TJC / GPO Oversight Committee

Joint Commission
This month JC announced a new initiative to create an umbrella "National Performance Measurement Data Strategy".  Their reasoning is that we all use different performance measurement tools or programs, so hospital to hospital or region to region comparisons are skewed; and sharing of information is difficult.  The strategy is laid out in their newest Public Policy White Paper, posted at their website.

JC also released this month an updated edition (8th) of their "Guide to Environment of Care," one of the primary prep tools for hospital accreditation inspections.

GPO Oversight
In response to this month's CMS report on looming cost increases and rising percentages of the GDP going to healthcare, HIGPA president Curtis Rooney took the opportunity to put out a press release on the importance of GPO's, bruiting again their claims of 10-15% annual market savings.

In a related February 21 HPN article the American Enterprise Institute stated its opinion that the Transparency in Medical Device Pricing Act of 2007 would likely result in higher prices paid by hospitals, not the other way around.  Their somewhat weak arguments included continued high sourcing costs; inability of any government agency to maintain current pricing; and hospitals' likely failure to pass savings on to consumers.  The act's intent is to lift the perceived veil of pricing secrecy manufacturers lay on hospitals, resulting in probable higher costs paid by CMS.

Ethics Pharmaceutical

Massachusetts proposes new bill banning vendor gifts:
Massachusetts Senate President Therese Murray proposed  broad measure to control healthcare costs by in part banning all gifts and freebies to doctors from drug companies, saying the perks have helped drive up costs for consumers. If adopted, the legislation would make Massachusetts the first state in the country to place an outright ban on drug-industry gifts. Prohibited gifts would include any payments, entertainment, meals, travel, honoraria, subscriptions -- and even a pen bearing a drug company logo. Companies would be forbidden from offering the gifts and doctors, their families and employees would be forbidden from accepting them.

Under the proposal, anyone who violates the ban could be fined $5,000, face two years imprisonment or both. The idea for the ban stemmed from a proposal put forward by State Senator Mark C. Montigny (D-Plymouth) in 2005 and again this year.

Source: Boston Globe,  March 3, 2008,  Megan Woolhouse

Hartford Health Care Corp. changes policy
After a lengthy process, Hartford Hospital embraced a near-zero tolerance policy for vendor gifts. Physicians and key employees accepting gifts of any substance is just too risky when it comes to medical decision making, says Nickie Braxton, the compliance officer for Hartford Hospital and Hartford Healthcare Corp.

Their policy provides that all employees and non-employed paid physician chiefs working on behalf of the hospital cannot solicit personal gifts, business courtesies or services from any patient, visitor, vendor or contractor, according to Hartford Hospital's new policy. Only unsolicited gifts of relatively little value — a total of $50 or less each year from any vendor — are allowed. That figure comes straight from the OIG compliance-program guidance, Braxton says.

Breaking the cycle of vendor largesse is a significant culture change, but experts say now is the time, given mounting evidence that both small and large gifts have distorted medical, prescribing, purchasing and other decisions. Some institutions are banning gifts from medical, surgical and pharmaceutical vendors altogether. A few — notably Henry Ford and Hartford Hospital — implemented a training and certification program that vendors must complete before they can cross the threshold of a company building for a pre-scheduled appointment. This plays into the vendor credentialing boom that is currently occurring.

Braxton says. "Going through the process of discussing and determining what is acceptable and what is not and setting limits is a valuable exercise. The approved policy sets the organization's cultural tone." The basis for barring vendor gifts is the anti-kickback statute. As she notes in the policy, the "federal anti-kickback statute prohibits the acceptance of any item of value (remuneration) made directly or indirectly, in cash or in kind, that may induce or appear to induce the purchase or referral of any kind of health care goods, services, or items reimbursed by a federal or state health care program (Medicare and Medicaid). Consequently, the acceptance of any gifts or business courtesies from vendors or others with whom we presently or potentially conduct business that would violate a federal law or state law is strictly prohibited."

Regarding vendor complaints that gifts don’t impact sales, Braxton states "These savvy companies would not continue to spend millions of dollars on bagels, etc., if they didn't believe this marketing strategy was effective." "[Doctors and decision makers] give the reps their time and attention and allow them valuable marketing opportunity as a result of their offer of meals and snacks."

It's somewhat more complicated when it comes to support of medical education. All financial support of education, conferences, etc. may be made only to a general, unrestricted education fund, and not directly to a physician.

AIS on March 25 will have an audio-conference titled “Vendor Gifts and Relations: How to Revise Your Hospital’s Strategies as the Feds Crack Down” and features two industry leaders outline compliance strategies that hospitals and health systems can use to deal with vendor gifts and relations.

Topics include:
- Applicable federal laws/regulations, including the anti-kickback statute and the False Claims Act, and the government’s enforcement interest in vendor relations.
-Other related challenges for hospitals, including IRS tax-exempt status, challenges to supply-chain process integrity, and vendor financial relations.
-Strategies you can incorporate into your policy to effectively manage vendor relations.
-How to avoid the pitfalls you might encounter when implementing new vendor gift and vendor relations policies.

Speakers
- DONALD E. KOENIG, JR. is vice president and assistant general counsel of corporate responsibility and enterprise risk management for Catholic Healthcare Partners (CHP) in Cincinnati.
- NICKIE BRAXTON is corporate compliance officer for Hartford Hospital/Hartford Health Care Corp. Located in Hartford, Conn.
- Moderator: Nina Youngstrom, managing editor of AIS’s Report on Medicare Compliance

Source: http://www.aishealth.com/Bnow/hbd012808.html
Information derived from the REPORT ON MEDICARE COMPLIANCE

Pricing Confidentiality / Transparency

The Transparency in Medical Device Pricing Act of 2007 remains in the 1^st step of the legislative process. This legislation was authored by Senators Spector and Grassley and recommends medical device manufacturers submit average and mean price data for all implantable devices (inpatient and outpatient). There has been no dissenting voices within congress at this point, however the lobbyists are busy trying to develop arguments. Proponents are targeting a January 1, 2009 kickoff. The general feedback is this may actually gain momentum legislatively and some dissenting members of congress may end up being exposed with regards to their connection to lobbyists.

The debate continues regarding the value or damage that ‘safe harbor’ legislation offers for the healthcare supply chain. MDMA and many manufacturers continue to lobby against ‘safe harbor’, and the GPOs and many members continue to lobby in favor. No news here,  just a lot of positioning and opinion offering.

MDMA issued their 2008 Public Policy Agenda (see at www.medicaldevices.org) which includes:

• Preserving strong intellectual property laws which promote innovation;
• Working with the FDA to implement elements of the FDA Amendments Act of 2007;
• Improving the Medicare coverage, coding, and payment processes to promote timely and adequate reimbursement for innovative technology; and
• Ensuring patients and caregivers have open access to innovative technologies that are safe and effective.

MDMA also recently lobbied to CMS regarding challenging the approach CMS is taking in refining the Outpatient Prospective Payment System. Basically, they’re attempting to allow for new technology introduction and higher payments. See attached for details.

On January 8, 2008, the Centers for Medicare & Medicaid Services (CMS) announced the Metropolitan Statistical Areas (MSAs) and product categories for the second round of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) new competitive bidding program. The program is designed to improve the effectiveness of Medicare's DMEPOS payments, reduce beneficiary out-of-pocket costs, and save the Medicare program money while ensuring beneficiary access to quality DMEPOS items and services by requiring suppliers to be accredited by a Medicare-recognized accreditation organization. All suppliers must meet quality standards and be accredited by a CMS-recognized accreditation organization in order to obtain a contract under the Medicare DMEPOS competitive bidding program. Due to the size of this expansion and our experiences from round 1 of the program, we strongly encourage suppliers to seek accreditation as soon as possible to avoid any potential difficulties that would affect their ability to bid. Information on accreditation requirements and a list of CMS-recognized accreditation organizations can be found on this web page.  

See http://www.cms.hhs.gov/CompetitiveAcqforDMEPOS/

From the GPO side, HIGPA is lobbying with CMS to increase the role of the GPOs to offset the projections that CMS has issued in their most recent Actuary Report. Those projections suggest growth in healthcare spending is expected to outpace GDP by an annual average of 1.9%.

The heat appears to be off the GPOs, with a general thought that self-policing is working. However, I’m told there was a recent advertisement in Modern Healthcare by MedAssets that challenges the GPO Coop model, and suggests their approach is more beneficial. Has anyone seen the ad? If so, please forward it to me so I can include it in the report out.

SCMetrix is evolving, as a prospective tool that will help us better understand comparative pricing and could potentially empower providers to report differences or similarities that would allow for a more informed decision regarding price transparency.

Quality / Medication Errors / Safety Issues

Quality:
“Medicare to provide better oversight of suppliers of certain medical equipment”,  Healthcare Purchasing News, February 2008, Vol. 32, No.2, pg. 8.

This article concerns the CMS (Centers for Medicare & Medicaid Services) announcement of 70 news areas across the national that will be part of the second phase of a competitive bidding programs designed to help lower Medicare beneficiaries’ out-of-pocket costs and improve their access to certain high quality durable medical equipment, prosthetics, orthotics and supplies.  This expanded program also enables federal officials to prevent unscrupulous supplies from participating in Medicare. Once the competitive bidding program is fully implemented nationally, it is expected to save beneficiaries and Medicare $1 billion annually.

Suppliers must meet a high quality of standards established by CMS and be accredited by one of ten organization chosen by Medicare.

Safety:
“Nonhospital healthcare workers at substantial risk of exposure to blood borne pathogens”, Healthcare Purchasing News, February 2008, Vol. 32, No. 2, pg. 8.

The Columbia University School of Public Health assessed the risk of exposure to blood borne pathogens among non-hospital based RNs and found that nearly one of 10 of the more than 1100 nurse participants reported at least one needle stick injury in the previous 12 months.  These rates of exposure are surprising since they are similar to rates reported for hospital-based nurses, even though hospitalized patients generally have high levels of acuity of patient care than are typically performed in community healthcare settings.

The population at risk is large, since non-hospital based nurses represent a substantial portion of the overall nursing workforce, approximately 40% of the 23 million RNs in the US are employed in non-hospital settings. 

The researchers found that 70% of the exposed nurses were never seen by a healthcare provider at all, even though appropriate and timely follow-up of these incidents can reduce the risk of infection.

EPA

The EPA has issued new regulations regarding the use and management of ETO (ethylene oxide) sterilant that take effect at the end of this calendar year. It is a rule aimed at minimizing ETO emissions by assuring that organizations using this chemical are minimizing the number of cycles run by maximizing the utilization of the sterilizer chamber (fill it up). For certain organizations there is a requirement to report the equipment on site, the amount of sterilant used and to document the cycles run...reporting this to the EPA routinely.

Supply Chain Data Standards

The Healthcare Supply Chain Standards Coalition voted to align with GS1 Healthcare US™, and will be meeting to iron out the specifics. GS1 Healthcare US™, a cross-industry activity-based group focused on driving adoption and implementation of GS1 standards in healthcare, held their first meeting with members and prospective members in Dallas on March 11-12. Work groups convened for product identification (GTIN), location identification (GLN), data synchronization (GDSN), traceability adoption, and auto identification in healthcare. Ongoing industry pilots are showing positive results. AHRMM will be launching a micro website in the next month dedicated to standards and will have links to all the pilot information as well as standards information.