’s not enough for the healthcare compliance directors quoted in this great article, Pressure Mounts to Manage Medical Device Vendor Reps in Operating Room.
This article on AIS’s Health Business Daily on March 5 2009 reports the issues these healthcare compliance directors face on the front line in managing medical device vendors in the hospital.
Here are a few requirements cited by these leaders:
Keeping reps focused on an identified business purpose. Assisting or selling, not milling around
Patient privacy. Even if the patient gives consent to a vendor rep attending a procedure, hospitals may have additional privacy practices that the rep should follow.
Immunization status. To limit susceptible patients’ exposure to communicable diseases.
Training and competency. A difficult area still being defined. What are the standards? Who provides the measurement?
Financial relationships. The most prominent involves relationships between consulting surgeons and vendor companies, such as training vendor reps for pay – As one compliance officer stated in the article, ”‘If they stopped buying products from the vendor, their teaching money would evaporate,’ he says.”
Imagine trying to convey an individual’s status on all these metrics through scrubs? Black scrubs with yellow stripes signify current immunizations. Red dots mean you’re fully trained. It’s not really viable.
It’s this complexity that is driving more and more healthcare systems to vendor badging integrated with their compliance programs. Beyond the color of the scrubs, healthcare systems need unique single-use badges that reflect today’s status of vendor reps and their companies.
Otherwise, you’re still left wondering – Is that a good guy in the black hat?
1 comment March 11, 2009
New Year Policy Resolutions
Business policies, like New Year resolutions, are written with the best intentions. With a new policy in place, operations will be more efficient. Universal understanding will be achieved. Expenses will be reduced and profits will soar.
These policies, like resolutions, are enthusiastically followed the first few months. Then they are forgotten. Keeping a policy “live” over time takes effort. Requires changes in core behaviors.
A recent article in Health-System Pharmacy News, quoted Dave Hicks, the University of Chicago Medical Center’s chief pharmacy officer, talking about their Vendormate-based vendor management application.
Hicks said the medical center already had a vendor-management policy in place, but compliance was inadequate.
“The vendor would make an appointment with somebody at the hospital, and that would get them through security,” Hicks explained. “And then they’d spend the day in the hospital trolling the hallways, essentially, and looking for people to have ad hoc conversations with.”
Hicks said the Vendormate system helped put teeth into the existing policy (emphasis added). The program rollout also included education for staff about permitted vendor activities and the medical center’s expectations for vendor behavior.
I’ll wager that the success University of Chicago and Hicks now are experiencing in policy compliance is based on the behaviors driven by educating the staff and the appointments and sign in process, rather than any new policy.
It’s not that the intent to comply wasn’t there before. Just like every night that I went to bed, intending to get up early and exercise. But come morning, the existing behavior of hitting the snooze bar was already there. Changing that behavior didn’t require a new, “don’t hit the snooze bar” policy, but it did require moving the alarm clock out of arm’s reach.
Add comment March 4, 2009
