Article Date: 1/1/2012

CMS Issues Proposed Rule for Sunshine Act Implementation

CMS Issues Proposed Rule for Sunshine Act Implementation


■ On December 14, the Centers for Medicare & Medicaid Services (CMS) issued its proposed rule for implementing the Physicians Payments Sunshine Act, which was signed into law March 2010 as part of the Patient Protection and Affordable Care Act.

The Physicians Payments Sunshine Act, created by Senators Herb Kohl (D-Wisc.) and Chuck Grassley (R-Iowa), goes a significant step further than the voluntary codes of ethics of the Advanced Medical Technology Association (AdvaMed) and the Pharmaceutical Research and Manufacturers of America (PhRMA) (see, by requiring the public disclosure of the financial relationships among physicians and the pharmaceutical, medical device and biologics industries.

Specifically, the law states that manufacturers and group purchasing organizations (GPO) (explained below) incur a civil monetary penalty (CMP) ranging from $1,000 to $10,000 for each payment that goes unreported, with a maximum of $150,000. Should the manufacturer or GPO knowingly fail to report payments, it will be subject to a CMP of at least $10,000, but no more than $100,000 for each payment. The maximum CMP with respect to each annual submission for knowingly failing to report: $1 million. In addition, the law required the Department of Health & Human Services (HHS) to establish reporting procedures for manufacturers to send this information along with procedures for making the submitted information publicly accessible by October 1, 2011. Translation: The CMS is two months late.

“The Sunshine Act guidance is a welcome, if late, step toward ensuring that the financial links between physicians and the drug, biologics and medical device industries are transparent,” Senator Kohl said in a press release issued on his website. “As we move forward, it's vital that stakeholders have a voice in this process to ensure transparency and accountability in our healthcare system.”

The CMS proposed rule would require manufacturers of Medicare-covered, Medicaid-covered or Children's Health Insurance Program (CHIP)-covered drugs, devices, biologicals and/or medical supplies to submit an annual report, via electronic format, to the Health & Human Services (HHS) Secretary on payments to physicians or teaching hospitals of $10.00 or more or any aggregate payments greater than $100.00.

In addition, GPOs (e.g. those that buy, arrange for or negotiate the purchase of a covered drug, device, biological or medical supply operating in the United States or in a U.S. territory, commonwealth or possession) and the aforementioned manufacturers would be required to report physician ownership or investment interests, including those held by immediate family members, on a yearly basis.

Finally, the HHS Secretary would be required to publish manufacturers' and GPOs'-submitted payment and ownership information on a public website, which is scheduled to go public Sept. 30, 2013. (To see the proposed rule in detail, visit

“ …The AOA is looking at how the newly proposed regulations can be improved for doctors so that they enhance the delivery of high quality eye care,” says Roger Jordan, O.D., F.A.A.O., chairman of the AOA Federal Relations Committee “When the regulations are finalized, the AOA will assist our membership in understanding both the scope of the requirements and the impact they would be likely to have on our profession.”

The CMS says it hopes to finalize the rule during 2012 and, depending on the final rule's publication date, it is considering requiring the collection of data for part of 2012 to be reported to the CMS by March 31, 2013 and subsequently the 90th day of each calendar year.

In the meantime, the CMS is inviting comments for consideration on the proposed rule due by 5:00pm Eastern Standard Time on February 17, 2012. To comment, refer to file code CMS-5060-P, and submit via

All comments received prior to the close of the comment period will be available on as soon as possible after they have been received, the CMS says.

Phase-in Period for Board Certification Coming to End


■ The American Board of Optometry (ABO) has issued the timetable for the expiration of the Phase-In Rules of its Board Certification process.

Specifically, after April 2013, the following modifications will go into effect for ABO Active Candidates to receive their 150 points of post-graduate requirements needed to qualify to register for the examination.

► ACOE Accreditation Residency. A total of 150 points if completed less than three years ago, or 100 points if completed three-to-10 years ago. (No points if completed more than 10 years ago). The former requirements: A total of 150 points (regardless of date of completion).
► Fellow, American Academy of Optometry. A total of 50 points if completed within 10 years (no points if completed more than 10 years ago). The former requirements: A total of 50 points (regardless of date of completion).
► Fellow, College of Optometrists in Vision Development. No longer accepted. The former requirements: A total of 50 points (regardless of date of completion).
► Experience in Active Clinical Practice. No longer accepted. Former requirements: A total of five points per year of Active Clinical Practice.

For ABO Active Candidates to qualify under the phase-in period rules, they must apply for active candidacy by April 30, 2013, submit their postgraduate requirements for verification by the ABO by June 30, 2013 and take the ABO Board Certification Examination by January 2014, the organization says. Further, for the ABO to verify the active candidate's credentials and post-graduate requirements and enable better seat selection at a nearby testing center, the organization recommends beginning the initial application no later than 90 days prior to the starting date of the examination desired by the candidate. January 2014 is the date of the last exam using Phase-In rules. Before this date, exams are available July 15 to 31, 2012 and January and July 2013, with exact dates to be announced.

For additional information, visit, and click on the “Get Certified” tab.

Non-Compliance to Recommended CL Wear and Care: The Latest Findings


■ Although a majority of established contact lens wearers could correctly identify risk factors for lens-related complications, and most perceived themselves as compliant with the recommended lens wear and care practices, almost none were fully compliant with their lens wear and care practices, shows a study in December's Optometry and Vision Science: The Journal of the American Academy of Optometry.

Specifically, 58% of patients in a general community and 91% within a medical center could identify by name a lens-related complication. The most frequently reported complications were linked with comfort, handling and infection.

Also, a majority of wearers were able to correctly identify risk factors for lens-related complications.

In addition, 85% of wearers saw themselves as compliant with their recommended lens wear and care regimen.

Yet, in using a standard scoring model to determine actual compliance, just 2% of wearers practiced “good” compliance, while only 0.4% were in full compliance with the correct wear and care regimen, the study shows.

The purpose of the study was to compare the effects of existing patient awareness of lens-related complications and underlying risk factors on a patient's actual behavior during wear and care practices in two separate clinical study populations.

To arrive at the aforementioned findings, the researchers gave established contact lens wearers in the Dallas-Fort Worth metroplex (281) and the University of Texas Southwestern Medical Center, in Dallas, Texas (152) anonymous questionnaires regarding their lens care practices and awareness of lens-related complications and risk factors.

In related news, a Bausch & Lomb survey of 2,000 adult contact lens wearers in the United Kingdom reveals that wearers have occasionally used baby oil, beer, cola, petroleum jelly, lemonade, fruit juice and butter, among other alternatives to contact lens solutions, to clean, disinfect and store their lenses.

Specifically, 20% of respondents reported using an unconventional solution/lubricant when inserting lenses, and an enormous amount of respondents reported using saliva or tap water as a solution when inserting their lenses.

Ocular Melanoma Initiative Announced


■ The Melanoma Research Foundation (MRF) is launching Community United for Research and Education of Ocular Melanoma (CURE OM), an initiative to advance research, provide educational resources and facilitate support for those affected by ocular melanoma, the organization says.

The catalyst for this initiative was the need for (1) better research, (2) more patient support and (3) opportunity, says MRF executive director Timothy J. Turnham.

“Over the past 30 years, physicians have made significant progress in early detection and in management of local disease with ocular melanoma, but have made virtually no progress in improving life expectancy once it has metastasized. Tremendous progress has been made in understanding the biology of cancer in general and of melanoma in particular,” he explains. “This has led to the approval of two new drugs for melanoma of the skin this year after a 13-year gap with no new drugs. We need a strong, coordinated effort to ensure that those advances work to the benefit of ocular melanoma patients.”

He adds that with any orphan disease, finding a community of support is difficult and that while online communities can help with this, in-person meetings work better.

“MRF has a long history of bringing patients together, both through in-person symposia and through online efforts. As we considered this effort, no meeting for ocular melanoma patients had happened in several months, and no meeting was scheduled at any future date,” he says. “This was a need we felt we had to meet.”

Finally, Mr. Turnham says two events took place that enabled the MRF to launch the in-person meetings: the recruitment of volunteer Sara Selig, M.D., to lead the effort and a gift from an anonymous donor that provided the seed money to move forward.

The result: CURE OM will create funding for medical research to identify effective ocular melanoma treatments and has developed a scientific steering committee to identify research priorities and award grants to support steps in discovering new treatments. Also, research meetings will be held twice a year.

In terms of education and support, the MRF's patient helpline staff has received additional training to help those who have OM.

In addition, starting in 2012, CURE OM will hold patient meetings, at which patients can connect with and hear from OM researchers. (The 1st Annual Eyes on a Cure: Patient & Caregiver Symposium will be held June 16 to 17 in Philadelphia, Pa.)

Finally, includes a definition of OM, how it's diagnosed and treated and a list of patient resources.

West Named Vision Source Vice President
■ Walt West, O.D., F.A.A.O., the chief optometric editor of Optometric Management, has been named vice president of Practice Development for Vision Source, a network that includes more than 2,300 independently owned optometric practices in the United States and Canada.
Well known in his roles as a consultant, lecturer, author and editor, Dr. West will spearhead practice management education for Vision Source member doctors and staff. His responsibilities will include content development and management of the Vision Source Experience program, as well as providing content for the network's online educational programs.
Dr. West founded Primary Eyecare Group in Brentwood, Tenn. in 1975. He sold his practice in 2003 and founded Walt West Management and Consulting to focus on education and consulting. He recently served as program director for The Vision Care Institute, a Johnson & Johnson company.
A graduate of the Southern College of Optometry, he's authored the books When Your Success Is On The Line (Westview 2009) and Pulse Points of the Million Dollar Practice.

FDA News
■ The C-flex Aspheric 970C IOL, from Rayner Intraocular Lenses Limited, has received FDA approval for sale in the United States. The lens features Anti-Vaulting Haptic technology, Rayacryl hydrophilic acrylic material and the Amon-Apple enhanced square edge for decreased posterior capsule opacity rates, the company says.
■ The TearLab Osmolarity System, from TearLab Corporation, has received Clinical Laboratory Improvement Amendments (CLIA) Waiver Categorization from the FDA, making it accessible at the point-of-care.

eye site - Odyssey Medical Revamps Website
Odyssey Medical, the maker of punctal plugs, dry eye diagnostics and ophthalmic instruments, such as jeweler's forceps, has revamped their website The new site includes videos, patient education materials and a place to submit new product ideas.

Optometric Management, Volume: 47 , Issue: January 2012, page(s): 12 - 16