August 2016 Newsletter

TOP HEADLINES

MAG calling for emails to oppose mergers

The Medical Association of Georgia (MAG) is calling on its members and their practice staff to send an email to mergercomments@oci.ga.gov as soon as possible to urge Georgia’s Division of Insurance (DOI) to block the pending Aetna/Humana and Anthem/Cigna mergers.

Key points…

– The mergers would reduce competition and place physicians and their patients at a growing disadvantage as these companies seize increasingly-dominant positions in the marketplace.

– The combined entities would control nearly 90 percent of the individual health insurance market in Georgia.

– A few insurers would be able to institute policies that will exacerbate the physician shortage and undermine the economic viability of Georgia’s health care system – especially in rural areas where hospitals and medical practices are struggling to keep their doors open.

– More than 30 percent of the physicians in Georgia who participated in a survey that MAG recently conducted said that they believe that the Aetna/Humana merger would threaten the long-term viability of their practice.

– In a related development, several key advocacy groups – including Consumer Action, Consumers Union, the Consumer Federation of America, the U.S. Public Interest Research Group, and Consumer Watchdog – recently submitted a letter to DOI to “urge [it] to take appropriate action under its authority to protect competition and consumers” and to “carefully evaluate (the mergers) and be ready to consider imposing additional requirements (on the insurers) to protect consumers from harm.”

Click for consumer groups letter

Click for MAG mergers web page

MAG’s 2016 legislative seminar another big success

More than 50 physicians and 25 legislators attended the Medical Association of Georgia’s (MAG) ‘Summer Legislative Education Seminar’ at the Westin Jekyll Island on Friday, July 29 and Saturday, July 30.

The event featured panel discussions that addressed a number of key issues, including out-of-network billing, how to address Georgia’s uninsured patient population, and the pending Aetna/Humana and Anthem/Cigna mergers. Attendees also received an update on developments at the federal level.

“The 2016 legislative seminar provided a great opportunity for physicians to discuss important issues with lawmakers and set the tone for MAG’s policy priorities heading into the 2017 legislative session,” says MAG Director of Government Relations Derek Norton. “This annual event is a key part of MAG’s overall advocacy effort in that it strengthens relationships between physicians and legislators and gives lawmakers a setting in which to address any specific healthcare questions directly with providers.”

Norton applauded the physicians and legislators who attended the event, and he thanked the legislators who took part in the panel discussions.

He also stressed that the meeting involved legislators who serve on the key committees that are aligned with MAG’s legislative priorities, including Health and Human Services, Insurance, and Judiciary.

Finally, Norton pointed out that, “We are fortunate to have had so many legislators attend this event and receive feedback directly from physicians who care for patients every day. This event is just another example of how MAG works to protect and preserve the medical profession in the state to ensure that Georgians continue to have access to the best medical care in the world.”

Contact Norton at dnorton@mag.org with questions.

MAG calls for VA to reject APRNs scope proposal

The Medical Association of Georgia (MAG) has called for the U.S. Department of Veterans Affairs (VA) to reject a proposed rule that would allow advanced practice registered nurses (APRNs) – including nurse anesthetists – to provide services to VA health care system patients without the clinical oversight of a physician (i.e., ‘RIN 2900-AP44-Advanced Practice Registered Nurses’ aka the ‘VA Proposed APRN Rule’) because it would undermine their care.

In a letter that he submitted to VA Sec. Robert McDonald on July 11, MAG President John S. Harvey, M.D., pointed out that, “Georgia law requires APRNs to work under the supervision of a physician, an approach that has a long and proven track record in our state. Changing this law would compromise the standard of care for veterans, which is one of our most vulnerable populations – and keeping in mind that VA patients often have complex medical conditions that pose a greater risk of complications during surgery.”

He added that, “MAG believes that the VA should continue to use a physician-led, team-based model of care to ensure that veterans have access to adequately trained physicians – especially in the event of an emergency or a complication during surgery and especially when it comes to imaging, imaging diagnostics, anesthesiology, perioperative medicine, and acute care settings.”

Dr. Harvey also stressed that there is no shortage of physician anesthesiologists in the VA system.

Finally, he said “MAG believes that creating different standards of medical care for non-physicians could result in widespread confusion and errors that will undermine the care that VA patients receive.”

And in a related development, MAG was one of nearly 100 physicians’ advocacy organizations that signed a letter that was sent to the Under Secretary for Health at the U.S. Department of Veterans Affairs on July 25 to call for the Veterans Health Administration (VHA) to “preserve the highest quality of care and protect the safety of our nation’s veterans and not move forward with a proposed rule” that would “permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.” 

Click for Dr. Harvey’s letter to the VA

Click for group letter to VA Under Secretary 

MAG supporting bill to clarify Sunshine Act

The Medical Association of Georgia is one of many physicians’ advocacy organizations that signed a June 29 letter that was sent to U.S. Sen. John Barrasso, M.D., to support a bill (S. 2978, the ‘Protect Continuing Physician Education and Patient Care Act’) that he has sponsored that “clarifies that certain applicable manufacturer transfers of value to support independent medical educational programs and materials are exempt from reporting under the Physician Payments Sunshine Act.”

Click for letter

Important HOD notes, deadlines & reminders

The Medical Association of Georgia (MAG) is reminding applicable members to make plans to attend the 2016 House of Delegates (HOD) meeting, which will take place at the Hyatt Regency in Savannah on Saturday, October 15 and Sunday, October 16. MAG’s Board of Directors will meet at the Hyatt on the afternoon of Friday, October 14.

Early bird registration will be available in the lobby of the Hyatt from 2 p.m. until 7 p.m. on October 14.

Attendees and their family members and guests are all encouraged to attend a welcome reception that the Atlanta Capital Group will host on the terrace on the fourth floor of the Hyatt from 6 p.m. until 7:30 p.m. on October 14.

2016 HOD Web Page

MAG has created a web page – www.mag.org/HOD – to serve as a one-stop shop for key information for this year’s HOD meeting. It includes meeting logistics, staff contacts, deadlines, and reports and resolutions.

MAG members can contact Dayna Jackson at djackson@mag.org or 678.303.9262 with any questions related to the HOD meeting.

Lodging

HOD meeting attendees who need assistance with accommodations in Savannah should contact Anita Amin at aamin@mag.org or 404.299.7700.

Elections

MAG members who are interested in running for MAG office for 2016-2017 should contact Donna Glass at dglass@mag.org or 678.303.9251. The elections will take place during the HOD meeting.

“We encourage our member physicians to participate in the process, whether that’s serving on a committee or running for office,” says MAG Executive Director Donald J. Palmisano Jr. “The only requirement to run for MAG office is that you must be an active MAG member for the two years preceding the election.”

The following is the list of candidates who have announced their plans to run for MAG office for 2016-2017 to date…

– President-elect: Frank McDonald Jr., M.D.

– Second Vice President: Lisa Perry-Gilkes, M.D.

– Speaker of the House of Delegates: Edmund R. Donoghue Jr., M.D.

– Vice Speaker of the House of Delegates: James W. Barber, M.D.

– AMA Delegate (for the seat that is held by Joy A. Maxey, M.D., that expires in 2017): Joy A. Maxey, M.D.

– AMA Alternate Delegate (for the seat that is held by John S. Antalis, M.D., that expires in 2017): John S. Antalis, M.D.

– AMA Alternate Delegate (for the seat that is held by Jack M. Chapman Jr., M.D., that expires in 2017): Jack M. Chapman Jr., M.D.

MAG President-elect Steven M. Walsh, M.D., will be installed as MAG’s president on October 15, while MAG’s Second Vice President Steven M. Huffman, M.D., will automatically become MAG’s first vice president.

Reports & Resolutions

Annual reports and resolutions for this year’s HOD meeting must be submitted by the end of the day on Wednesday, August 31.

HOD resolutions can be submitted by a CMS or state specialty society delegate or any HOD delegate who agrees to present an item of business.

MAG directors and officers must prepare an annual report for the 2016 MAG HOD. These reports should include 1) meeting dates 2) activities and 3) a current list of directors. Alternate directors, meanwhile, are required to assist in the preparation of these reports as a bylaws requirement.

Resolutions and annual reports must be submitted in a Microsoft Word document format to MAG Executive Director Donald J. Palmisano Jr. at dpalmisano@mag.org by the end of the day on Wednesday, August 31 to be included in the HOD delegates’ handbook. That cutoff date is especially relevant for resolutions that are related to MAG’s Constitution and Bylaws given a 45-day bylaws requirement.

MAG will confirm the receipt of resolutions that are submitted with an email reply, but Palmisano emphasizes that, “If a delegate or director or an officer does not receive such an e-mail, their report will not have been considered received.”

Go to www.mag.org/about-us/house-of-delegates or contact Palmisano at dpalmisano@mag.org with questions related to HOD reports or resolutions.

MAG is also reminding county medical society (CMS) presidents and secretaries and executives to submit a list of their delegates and alternate delegates for the HOD meeting by the end of the day on Friday, September 2.

Contact Kate Boyenga at 678.303.9263 or kboyenga@mag.org with any questions related to HOD delegates/alternates.

Finally, CMS presidents and secretaries and executives should submit the names of any new directors or alternate directors for MAG’s Board of Directors to Donna Glass at dglass@mag.org.

Click for HOD delegate/alternate form

GAMPAC

GAMPAC Chair James Barber, M.D., has announced that every current GAMPAC member who attends the HOD meeting will be able to get a professional headshot photograph taken for free.

GAMPAC members will be able to have their photo taken at their convenience by Chris Savas from 8 a.m. to 12 p.m. on Saturday, October 15 or from 8 a.m. to 12 p.m. on Sunday, October 16, at a studio that will be set up next to the GAMPAC exhibit and near the main HOD meeting room.

As an added bonus, Dr. Barber says that GAMPAC will host a free and exclusive luncheon for its members at the Hyatt Regency Savannah at 12:30 p.m. on Sunday, October 16 that will feature a special panel discussion that will include four congressional leaders, including Reps. Tom Price, M.D., and Buddy Carter from Georgia and Reps. Michael Burgess and Phil Roe from Texas and Tennessee.

Dr. Barber believes that, “GAMPAC is an easy and effective way for physicians to support candidates for political office in the state who want to enhance the practice environment in Georgia and who want to protect the patient-physician relationship.”

And Dr. Barber notes that, “You can join GAMPAC at the membership level that suits your needs – whether that’s the Chairman’s Circle at $2,500 or the Capitol Club at $1,000 or the general membership level at $250.”

Contact Kimberly Ramseur at 678.303.9273 or kramseur@mag.org or go to mag.org/affiliates/gampac to join GAMPAC.

Click for 2016 HOD web page

Deadline for MAG awards extended until August 5

The Medical Association of Georgia (MAG) is reminding county medical society and specialty society leaders and MAG members to nominate the individuals that they believe deserve to be recognized for their contributions to the medical profession for MAG’s annual awards, which will be presented at MAG’s HOD meeting on Saturday, October 15.

The deadline for nominations has been extended until the end of the day on Friday, August 5.

Nominations for the Lamartine Hardman Cup, the Joseph P. Bailey Jr., M.D., Physician Distinguished Service Award, and the John B. Rabun Award must be submitted by a county medical society. The Jack A. Raines, M.D., Humanitarian Award, the Donna Glass Non-Physician Distinguished Service Award, and the Physician’s Award for Community Service nominations may be submitted by a county medical society or an individual member.

Sponsors must complete the ‘Online Nomination Form’ by 5 p.m. on Friday, August 5. Sponsors may also submit optional supporting documents (e.g., letters, articles, CV) to Samantha Grantham at sgrantham@mag.org by the deadline on August 5. Nominations that are mailed through the U.S. postal system will not be accepted. The MAG Awards Committee will accept re-nominations.
Contact Grantham at sgrantham@mag.org with questions.

Click for list of past award recipients

 

MAG encouraging students to enter abstract competition

The Medical Association of Georgia (MAG) will host a medical student abstract competition for MAG student members in conjunction with its annual House of Delegates meeting – an event that will take place at the Hyatt Regency Savannah on Saturday, October 15.

The competition will have four categories, including basic science/bench work, clinical research, public health, and case studies.

Just one winner will be selected in each category, and the winning abstracts will be published in the Journal of the Medical Association of Georgia.

Every student will also be given the opportunity to participate in a “Best Pitch Competition,” where they will have 45 seconds to “pitch” a panel of physician judges. The winner of this competition will be featured on MAG’s website.

Contest details…

– The deadline for the abstracts of 350 words or less is the end of the day on Friday, September 9.

– The contest is open to every MAG student member in every class in every medical school in the state.

– Submissions are limited to one abstract per primary author.

– Acceptance emails that include additional details will be distributed by September 21.

– Contestants must set up their poster exhibits in the lobby of the Hyatt Regency Savannah no later than 12 p.m. on Saturday, October 15.

The posters should…

– Not exceed 36 inches by 48 inches.

– Include a title in all capital letters that is brief and clearly states the abstract’s content.

– List the presenting author’s name first.

– List the name and just one degree (e.g., BA or MPH or M.D.) for each author.

– List names of the authors’ institution(s), city, and state.

Participants must attend the meeting in Savannah, they must set up their posters, and they must be a MAG student member.

Contact Dayna Jackson at djackson@mag.org to register for the abstract competition or with questions.

Click for MAG student membership application

‘Top Docs’ shows on compliance issues & Medicare pay now online

Dr. Adrienne Mims with ‘Top Doc Radio’ host C.W. Hall

Recordings of the two Medical Association of Georgia (MAG) ‘Top Docs Radio’ shows that aired in July are now available online.

On July 12, Liz Schoen, J.D. – a legal and business advisor with E.S. Schoen & Affiliates – discussed what physicians and their staff need to know about complying with state and federal laws.

Schoen said that, “Understanding the complex array or federal and state laws and regulations is a daunting task for today’s medical practice, regardless of size. The same holds true when it comes to distinguishing between the marketing ‘hype’ from outside consultants and reality when determining how to allocate resources in a way that doesn’t undermine patient care.”

She added that, “Physicians and practice staff really need to take the time to understand how these compliance issues present risk to their practice.”

And Schoen stressed that, “It is essential for medical practices to take advantage of the best practices that are available to them to formulate a game plan for addressing any gaps.”

Then on July 26, Adrienne Mims, M.D., MPH – the vice president and chief medical officer for Medicare Quality Improvement for Alliant Quality – discussed Medicare’s new Merit-based Incentive Payment System (MIPS).

Dr. Mims pointed out that, “Beginning in 2019, the government will employ a mandatory single payment platform – but the Centers for Medicare and Medicaid Services will use 2017 as the basis for the initial reimbursement.”

MIPS is the result of the Medicare Access and CHIP Reauthorization Act (MACRA) that was signed into law in 2015, and Dr. Mims explains that “it is replacing the Sustainable Growth Rate formula as the basis for Medicare pay.”

She emphasized that, “This does not mark the end of the Medicare fee-for-service system for small practices.”

Dr. Mims discussed how the new 100-point MIPS Composite Performance Score (CPS) will work, noting “there is going to be a direct relationship between a practice’s CPS score and its Medicare pay.”

When it comes to key steps to take in the short term to succeed under MIPS, Dr. Mims suggests that medical practices 1) review their Medicare Quality and Resource Use Reports (QRUR) as soon as possible and 2) use the Medicare PQRS system to begin to report their quality measures and 3) use an electronic health records (EHR) system.

She also emphasized that physicians and practice staff can contact Alliant Quality with questions related to MIPS (e.g. QRUR, PQRS).

Contact Dr. Mims at Adrienne.Mims@gmcf.org.

MAG sponsors the ‘Top Docs’ program at 12 p.m. on the second and fourth Tuesday of every month.

Listeners can go to https://twitter.com/TopDocsOnBRX to submit questions to ‘Top Docs’ host C.W. Hall during the program. Between downloads and live listeners, MAG’s ‘Top Docs’ show has reached more than 6,000 listeners – which includes people in all 50 states and 84 countries.

Click for ‘Top Docs’ show on compliance issues

Click for ‘Top Docs’ show on Medicare/MIPS

Click for E.S. Schoen & Affiliates website

Click for CMS MACRA/MIPS website

Click for Medicare QPP website

Click for Alliant Quality website

MAG seeks volunteers for CME committee

The Medical Association of Georgia (MAG) is recruiting MAG members to volunteer to serve on its Committee on Continuing Medical Education (CME).

The MAG Committee on CME is a “[special committee that is] charged with the responsibility of accrediting organizations that desire to provide accredited CME activities to Georgia physicians. [It] reviews and approves applications for accreditation and reaccreditation, establishes accreditation policies, provides supervision and guidance to surveyors and holds periodic training sessions for staff of accredited organizations. [It] keeps all accredited organizations updated concerning MAG, Accreditation Council for Continuing Medical Education (ACCME) and American Medical Association (AMA) requirements and policies related to CME.”

The committee’s chair, Darrell Dean, D.O., says that, “This is an easy and rewarding way to make a contribution to the medical profession in Georgia. The primary role of this group is to ensure that the CME providers that MAG accredits offer interesting and relevant CME programs.”

He stresses that, “Of course, this is ultimately a great way to enhance patient care.”

Dr. Dean says that the time commitment is nominal – as the committee generally only meets by conference call four times a year.

MAG accredits 39 organizations that are authorized to offer physicians AMA PRA Category 1 Credit(s)™ that meet Georgia and Tennessee license renewal requirements. This includes hospitals, voluntary health organizations, and specialty societies.

Go to http://www.mag.org/affiliates/accreditation or contact Andrew Baumann at abaumann@mag.org for additional information.

MAG encouraging Georgians to remain current on vaccines

Keeping in mind that August is National Immunization Awareness Month (NIAM), the Medical Association of Georgia (MAG) is encouraging Georgians of all ages to make sure that they remain up-to-date on their vaccines.

“Getting vaccinated can prevent serious and sometimes deadly diseases,” says MAG President John S. Harvey, M.D., “And with school starting, parents should confirm that their children have been vaccinated according to the recommended immunization schedule – as diseases can spread quickly among children who aren’t vaccinated.”

Dr. Harvey is also quick to point out that, “Those same parents also need to make sure that they are up-to-date with their recommended vaccinations.” He suggests that patients discuss their vaccine schedule with their primary care physician.

And Dr. Harvey is calling for his fellow physicians to register for the Georgia Immunization Registry (GRITS), which is “designed to collect and maintain accurate, complete and current vaccination records to promote effective and cost-efficient disease prevention and control.”

Finally, he is applauding the MAG Foundation for supporting a new ‘Move the Needle – Raise Adult Immunization Rates’ campaign that will feature a website that contains a wide array of physician resources that will be activated on the Medical Association of Atlanta’s (MAA) website at www.maa-assn.org in the next several days.

“This will be a multi-media initiative that will focus on increasing influenza, Tdap and HPV vaccination rates,” says Sandra Fryhofer, M.D., who is a MAG and MAA member – as well as a member of the current class of the MAG Foundation’s Georgia Physicians Leadership Academy. “It will include educational and motivational videos, social media resources, and a tool box of reasons to help physicians purchase vaccines and streamline the administrative process.”

NIAM notes: NIAM is asking physicians and other health care professionals to “show [their] support for NIAM by including the hashtags #NIAM16 and #VaxWithMe me in [their] social media messages.” The NIAM resources are also available in Spanish.

Click for Georgia Immunization Registry (GRITS)

Click for Georgia DPH “Immunization Section’ web page

Click for NIAM resources/website

Click for MAG Foundation ‘Move the Needle – Raise Adult Immunization Rates’ website

Click for CDC Cardiovascular Disease/Adult Vaccination web page

Click for CDC Diabetes/Adult Vaccination web page

Click for CDC Lung Disease/Adult Vaccination web page

MAG offers “Medical Cannabinoid Oil Registry” fact sheet

The Medical Association of Georgia (MAG) is reminding its members that it offers a one-page fact sheet that explains how applicable patients can register to possess medical cannabinoid oil in the state.

Georgians who have one or more of eight covered conditions can obtain a written verification from a physician to possess up to 20 fluid ounces of low-level THC cannabinoid oil – including up to five percent for adults and up to three percent for children.

MAG Legislative Associate Kimberly Ramseur explains that, “Patients who wish to obtain the oil must consult with their physician who must agree to submit the required forms verifying that the patient is suffering from one of the covered conditions.”

She says the covered conditions include cancer (end-stage or when the treatment produces a related wasting illness and/or recalcitrant nausea and vomiting); seizure disorders that are related to epilepsy or trauma-related head injuries; ALS; multiple sclerosis; Parkinson’s disease; sickle cell disease (severe or end-stage); and Crohn’s or mitochondrial disease.

Ramseur also stresses that, “The decision to allow patients to obtain cannabinoid oil is solely at the discretion of the physician.”

Finally, she notes that the process includes three primary steps, including having the patient sign a waiver, having the physician register for and log into the Georgia Department of Public Health’s ‘Low THC Registry,’ and having the physician submit quarterly reports to the Georgia Composite Medical Board.

MAG members can contact Ramseur at 678.303.9273 or kramseur@mag.org with questions.

Click for MAG fact sheet

Click for Georgia DPH “Low THC Oil Registry” website

Click for patient waiver

Compass PTN hosting free practice transformation event

The Compass Practice Transformation Network (PTN) is encouraging physicians and applicable practice staff to make plans to attend a free ‘Partner Learning Community Conference’ that it will host at the Macon Marriott City Center from 8:30 a.m. to 2:30 p.m. on Saturday, August 20.

The Compass PTN says that participants will be able to “learn from national experts and hear success stories from local physicians and clinicians on how to survive the value-based environment. There are four PTNs that support physicians in Georgia, including the Compass PTN – which has been endorsed by the Medical Association of Georgia (MAG) given MAG’s ‘multi-year collaboration with GHA on matters related to quality, safety and community health.’”

The PTNs are designed to help their practices make a successful transition to Medicare’s new “quality-based” payment system. The Compass PTN will serve more than 7,000 primary and specialty care clinicians in six states.

Monitor www.mag.org for registration and other details. Contact Joyce Reid at jreid@gha.org with questions.

Click for conference flyer

Click for details on Compass PTN

MAG to host free ‘Revenue Cycle Management’ webinar on 8/16

The Medical Association of Georgia (MAG) will host a free ‘Best Practices in Revenue Cycle Management’ webinar for its members and their practice staff from 12 p.m. to 1 p.m. on Tuesday, August 16.

The event will feature Elizabeth Woodcock, who is a leading third party payer and practice management expert.

“When you consider that 2017 will bring a host of significant challenges in the revenue cycle management arena, we that believe this program is really timely,” says MAG Director of Third Party Payer and Health Policy Susan Moore. “It will provide a roadmap for addressing pre-visit, time-of-service, and post-visit collection processes – as well as denial prevention and management strategies.”

Moore also promises that webinar participants will be “armed with an action plan that they can implement at their practice immediately.”

MAG members are encouraged to forward this email to applicable practice staff.

Registrants will receive a confirmation email that contains information about how to join the webinar on August 16.

Contact Moore at smoore@mag.org with questions.

Click to register for webinar

Click for webinar system requirements

MAG hires communications manager/webmaster

 

The Medical Association of Georgia (MAG) hired Mandi Milligan to become its communications manager and webmaster on July 18.

“We are genuinely excited to have Mandi join the MAG family,” says MAG Director of Communications Tom Kornegay. “She emerged as a great candidate very early in the process given her outgoing personality and exemplary background, especially when it comes to managing websites and social media campaigns.”

Milligan explains that, “I have always had a strong interest in health care, so MAG’s mission – and the chance to help physicians and their patients – is fully aligned with my professional goals.”

She adds that, “I am grateful and honored and excited about this opportunity.”

Kornegay says that, “I am confident that Mandi will hit the ground running and create great value for MAG and its members.”

Milligan has held a number of communications roles with CBS46 News in Atlanta since 2008 – and she won multiple awards for the websites she managed while she was with the station.

Milligan has a degree in communications from the University of North Alabama.

MAG members can contact Milligan at mmilligan@mag.org or 678.303.9258.

Milligan will be replacing Samantha Grantham, who will be moving to Germany in September.

FDA process key part of bringing medical devices to life

By Lance M. Black, M.D., medical affairs manager, Global Center for Medical Innovation

“Regulations grow at the same rate as weeds.”

– Norman R. Augustine

The most common question I hear from physicians who are trying to bring an idea for a medical solution or innovation to life is, “Where do I start?”

“What classification is my device?” should be among the first questions they ask.

As physicians, we are trained to be conservative. We operate in a manner that is consistent with clinical guidelines, specialty boards, and expert opinion.

The Food and Drug Administration (FDA) is the governing body that prescribes guidelines and outlines best practices for medical device development in the U.S. It is, therefore, critical for innovators to understand FDA’s “rules of the game” before they spend a considerable amount of time or money developing their idea.

Remember, too, that the FDA is responsible for public health. One of the ways the agency accomplishes this is to scrutinize prospective devices and drugs using a tiered classification system. And when it comes to the development process, the difference between a Class I medical device and a Class III medical device can equate to years and millions of dollars. So it is essential to understand this classification system early in the development process.

The following descriptions address medical devices in particular, but it is also worth noting that the process for pharmaceutical drugs is comparable.

Class I – Low Risk Devices that are subjected to the lowest level of regulatory controls. This classification covers a little less than half of the medical devices that are regulated by FDA. Class I devices are subjected to what is known as “General Controls.” Examples: mechanical wheelchairs, toothbrushes, bandages.

Class II – Moderate Risk Devices also account for a little less than half of all medical devices. Class II devices are subject to “General and Special Controls.” Examples: blood pressure cuffs, ureteral stents, contact lenses.

Class III – High Risk Devices account for less than 10 percent of medical devices, which can be “implanted, sustain life, or have considerable risk of harm.” These are subject to “General Controls and Premarket Approval (PMA).” Examples: heart valves, lap bands, silicone gel-filled breast implants.

It is also worth pointing out that an FDA device classification also depends on both its intended and indications for use. So, for example, a scalpel can be classified in several ways dependent on how it is sold to be used.

Once a classification has been selected – which is generally done by the innovator and confirmed by FDA – the designer can choose the correct “FDA Premarket Submission” pathway.

Finally, I would encourage physicians who have an interest in bringing a medical device to market to 1) talk to a regulatory professional consultant and 2) contact the FDA early in the process.

Go to www.fda.gov for additional information on the terms that are described in this article – as well as next steps in the medical device development process.

This is part of an ongoing series of exclusive articles that Dr. Black is writing for MAG’s ‘e-News from MAG’ newsletter that address the factors physicians should take into account when they have a concept that they would like to develop for a marketplace application. Dr. Black is a MAG member. Contact him at 850.218.5259 or lblack@devices.net

Click for MAG’s ‘Georgia Health Care Innovation Portal’

GDC flags article that says Rx drug costs will climb by 13% in 2016

The Georgia Drug Card is flagging a recent Pharmacy Times article that said that prescription drug costs in the U.S. are projected to increase between 11 percent and 13 percent in 2016, according to a study that was conducted by a research team at the University of Illinois at Chicago’s College of Pharmacy.

In particular, the article says, “[the researchers] projected that drug spending will increase by 15 percent to 17 percent in clinics, and 10 percent to 12 percent in hospital settings.”

The Georgia Drug Card is reminding Medical Association of Georgia members that their patients who have high-deductible plans, who do not have prescription coverage or who take prescription drugs that aren’t covered by their health insurance plan can use the Georgia Drug Card – which is free – to obtain savings of up to 75 percent off the retail price for brand and generic FDA-approved medications.

Georgians can 1) print the Georgia Drug Card at www.GeorgiaDrugCard.com or 2) they can request the Georgia Drug Card savings at any CVS/pharmacy in the state or 3) they can request a hard card by sending an email to John Cenerazzo at johnc@georgiadrugcard.com.

Click for ‘Pharmacy Times’ article

 

New Members

MAG welcomed the following new members during July…

Lisa Denardi, M.D., Buffalo, NY
Kimberly Ann Funches-Jackson, M.D.,
Ranjana Satyamurthy Bhargava, M.D., Athens, GA
Ellica M. Chu, M.D.
Jason M. Langer, D.O., Athens, GA

NEWS BRIEFS

AMA issues QMB balance billing reminder

The American Medical Association (AMA) is reminding physicians that “balance billing is prohibited for Medicare beneficiaries enrolled in the Qualified Medicare Beneficiary (QMB) program” – adding that the Centers for Medicare & Medicaid Services (CMS) has “conveyed [its] concern that some physicians are still billing QMB beneficiaries, despite the existing prohibition.”

AMA explains that, “The QMB program is a Medicaid program that helps very low-income dual eligible beneficiaries…(who have) annual incomes of less than $12,000.”

It says that, “Federal law protects QMBs from any cost-sharing liability and prohibits all original Medicare and Medicare Advantage providers — even those who do not accept Medicaid — from billing QMB individuals for Medicare deductibles, coinsurance, or copayments. All Medicare and Medicaid payments that physicians receive for furnishing services to a QMB individual are considered payment in full.”

And AMA stresses that, “It is important to note that these billing restrictions apply regardless of whether the state Medicaid agency is liable to pay the full Medicare cost-sharing amounts (federal law allows state Medicaid programs to reduce or negate Medicare cost-sharing reimbursements for QMBs in certain circumstances). Physicians may be subject to sanctions for failing to follow these billing requirements, and CMS has indicated that they may start conducting more frequent audits to address this practice.”

Click for additional details

DPH to host health systems symposium

The Georgia Department of Public Health (DPH) is encouraging health care providers to make plans to attend a ‘Health Systems Symposium’ that it will host at the Atlanta Evergreen Marriott Conference Resort in Stone Mountain on August 18-19.

DPH says it will distribute registration and additional details in the near future.

Send an email to chronicdisease@dph.ga.gov with questions.

Click for save-the-date flyer

DPH promoting ‘Immunize Georgia’ conference

The Georgia Department of Public Health (DPH) is encouraging health care providers in the state to register for the ‘23rd Annual Immunize Georgia Conference,’ which will take place at the Wyndham Peachtree Hotel and Conference Center in Peachtree City on Friday, September 9.

DPH says the event will address “the latest recommendations and best practices in immunization services.”

Click to register

DCH Medicaid provider updates

According to the Georgia Department of Community Health’s (DCH) July newsletter, DCH “will exercise the second of two six-month contract extensions for Medicaid Care Management Organization (CMO) services with WellCare of Georgia, Amerigroup Community Care, and the Peach State Health Plan for the period January 1, 2017 through June 30, 2017.”

It says that, “The first contract extensions with the CMOs cover the period July 1, 2016 through December 31, 2016. DCH chose this course of action in an effort to ensure a seamless transition and implementation of new CMO contracts with no disruption of services to current members.”

Contact Dana Harris at dana.harris@doas.ga.gov with questions.

DCH also notes that it has updated the pending PCP rate increases for 32 procedure codes that were approved by the Georgia General Assembly in 2016.

It does, however, stress that, “This rate increase must be reviewed and approved by the Centers for Medicare and Medicaid (CMS) before the Georgia Medicaid Management Information System (GAMMIS) is configured for payments.”

Click for details on pending PCP rate increase

Click for PCP Enhanced Fee Schedule (effective July 1, 2016)

Finally, DCH says that it has assumed administrative oversight of the Community Care Services Program (CCSP) from the Georgia Department of Human Services.

CCSP is a “Medicaid waiver program that provides a range of community-based services to assist individuals who are older and/or have disabilities to achieve safe, self-reliant lives.”

Click for Medicaid Provider CCSP FAQ

MAG Foundation: Naloxone credited with saving Gordon County man

The Medical Association of Georgia Foundation reports that a Gordon County Deputy recently used naloxone to save an overdose victim’s life.

In a July 21 press release, the MAG Foundation said that, “The Gordon County patrol deputy responded to a call at the Gordon County Jail. A male victim, who was brought to the jail by another agency, was having a medical issue. The deputy recognized the victim’s symptoms were consistent with a heroin overdose. He applied the naloxone spray (which counteracts the effects of an opiates overdose) and the victim survived.”

The MAG Foundation also noted that, “Gordon County Sheriff’s deputies received training in the application of naloxone through [its] Project DAN (Deaths Avoided by Naloxone).”

Georgia’s ‘Medical Amnesty Law’ allows physicians to prescribe naloxone to first responders and others who are “in a position to assist a person who is at risk of an opioid overdose.”

“We are seeing life-saving results from the first responder training,” MAG Foundation President Jack M. Chapman Jr., M.D., said. “In communities all over the state, first responders have put their training to use in the field and saved the lives of overdose victims by administering naloxone.”

Click for press release

DCH releases PCP attestation rate increase summary

The Georgia Department of Community Health (DCH) has released a ‘State Fiscal Year 2017 H.B. 751 – PCP Attestation Rate Increase (Fee-For-Service [FFS] and CMO Providers)’ summary.

DCH says the information is also available in the ‘Provider Information/Provider Messages’ section on the GAMMIS website at http://www.mmis.georgia.gov.

Click for ‘PCP Attestation Rate Increase (FFS/CMO Providers)’ summary