Regulations

From time to time, changes to regulations on a state or federal level may be made or implemented. If MSDA becomes aware of any major changes in the dental industry, we will send information to our membership via email, through MSDA Newsletter articles and on our website. Please be sure that your email address is on file and that your address is up to date. 

For information on regulations, you may also email Monique Moore at monique@msda.com.

For regulations effecting the state of Maryland, you may also contact the Maryland State Board of Dental Examiners at 410-402-8501. 

Section 1557 - Affordable Care Act
Under Section 1557 of the Affordable Care Act, dental offices that receive reimbursement under Medicare Advantage or Medicare Part C must provide free of charge translation services for patients who are not able to speak English. Dental Offices must post taglines explaining this in the top 15 non-English languages in the state. The article above contains information on what the tagline should read, the top languages in MD and other sources of information for new regulation.

FDA Bans Powdered Gloves; Do Not Use After Jan. 18

The Federal Register on Dec. 19, 2016, published its final rule establishing the Food and Drug Administration’s ban on powdered surgical and exam gloves. The FDA says powdered gloves are an adulterated product and are unsafe for use. This ban takes effect in 30 days. Unfortunately, the ban’s effective date also applies to end-users who have already purchased and are using powdered gloves. These gloves may not be used after Jan. 18, per the FDA and are subject to enforcement action. Powdered gloves represents a small percentage of the current exam glove marketplace and there are many high-quality powder-free gloves available as alternatives. The staff at Association Gloves, which is endorsed by Maryland State Dental Association, is prepared to help you find a powder-free latex, nitrile or chloroprene glove that will satisfy your unique needs. Please contact Association Gloves at 877-484-6149 for assistance selecting a new glove. Free samples are available.

If you wish to read the rationale behind the ban and further details, please see the Final Rule in the Federal Register https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf.

EPA to Require Dental Offices to Use Amalgam Separators
This article has been reprinted, in part, from www.ADA.org. Please click HERE for the full article.  

Washington — The U.S. Environmental Protection Agency released a final rule Dec. 15 requiring dental practices nationwide to install amalgam separators.

"EPA has concluded that requiring dental offices to remove mercury through relatively low-cost and readily available amalgam separators and BMPs makes sense," said the EPA in its executive summary of the final rule.

The rule closely follows ADA's own best management practices and incorporates three of those BMPs: one, requiring use of separators; two, prohibiting providers from flushing down a drain waste amalgam (such as from traps or filters); and, three, prohibiting the use of bleach or chlorine-containing cleaners that may lead to the dissolution of solid mercury when cleaning chair-side traps and vacuum lines.

The rule is effective 30 days after publication in the Federal Register. The date for compliance for most dentists will be three years from now, at the end of 2019.

Additional highlights of the rule include:

• Dentists who practice in oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, and prosthodontics are exempt from the rule;
• Dentists who do not place amalgam and only remove amalgam in unplanned or emergency situations (estimated at less than 5 percent of removals) are also exempt;
• Mobile dental units are exempt;
• Dentists who already have separators are grandfathered for 10 years.

Although less than one percent of mercury released to the environment from man-made sources comes from dentistry, the ADA has encouraged dental offices to follow its Best Management Practices for Amalgam Waste to help reduce discharges of used amalgam into dental office wastewater. In 2007, the Association amended its BMPs to include the use of amalgam separators that comply with ISO Standard 11143, part of the International Organization for Standardization, a worldwide federation of national standards bodies.

The MSDA Endorsed program has partnered with Biomedical Waste Services, a vendor that offers MSDA member dentists special pricing on an amalgam separator device that will meet the federal regulatory requirements along with recycling services.

For more information, visit ADA.org/RecycleAmalgam.