The Patient Protection and Affordable Health Care Act of 2010 (signed on March 23, 2010 and as amended by the Health Care and Education Act of 2010 on March 30, 2010) (collectively the "PPAHCA") resulted in a number of significant changes to our health care delivery system.  Although the media has focused much of its attention on the expansion of health care coverage, the PPAHCA also included a number of significant changes to the 340B Drug Pricing Program (as enacted by Section 602 of the Veterans Health Care Act of 1992). Most notably, the PPAHCA expanded the definition of "covered entity" effective January 1, 2010, thereby allowing additional provider types to participate in the 340B program.
 

As originally enacted, the 340B program required drug manufacturers to provide covered outpatient drugs at discounted prices to "covered entities."  Covered entities who are enrolled in the 340B program receive covered drugs at rates not to exceed the price paid by the state Medicaid program.  In other words, 340B covered entities can obtain covered outpatient drugs at a cost equal to or lesser than the amount that Medicaid pays the manufacturers for the drugs.  Participating covered entities generally save approximately 30% or more on the cost of covered drugs through the 340B program.  To obtain the discounted rate, covered entities have to be enrolled with the Office of Pharmacy Affairs (within the Health Resources and Services Administration).

 
Under the original 340B program rules, the term "covered entities" included the following:
     1.     FQHCs, FQHC look-alikes, and other entities defined at 42 USC 1396d(l)(2)(B)
     2.     Section 256a grantees
     3.     Family Planning Clinics under Title X
     4.     Ryan White/HIV Clinics
     5.     State-Operated AIDS drug assistance programs
     6.     Black Lung Clinics
     7.     Children's Hospitals in limited circumstances
     8.     Disproportionate Share Hospitals with a DSH rate of 11.75% or more
 
The PPAHCA expanded the definition of "covered entity" to include the following organizations, provided that applicable DSH rates are met, among other requirements: 
     1.     Critical Access Hospitals
     2.     Sole Community Hospitals (DSH rate of 8% or more)
     3.     Rural Referral Center (DSH rate of 8% or more)
     4.     Children's Hospitals (DSH rate of 11.75% or more)
     5.     Freestanding Cancer Center (DSH rate of 11.75% or more)
 
Expansion of 340B Program

Congress' expansion of the 340B program to new covered entities is an important step in recognizing that many rural providers need access to preferred pricing in order to continue to provide critical services to patients in rural areas.  Please note that the definition of "covered drugs" does not include orphan drugs relative to the above newly added entities.  However, existing covered entities will continue to receive discounted pricing on orphan drugs.  Orphan drugs are those drugs administered for the purpose of treating rare conditions.
 
Congress's expansion of the 340B program to the above entities represents an excellent opportunity for additional providers to reduce costs associated with the provision of pharmaceuticals.  Over the last several years, 340B program participants have benefited greatly from discounts on infusion meds which in turn allows providers to expand their cancer and pain treatment programs.  It is critical that all provider types referenced in the PPAHCA's definition of a covered entity immediately assess whether they meet 340B eligibility criteria.  For those that do not, circumstances may change or transactions may be available that can result in eligibility.  Therefore, it is always important to consider 340B implications when engaging in organizational changes.
 
Murer Consultants has assisted a number of providers, including DSH hospitals, with 340B eligibility and enrollment.  Murer Consultants has also worked with multi-campus hospitals to achieve eligibility by way of organizational changes, such as hospital mergers.  We are happy to help all provider types assess their current eligibility and enroll in the 340B program.  Please keep in mind that 340B program enrollment begins the first day of a quarter (January 1, April 1, July 1,  and October 1).  Also, enrollment applications are due no later than thirty (30) days prior to the corresponding quarter (i.e. December 1, March 1, June 1, and September 1).
 
In addition to expanding the definition of a 340B covered entity, the PPAHCA also includes new 340B program integrity and administrative dispute resolution processes.  Manufacturers and covered entities should be aware of the new program integrity rules that seek to minimize abuse of the 340B program.  With respect to manufacturers, the primary purpose of the program integrity rules is to reduce discrepancies in the ceiling price that manufacturers charge covered entities for covered drugs.  With respect to covered entities, the new program rules were established to monitor compliance with 340B program eligibility criteria and to reduce duplicate discounts for drugs covered by state Medicaid programs. The Office of Pharmacy Affairs must implement regulations addressing the new program integrity requirements within 180 days of enactment of the PPAHCA.  Murer Consultants will continue to monitor the 340B program rules and regulations, and is happy to work with your program or institution to ensure compliance with the new regulations.

On April 29, 2010, Cherilyn G. Murer received the most prestigious award given by the NIU (Northern Illinois University) Aumni Association in DeKalb, Illinois.  She was honored that evening at a dinner and reception where she received the 2010 Northern Illinois University Distinguished Aumni of the Year Award. 

This award is presented by the Alumni Association to one individual each year who has achieved national, regional or statewide prominence.

United Cerebral Palsy's annual Great Chef's Tasting held at the Bolingbrook Golf Club on May 22 was a wonderful success this year, raising a record amount of money to support the agency's day school, adult programs and home-based services.  This year, Lyndean Brick, received special recognition via a "Chef Fred Ferrara Award for Volunteerism".  Ms. Brick has been active in a wide variety of civic, philanthropic and social service agencies.  She was a critical member of the team that guided the growth of the agency during the past seven years and is a tireless and generous volunteer.

Murer Consultants, Inc. is pleased to announce that Advance for Health Information Professionals, the nation's leading Health Information publication, has named Murer Coding Consultant, Lynn Kuehn, MS, RHIA, CCS-P, PCS, CHAP, FAHIMA, as one of the Nation's Top Ten Health Information Management Prodfessionals for 2010.  With over 20 years of experience in the healthcare industry, in her role at Murer Ms. Kuehn provides operational assessment, coding and reimbursement system assessment, data quality management, compliance training, and information systems management for physician practices, surgery centers, and ancillary diagnostic service providers.