LEGISLATIVE NEWS-ON THE HILL
ASC NEWS
MEDICARE NEWS
FDA NEWS
ICD 10/5010 NEWS
ERX NEWS
Senate Food and Drug Administration (FDA) User Fee Bill Passes Out of Committee; Consideration of House User Fee Bill Delayed
On Wednesday, April 25, the bi-partisan Senate FDA user fee bill, the “Food & Drug Administration Safety and Innovation Act”(FDASIA), passed out of the Senate Health, Education, Labor, and Pensions (HELP) Committee by voice vote and is expected to be considered by the full Senate in May. The bill extends user fee programs for prescription drugs and medical devices, in addition to creating new programs for generic drugs and biosimilars. The committee made no major changes to the revised version of the final bill, which included provisions supported by Republican Senators Richard Burr (R-NC) and Tom Coburn (R-OK). These additional provisions addressed customized devices, 510(k) modifications, the drug approval risk-benefit framework, global clinical trials, regulatory science, information technology, reporting requirements, and the FDA’s integrated management plans. The majority of these additions were included in legislation introduced by the Senators last week.
Specifically, the provisions would direct the FDA to use a consistent approach to incorporate its risk-benefit framework into regulatory decision-making and communications, establish a strategy and implementation plan for advancing regulatory science, work with other regulators to reduce duplication of studies necessary for premarket approval, report on a comprehensive information technology strategy plan, enhance annual reporting requirements for medical products covered by the user fee agreements, and submit an integrated management strategy to Congress. Although the legislation does not include all of the medical device reforms that were included in the Burr-Coburn bill, it does propose that FDA clarify its policy on customized devices for small populations and to withdraw its recent 510 (K) modification guidance, which is likely a placeholder for additional language that will be agreed to with the stakeholders. While some potential amendments were discussed during the committee markup, the majority of them were withdrawn. However, they could be offered when the bill goes to the Senate floor. One amendment was approved, offered by Senator Orrin Hatch (R-UT), which eliminated a provision relating to drugs coming into the U.S.
In the House, however, the Energy and Commerce negotiations on the user fee legislation have faltered, which has forced the postponement of the markup from this week until Thursday, May 8. Late on Tuesday, the 24, the Energy and Commerce Health Subcommittee leadership had initially announced that the markup would occur on April 26 and released a “committee print,” which contained many provisions that have no chance for Democratic support. The delay will give the committee additional time to reach a broader bi-partisan consensus. Click on the following link for a copy of the bill summary.
Last week, ASCRS, in conjunction with AdvaMed and several other medical societies, submitted a comment letter to the FDA, expressing support for several elements within the Draft User Fee Agreement, including
We will continue to keep you updated.
Additional Ambulatory Surgical Center (ASC) Quality Reporting Information Released
The Centers for Medicare & Medicaid Services (CMS) has released proposed guidelines for Medicare’s new ASC quality reporting program. The proposal which was included in the Inpatient Prospective Payment System (IPPS) proposed rule provides the following information about the program:
Click here to view the CMS fact sheet.
ASCRS will continue to work with CMS as implementation of the new ASC quality reporting program continues.
Specialist Services Removed from CMS Provider Identifier Final Rule
Prior to issuing a final rule to fight Medicare fraud and abuse, CMS removed specialist services from the provision that requires providers who order and certify Medicare-covered services and supplies to include their identification number, called a National Provider Identifier (NPI), on reimbursement claims and applications to enroll in Medicare and Medicaid. CMS removed specialist services because Medicare beneficiaries do not have to get referrals from physicians to receive services from specialists, particularly now that Medicare no longer pays for consultations.
The regulation requires providers to retain records for orders, referrals, and certifications of home health services, durable medical equipment, and other items and services that have been prone to fraud, waste, and abuse.
Provider Groups Urge CMS To Reconsider 10-Year Lookback For Overpayments
On February 16, 2012, CMS published a proposed rule regarding reporting and returning overpayments under the Medicare program. Last week, in conjunction with the American Medical Association, Surgical Quality Alliance, and Alliance of Specialty Medicine, ASCRS submitted three comment letters to CMS on those proposed policies, urging CMS to limit the regulation to the simplest statutory requirements, amend the proposed definition of “identify,” shorten the proposed 10-year lookback period—to coordinate clearly with existing audit programs—and to provide specific guidance for providers.
We will keep you updated.
CMS Rejects Office of Inspector General (OIG) Call For National Pay Code for Off-Label Avastin
In a report released by the OIG on April 23, CMS is rejecting a call for the agency to create a national payment code that authorizes the off-label use of Avastin for treating wet age-related macular degeneration (wet AMD). As we reported previously, last year the OIG reported that in 2008 and 2009 alone, Medicare Part B could have saved $1.1 billion if it had reimbursed treatment for all beneficiaries suffering from wet AMD at Avastin rates, and beneficiaries would have saved $275 million in lower copayments.
According to the report released earlier this week, CMS told the OIG that there already is a related code and national payment amount for intraocular doses of Avastin administered in the hospital outpatient setting. CMS also said it already tried to set a national pay amount but had to abandon that code because physicians said they would not be able to provide the drug at the reimbursement level suggested by CMS.
The Medicare Part B-covered injectable drug approved to treat wet AMD, Lucentis, is much more expensive than off-label Avastin for the same use. Avastin is not approved to treat wet AMD, but doctors often prescribe smaller doses of the drug off-label for treatment of the condition. CMS established a national Medicare payment amount for Lucentis, but there is no national Medicare payment amount for Avastin when used to treat wet AMD in physician offices. Physicians paid an average of $1,928 per vial of Lucentis and $26 per dose of Avastin in the first quarter of 2010.
CMS Posts Corrections to Stage 2 Meaningful Use Proposed Rule
On April 17, CMS posted an 11-page list of corrections to its Stage 2 proposed rule on meaningful use. The revision includes corrections, technical and typographical errors, and a clarification to the reference to clinical quality measures to be used by Medicare and Medicaid eligible professionals beginning in 2014. The update corrects listings for 20 "other quality measure programs that use the same measure."
The proposed rule was made public in February and officially published in the Federal Register on March 7. A final rule is expected to be issued this summer.
Proposed Stage 2 Meaningful Use Clinical Quality Measures Present Significant Challenge for Specialists
On April 24, the quality measures work group of the federally chartered Health IT Policy Committee met in Washington to review its final list of recommendations to the full policy committee on the proposed rule for the Stage 2 meaningful use criteria issued by CMS in February. At issue was how clinical quality measures (CQM) for physicians and other eligible professionals could best be incorporated into the Stage 2 meaningful use requirements, expected to take effect in 2014 as part of the EHR incentive payment program. The work group discussed the option of requiring eligible professionals (EPs) to select and submit 12 CQM from a table of 125 possible measures. In addition, at least one measure would have to address each of six care-improvement "domains": patient and family engagement, patient safety, care coordination, population and public health, efficient use of health resources, and clinical process/effectiveness.
One of the main points of contention regarding this option is trying to find measures to fit all of the various medical specialties. The work group acknowledged that specialists will face "a significant challenge" finding a dozen measures, even out of 125, that are applicable to their practices and cover all six domains.
The work group has another meeting scheduled for today. Its final list of recommendations on the proposed rule is to be presented to the full policy committee May 4.
The 30-Day Comment Period is Now Open for the HHS Proposed Rule to Delay ICD-10
On April 9, Health and Human Services (HHS) released a proposed rule that would delay the compliance date for ICD-10 from October 1, 2013, to October 1, 2014. ASCRS and the AMA pressed CMS to postpone the October 1, 2013, deadline for conversion of billing codes from ICD-9 to ICD-10. The proposed change in the compliance date for ICD-10 would give providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition to these new code sets.
Comments are due to HHS no later than 5:00 pm ET on May 17 and can be submitted two ways:
Department of Health and Human Services
Attention: CMS–0040–P
P.O. Box 8013
Baltimore, MD 21244–8013
2013 eRx Payment Adjustment Update
The Quality Reporting Communication Support Page is now open to allow individual eligible professionals and CMS-selected group practices the opportunity to request a significant hardship exemption for the 2013 electronic prescribing (eRx) payment adjustment.
Hardship exemption requests will be accepted now through Saturday, June 30, 2012.
For additional information on the 2013 eRx payment adjustment, go to the following links:
Quality Support Page User Manual
ASCRS/ASOA eRx Webpage
2012 ERx Incentive Program Overview for Ophthalmic Practices
2012 eRx Incentive Program: Future Payment Adjustments
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