CMS Proposes Strict Physician Visit Requirement for Home Dialyzors

Cross Posted from DSEN

CMS Proposes Strict Physician Visit Requirement for Home Dialyzors
By Bill Peckham

Right now there is a comment period for a proposed rule having to do with Medicare payments called: Medicare Program: Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B (for CY 2011) (Document ID CMS-2010-0205). This is another giant 671 page proposed rule (PDF link), this one covers Medicare payments to physicians under Part B.

There doesn’t seem to be any submitted comments, even though the 30 day comment period closes August 24th so maybe it’s not very controversial. There’s a lot in there and I can’t say I’ve reviewed the whole thing but I have looked at one section that was brought to my attention.

On Pages 62 to 64 there is a section that refers to nephrologists providing care to people on home dialysis:

[INDENT]C. End-Stage Renal Disease Related Services for Home Dialysis
(CPT Codes 90963, 90964, 90965, and 90966)

  1. End-Stage Renal Disease Home Dialysis Monthly Capitation Payment Services
    (CPT Codes 90963, 90964, 90965, and 90966)

In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G-codes for end-stage renal disease (ESRD) monthly capitation payment (MCP) services. For center-based patients, payment for the G-codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2–3 visits and 4 or more visits). Under the MCP methodology, the lowest payment applied when a physician provided one visit per month; a higher payment was provided for two to three visits per month. To receive the highest payment, a physician would have to provide at least four ESRD-related visits per month. However, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required visits for home dialysis MCP services, we stated that we ‘‘expect physicians to provide clinically appropriate care to manage the home dialysis patient’’ (68 FR 63219).

Effective January 1, 2009, the CPT Editorial Panel created new CPT codes to replace the G-codes for monthly ESRD-related services, and we accepted the new codes for use under the PFS in CY 2009. The CPT codes for monthly ESRD-related services for home dialysis patients include the following, as displayed in Table 32: 90963, 90964, 90965, and 90966. In addition, the clinical vignettes used for the valuation of CPT codes 90963, 90964, 90965, and 90966 include scheduled (and unscheduled) examinations of the ESRD patient.

Given that we pay for a physician (or practitioner) to evaluate the ESRD patient over the course of an entire month under the MCP, we believe that it is clinically appropriate for the physician (or practitioner) to have at least one in-person, face-to-face encounter with the patient per month. Therefore, we are proposing to require the MCP physician (or practitioner) to furnish at least one in-person patient visit per month for home dialysis MCP services (as described by CPT codes 90963 through 90966). This requirement would be effective for home dialysis MCP services beginning January 1, 2011. We believe this requirement reflects appropriate, high quality medical care for ESRD patients being dialyzed at home and generally would be consistent with the current standards of medical practice.

  1. Daily and Monthly ESRD–Related Services
    (CPT Codes 90951 through 90970)

In CY 2008, the AMA RUC submitted recommendations for valuing the new CY 2009 CPT codes displayed in Table 32 that replaced the MCP HCPCS Gcodes for monthly ESRD-related services. We accepted these codes for use under the PFS.

There are four additional CPT codes for ESRD-related services that are reported on a per-day basis. These daily CPT codes are: 90967 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients younger than 2 years of age); 90968 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 2–11 years of age); 90969 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12–19 years of age); and 90970 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 20 years of age and older).

For the MCP codes displayed in Table 32, the AMA RUC initially recommended 36 minutes of clinical labor time for the pre-service period. They also recommended an additional 6 minutes in the post-period for CPT codes 90960, 90961, 90962, and 90966. For the four codes describing daily services (CPT codes 90967 through 90970), the AMA RUC recommended including 1.2 minutes of clinical labor per day, which is the prorated amount of pre-service clinical labor included in the monthly codes. The AMA RUC also recommended that CPT codes 90952 and 90953 be contractor-priced.

In the CY 2009 PFS final rule with comment period (73 FR 69898), we asked the AMA RUC to reconsider their recommended PE inputs in the interest of making certain that they accurately reflected the typical direct PE resources required for these services. In addition, we asked the AMA RUC to review the physician times for CPT codes 90960 and 90961 that are used in the calculation of the PE RVUs. We accepted the work values for the new CPT codes for ESRD-related services that were recommended by the AMA RUC.

Since CY 2009, we have continued to calculate the PE RVUs for the entire series of MCP codes displayed in Table 32 by using the direct PE inputs from the predecessor HCPCS G-codes, except for CPT codes 90952 and 90953 which are contractor-priced. We have also continued to use the physician time associated with the predecessor HCPCS G-codes for CPT codes 90960 and 90961 for purposes of calculating the PE RVUs.

In CY 2009, the AMA RUC submitted new recommendations for CPT codes 90951 and 90954 through 90970. For each of the MCP codes (CPT code 90951 and CPT codes 90954 through 90966), the AMA RUC recommended an increased pre-service clinical staff time of 60 minutes. For each of the daily dialysis service codes (CPT codes 90967 through 90970), the AMA RUC recommended an increased clinical labor time of two minutes, which is the prorated amount of clinical labor included in the monthly codes. The AMA RUC also recommended an additional 38 minutes of physician time for CPT codes 90960 and 90961. This resulted in a total physician time of 128 minutes and 113 minutes, respectively, for these codes. The AMA RUC continued to recommend that CPT codes 90952 and 90953 be contractorpriced.

For CY 2011, we are proposing to accept these AMA RUC recommendations as more accurate reflections of the typical direct PE resources required for these services. Therefore, we are proposing to develop the PE RVUs for CPT code 90951 and CPT codes 90954 through 90970 using the direct PE inputs as recommended by the AMA RUC and reflected in the proposed CY 2011 PE database, which is available on the CMS Web site under the supporting data files for the CY 2011 PFS proposed rule at: http:// www.cms.gov/PhysicianFeeSched/. We are also proposing to use the AMA RUCrecommended physician times for CPT codes 90960 and 90961. Consistent with the AMA RUC’s recommendations, we are proposing to continue to contractorprice CPT codes 90952 and 90953.[/INDENT]

That’s the whole home dialysis related section from the 632 page document but the part I have concerns about, and I think will submit a comment about, is the last paragraph of the first section (my emphasis):

[INDENT]Given that we pay for a physician (or practitioner) to evaluate the ESRD patient over the course of an entire month under the MCP, we believe that it is clinically appropriate for the physician (or practitioner) to have at least one in-person, face-to-face encounter with the patient per month. Therefore, we are proposing to require the MCP physician (or practitioner) to furnish at least one in-person patient visit per month for home dialysis MCP services (as described by CPT codes 90963 through 90966). This requirement would be effective for home dialysis MCP services beginning January 1, 2011. We believe this requirement reflects appropriate, high quality medical care for ESRD patients being dialyzed at home and generally would be consistent with the current standards of medical practice.[/INDENT]

I agree with the statement that it is clinically appropriate for the physician to have at least one in-person, face-to-face encounter with the patient per month, however, I think there should be some flexibility built into the system. This rule is proposing that if I don’t get into see my doc during the month he doesn’t get paid, even while he attends to my care by reviewing labs, is available to the unit and to me whether or not I have gotten in to see him that month.

My initial reaction is that there should be some patient autonomy, and that the physician must make themselves available for monthly, face to face office visits BUT the patient needs to have some flexibility. I’m worried that this will create a barrier to home dialysis, particularly among patients who can most benefit from dialysis at home, those that can thrive while combining home dialysis with a busy life. I’m worried about adding to the dialyzor burden that comes with home dialysis. A no exceptions policy does not sound optimal.

Thoughts? Comments are due by August 24th.

Here’s the comment I submitted to CMS. It’s important that others send in their comments. We had over 1500 comments to the proposed rules on Bundling. At the time, we urged dialyzors to remain engaged. We said the public policy advocacy never ends. This is an example of why a dialyzor must keep her foot to the pedal. The QIP rules are another example. The comment period end on September 24th for that. Let’s keep the ink flowing.

Re: Medicare Program: Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B (for CY 2011) (Document ID CMS-2010-0205) and more specifically End-Stage Renal Disease Related Services for Home Dialysis (CPT Codes 90963, 90964, 90965, and 90966) and End-Stage Renal Disease Home Dialysis Monthly Capitation Payment Services (CPT Codes 90963, 90964, 90965, and 90966)

I am a home dialyzor and have been doing it for over 4 ½ years. That means I have bought into the concept of self-care. But as much as I depend on myself, I also depend on the rest of my dialysis team. That team is headed up by my nephrologist. I’ve come to rely on him constantly, not just the one monthly appointment I have scheduled. During the month I will email him with questions about my treatments and issues that might crop up. I simply don’t wait for my clinic visit. That’s not how dialysis works. It’s not a once a month- face-to-face meeting. It’s an every day occurrence and critical to maintaining my life.

I’ve been with my nephrologist since 1998 when I had a radical nephectomy due to renal cell carcinoma. Immediately I had chronic kidney disease (CKD) because of my additional hypertensive condition I had since becoming an adult. My CKD progressed until I had to go on dialysis on 2003. At that time, my nephrologist told me about home hemodialysis. That’s what I decided to do. But there was a problem. Nobody in my area was offering it. He wanted the hospital to sponsor it and was hoping a program would be approved shortly. However, shortly it wasn’t. It took three years before the hospital approved just me for home hemodialysis. He fought touch and nail to get it approved. And by getting me on home hemodialysis, he saved my life.
Like many others doing in-center conventional hemodialysis (CHD), I was failing. The three treatments per week proved to not be enough to keep me healthy. After the 18 months of CHD, I suffered a heart attack driving home from a dialysis session. My cardiovascular system couldn’t handle the constant battle with the ups and downs of fluid imbalance. I was unable to remove as much fluid as I was in the beginning. If something didn’t change I would probably die.

My nephrologist doubled his efforts and urged me to get more involved in getting the hospital to allow me to do home hemodialysis. Eventually, after three years of CHD, with a fourth justified treatment added due to my medical condition, I got the word I was to start training for home hemodialysis. That changed my life! That saved my life! I could never thank my nephrologist enough for the role he’s played in my life.

I continue to be under his care. It’s different now because I am now the leader of my medical team. That’s what happens when one is successful with the home modality. I have learned so much about CKD5 since going home that I can now make recommendations to my nephrologist about my care and bounce ideas off of him. He became open to the idea of me changing for short daily treatments to nocturnal. This has even enhanced my life further. As much as I now know, I still need him… And it’s not because CMS regulations say I need him.
I diligently see him every month, and he gets paid for that. The proposed rules stipulate he must see me once a month to get paid. But! But life happens. For various reasons, no fault to him, I might have to cancel an appointment. Perhaps it’s a family obligation that causes me to miss an appointment. It might be my wife and I go away for a vacation. Or I might be sick. Or I might even have been hospitalized for a couple of days. The point is that based upon the proposed rule, he wouldn’t get paid because he didn’t see me that one day, even though he may be following my care the remainder of the month.

I don’t believe it’s fair to penalize him for my actions. Remember, I’m still relying on him. Being a nephrologist is a full time job. He must be available to deal with an issue during the entire month and not just the half hour block he may have set up for me to see him. Yet, the rule predicates payment for that one short period of time. Never mind the rest of the time. For those reasons, I don’t think a hard and fast rule should be present. As it is right now, it is too arbitrary without exception. Maintaining a relationship with my nephrologist is essential to my well being. I don’t want to see anything get in its way. If he doesn’t get paid because I’ve missed the monthly appointment, that’s a reason for him not to be able to give me his full attention when I need it.

Please reconsider this part of the new rules. Perhaps more flexibility can be put in. Maybe documentation can be made available of other encounters during the month. Perhaps that would be sufficient to indicate his ongoing care on my behalf. My life depends on him continuing to get paid.

Great letter, Rich. I hope others will take the time to write one and send it to the link at the bottom of Bill’s post. You guys are exactly who CMS needs to hear from on this.

Cross posted from DSEN

My Comment to CMS on the Proposed Physician Fee Schedule for MCP Physicians
By Bill Peckham

The deadline to submit comments on CMS’s proposed payment policies for the ESRD Monthly Capitation Payment to physicians who are following home dialyzors is NOW. Comments are due by 5PM EDT tomorrow, Tuesday August 24th. What follows are my comments on the proposed rule:

[INDENT]Dr. Donald Berwick
Administrator
Centers for Medicare and Medicaid Services

RE: Codes 90963-90966 under CMS-1503-P: Proposed Rule for Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2011

Dear Administrator Berwick:

Dr. Berwick when you were nominated to head CMS you were quoted saying something that is very wise:

[INDENT]The best health care is the very least health care we need to gain the long, full and joyous lives that we really want. The best hospital bed is empty, not full. The best CT scan is the one we don’t need to take. The best doctor visit is the one we don’t need to have.

Indeed.

Dr. Berwick you gave voice to my experience and something I believe is often true among people who use home dialysis. Missing an appointment can be a sign of health. Of success. The physician fee schedule should allow less than perfect adherence to the best practice of monthly visits. CMS should accommodate, rather than punish, success at home. I urge you to maintain current policy.

I live with stage 5 chronic kidney disease (CKD5), and have been a Medicare beneficiary under the ESRD Entitlement since 1988 when I had a preemptive transplant (I was 24 at the time; 46 today). My underlying condition - FSGS - recurred after just 26 months. Since September 1990 I have treated my kidney disease with hemodialysis (HD). Initially I used conventionally incenter HD but for the last nine years, since September 2001, I have enjoyed using a healthier, more frequent dose of HD in the comfort of my home.

I would like to offer a comment concerning the language, in Section C.1. (p 219-224) of the proposed rule, with its firm requirement for a monthly face-to-face visit as part of codes 90963-90966. I am a HD advocate and as a member, have joined a comment submitted by the Home Hemodialysis Workgroup, these additional comments are less big picture; based on my extensive personal experience.

I believe this no exceptions policy will be unfair to the dwindling number of MCP nephrologists willing to follow home patients.

I agree that it should be routine and is a medical best practice to see my MCP physician every month but a perfect attendance record is hard to achieve and unreasonable to expect. My doctor and I are in this for the long term – it would not have been fair if a 90% attendance record over the last nine years had resulted in my doctor not being paid a dozen times. Under the proposed rule my inability - due to travel, work, or family obligations - to keep an appointment would cause my doctor to pay a price. This is unfair.

Life happens. Particularly for those of us getting a higher dose of dialysis at home, it’s good news. We feel well enough that other elements of our lives have higher priorities than seeing our doctor. It is a sign of health and optimal dialysis when our medical needs are no longer our highest priority and we feel well enough to live the lives we were meant to live.

When I feel unwell or have medical issues to resolve I will give seeing my doctor a high priority. Month to month, seeing my doctor is given the priority of the routine: one of life’s tasks that needs to be done every month, like paying bills. That’s healthy. This rule would require that I give my doctor appointments the highest priority which is inappropriate.

I routinely organize my work schedule to accommodate an appointment (note as a union worker I’m off the clock when I am at the doctor’s office) but it is possible, and over a period of years likely, that my obligations as an employee, that my obligations to my employer, will trump the need to keep a routine doctor’s appointment. To make my doctor pay a price for this healthy situation would be unfair.

It would be doubly unfair because my doctor is following my care even when I miss the appointment. Every month, day in and day out he is available to me and my provider, he is still reading my labs and coordinating changes in my treatment with my unit. Given this baseline of work that occurs day in and day out it is not unreasonable to continue to support the MCP physicians of healthy, thriving patients when the patients miss their appointments.

CMS should accommodate, rather than punish, success at home. I urge you to maintain current policy

Thank you for your consideration.[/INDENT][/INDENT]

Hopefully the final rule will not do anything to limit access to home dialysis. You can submit your comment online.

So, how do you like Big Government Health Care now? I knew this kind of garbage was coming down the pike, where have we heard this before???

Mark, this topic has zip to do with “Big Government Health Care.” It’s just part of Medicare, which was already in place. And, I’ve never said I like the new plan–if anything, I’ve said I think it’s a terrible way to go. You are beating a dead horse.

Actually, Big Government should be trying to grt peole to do the best therapy available. In the case of dialysis, that means at home nocturnal. It so happens that at home nocturnal would cost less to the system than any other modality. Rather than looking at dialysis as just a treatment o maintain a person’s life who hqaas CKF, it should be rehabilitative and allow people to regain a more healthful and productive life. It should even put people back to work (if the jobs were available). In a case like this, dialyzors wouldn’t have to see their nephrologists as often as the stipulated once per month in person face-to-face appointment. In many other countries that have better outcomes, the health care system is based on a “socialized medicine” system where doctors get paid a salary and aren’t as money grubby with setting up as many appointments as possible with their patients. We may have a chronic illness, but that doesn’t mean we should be seeing our nephs every month. But they still are overseeing our care and, under our system, shouldn’t be penalized because their patient doesn’t show up the one time per month an appointment is set up.

I agree, Rich. My point about Big Government is that I agree with Rich, the government does not have any business mandating that we see the Nephrologist, once a month. For someone like me, it is not necessary. With ObamaCare, this foolishness is only going to get worse. Home Nocturnal is most cost effective, it has been proven time and again. Not every dialysis consumer needs to see the Nephrologist, once a month. Have read various reports that there will not be enough Nephrologists in the future, with profit, you could get rid of that problem. However, what the Nephrology field needs is competition, this is why prices are so outrageous, no competition. With profit, you creat a huge incentive for medical students to go into the field, creating oversupply and cutting costs. We see this in every other field, why not the Nephrology field? My Nephrologist in the past has only seen me once every 4-6 months, this new requirement is excessive and stupid. As we know, Government knows best. If a Nephrologist scheduled excessive appointments for me, they would be replaced.

Just to be clear, the proposal is not that you have to visit your doc or something would happen to you … the proposal is that if you don’t visit the doc she doesn’t get paid.

Ask yourself: if you were self paying would you pay your doc every month whether you saw her or not? Maybe you would but it isn’t obvious to most people and it isn’t obvious to Medicare. Which is why there are comment periods and why people should comment. There is no use in pretending this is a simple issue.

Actually, most of us already see our nephrologist once a month while we are on dialysis, so I don’t see this as much of any issue. Unfortunately, there are many dialysis units where the nurses run the entire show with the doctors mostly absent. If the docs would step and do what is right in the first place, minimal standards would not be needed. Greed has dominated the nephrology/dialysis community since the 1970s and it is now coming back to roost.

Greed? I am curious, when you worked as a physician, did you work for free? Profits enable large dialysis chains, such as DaVita to forgive outstanding bills. The average corporate profit, per year, is 6 percent. Davita’s profit rate per year, the last time I looked, was 5.1 percent(Wall Street Journal). Are they still greedy??? I think taking 41 percent of an individual’s paycheck is greedy.

Statistics Department: George Mason University:

“An important feature of relative risk is that it tells you nothing about the actual risk.” If physicians were not on the take from the drug industry, why does the drug industry spend over $20 billion per year to wine and dine physicians? The drug industry does not spend this amoun of money because they are nice people. Physicians proclaim that they cannot be bought, however, research says otherwise. In fact, most individuals become diabetics after the age of 50, according to many senior academic Endocrinologists. What the pushing of EPO on diabetics? Dr. Jerome Kassirer, Former Editor of the New England Journal of Medicine, Nephrologist, said there is not any clinical benefit of pushing EPO on diabetics.

Changing Standards for Diagnosis

In 1997, the American Diabetes Association (ADA) and the federal government lowered the per se standard for diagnosing diabetes from a fasting blood glucose level of 140 mg/dL to 126 mg/dL.7 The CDC’s Morbidity and Mortality Weekly Report notes that “the potential impact on the prevalence estimates of the change in diagnosis of diabetes adopted by the ADA in 1997 should be accounted for.” However, the CDC’s estimate of a 61 percent increase fails to account for changes in how diabetes is diagnosed.

The ADA’s “Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus” notes:
“Widespread adoption of the new criteria may, however, have a large impact on the number of people actually diagnosed with diabetes. Presently, about half the adults with diabetes in the U.S. are undiagnosed, but many might now be diagnosed if the simpler FPG [Fasting Plasma Glucose] test were always used.”
Doctors Steven Woolf and Stephen Rothemich from Virginia Commonwealth University report in the journal American Family Physician that among American adults this redefinition increased the number of diabetics by nearly 50 percent:
“Lowering the diagnostic threshold shifts the definition of diabetes into the central bulge of the bell curve where the glucose level of most Americans falls. Among U.S. adults 40 to 74 years of age who have not been diagnosed with diabetes, 1.9 million have fasting plasma glucose levels of 126 to 140 mg per dL (7.0 to 7.8 mmol per L), which is almost as many as the 2.2 million who have levels over 140 mg per dL (7.8 mmol per L). Under the new guidelines, at least 1 million Americans (and possibly more) with fasting plasma glucose levels of 126 to 140 mg per dL (7.0 to 7.8 mmol per L), who previously would have been told that they had normal (or impaired) glucose tolerance, will now be informed that they harbor a disease … The evidence used for the new diagnostic criteria is from epidemiologic studies cited by Mayfield that show a progressive increase in the risk of complications beginning with fasting plasma glucose levels as low as 110 to 120 mg per dL (6.1 to 6.7 mmol per L). There are three problems with basing the new policy on these data. First, other studies show no increase in risk at these low levels. Second, even if risk is increased, the new policy argues that having a risk factor (a mildly elevated fasting plasma glucose level) is tantamount to having a disease … Third, and most important, there is no prospective evidence that correcting these mild elevations improves health … Whether normalizing fasting plasma glucose levels in the range of 126 to 140 mg per dL (7.0 to 7.8 mmol per L) has a meaningful impact on patient outcomes is unknown.”
Case Western Reserve University professor Paul Ernsberger explains the implications of the ADA’s 1997 redefinition:
“Is the overall incidence of diabetes rising? It is difficult to say. This is because the standards for diagnosing diabetes have changed radically over the last 30 years. We have gone from measuring glucose in the urine to carrying out an elaborate procedure known as the oral glucose tolerance test and finally to relying solely on fasting blood glucose. The level defining diabetes was dropped from 140 to 126 mg/dL in the 1990s. Loosening the diagnostic standards greatly increased the number of people classified as diabetic. Also, screening for diabetes has been stepped up, and now most people over age 45 are supposed to be checked every 3 years. In contrast, the average fasting blood glucose level in the adult population is about 85 mg/dL, and this value has not changed in decades. If there truly were an epidemic of diabetes, the average blood glucose level would rise, just as the average body weight has risen.”
“Lowering the diagnostic threshold shifts the definition of diabetes into the central bulge of the bell curve where the glucose levels of most Americans falls”

My paycheck NEVER came from the same pool of money to pay for the patients treatments as do many of the dialysis units. I was essentially payed by the hour since we were paid according to 4 hour “W’s” of work. The patient’s services were paid through Kaiser Foundation Health which is separate from the Southern California Permanente Medical Group. I thus did not have incentives to cut corners to add to my paycheck.

Greed is indeed what has taken over dialysis care when nephrologists receive capitated payments for each patient and limiting patient’s supplies and time on the machine increases the payments to the nephrologist and to the dialysis center. In such, while I NEVER, EVER considered my own paycheck in all my years of practice when considering the best treatment option, many nephrologists and dialysis centers cannot say the same thing. You need not take my word for this, just go and read Dr. Belding Scribner’s comments on this subject.