By Bruce Lundegren, Assistant Chief Counsel
One issue stood out above others at Advocacy’s recent Regulatory Reform Roundtable in Jackson, Miss.: the concern of small, independent pharmacy owners about the Center for Medicare and Medicaid Services’ (CMS) rules on “Direct and Indirect Renumeration” fees. The DIR rules, as they are known, relate to the impact of rebates and other price concessions from drug manufacturers on drug prices in Medicare Part D that are not accounted for at the point of sale. One speaker affiliated with the Mississippi Independent Pharmacists Association – a group representing 180 independent pharmacists in Mississippi – explained that because pharmacists do not know what these price adjustments are at the time of sale, they may be actually losing money on these transactions. He blamed pharmacy benefit managers (PBMs) and large Part D plans for taking advantage of patients and independent pharmacists through a lack of transparency. Other pharmacists expressed similar concerns and stated that CMS’ failure to issue final rules to correct the problem was extremely disappointing.
However, pharmacy issues and the DIR rules were not the only issues raised in Jackson. Another speaker, a small business owner whose company provides custodial and maintenance services to federal agencies like the Customs and Border Protection and the Department of Defense, complained about contracting and procurement rules. He said he had bid on federal contracts as a subcontractor to a large prime contractor, but the prime terminated several of his contracts after they were awarded to keep the work for itself. He stated that the U.S. Small Business Administration and other federal agencies need to do a better job of overseeing these contracts and enforcing small business utilization rules.
Another small business owner discussed her biometric company that develops fingerprint and facial recognition technology for security background checks and passport recognition. She is now advocating for state and federal rules to require background checks for in-home health care and mental health workers because of the potential for abuse or violence against vulnerable patients. She said that these workers are not properly vetted and can pose a significant safety risk to patients. Other small businesses discussed the difficulty of finding qualified workers in the tight labor market – a familiar concern raised at many of Advocacy’s recent roundtables. One small business stated that programs need to focus on workforce training and development so that small businesses can recruit and retain qualified employees to remain competitive.
There were also several federal agencies in attendance who explained some of their programs. A representative from the Occupational Safety and Health Administration’s district office talked about OSHA’s On-Site Consultation program that funds free workplace safety inspections to small businesses and is not affiliated with OSHA’s enforcement side. A representative from the U.S. Small Business Administration’s SCORE program spoke about their free program to mentor startup businesses in planning and management. A representative of the local Small Business Development Center discussed opportunities for entrepreneurs to receive training and assistance in their small business incubator located at Jackson State University. SBA’s District Director and several local bankers answered questions and discussed funding opportunities through various SBA lending programs.
It was an enthusiastic, civic-minded discussion led by small businesses and community leaders who took obvious pride in their city and state. Attendees expressed appreciation for the opportunity to provide their input and learn about some of the resources that are available to their community.
Advocacy was in Arkansas, Tennessee, and Mississippi for Regional Regulatory Reform Roundtables June 4-6.
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Bruce Lundegren is an Assistant Chief Counsel for Advocacy whose portfolio includes safety, transportation, and security. Lundegren can be reached at bruce.lundegren@sba.gov.