The Sunshine Act – What Optometrists Need to Know

Dr. Elizabeth MuckleyBy Elizabeth Muckley, OD – Overview: The Sunshine Act, also referred to as the “Open Payments” Initiative, requires certain manufacturers that produce drugs, medical supplies and devices to publicly report payments or “other transfers of value” they made to physicians (including optometrists) and teaching hospitals.  Certain Group Purchasing Organizations (GPOs) will also be required to report annually to CMS ownerships or investments held by physicians or their immediate family, in addition to, payments and other transfers of value from the GPO to a physician that holds an ownership or investment interest in the GPO.

Impact on ODs: The Sunshine Act will affect optometrists because manufacturers will be required to track and report payments and transfers of value made to optometrists.  Manufacturer reports will be submitted to the Centers for Medicare & Medicaid Services (CMS) and CMS will ultimately make these reports publically available. Patients who are treated by optometrists may review this data.  It is important to emphasize that the burden of compliance falls to manufacturers. ODs are not required to report any information to CMS. However, to ensure that manufacturer and GPO reports are accurate, ODs may want to register to access their data prior to public posting and keep a record of payments and transfers of value received from manufacturers and GPOs.

Open Payments encourages physicians and hospitals to participate by tracking their financial relationships with applicable manufacturers and applicable GPOs and by reviewing data reported about them to ensure the accuracy of the information.

Key Dates: Manufacturers and GPOs began collecting data on Aug. 1, 2013.  Manufacturers and GPOs must report data to CMS as of March 31, 2014, and public reporting is scheduled to begin September 30, 2014. ODs can register, view and dispute July 14 – August 27, 2014.

Do you want to review Open Payments data reported about you before it is available to the public? Get started now by registering in CMS’ Enterprise Portal.

For more information visit:

http://www.aoa.org/advocacy/health-care-reform/the-sunshine-act?sso=y

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html

To register visit:

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Program-Registration.html

or

http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html

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Changes in Prescribing Narcotics

By Elizabeth Muckley, OD – Dr. Elizabeth MuckleyOhio Optometrists need to be aware of new regulations in Ohio regarding prescription pain medications. Ohio professional licensing boards, including the Ohio Board of Optometry, have been active participants in the various working groups led by the Governor’s Cabinet Opiate Action Team (GCOAT) in efforts to address public safety concerns associated with inappropriate prescribing of opioids, other controlled substances, and tramadol.

There are two changes that affect Ohio ODs:

1) Tramadol

Effective August 18, 2014, tramadol and products containing tramadol will now be classified by the DEA as Schedule IV controlled substances. Previously, tramadol was not a classified narcotic. Pharmaceuticals classified in schedules 1, 2, 4 and 5 are not within Ohio optometric scope of practice. As of August 18, 2014, you will no longer be able to write a prescription for Tramadol.

2) Hydrocodone

The FDA most likely will also move hydrocodone from a Schedule III controlled substance to Schedule II controlled substance. The final recommendation when this is to occur has not yet been released. Our current law allows for only select Schedule 3 narcotics to be prescribed. Hydrocodone currently is one of the two agents ODs are authorized to prescribe in this class.

When this occurs, optometrists would be unable to prescribe hydrocodone and tramadol.  The only narcotic available for DEA certified ODs to prescribe would be Codeine (used in Tylenol 3).

The OOA has been proactive in anticipating these proposed changes and has legislation pending (unanimously voted out of House Health Committee) to accommodate the FDA’s changes to restore our prescribing authority for tramadol and hydrocodone.  This legislation should move forward in the autumn when the legislature returns. This could take up to 30 days for Governor to sign, then 90 days to become a law. When this becomes a law, you would need a DEA number if you wish to prescribe tramadol. Previously, a DEA number was not necessary since it was not classified as a narcotic.

The OOA encourages all ODs to obtain a DEA license even if you rarely prescribe narcotics. DEA numbers are nationally recognized and generally utilized by pharmacists compared to your TPA number. DEA numbers are used to track optometric prescribing habits. This helps further scope expansion initiatives as well as help ODs receive pharmaceutical samples from drug manufacturers and reps as appropriate.

Lastly, the OOA also wants to remind you about a recent rule added to our administrative code regarding the Ohio Automated Rx Reporting System (OARRS), 4725-16-04.  OARRS was created to help providers minimize the potential for prescription drug abuse and misuse and to help reduce the number of unintentional complications associated with pain medications. Any pharmacy that is licensed by the Ohio State Board of Pharmacy, even if located outside of Ohio, is required to report the dispensing of all Schedule II through Schedule V controlled substances plus tramadol products to the OARRS database at least weekly. DEA certified optometrists will be required to review the OARRS system and register for the program per the Optometry Board for the upcoming license renewal period.  You must also submit your DEA number with expiration date to the State Board.

To register for an OARRS account:

  • Visit the website at ohiopmp.gov
  • Click on “Register” and follow the prompts.
  • Complete the on-line portion and print. Sign and date in the presence of a Notary public.
  • Mail the completed application and any required documents to the OARRS office.
  • Once the completed application has been received at the OARRS office and credentials are verified, an email will be sent containing your user name. A password will be mailed to your home.

A detailed handout on OARRS can also be found at the Ohio Board of Optometry’s website: https://www.ohiopmp.gov/portal/brochure.pdf