2007 Reimbursement Updates
Congress Passes Scaled-down Medicare Package
December 21, 2007 - Congress passed a Medicare package that is significantly scaled-down from what was initially speculated. Having to contend with a scheduled 10.1 percent reduction in Medicare payments to physicians, Congress enacted a temporary 6 month patch to ensure that the reductions would not go into effect. At the same time, the legislation will also increase payments by .5 percent. |
New Certification to Accompany Device Applications/Submissions
December 14, 2007 - As a result of the Food and Drug Administration Amendments Act of 2007, a new certification is now required to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials. Applicants must certify at the time of an application or premarket notification submissions that they have complied with this new requirement. Applications must be submitted to the agency beginning on December 26, 2007 and the new requirement applies to all applications made on or after the 26th.
Click here for more guidance
Final Certification Form 
Value-Based Purchasing Report
November 30, 2007 - The Department of Health and Human Services (HHS) delivered to Congress a Report on the Medicare Hospital Value-Based Purchasing Program (VBP). The report provides suggestions on how Medicare can be a more prudent purchaser of higher quality health care for Medicare beneficiaries; including a plan for all facets of the proposed Medicare Hospital VBP program.
Click here for the complete report
CMS Announces Final Decision on Clinical Trial NCD
October 17, 2007 - The Centers for Medicare and Medicaid Services (CMS) announced its final determination regarding the Clinical Trial National Coverage Decision. CMS decided that no change to the July 9, 2007 policy is necessary appropriate. Therefore, no additional conditions of coverage will be imposed. The decision comes in light of the recently passed Food and Drug Amendments of 2007 which establishes significant requirements for clinical trials. CMS stated that it will continue to review the legislation to avoid imposing duplicative or inconsistent obligations.
MDMA Submits OPPS Comments to CMS
September 14, 2007 -- MDMA filed comments with the Centers for Medicare and Medicaid Services (CMS) regarding proposed changes to the Outpatient Prospective Payment System. MDMA’s comments focus on ensuring that any changes under OPPS will not negatively impact reimbursements for medical devices. To this end, MDMA made several recommendations to CMS including: delaying implementation of its packaging proposal until it has made cost data available to all stakeholders; requiring complete and correct coding for packaged services to ensure that APC configurations remain adequate to protect access to innovative devices and services; requiring the use of C-codes for all device-dependent APCs in the 2008 final rule; requiring hospitals to code for procedures performed in connection with separately payable devices; urging CMS to address the effects of charge compression; and urging CMS to maintain a two-year minimum threshold for New Technology and pass–through APCs.
MDMA's Comment Letter
MDMA Voices Concerns with Clinical Research Policy (CRP) Proposed Decision
August 16, 2007 -- MDMA submitted comments to CMS on the proposed decision memorandum for the second reconsideration of the clinical trial policy, renamed the clinical research policy (CRP). Specifically, MDMA stated that the national coverage determination (NCD) is not the appropriate forum to address the concerns of CMS and that CMS should issue a notice of proposed rulemaking. However, if CMS moves forward MDMA made a series of recommendation including clarifying the definition to “usual patient care”.
To read MDMA’s comment letter click here.
CMS Issues IPPS Final Rule
August 1, 2007 -- The Centers for Medicare and Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) final rule. The IPPS payment reforms would restructure the inpatient diagnosis-related groups (DRGs) to account more fully for the severity of each patient’s condition. In addition, the rule includes provisions to ensure that Medicare no longer pays for the additional costs of certain preventable conditions (including certain infections) acquired in the hospital. The rule also expands the list of publicly reported quality measures and reduces Medicare’s payment when a hospital replaces a device that is supplied to the hospital at no or reduced cost.
Press Release
Fact Sheets
IPPS Final Rule
CMS proposes new National Coverage Decision for Clinical trials
July 27, 2007 -- Among other things, the NCD would impose thirteen new and potentially burdensome criteria for coverage of routine "usual patient care" items and services furnished to Medicare beneficiaries if they are enrolled in a clinical study - even if those items and services would otherwise be covered by Medicare irrespective of any such additional criteria. As applied to "usual patient care," MDMA believes that the NCD exceeds CMS's legal authority, and could prove a disincentive to clinical trials involving Medicare beneficiaries. MDMA is in the process of drafting comments to be submitted before the August 19 deadline.CMS will be hosting an Open Door Forum on this issue on August 7th from 2:00pm-4:00pm EDT. Companies can attend in person or dial 1-800-837-1935 and enter the conference ID: 10584169.
Click here for more information
https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210
MDMA Submits Comments to CMS on CRP Interpretation
June 28, 2007 -- MDMA submitted a letter to CMS expressing concern about a possible interpretation of the forth coming Clinical Research Policy (CRP) National Coverage Determination (NCD). Because coverage of routine clinical services already is available to Medicare beneficiaries in many types of post-approval studies, MDMA is seeking clarification that CMS is not intending to interpret the CRP to permit Medicare coverage of routine clinical services in a post-approval study only pursuant to the CRP. This type of routine care is covered by Medicare today, and MDMA is concerned that CMS may be seeking to subject these studies to the CRP unnecessarily. MDMA specifically asked CMS to reject the proposed interpretation and clearly state in the final NCD that it create a "safe harbor," providing coverage for qualifying trials that would otherwise not be covered, while continuing to cover "routine patient care" that otherwise would be available.
To read MDMA’s letter to CMS, please click here.
MDMA Submits Comments on the IPPS Proposed Rule
June 12, 2007 -- Today, MDMA submitted a comment letter to the Centers for Medicare and Medicaid Services (CMS) on the Inpatient Prospective Payment System (IPPS) proposed rule. MDMA made 13 recommendations to CMS to improve the rule including recommending that CMS should phase in implementation of the MS-DRGs over three years to allow hospitals the time to adjust to the changes. In addition, MDMA recommended that CMS should address the effects of charge compression on payments for procedures involving advanced devices by adjusting DRG weights as recommended by the RTI report released earlier this spring. Further, CMS should implement changes to cost reports in fiscal year 2008 to allow the agency to gather more accurate cost data regarding advanced medical devices for use in future rate-setting. MDMA looks forward to working with CMS as it refines the Inpatient Prospective Payment System.
To read MDMA’s comment letter, please click here.
CMS Releases IPPS Proposed Rule
April 13, 2007 -- Today the Centers for Medicare and Medicaid Services (CMS) released the inpatient prospective payment system (IPPS) proposed rule for fiscal year 2008. The proposal continues the steps that CMS started last year to adjust payments to hospitals based on a patient’s severity of illness by expanding the number of diagnosis-related groups (DRGs) from 538 to 745. The proposal also continues the phase-in of moving from charge based weights to cost based weights. Under the proposal, two-thirds of a DRG payment will be based on costs and one-third based on charges. On average, hospitals are going to receive a 3.3 percent payment increase with urban hospitals faring better than rural hospitals.
To read the proposed rule, please click here.
CMS Releases DME Final Rule
April 2, 2007-- Today, the Centers for Medicare & Medicaid Services (CMS) issued the final rule to implement a competitive bidding program in Medicare for certain durable medical equipment prosthetics, orthotics and supplies (DMEPOS). MDMA remains concerned about the impact this program will have on beneficiary access as well as the ability for small medical device companies to participate in the program due to the restrictive definition of "small" suppliers (gross revenue of $3.5 million or less in annual receipts). MDMA will continue to engage CMS and advocate for a more reasonable approach to address the concerns of beneficiaries and medical technology companies.
To read the final rule please click here.
CMS APC Advisory Panel Meeting
March 9, 2007 -- The Centers for Medicare and Medicaid Services (CMS) held its first biannual meeting of the APC Advisory Panel for 2007 this week. The Panel heard presentations given by CMS staff, individual device manufacturers as well as MDMA and other industry trade associations. Specifically, MDMA requested that the panel recommend to CMS to maintain a two year minimum threshold of New Technology APCs so that data has time to mature before being placed into a clinical APC. At the meeting, CMS presented preliminary data stating that of the 42 device dependent APCs only 6 of them are likely to see a payment decrease in 2008 and of the 6 only 2 will decrease by more than 10 percent. To view the table, please click here.
MedPAC Releases Report to Congress on Medicare Payment Policy
March 2, 2007-- On Thursday, March 1st the Medicare Payment Advisory Commission (MedPAC) released its Report to Congress detailing its recommendations to Congress on Medicare payment policy. In the report, MedPAC recommended for both inpatient and outpatient services that they receive the full hospital market basket update concurrent with a quality incentive payment program. This would equal a 3.1% increase. In addition, MedPAC issued a report regarding "Assessing Alternatives to the Sustainable Growth Rate System" (SGR) which is the current statutory formula for paying for physician services. While MedPAC did not recommend a specific path for Congress, they did make clear that payment policies should reward providers for efficient use of resources and create incentives to increase quality and coordinate care.
CMS Holds New Technology Informational Workshop
February 26, 2007-- On Thursday, February 22nd the Centers for Medicare and Medicaid Services (CMS) held a New Technology Informational Workshop in conjunction with their annual New Technology Townhall meeting. CMS presented on the factors involved in deciding whether a technology will receive a new technology add-on payment (i.e. newness criteria, costliness, and whether the technology provides a substantial clinical improvement over existing technologies). In addition, they also provided background on requesting an ICD-9 diagnosis or procedure code and then being placed into the corresponding Diagnosis Related Group (DRG). Finally, they discussed the process for obtaining Pass-Through and New Technology Payments in the Outpatient Prospective Payment System (OPPS).
To review the slides presented at the meeting, please click here.
MDMA Submits Comments to CMS on Next Month's APC Panel Meeting
February 16, 2007-- MDMA submitted comments which will be presented at the CMS Advisory Panel on Ambulatory Payment Classifications (APC) meeting next month. Specifically, we made the following recommendations: 1) we asked the Advisory Panel to recommend that CMS require the use of C-codes for all device-dependent APCs in the 2008 OPPS proposed rule; 2) we requested that the Panel recommend that CMS institute a payment floor in 2008 or keep all rates at the 2007 payment level; and 3) we requested that the panel urge CMS to maintain a two year minimum threshold of New Technology and Pass Through APCs so that data has the time mature before being placed into a clinical APC.
Click here to view MDMA's comment letter.
First Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups: March 7-9, 2007
February 14, 2007 -- The first biannual meeting of the APC Advisory Panel for 2007 will be March 7-9, 2007 at CMS headquarters in Baltimore, MD. The Panel will review the APC groups and associated weights to advise the Secretary of HHS and the CMS Administrator about the clinical integrity of the APC groups and their associated weights. The Panel's advice will be considered by CMS as it prepares updates to the hospital Outpatient Prospective Payment System through rulemaking. For those planning to present, the comment deadline is Wednesday, February 7, 2007 and the attendee registration deadline is Wednesday, February 28, 2007. Agenda items for the March meeting include:
- Reconfiguration of APCs
- Evaluation of APC weights
- Packaging devices and drug costs into APCs
- Removal of procedures from the inpatient list for payment under the OPPS
- Use of single and multiple procedure claims data
- Packaging of HCPCS codes
- Other technical issues concerning APC structure
For more information about the meeting please click here.
To read MDMA's written comments, please click here.
MedPac Recommends that Hospitals Receive a Full Market Basket Update
January 10, 2007 -- The Medicare Payment Advisory Committee (MedPAC) met to discuss the recommendations that they will be making to Congress in their March report. The Commissioners voted unanimously to give hospitals a full market basket increase for fiscal year 2008 payments for inpatient and outpatient care. This will equal a 3.1% increase. However, the Commissioners did tie the update to implementation of a quality incentive payment program. To view the meeting transcript, please click here.