Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E Prescribing Exemption for Computer Generated Facsimile Transmissions
2008-08-22 2008-08-25 2008-08-25 2008-08-25 2008-08-25 2008-08-26 2008-08-26 2008-07-17 2008-07-18 2008-07-18
CMS-2008-0073-0321 CMS-2008-0073-0327 CMS-2008-0073-0339 CMS-2008-0073-0358 CMS-2008-0073-0373 CMS-2008-0073-0384 CMS-2008-0073-0378 CMS-2008-0073-0016 CMS-2008-0073-0019 CMS-2008-0073-0020
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https://api.regulations.gov/v4/comments/CMS-2008-0073-0321 https://api.regulations.gov/v4/comments/CMS-2008-0073-0327 https://api.regulations.gov/v4/comments/CMS-2008-0073-0339 https://api.regulations.gov/v4/comments/CMS-2008-0073-0358 https://api.regulations.gov/v4/comments/CMS-2008-0073-0373 https://api.regulations.gov/v4/comments/CMS-2008-0073-0384 https://api.regulations.gov/v4/comments/CMS-2008-0073-0378 https://api.regulations.gov/v4/comments/CMS-2008-0073-0016 https://api.regulations.gov/v4/comments/CMS-2008-0073-0019 https://api.regulations.gov/v4/comments/CMS-2008-0073-0020
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OTHER ISSUES-SLEEP TESTConsumers are provided a listing of CPAP providers to meet the Patient Choice requirement.  By taking the listing and allowing non-afilliated healthcare systems that have both the sleep lab and a DME is restricting access. The physician ordering the test should not provide the CPAP because an accredited DME provider should provide the equipment.  Physicians diagnose, suppliers provide the education on the use and monitor compliance, this is written in the supplier standards that is distributed.The population is growing and the diagnosis is not simple. There are many criteria which must be met prior to the decision to treat with a CPAP.  This is scientific protocal and not based on a biased opinion. Maybe this proposed regulation is just that-a biased opinion to keep the most qualified locally based health care systems who also have a sleep lab and a DME  from providing the much needed services to the Medicare beneficiary. This is restrictive care.I oppose this proposed regulation. I vote for option #2 of the Proposed Changes to Enrollment and Billing Rights change. INDEPENDENT DIAGNOSTIC TESTING FACILITIESPlease refer to file code CMS-1403-P.I am writing to comment on the proposed rule change regarding diagnostic imagingfacilities referenced above.  Although I am not opposed to applying standards toensure patient safety and improve quality of care, I feel that there are severalimplications of the proposed rule that are unnecessary and will instead decreaseaccess to care by Medicare beneficiaries and increase costs.  Here are my concerns:1. IDTF designation is not appropriate or necessary for office-based imaging. As an orthopaedic surgeon, diagnostic imaging is essential to my medicaldecision-making process for my patients.  If I am restricted from obtainingx-rays, MRI studies, or other studies by the new regulations, then it willnegatively impact my ability to provide care to Medicare patients by delayingaccess to these studies.  Furthermore, it will increase costs by requiringmultiple office visits to order and then review studies.  Finally, I am likelyto choose to see fewer Medicare patients if obtaining the studies I need fortheir treatment requires cutting through red-tape and jumping over hurdles.  Theend result is less access to care for Medicare beneficiaries.2. Supervision of diagnostic imaging facilities should not be limited toradiologists.  As an orthopaedic surgeon, I am trained and able to interpret thediagnostic studies that I order.  Any attempt to limit the physicians who cansupervise diagnostic imaging must include a mechanism for non-radiologists toobtain certification to perform the imaging that they need.  Limitingsupervision to radiologists will increase the cost of studies by decreasingcompetition between imaging providers.  It is also unnecessary as anon-radiologist physician can be just as proficient at interpreting imagingstudies as a radiologist.3. Requiring general supervision by a radiologist can also decrease the qualityof studies performed.  In my practice, we choose to have our studies interpretedby remote radiologists who have subspecialty training in reading musculoskeletalimaging.  Radiologists with these qualifications are not readily available inour local market.  If we were required to have supervision of our imaging by alocal radiologist, the quality of interpretation could decrease.4. Direct supervision of contrast administration by a radiologist isunnecessary.  As a surgeon with clinical experience dealing with contrastextravasation and reactions, I am at least as qualified, if not more qualified,as a radiologist to supervise the administration of contrast for imagingstudies.  Limiting these studies to direct supervision by a radiologist willincrease the cost of these studies by decreasing competition, and will notimprove the safety or quality of these procedures for Medicare beneficiaries.In summary, I urge you not to adopt the proposed rule change without makingchanges to ensure available access to quality imaging and interpretation forMedicare beneficiaries.Thank you. RE:  CMS-1403-PI am writing to comment on the propsed changes to the ENROLLMENT RULES.  Currently, a physician is enrolled retroactively to the first date of service.  The propsoed rules would delay the enrollment to the date Medicare approves the application or either the date of filing or the date an enrolled supplier started rendering services.  Either of these approaches would be difficult for anesthesia.  As you are aware, there is a serious shortage of anesthesiologists and recruiting a new physician can be very difficult and time consuming.  A delay in credentialing a physician for Medicare would be a serious problem for our group because Medicare comprises 25% of our patient population.  Our physicians choose to not look at a patients insurance when providing care in order to be totally objective.  If one of these changes is implemented we might be forced to look at insurance and delay a surgery until a Medicare credentialed physician was available.  This does not provide quality care for the patient, surgeon or hospital.  We do not want to begin looking at insurance before providing service.  And we certainly do not want to be placed in the position of delaying surgery simply because the Medicare credentialing is not complete.  We do not have the luxury of starting a physician after all insurance credentialing is completed.The second approach would be the preferred approach if a change is inevitable.  If the change is implemented, I would suggest part of the change be that Medicare carriers be required to process applications in a timely manner, with a resonable time frame spelled out, and penalties imposed if they cannot meet the time frame.  It is unfair for physicians to be penalized for the delayed action of the carriers. The burden of hiring a supervising radiologist for in-office x-rays would only add another layer of cost and oversight, negatively impacting patient care. WEST COUNTY HEART ALLIANCE2335 DOUGHERTY FERRY RD.ST. LOUIS, MO 63122August 25, 2008Kerry N. Weems, AdministratorCenters for Medicare and Medicaid ServicesDepartment of Health and Human ServicesAttention:  CMS-1403-PMail Stop:  C4-26-057500 Security BoulevardBaltimore, MD 21244-1850Re:Revisions to Payment Policies Under the Physicians Fee Schedule and Other Revisions to Part B for CY 2009; Proposed RuleDear Mr. Weems:On behalf of the West County Heart Alliance and our 18 individual practicing cardiologists and 15 staff, we appreciate the opportunity to submit comments to the Centers for Medicare  Medicaid Services (CMS) regarding the Resource-Based PE RVUs section of the above referenced July 7, 2008 Proposed Rule.  We are specifically concerned with the 2009-2010 PE RVUs established for non-facility outpatient cardiac catheterization procedure codes and the significant negative impact that could result for our practice and our Medicare patients if these values are finalized for the 2009 Physicians Fee Schedule.  The West County Heart Alliance is a Physician owned outpatient cardiac catheterization lab servicing 2000 cardiac patient annually with a service area covering East Central and Southern Missouri.The West County Heart Alliance is a member of the Cardiovascular Outpatient Center Alliance (COCA) and as such we have actively been involved in the effort that COCA made in 2007-2008 to collect and submit direct and indirect cost data to the CMS Center for Medicare Management in response to their specific November 2007 request.   Unfortunately, the Center senior staff chose not to share the results of their analysis with COCA or the Congressional offices that requested this information and instead returned the issue to the AMA PERC/RUC for reconsideration.  The AMA PERC/RUC declined to reconsider their 2007 recommendations without contacting COCA for any information or comments.  As a result, CMS states in the July 7, 2008 Federal Register, page 38512: We are in agreement with RUC recommendations, (including the recommendation that no change be made to the direct inputs for CPT 93510, a cardiac cath code).  We are disheartened that CMS chose not to use or even share its own analysis of COCAs complete cost data; once again resulting in PE RVU recommendations that severely undervalue the direct and indirect costs associated with providing these procedures to our patients.  The PE RVU values published in the July 7, 2008 Proposed Rule would result in additional draconian cuts in reimbursement for cardiac catheterizations performed in physician practice or IDTF locations.  For example, the 2008 reimbursement for the technical components of the primary three CPT codes for a Left Heart Cath (93510TC, 93555TC, and 93556TC) were cut by 23.33% in 2008, would be cut by an additional 14.38% in 2009, and cut another 18.29% in 2010 for a total reduction of 46.36% from 2007 levels.  At the same time, the outpatient hospital APC payments for the exact same procedure were increased by 8.56% in 2008 and are proposed to increase by another 4.84% in 2009.  Since the APC reimbursement was already 6.35% higher than the PFS rates in 2007, this means that as of January 1, 2009 the reimbursement for this procedure in a non-hospital outpatient cath lab (OPCL) will have dropped from 93.65% of the APC rate to 54.02%.These severe and unsupported reductions have already resulted in the closing (or sale to hospitals) of several OPCLs and if not reversed will more than likely result in the closure of the majority of OPCLs in the country.  This result would force thousands of Medicare patients who now benefit from improved access and lower costs into more acute hospital settings where their copayments will cost each of them several hundred dollars more than the same procedure in an OPCL.  Even comparing the original 2007 Physician Fee Schedule payment with the proposed 2009 APC rate, the increased cost to the Medicare Trust Fund and Medicare beneficiaries from this shift would conservatively add up to $28.5 million.  If the current 2008 PFS payment is compared to the 2009 APC rate, the additional cost to the Medicare program increases to $59.5 million.COCA is on record in their April 30, 2008 meeting with Dr. Jeffery Rich requesting that CMS reconsider the complete cost data provided to them by COCA in December 2007 and establish PE RVUs for non-facility outpatient cardiac catheterization procedures that more reasonably reflect the direct and indirect costs of providing these procedures.  In addition, the American College of Cardiology is on record in their June 11, 2008 letter to Dr. Rich requesting that CMS at least freeze the 2009 reimbursement at 2008 levels until an additional review of OPCL indirect costs can be conducted.We request that CMS listen to the recommendations of COCA and ACC and develop fair and reasonable reimbursement for non-facility outpatient cardiac cath procedures for 2009 before it is too late and we are forced to close or sell our OPCL to a local hospital.  The ultimate severe negative impact on the Medicare program, our Medicare patients, and our practice is unnecessary if CMS would only utilize the data that they have already analyzed.Thank you for the opportunity to comment on this critical issue.  Please contact me at 314-570-3312 if you are interested in the specific details of our request.Sincerely, Scott W. Hylton R.N.Manager West County Heart Alliance I am writing to comment on proposed changes to ENROLLMENT RULES for providers.Starting a new Anesthesiologist in a new practice typically takes 3-6 months from interviews to Hospital privileges. Quite often privileges are obtained mere hours before starting to work in the OR. Only then can a new provider apply for enrollment as a Medicare provider. Current rules allow retroactive enrollment to day of application. Proposed changes would delay our ability to bill for the new Anesthesiologists services for up to a couple of months.Our choices are then all bad: do we try to have the new physician avoid Medicare cases, nearly impossible when call is taken into account. Or are we put in a position of providing his/her uncompensated services for a time? We simply do not have the luxury of waiting for an Anesthesiologist to have all enrollments in hand to start work in a new practice. Enrollment works as is, do not change it. CMS 1403-P once again illustrates the lack of understanding and lack of awareness present with CMS officials today, as demonstrated in the Competitive Bidding Debacle. The definition and rule change that will not allow an individual or a company to own a Sleep Lab and a seperate Medical Equipment company entity not only infringes once again upon free enterprise, but quite frankly misses the mark if the target idea is to curb abuse.These DME entities still must receive referrals and orders from physicians; the Sleep lab cannot order a CPAP, nor can the DME company initiate the therpay without the physicians order. There is no danger of self gratification because the ordering physician decides where the referral will go. The Sleep Lab performs the sleep study, the study is interpreted by a doctor, the final report is then sent to the ordering physician, who them refers the CPAP to a qualified provider.It should also be noted that many DME companies that are seperate entities and owned by the same owenr as a Sleep Lab arer also accrediited companies.The real targets should be Labs and DME operations jointly owned by physicians or Labs and DME operations owned by hospitals. In those cases, the entities can benefit from self referral. The fact that that has occurred for years has created an unstable playing field for many honest privately owned companies.As written, this change will only hurt small companies, while directing more business to larger national companies, once again limiting patient choice and free enterprise.as i have stated before, the real target should be limiting physician and hospital ownership in such realted entities, not private ownership that cannot and do not write the ordrs necessary for self referral. CMS should be applauded for recognizing the need for inpatient telemedicine subsequent visit codes for consults provdided via telemedicine. Further, they should be applauded for recognizing the value of this service and the injustice of seeking to avoid compensating physicians for this service, now being provided for free via telemedicine, when it is a billable service in person.  There are not too many things that I have been involved with that I can honestly say everyone is happy with but telemedicine is one of them.  Referring physicians are happy, patients are happy and consulting physicians are happy.  Not to mention that it is far better care than that provided by the telephone which is likely to be inadequate, leave no one particularly happy and end up costing more in the long run.  Thank you for acting on this important and pressing issue!!! I agree with the proposed regulations which would not allow any entity to provide a sleep test and to also provide any equipment to a patient who has been tested by that that same entity.As physicians and physician groups are being bought by hospitals, the physician is coming under more pressure by hospital administrations to administer more test and to prescribe more services and equipment to patients being tested. There can also be a bias in the interpretation of sleep studies by a physician who is employed by a hospital. This could be especially possible when his salary and/or bonus is directly related to the income generated by the test and prescription of equipment which will also be supplied by a hospital owned medical equipment company. We have also seen in the Charlotte community, the monopolization of referrals for equipment by hospital owned sleep labs. Patients are not always offered a choice of providers. The result is that there is no competition and thus no reason for a hospital owned company to offer quality service or competitive pricing. Physicians who are employed by a hospital should not be allowed to refer patients to a hospital owned medical equipment company!Another respondent has suggested that a company not owned by the sleep lab may not provide the same mask as used in the sleep test. This is doubtful as most homecare companies carry a wide variety of mask for existing customers. It is in the best interest of the company and the patient to provide the patient with a mask that will best ensure compliance by the patient. Homecare companies also have more time to spend with the patient in the home environment fitting the most appropriate mask for the patient to use in his own sleeping environment. The sleep environment of a diagnostic lab and that of the patients home are completely different. Also not all sleep labs send the mask home used in the test. Additonally, private physicians who own sleep labs are currently not allowed to refer Medicare or Medicaid patients to medical equipment companies in which they have ownership. Thus, there is no incentive to prescribe equipment that the patient may not need.I strongly urge the adoption of this regulation. It will surely result in more choice of providers to Medicare patients. It will also result in a higher quality of service to the Medicare patient and can help to keep competitve pricing in the marketplace.My final argument for this regulation is the positive effect it will have on the tax payer in general. No longer will tax paying private companies have to unfairly compete with not for profit hospitals. This will allow private companies to continue in business, grow as they provide quality service and continue to pay taxes to local governments. As not for profit hospitals gobble up the business, the profits they generate are used to buy more and more property which becomes nontaxable. This is not good for the community and places an additional burden on local taxpayers.Respectfully,H. Edward Eubanks23 Washington LaneConcord, NC 28025