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| Medicare Adding Conditions to Its ASC Coverage
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On the heels of its revisions to Medicare's ASC payment system, CMS has issued a proposed rule amending Medicare's conditions for coverage, improvements that the agency says reflect new standards of practice for ASCs as well as recommendations from the Department of Health and Human Services' inspector general.
The conditions proposal, issued on Aug. 24, includes the following additions for ASCs providing services to and billing for services rendered to Medicare beneficiaries:
a revamped quality assessment and performance improvement condition for more proactive quality assurance and a requirement that ASCs' governing bodies take responsibility for this program;
a disaster preparedness standard requiring ASCs to institute emergency response plans and to build their interaction with local and state emergency officials;
requirements that bring ASC-provided radiologic services up to the standards required of ASC-provided laboratory services;
a new patients' rights condition, covering such issues as physicians' financial interests and disclosure, advance medical directives and information confidentiality;
an expansion of the infection control requirement as a condition; and
a patient assessment requirement that aims to ensure the safety and suitability of surgical procedures.
Public comment on the proposed rule will be accepted until Oct. 30. The agency expects to issue a final rule later in the year.
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| CMS Issues Final Phase of Stark Law
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The Centers for Medicare and Medicaid Services has issued its third and final phase of the Stark Law's implementation, a rule that does not establish new exceptions to current self-referral prohibitions but could result in the restructuring of established arrangements, according to CMS officials.
CMS reports that the Phase III rule eases restrictions on hospitals' abilities to recruit and retain physicians. It also allows for the correction of hospitals' non-monetary compensations that inadvertently exceed a physician's personal services arrangement if the overpayment does not exceed 50 percent of the permitted amount or if the physician repays the amount within 180 days of the excess payment's receipt.
Healthcare industry observers from the law firm Waller Lansden Dortch & Davis warn that Phase III does not address such hot button issues as "under arrangements" joint ventures and "per click" equipment service leases, both of which raised much debate when they were included in the proposed 2008 Medicare Physician Fee Schedule. The observers say "providers should be cautious when contemplating relationships that appear to comply with Phase III regulations, but may not meet the standards of proposed Stark changes included in the Physician Fee Schedule."
This rule "strikes the proper balance between protecting patients and the program, and providing needed flexibility to healthcare entities to ensure the provision of quality care to our beneficiaries without unnecessarily impeding non-abusive arrangements," says Herb Kuhn, CMS's acting deputy administrator. CMS will publish Phase III as a final rule in the Sept. 5, 2007 Federal Register.
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| Human Plasma Thrombin May Soon Reach Market
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A study published last month suggested the advantages to be gained from the use of recombinant thrombin derived from human plasma for controlling surgical bleeding as opposed to the use of standard bovine-derived thrombins. Now two biomedical manufacturers are employing this technology in a treatment to reduce patients' risks of developing antibodies or suffering heavier bleeding.
In August, the FDA approved Evithrom, a human-derived thrombin developed by OMRIX Biopharmaceuticals in collaboration with Johnson & Johnson Wound Management (a division of Ethicon). According to OMRIX, this product will be commercially available in the fourth quarter of this year and sold individually or with an absorbable gelatin sponge.
The company says the Evithrom introduction won't be it's last surgical adhesive effort. "This innovative concept for providing a one-stop-shop of biological hemostats will be getting closer to fruition once Evicel, our fibrin sealant, is approved with a general hemostasis indication," says Robert Taub, president and CEO of OMRIX. "We anticipate this approval in January 2008 and the one-stop-shop concept will be further supplemented by the subsequent expected approval of our fibrin patch."
Another company, ZymoGenetics, has submitted an application to the FDA for its currently unnamed recombinant thrombin product, for which it is collaborating on development and marketing with Bayer Healthcare. At present, the FDA's deadline for a decision on the product is Jan. 17.
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| News and Notes
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A study published last month suggested the advantages to be gained from the use of recombinant thrombin derived from human plasma for controlling surgical bleeding as opposed to the use of standard bovine-derived thrombins. Now two biomedical manufacturers are employing this technology in a treatment to reduce patients' risks of developing antibodies or suffering heavier bleeding.
In August, the FDA approved Evithrom, a human-derived thrombin developed by OMRIX Biopharmaceuticals in collaboration with Johnson & Johnson Wound Management (a division of Ethicon). According to OMRIX, this product will be commercially available in the fourth quarter of this year and sold individually or with an absorbable gelatin sponge.
The company says the Evithrom introduction won't be it's last surgical adhesive effort. "This innovative concept for providing a one-stop-shop of biological hemostats will be getting closer to fruition once Evicel, our fibrin sealant, is approved with a general hemostasis indication," says Robert Taub, president and CEO of OMRIX. "We anticipate this approval in January 2008 and the one-stop-shop concept will be further supplemented by the subsequent expected approval of our fibrin patch."
Another company, ZymoGenetics, has submitted an application to the FDA for its currently unnamed recombinant thrombin product, for which it is collaborating on development and marketing with Bayer Healthcare. At present, the FDA's deadline for a decision on the product is Jan. 17.
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