LEGISLATIVE NEWS-ON THE HILL
FDA NEWS
MEDICARE NEWS
ERx NEWS
HIPAA ICD 10/5010 NEWS
GOVERNMENT RELATIONS ANNOUNCEMENT
EYEPAC
Senate Health, Education, Labor, and Pensions (HELP) Committee Ready to Mark-up Food and Drug Administration (FDA) User-Fee Legislation
During a recent hearing on the user fee issue, Senate HELP Committee Chairman Tom Harkin (D-IA) and Ranking Member Michael Enzi (R-WY) indicated that it is their desire to move user-fee legislation quickly. The plans are to mark-up a single authorization bill for four programs that would allow the FDA to collect user fees, which will be used to help fund reviews of drugs and medical devices. Typically, the user-fee program reauthorization attracts numerous health-related amendments, but both Senators warned other committee members not to slow down the process by attaching controversial provisions. They stressed that they would accept a small number of bipartisan policy riders to the legislation.
Members of Congress in both the House and the Senate are pushing to pass the legislation before the current authorizations for the prescription drug and medical device fee programs expire September 30. The legislation is also expected to create a new user-fee program for generic drugs and one for generic biologic drugs. As we have reported, the House is also working on user-fee reauthorization legislation but has not decided whether they will move the proposals separately or create a single bill.
We will keep you updated.
Updated LASIK Advertising Guidelines Posted by Food and Drug Administration (FDA)
On Monday, the FDA circulated another letter to ASCRS and the American Academy of Ophthalmology (AAO) providing additional information about disclosing risk information in eye-care professionals' advertisements and promotional materials concerning FDA-approved lasers intended for LASIK. Due to various requests that they received from individual practices, etc., the FDA posted on their website the risk information that they believe should be included in all LASIK marketing and advertisements.
Specifically, the risk information that is on all FDA-approved labeling for all lasers, which includes the "risks of dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision," should be included.
The letter is a follow up to two previous FDA letters dated September 2011 and May 2009. The letters are in response to information received at an April 2008 Ophthalmic Devices Panel public meeting that "eye-care professionals” advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures."
The FDA noted that any corrections should be made within 90 days to avoid regulatory action.
Questions can be directed to Jenny Liljeberg, associate director of regulatory affairs, at jliljeberg@ascrs.org.
ASCRS, in Conjunction with Alliance of Specialty Medicine, Submits Comment Letter on FDA Guidance on Unsolicited Requests for Off-Label Information
On Thursday, March 29, in conjunction with the Alliance of Specialty Medicine, ASCRS submitted a comment letter to the FDA in response to the draft guidance released by the Agency in December, 2011, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. While FDA recognizes that health-care professionals can lawfully use FDA products for off-label uses or treatment regimens, in the draft guidance the FDA states that physicians speaking in a Speaker’s Bureau, firm-sponsored webinar, engagements (or other firm sponsored event) are prohibited to respond to any off-label question from audience participants. The speaker would have to cease all discussions (“thank you for the off-label question…”) and refer that person to the firm’s Medical or Scientific Department for a written response.
ASCRS and the Alliance’s comments focus on protecting the value of physician’s ongoing education; specifically, raising concerns with the proposed policy for handling public unsolicited requests that overly restricts the ability of any physician to openly discuss and respond to questions about off-label uses of drugs and devices in an educational public forum with their colleagues, as is the current custom. The letter requests that the draft guidance be amended to remove the new restrictions and continue to allow physicians to respond to their colleagues at industry-sponsored events regarding off-label information.
FDA Releases Final Guidance on Benefit Risk Determinations in Medical Device Premarket Approval
On March 27, the FDA published a first-of-a-kind guidance for medical device manufacturers, Factors to Consider When Making Benefit-Risk Determination in Medical Device Premarket Approval and De Novo Classifications, describing how the benefits and risks of certain medical devices are considered during pre-market review. Unlike the draft guidance, which stated that, at least in “limited cases,” the benefit-risk determinations would be applicable to 510(k) notifications as well as premarket approval applications (PMAs), the final guidance applies only to PMAs and de novo petitions.
The guidance states that “a ‘probable risk’ and ‘probable benefit’ do not include theoretical risks and benefits, and instead are ones whose existence and characteristics are supported by valid scientific evidence.” The statement seems designed to respond to assertions by sponsors that reviewers sometimes cite hypothetical risks unsupported by data as the basis for not approving or clearing a device. Also of note is the discussion of patient tolerance for risk and perspective on benefit, where the FDA is recognizing that patients and practitioners should ultimately be responsible for determining whether a certain risk is acceptable for that particular patient in light of the potential benefits.
Government Accounting Office (GAO): Medical Device Reviews Taking Longer Despite FDA Meeting Goals
On March 29, the US GAO released a report, Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer, indicating, as the title states, the FDA is meeting its performance goals for medical device reviews but that overall medical device review time was increasing. The report was compiled in response to a request by Senators Richard Burr (R-NC) and Tom Coburn (R-OK) to examine FDA’s medical device review process, in preparation for the reauthorization of the medical device user-fee program.
Under “FDA time”, the total time it takes to review a medical device under the 510(k) clearance process, the Agency stops the review clock every time it requests that a sponsor submit additional information necessary to complete the application. This time lost does not count toward FDA’s Medical Device User Fee Act III (MDUFA) performance goals, but does serve to increase the amount of time spent per application. “Although FDA review time decreased slightly from FY 2003 through FY 2010, the time that elapsed before FDA’s final decision increased substantially,” wrote GAO in its report.
The FDA failed to review premarket application (PMA) submissions to agreed-upon performance goals in three of the seven years since 2005 and only twice in seven years for expedited PMAs. The GAO report stated the “average time to final decision for original PMAs increased from 462 days for FY 2003 to 627 days for FY 2008 (the most recent year for which complete data are available).”
Centers for Medicare and Medicaid Services (CMS) Publishes Ambulatory Surgical Center (ASC) Quality Reporting Codes
On March 16, CMS announced the CPT Category II or HCPCS Level II G codes to be used in the new ambulatory surgical center (ASC) quality reporting program. As of October 1, 2012, ASCs will be required to report data on five quality measures for Medicare Part B fee-for-service beneficiaries:
ASCs may begin to report these quality measures on submitted ASC facility claims beginning with dates of service of April 1, 2012. This is to give centers an opportunity to test out the codes and get used to reporting them before the program officially begins. Failure to report the required information will result in a reduction to the ASCs Medicare payments in the future.
2013 will usher in the addition of two more measures:
Each center will have to report either "yes" or "no" on whether they used a safe surgery checklist in 2012. These reports will be due between July 1 and August 15 of 2013. We are awaiting further clarification on how the reports will be filed and other program features.
On or around April 4, CMS will post the ASC Quality Reporting Program specifications manual at cms.hhs.gov. There will also be a link to the manual from the ASCRS Regulatory web page. Our website will be constantly updated as information becomes available.
ASCRS and Physician Organizations Submit Comments on Burdensome Reporting Programs
ASCRS, the AMA, and multiple organizations within the medical community submitted a letter to HHS outlining concerns with the multitude of regulatory mandates and programmatic deadlines and associated penalties physicians are facing simultaneously. These programs include the value-based modifier, penalties under the electronic prescribing (e-prescribing) program, physician quality reporting system (PQRS) and electronic health record (EHR) incentive program, along with the transition to ICD-10.
The letter urges CMS to re-evaluate the penalty timelines associated with these programs and examine the administrative and financial burdens and intersection of these various federal regulatory programs. It also asks CMS to use its discretionary authority provided by Congress under these programs to develop solutions for synchronizing these programs to minimize burdens to physician practices and propose these solutions in the physician fee schedule proposed rule for calendar year 2013.
CMS to Re-evaluate 2012 Exemption Requests from 2012 E-Prescribing Penalty
CMS has confirmed that the Quality Net Help Desk is now prepared to take calls from physicians on the Medicare e-prescribing penalty. We understand that in the past few weeks physicians have attempted to contact the Help Desk to discuss their individual situation which resulted in a 2012 penalty, but in many cases were turned away. CMS has been working diligently with the Help Desk to ensure that a physician's case is adequately reviewed. CMS wants physicians to know that the issues they are having are being examined.
Eligible professionals should contact CMS’ Quality Net Help Desk immediately if they have not received a formal notice from CMS regarding the final status of their exemption request or if they believe they are receiving the 2012 e-prescribing penalty in error.
The Quality Net Help Desk can be reached via telephone at 1-866-288-8912 or via email at Qnetsupport@sdps.org.
2011 E-Prescribing Program Status Reports Released by CMS
Physicians who participated in the 2011 Medicare e-prescribing incentive program can now access feedback reports from CMS to determine whether they met the requirements to receive the incentive payment that will be paid later this year.
Physicians who e-prescribed 25 times and reported the e-prescribing G-code (G8553) on their Medicare claims in 2011 are eligible to receive a 1 percent bonus payment and are automatically exempt from the 2013 e-prescribing penalty imposed on providers who do not meet program requirements. Ophthalmologists who did not meet the e-prescribing requirements for 2011 may be eligible for exemption from the penalty. Qualifications for exemption include writing fewer than 100 prescriptions in the first six months of 2012.
Eligible professionals can request an exemption through the CMS Communications Support Page any time before June 30.
Additional details are available on the ASCRS eRx webpage.
REMINDER – 5010 Enforcement Delay - Now June 30, 2012
Last week, CMS announced an additional three-month delay to the enforcement deadline for Version 5010 compliance. The CMS' Office of E-Health Standards and Services said no action will be taken against non-compliant medical practices, hospitals, and other healthcare entities through June 30. The deadline for the switch to the 5010 standards was January 1. The enforcement action deadline was originally March 31.
The delay comes after medical specialty groups including ASCRS and the AMA expressed concerns regarding the timeline and requested more time and more help from health plans and clearinghouses in identifying errors in Version 5010 claims.
ICD-10 Implementation Deadline Still To Be Determined
As we reported previously, on February 16, Health and Human Services (HHS) announced it would initiate a process to postpone the date by which certain health-care entities have to comply with ICD-10. Additional details of the delay have not been publicized, but industry experts are speculating that a one-two year delay is in the works.
We will keep you updated.
Mark Your Calendars: Sunday, April 22 from 11:00 AM to 12 PM, Government Relations General Session: Update from Washington: Fighting to Maintain American Leadership in Medical Innovation -Congressman Erik Paulsen (R-MN) Co-Chair, Congressional Medical Technology Caucus
Congressman Erik Paulsen, a second-term member representing Minnesota’s Third Congressional District, which is made up of the western suburbs of Minneapolis, is the guest speaker for the ASCRS Government Relations General Session.
Paulsen is a member of the House Committee on Ways and Means, which has jurisdiction over health care, economic and trade policy and is the chief tax writing committee in the House. He is co-chair of the House Medical Technology Caucus and is a leader in advocating for the medical technology industry, and the life-saving technologies it provides to patients, as well as the hundreds of thousands of jobs it supports.
eyePAC Adds New Contribution Levels for 2012
As of January 2012, eyePAC is offering 2 new contribution levels for ASCRS eyePAC contributors, in addition to, the established 5 contribution levels. Registration is now open for the eyePAC event at the Art Institute of Chicago on April 20, 2012 from 6:00 to 8:00 PM. An overview of all contribution levels and their benefits is listed below.
Presidential Club−A $5000 contribution; includes a plaque and special recognition at the annual eyePAC reception, admission for 10 for the annual eyePAC event, as well as admission to special, invitation-only, VIP events, and the eyePAC contributor newsletter.
Senatorial Club−A $2500 contribution; includes a membership pin, admission for 7 for the annual eyePAC event, as well as admission to special, invitation-only, VIP events, and the eyePAC contributor newsletter.
Congressional Gold Circle Club—A $1000 contribution; includes a membership pin, admission for 5 to the annual eyePAC event, as well as admission to special, invitation-only, VIP events, and the eyePAC contributor newsletter.
Congressional Insider Club—A $500 contribution; includes a membership pin, the newsletter, and admission for 3 to the annual eyePAC event.
Congressional Silver Club—A $300 contribution; includes a membership pin, the newsletter, and admission for 1 to our annual eyePAC Event.
Congressional Bronze Club—A contribution of $100; includes a membership pin.
Young Physicians Club—A contribution of $50.
For additional information, please contact ASCRS PAC/Grassroots Specialist Gerrie Gray-Benedi by email at gbenedi@ascrs.org or by phone at 703-591-2220.
Register for the Annual eyePAC Event Scheduled for Friday, April 20, 2012, from 6:00 to 8:00 PM at the Art Institute of Chicago
Registration is now open for the exclusive annual eyePAC event being held at the Art Institute of Chicago, Friday, April 20, 2012. Those eyePAC contributors who make a 2012 contribution of $300 or more will be invited to spend the evening with their guests and colleagues, which includes a private viewing of the gallery. If you are a young physician and have been in practice 3 years or less, please register HERE.
To find out more about the articles in this communication or to read more about legislative and regulatory issues that affect you and your practice, visit the ASCRS and ASOA websites. You can also visit http://www.specialtydocs.org/, the web site of the Alliance of Specialty Medicine.
© 2012 ASCRS/ASOA