Mark Kirchner, CPO, LPO, President of MK Prosthetic and Orthotic Services in San Antonio, TX, delivered the good news to AOPA: Senate Bill 1271 has been filed in the Texas legislature by Sen. Carlos Uresti. SB 1271 spells out that registration for manufacturing O&P devices applies to manufacturers as defined by Federal law and exempts O&P patient care facilities from being compelled to register as device manufacturers.
 
There is currently no indication that the Texas Department of State Health Services will oppose the bill. This would also indicate that it is unlikely there would be enforcement of the registration effort directed at any patient care facilities. As previously reported in the 2/24 AOPA in Advance, the announced policy would have subjected AOPA members to annual fees ranging from $495 per facility for businesses with less than $500,000 in annual revenue; $2,225 per facility for businesses with $500,000 to $10,000,000 in revenue; or $3,708 per facility for businesses with more than $10,000,000 in revenue.

Passage of the bill will help assure that AOPA members are unlikely to face similar actions in other states.
 
AOPA´s collaboration with the Texas O&P community appears to have had a positive impact on the issue, particularly the contribution made by AOPA´s consultants, Richard Cooper, JD, a former chief counsel to the Federal Food & Drug Administration and Larry R. Pilot, Esq, a former FDA compliance officer.

Click here to read SB 1271.