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By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

Recently, President Obama signed the $6.3 billion, 21st Century Cures Act. The measure dedicates $5.3 billion for the FDA and National Institutes of Health to facilitate research and revise the approval process, while also authorizing increased appropriations for NIH from fiscal 2018 through 2020.

Specific amounts would be allocated to several initiatives during the 10-year period. The total funding allocated for each initiative would be capped at:

  • $1.46 billion for a precision medicine initiative, with specific funding amounts from fiscal 2017 through 2026.
  • $1.51 billion for the Brain Research through Advancing Innovative Neurotechnologies Initiative or “BRAIN Initiative,” with specific amounts allocated for fiscal 2017 through 2026.
  • $1.8 billion for Vice President Biden’s Cancer Moonshot to aid the development of cancer vaccines, tests, immune therapies and other treatments.
  • $30 million for clinical research in the field of regenerative medicine using adult stem cells.

This article was prepared by Patrick Cooney in his personal capacity. The opinions expressed in this article are the author's own and do not reflect the view of the Dental Trade Alliance.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

On December 5, Health Affairs, a publication dedicated to analysis on health policy and issues affecting health and healthcare, released its December issue which explored the state of oral health. Editor-in-chief Alan Weil wrote that, “the divide between dental care and medical care is vast, has significant consequences for patients, and is entirely of our own making.”

The publication featured more than 15 articles on an array of topics including the cost, use, and access to oral health, oral healthcare in Medicare and Medicaid, and the oral healthcare workforce. On December 7, Health Affairs hosted a briefing in Washington, D.C., where article authors explained their findings relating to seniors' dental care, a dental-medical divide, cost barriers to dental care and many other topics.

You can read the issue here.

This article was prepared by Patrick Cooney in his personal capacity. The opinions expressed in this article are the author's own and do not reflect the view of the Dental Trade Alliance.

Please join us in welcoming our newest members:

Ascendant Capital Markets, LLC - Dr. Chris Gayde’s previous dental company, Hunter Wise (also a lender), was absorbed by Ascendiant. Because of his many prior years of working with dental companies, Dr. Gayde was brought in to grow their dental (healthcare) portfolio.  

Best Buy Dental - Best Buy Dental distributes infection control products, disposables, small hand instruments, burs, anesthetics, autoclaves, composite materials, syringe tips and more. On–line and fax ordering for their dentist customers is a large part of their business. 

Dental Market IQ -  Dental Market IQ is an industry consultant, lead generator, and—for the dental industry—a provider of healthcare data, aggregated from insurance providers.   

Nanova Biomaterials, Inc. - Nanova Biomaterials manufacturers and sells composites, whitening gels, and varnish utilizing a new nano fiber technology.      

O’Neal Solutions - O’Neal Solutions is a dental and medical company consultant providing a suite of services including: company reorganization, brand building, domestic and international distribution assistance, and organizational assessment.

Rubicon 360, Inc. - Rubicon 360 advises dental companies on business expansion, exhibitions, the U.S. market, international exports and company new product launches.

Verena Solutions - Verena Solutions is a manufacturer of a new syringe/capping system for dentists. This is a new company and has FDA approval to sell their syringe system. They plan to sell through distribution channels but are also considering private label or licensing opportunities.

Winsix USA, Inc. - Winsix USA, Inc. is a manufacturer of dental implants. The parent company (Biosafin) is based in Italy and manufacturers implants, abutments and other laboratory products. The company will sell through distribution channels but is also interested in private label manufacturing.      

See all the companies that joined DTA in 2016.

Browse the DTA Member Directory.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

The Dental Trade Alliance annual meeting in Arizona is going to be a special event. One highlight will be the attendance of Rep. Paul Gosar (R-AZ) who represents Arizona’s 4th Congressional District. He will speak briefly to the attendees the day after the elections and will be able to give an update about how he sees the new administration and the new 115th Congress working together in 2017. Rep. Gosar is a member of the Freedom Caucus in Congress and one of the more conservative members of the House of Representatives.

On healthcare, Rep. Gosar wants the 2010 Affordable Care Act repealed and replaced with what he calls, “free-market, patient-centered” alternative as well as legislation to address the threat of medical malpractice lawsuits. He believes that everybody’s healthcare needs are different and only competition in the market will lead to quality care. Rep. Gosar earned a bachelor’s from Creighton University and dental degree from Creighton’s Boyne School of Dentistry in 1985. He owned his dental practice in Flagstaff for 25 years. He was named Arizona dentist of the year in 2001.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

The House of Representatives and Senate were busy since early September after the long summer break. Since returning, they had been laboring to finish must-pass funding legislation for the federal government to operate and other key pieces of legislation. However, many are surprised that the Republican-led House and Senate were still in session so late into September with the elections not far off. Many Republicans in the House and Senate are concerned with possible election losses and were anxious to finish legislative work so they can get home and campaign.

Republicans and Democrats have been fighting over details of a stop-gap spending bill to fund the government through Dec. 9. Congress will return after the election to finish the spending bill for the rest of fiscal year 2017. Democrats have been seeking riders to the stop-gap measure that would address drinking water problems in Flint, Mich., and also funding for the Zika virus outbreak. Republicans have sought riders to stop funding of Planned Parenthood and provide emergency flood relief in Louisiana.

Last week the Congress reached agreement on the stop-gap spending bill and the House enacted legislation prior to leaving for the elections.

After discussions with exhibitors and DTA leaders, we have determined that our goals for the DTA Preview Show have been met. Therefore, beginning in 2017 the DTA will no longer host its Preview Show in Chicago prior to the Midwinter Meeting.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

Members of Congress left Washington early this year to attend July’s political conventions, turning a typically four-week summer recess into a seven-week recess. Neither the House or the Senate are scheduled to be in session until after Labor Day. Congress is expected to focus its attention when they return on passing a short-term spending patch to avoid a government shutdown on Oct. 1, just weeks before the elections. Despite promises from House Speaker Paul Ryan (R-WI) and Senate Majority Leader Mitch McConnell (R-KY) to return the appropriations process to regular order, not even one of the 12 appropriations measures have made it to President Barack Obama’s desk. The House is scheduled to be in session only 17 days before taking off again for the month of October to campaign for the upcoming election. It is unclear what Congress will accomplish before the elections—besides the must-pass spending measure—but the following items are atop Congress’ radar:

One of the best ways you can help advocate for your industry is by sharing your business’s story with your local elected officials. Manufacturing Day, held Oct. 7, draws attention to manufacturers with its social media presence (follow the #MFG16 hashtag) and with local events in which manufacturers like you invite elected officials, students and community members to tour your facilities. It is an excellent opportunity to discuss the issues affecting the dental industry with those who can help alleviate onerous regulations.

Members of Congress as well as other local elected officials are up for reelection in November.  Now is a perfect time to reach out to these officials and candidates to make certain they are aware of your business and its footprint in the community. Legislators are looking for opportunities to meet with business leaders and to widen their net of contacts as they learn the needs of their communities. There is no need to wait until October 7th.  DTA urges you to reach out today.

Roskam2Recently, Young Innovations Inc. CEO Dave Sproat hosted Rep. Peter Roskam (R-IL) at the dental manufacturer’s headquarters in Algonquin, Ill. After the tour, Mr. Sproat and Rep. Roskam meet with Young Innovation’s executive management team to discuss important issues such as, the full repeal of the Medical Device Excise Tax, current and future global trade initiatives, increased regulatory oversight and subsequent costs, the Sunshine Act, and concerns about providing continuing education to dentists without the burdensome administration costs because of the Act. Rep. Roskam listened to the team’s concerns and answered questions about immigration, trade, tax repatriation and U.S. economic growth.

“The congressman was very engaged and open to learning our specific concerns and the employees were very excited to hear him speak,” Mr. Sproat said. “I would encourage other DTA members to (host an elected official at their facility) as you are better off knowing your congressman than not.”

Whether you’d like to host your elected officials on Manufacturing Day on Oct. 7 or another time during the year, DTA has the member resources to help. One of the best is our Washington Advocacy Guide, which outlines the issues affecting the dental industry and the ways representatives in Washington can help.

Click here for even more resources and information about Manufacturing Day.

By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance

House Speaker Paul Ryan (R-WI) used his address at the American Enterprise Institute on June 22 to fully reveal the House GOP's health care reform plan. As of press time, the health reform proposal is expected to call for broadening use of health savings accounts and health reimbursement arrangements, selling insurance policies across state lines, capping the employer tax exclusion, keeping the guaranteed-issue mandate with exceptions, setting up high-risk pools for those with pre-existing conditions, repealing Medicare's Independent Payment Advisory Board, changing age-banding, and ending the individual mandate, among other ideas.

On June 10, members of the House energy and commerce health subcommittee held a hearing on several changes to the Affordable Care Act, including a bill that would allow issuers to charge older Americans five times more than younger people unless a state has enacted a different age rating band. Consumer advocates say increasing the age band would put coverage out of reach for older people, while those supporting the bill say it would encourage younger people to enroll and help stabilize overall pricing.

At the hearing, members also discussed legislation that would:

  • Limit the ACA's current's 90-day grace period for premium nonpayment to 30 days or defer to state law.
  • Require exchanges to verify consumers' eligibility prior to enrolling via a special enrollment period.
  • Make state exchanges return any unspent grant money to the federal government.
  • Align pediatric dental benefits for plans both inside and outside the exchanges.

The Aligning Children's Dental Coverage Act (H.R.3463) was introduced in the House of Representatives by Rep. Morgan Griffith (R-VA). This bill amends the Public Health Service Act to ease restrictions on health insurance plans without pediatric dental benefits (an essential health benefit) to allow such insurance to be offered in any state where a dental plan in the individual or small group market provides pediatric dental benefits, even in states where the dental plan is not offered on the health insurance exchange. This Act is retroactively effective as if included in the Patient Protection and Affordable Care Act.


This article was prepared by Patrick Cooney in his personal capacity. The opinions expressed in this article are the author's own and do not reflect the view of the Dental Trade Alliance.

By September, medical device manufacturers and distributors—including dental manufacturers and distributors—are required to implement Unique Device Identification (UDI) for all class II devices that are sold in the U.S. There are very few exemptions allowed.

The UDI is a new track and trace system for devices mandated by Congress with the final rule announced by the FDA. There are a number of moving parts to this UDI tracking system. This includes a unique bar code accompanied by a human readable element (numerals or numerals and letters) for all devices. The UDI itself may be located on the packaging or on the device itself. There are two parts to each UDI. They include: the device identifier, which is a fixed element consisting of the manufacturer (or labeler) and the specifics of that device. The second part is the product identifier, which describes the lot or batch number, serial number, expiration date, etc.

Device manufacturers and distributors must select from one of several issuing agencies that provide UDI numbers and bar codes. These include HIBCC, GS1 and ICCBBA. There are fees to get UDI licenses from the issuing agencies. There are discounts for multiple device UDI licenses. In addition, companies must upload their devices with the proper UDI to the FDA managed Global Unique Device Identification Database (GUDID). Device companies can upload the UDIs themselves or pay a vendor to upload these UDIs for them.

It may be useful to discuss your UDI project with your preferred distributor or manufacturing partners. In some cases, a device package may have to be redesigned to accommodate the UDI in both the bar code and human readable formats. FDA is allowing a grace period of 180 days for devices that are already manufactured and have been shipped to other warehouse facilities. Following the grace period, there could be fines assessed for non–compliance. In a worst case scenario, companies could be prevented from selling their non–compliant devices in the U.S.

For questions regarding UDI, contact the FDA’s UDI Help Desk. Do not telephone or e-mail the FDA separately. All inquiries flow through the UDI help desk. Companies may need to discuss the project with an outside consultant to assist with UDI compliance.