LEGISLATIVE NEWS-ON THE HILL
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GOVERNMENT RELATIONS ANNOUNCEMENT
EYEPAC
Authors of Physician Payments Sunshine Act (“Sunshine Act”) Urge the Centers for Medicare and Medicaid Services (CMS) to Issue a Final Rule
On April 4, 2012, Senators Charles Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, and Herb Kohl (D-WI), Chairman of the Senate Special Committee on Aging, sent CMS Acting Administrator Marilyn Tavenner another letter encouraging the administration to issue a final rule by June to implement the Sunshine Act. The statutory deadline was October 1, 2011. The new law requires “accurate” public reporting of financial transactions between health care providers and the drug, device, and group purchasing industries.
Senate Health, Education, Labor, and Pensions (HELP) Committee Releases Bipartisan Drug Approval and Patient Access Plan Draft; Mark-up Scheduled for April 25, 2012
This week, Senate HELP Committee Chairman Tom Harkin (D-IA) and Ranking Member Michael Enzi (R-WY) released a bipartisan Drug Approval and Patient Access Plan draft. The proposal, which is the fifth discussion draft released by the Committee to lay the groundwork for an omnibus bill reauthorizing user fees for brand name drugs and medical devices, and authorizing new fees for generic drugs and biosimilars, instructs FDA to release social media guidance, and includes previously introduced measures codifying the accelerated approval process, creating a new breakthrough drug designation to speed up the development of promising medications, and expanding the FDA’s use of experts for advice on rare diseases.
As we have reported, the committee has already released consensus bipartisan draft bills addressing medical device reform, drug shortages, antibiotic development, and the drug supply chain. The committee has scheduled the mark-up for the legislation on April 25, 2012.
Health and Human Services (HHS) and Department of Justice Highlight Administration Efforts on Health Care Fraud as Republican Members of Congress Question Whether CMS is Doing Enough
This week at a summit on regional health care fraud prevention, HHS Secretary Kathleen Sebelius and Attorney General Erik Holder discussed how the health care reform law and the Administration’s Health Care Fraud Prevention and Enforcement Action Team (HEAT) are helping fight Medicare fraud. Also this week, four Republican members of Congress, Senators Orrin Hatch (R-UT) and Tom Coburn (R-OK) and Representatives Charles Boustany, Jr. (R-LA) and Wally Herger (R-CA), key members of healthcare related committees, requested information about whether CMS is doing enough to weed out waste, fraud and abuse from its programs.
Specifically, the members of Congress asked for details of the agency’s efforts to identify “nominee owners,” or individuals who are being named as providers or suppliers for Medicare, Medicaid or CHIP but instead are just shielding the identity of the real owner. They also requested information about what CMS is doing to combat fraud committed by individuals and groups that set up false storefronts and shell companies lacking real operations. The regional summit, which was the seventh to be held, was attended by public and private partners, and is part of the HEAT partnership between HHS and the Department of Justice to prevent and combat health care fraud.
Safety and Consumer Group Advocates Pushing for Conflict of Interest Reform
Safety and consumer group advocates are pushing for stronger conflict of interest requirements as part of the user fee reauthorization legislation that is moving in the House and the Senate. Patient groups have been advocating for loosening FDA’s conflict of interest waiver policy, indicating that it is difficult to find experts to serve on advisory committees. The Senate proposal would allow FDA to “take a deeper look at what conflicts really are,” giving the agency discretion on whether or not to disqualify someone solely on the basis of a conflict. A draft House user fee bill would repeal the conflict of interest standards passed during the last reauthorization of user fees, which allowed FDA to grant waivers for experts serving on advisory committees and set caps on how many could be used. The draft Senate bill would not repeal the entire conflict of interest section, but would keep the waivers, while eliminating the caps. The Senate bill also keeps the current law disclosure requirements and allows FDA to look at factors when there is conflict, such as the public health interest.
On a separate track, advocates are focusing on passing the Federal Advisory Committee Reform Act (FACA), which includes provisions that would permit the public to have a role in the selection and vetting process for advisory panel members. The House Oversight and Government Reform Committee recently approved the bill unanimously; however, in previous Congresses, the House passed a FACA bill, but the Senate never considered it. Consumer and safety groups indicated that they want to work with the FDA to improve its process, including increasing outreach for non-conflicted experts, conducting advisory panel meetings remotely, and increasing transparency about decisions that occur outside of advisory committee meetings.
Medicare Participation Option Policies Clarified by CMS
In response to a request from the American Medical Association (AMA) and more than 70 state and medical specialty societies regarding Medicare’s policy for covered services furnished by physicians who are not enrolled in the program, CMS confirmed that physicians can enroll in Medicare as a participating or non-participating physician, or opt out of Medicare and furnish services to beneficiaries under private contracts. CMS also stated that physicians must enroll in Medicare in order to bill for services furnished to beneficiaries, whether payment is being requested directly from Medicare or from the beneficiary who is, in turn, reimbursed by Medicare. If a physician furnishes a covered service to a beneficiary, the physician is required to complete a claim form and submit it to Medicare on their behalf. Penalties can apply to physicians who do not follow this requirement.
Electronic Health Record (EHR) Program, Data Collection Methodology, and Medicare Benefit Redesign Under Medicare Payment Advisory Committee (MedPAC) Scrutiny
On Thursday, MedPAC discussed the Medicare EHR Incentive Program, with several commissioners expressing concern about the small number of hospitals and eligible professionals—especially small independent hospitals and physician practices—who have successfully attested to "meaningful use" of EHRs to date. Commissioners also expressed interest in monitoring the program going forward to see whether EHR implementation facilitates system efficiencies and cost savings.
In other business, the Commission discussed the advantages and disadvantages of alternative approaches to collecting data to improve the accuracy of payments under the fee schedule. This is based on the October 2011 MedPAC recommendation for Congress to direct the Health and Human Services (HHS) Secretary to regularly collect data to establish more accurate work and practice expense values. The Commission is evaluating two options: Option 1 is to collect the data service by service, a bottom-up approach. Option 2 is more top down, with the physician or other health professional as the unit of analysis.
Also, the Commission unanimously voted to recommend that Congress direct HHS to develop and implement a new Medicare Fee for Service (FFS) benefit design to replace the current design. The proposal would not change the benefit aggregate cost sharing liability, and would include an additional charge on supplemental insurance.
ASCRS Joins AMA in Submitting Comment Letter on Recovery Audit Prepayment Review Demo
Earlier this week, ASCRS, in conjunction with the AMA and other medical specialty societies, submitted a comment letter regarding the Recovery Audit Prepayment Review demonstration project. The demonstration project, aimed at reducing improper payments in the Medicare program, would allow Medicare Recovery Audit Contractors (RACs) to review claims before they are paid to ensure that the provider complied with all Medicare payment rules, as well as conduct prepayment reviews on certain types of claims that historically result in high rates of improper payments.
The letter requests that CMS withdraw the RAC demonstration on the grounds that it “would threaten patient access to care and inappropriately utilize the Recovery Auditors”. CMS intends to launch the Recovery Audit Prepayment Review demonstration project on or around June 1, 2012. The three-year project was announced in November and initially was slated to begin on January 1, 2012.
CMS Clarifies Same Day Surgery Policy
On March 30, CMS issued a letter clarifying a regulatory revision that became effective on December 23, 2011. ASCs can provide required notifications to all of their patients on the day of surgery, without exception, as long as the information is provided before the surgery begins. According to the letter, an ASC:
Because CMS did not send specific instructions in December to Medicare state survey agencies regarding the change, many facilities have encountered problems with inspectors applying the prior requirement that notice be provided at least one day prior to surgery.
Institute of Medicine (IOM) Report Recommends Steps for Improvement of Developing Regulatory Systems
A new report from the IOM concludes the U.S. Food and Drug Administration (FDA) needs to make investments into advancing the regulatory capacity of developing low- and middle-income nations in order to secure the pharmaceutical supply chain and safeguard the American public. The report, “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” recommends 13 steps FDA and other regulatory bodies can take in the next five years to improve the regulatory systems of developing nations. According to the IOM, the report “urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort.”
Deadline for EHR Incentive Program Appeals Extended to April 30, 2012
Eligible professionals who participated in the CMS EHR Incentive Program in 2011, but were denied payment now have until April 30, 2012 to file an appeal. If the provider met all the requirements of the Medicare EHR Incentive Program, and did not receive the incentive payment they now have until the end of the month to contact the appeals support contractor or the Office of Clinical Standards & Quality (OCSQ) Appeals Support Center either by email at OCSQAppeals@provider-resources.com or the toll free number at 1-855-796-1515. The OCSQ Appeals Support Center is available between the hours of 9 a.m. and 5 p.m. EST Monday through Friday.
For additional information, visit the CMS EHR Incentive Program Appeals webpage.
Ophthalmology Continues to Lead in Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Reporting
On March 30, CMS released a report detailing the 2010 participation rates and incentives paid to eligible professionals (EPs) for PQRS and eRx. As compared to 2009, ophthalmologists continue to improve their rates of participation and success.
In the eRx program, ophthalmology had the second highest rate of participation at 33.8%. 63% of those who participated qualified for the 2% incentive payment (2% of CMS’s estimate of allowed charges under Medicare Part B for covered professional services furnished during the reporting period).
In PQRS, 39.9% of ophthalmologists participated via claims-based reporting in 2010. Nearly 60% of those that participated qualified for the incentive payment (2% of CMS’s estimate of allowed charges under Medicare Part B for covered professional services furnished during the reporting period).
EPs who successfully participated in both programs averaged incentive payments of nearly $6,000.
In the 2010 PQRS program, for individual measures where EPs who participated had at least a 90% performance rate, compared to 2009, ophthalmologists improved reporting performance across the board.
To ensure participation and reporting success, and to prepare for eventual payment adjustments, ASCRS continues to work with CMS and other physician organizations on improvements to the PQRS and eRx programs.
Provider Call on the Electronic Prescribing (eRx) 10-Month Feedback Report—Tuesday, April 17; 1:30—3:00 PM EDT
Join experts from CMS as they provide an overview on the Electronic Prescribing 10-Month Feedback Report. A question and answer session will follow the presentation.
Agenda:
Provider Call: Current Status of Medicare Fee For Service (FFS) Implementation of HIPAA Version 5010 and D.0—Wednesday, April 25; 2:00—3:30 PM EDT
CMS is hosting a call for providers who need to make Medicare FFS-specific changes in compliance with HIPAA Version 5010 requirements, focusing on the current status of Medicare FFS implementation of HIPAA Version 5010 and D.0 as well as possible outstanding fixes impacting the Part A and Part B Version 5010 transition.
Agenda:
Presentation (emailed to all registrants on the day of the call)
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