KIDNEY STORIES ON BLOGGER: July 2014

JAMES MYERS

KELLER GRADUATE SCHOOL OF MANAGEMENT-ONLINE MGMT-520-60804

JULY 17, 2014

STATEMENT OF THE ISSUE AND FEDERAL REGULATION TO BE ADDRESSED

On or near the 4^th of July every year, Medicare Dialysis patients hold their breath a little, because it is around this time that the Centers for Medicare and Medicaid Services[i] issue its new proposed rules for how dialysis centers will be paid from Medicare for their services.

2014 was no exception. On or about July 2, 2014, CMS released its new rules concerning Medicare payments to dialysis facilities.[ii] The new proposed regulations raise several striking issues for kidney patients. This is a proposed big change because in past QIP rules[iii] and payments were not based on patient satisfaction and clinic performance. The new proposed rules would change that.

The issues that I see are:

1. The National Kidney Foundation has stated that the proposed regulations may hurt rural dialysis clinic due to the flat payments anticipated for 2015, no increase in Medicare payments to dialysis centers and in turn to service dialysis patients is proposed; will rural centers be forced to cut services and/or staff[iv]?

2. Is the proposal concerning reduced Medicare payments for readmission to the hospital within 30 days for the same condition fair to dialysis clinics who may not have as much control over readmissions as the hospital does[v]?

3. Is the proposal concerning anemia management too difficult for dialysis clinics to manage[vi]?

4. Is it reasonable to base Medicare payments to dialysis clinics on Patient Satisfaction[vii]?

QUESTIONS TO BE ADDRESSED

1. State The Administrative Agency That Controls The Regulation;

2. Explain Why This Agency And Your Proposed Regulation Interests You (Briefly). Will This Proposed Regulation Affect You, Or The Business In Which You Are Working? If So, How?

3. Describe The Proposal/Change;

4. Provide The "Deadline" By Which The Public Comment Must Be Made. (If The Date Has Already Passed, Please Provide When The Deadline Was);

5. Write The Public Comment That You Would Submit To This Proposal. If The Proposed Regulation Deadline Has Already Passed, Write The Comment You Would Have Submitted. Explain Briefly What You Wish To Accomplish With Your Comment.

6. Once You Have Submitted Your Comment, What Will You Be Legally Entitled To Do Later In The Promulgation Process (If You Should Choose To Do So)? (See The Textbook's Discussion Of The Administrative Procedure Act.)

7. If The Proposal Passes, Identify And Explain The Five Legal Theories You Could Use In An Attempt To Have (Any) Administrative Regulation Declared Invalid And Overturned In Court.

8. Which Of These Challenges Would Be The Best Way To Challenge The Regulation You Selected For This Assignment If You Wanted To Have The Regulation Overturned, And Why?

9. Conclusion

I. THE ADMINISTRATIVE AGENCY THAT CONTROLS THE REGULATION

In this case it is the Center for Medicare and Medicaid Services.[viii] They are responsible for making all of the rules for the Medicare ESRD program. [ix]

II. WHY THIS AGENCY AND YOUR PROPOSED REGULATION INTERESTS ME

First and foremost I am a dialysis patient, so whatever rules they make affects me directly. When your kidneys fail you have only 3 choices: dialysis, a kidney transplant or death.[x] I am on two transplant lists, at Indiana University and Rush Medical in Chicago.[xi] I am currently in my second year of dialysis. Secondly, I am a kidney advocate for my fellow kidney patients.[xii] I am the State of Indiana’s Advocate for the National Kidney Foundation, an Ambassador for the Dialysis Patient Citizens and an Ambassador for the PKD Foundation. [xiii] I am very active in the political community as I have been to Washington DC twice to advocate for my fellow patients, I frequently speak at Kidney Walks sponsored by the National Kidney Foundation of Indiana, and I run petitions online for new laws that could affect kidney patients throughout the United States.[xiv] I recently won an award from the Renal Network for my advocacy.[xv]

III. WILL THIS PROPOSED REGULATION AFFECT YOU, OR THE BUSINESS IN WHICH YOU ARE WORKING? IF SO, HOW?

Yes, I believe it will have affects both positive and negative. I take dialysis at a Fresenius clinic in Crown Point, Indiana.[xvi] The National Kidney Foundation has expressed concerns about the new regulations and rural clinics like mine:

“As expected, CMS proposes to keep payment for dialysis services relatively flat in 2015. However, proposed changes to how CMS calculates annual updates to payment will result in a cut to rural dialysis facilities by half a percent next year and likely another half percent in 2016. This is because CMS is proposing to use more recent information on dialysis facility costs to determine how much they should be paying dialysis facilities….

While basing payment on more recent costs may be a fairer way to control federal health care spending, it will result in lower payments to facilities in areas where wages are typically lower and a small increase to dialysis facilities in areas where wages are higher. Wages are typically lower in rural areas because the cost of living is also less. Unfortunately, on average, rural facilities are already losing money on treatments for patients who have only Medicare and/or Medicaid as their insurance. Some dialysis providers have indicated that in the face of flat and declining payments by Medicare, Medicaid and even by some private insurance companies, they may decide to close some of their clinics that are losing money.

While we expect overall access to dialysis facilities to remain stable in the near term, the National Kidney Foundation is concerned that providers may decide to close clinics that are in rural areas, causing patients in those areas to have to travel even further to obtain dialysis care. Longer travel times for dialysis have been associated with an increase in death and hospitalization because patients are more likely to miss treatments when they have more challenges getting to dialysis. CMS is giving the public 60 days to comment on the proposed rule. Over the next several weeks, NKF will evaluate the impact of the proposed rule on patients’ access to care; particularly in rural areas. We will then offer recommendations on how CMS can modify its proposal to make sure that patients are able to receive high quality dialysis care near their homes.[xvii]”

My concerns here are:

1. The proposal envisions a 0.5% cut to rural centers like mine. This would mean a cut back in services like social workers, dieticians, nurses and dialysis technicians to a point where the patient ratio to techs/nurses is a much more reduced level[xviii];

2. “One issue that patients will not have to worry about this time around is payment cuts to dialysis facilities. The base payment for 2015 will be the same as it is in 2014, due to a directive from Congress. That said the cost of care continues to increase, so even though payment remains the same, providers will be asked to do more with the same level of funding. At the same time, there are some adjustments to payment formula, increasing the weight accorded to labor costs (which vary geographically) and decreasing the weight accorded to drug costs (which are the same everywhere). This means that more of the overall dialysis budget will be directed to facilities in regions with a high cost of living, and less to areas with a low cost of living. This is expected to reduce payments to rural facilities by a little over one percent. DPC will be evaluating the effect that this could have on patient access in areas with low population density, while encouraging CMS to consider an unintended consequences.[xix]”

3. According to the NKF, due to past cuts where Medicare is already not paying the actual incurred costs, rural centers may close[xx];

4. The closings could then lead to a drastic relocation of patients. This could result in increased travel time and fuel costs when most of us are on Social Security Disability[xxi]. For example, I could be relocated to Lafayette[xxii] (78.41 miles away) or Indianapolis[xxiii] (138.8 miles away).

a. According to the NKF & the DPC, the CMS has proposed that Patient Satisfaction Surveys will no longer just be passed out to dialysis patients, but filled out and returned to be tabulated and scored for overall patient satisfaction.[xxiv] The idea behind this is that the Quality Incentive Program(QIP) will sets the performance standard for each dialysis clinic and penalizes those who do not meet or make progress towards those standards by cutting their payments by up to 2%.[xxv] The purpose is to incentivize providers to do a better job by tying payment to performance. Clinic are judged by making improvements against past records or they are judged by their peers and can be judged by improvements they make in comparison to other neighboring/local clinics.[xxvi] The goal is to achieve an acceptable score and receive their full payment. Deviations from the assigned score can cause cuts in payments that begin in increments of .5% (1/2 of a percent) to a maximum of 2%.[xxvii]

5. Nowhere is this more evident than in Proposal #1 concerning Patient Satisfaction. If the proposed rule is finalized, results from the CAHPS[xxviii] survey would be tabulated and used to set payment. This should incentivize facilities to improve their environment and amplify the patients’ voice when giving feedback on their experience.[xxix]

6. Once you take the survey, beginning next year in 2015, instead of just giving you the survey or suffering a penalty for not giving it, the new CMS rule proposes that the results be tabulated and they will compare them against the results in 2016 to adjust payments in 2017 & 2018. Questions like how frequent is your access with your nephrologist? How satisfied are you with the service at your clinic? Your answers to these survey questions will be reduced to a score for each facility and the lowest score among your neighboring facilities, and that will count vs them in their total performance score. This in turn could lead to a reduction in payments.[xxx]

7. Medicare has done this in their Pay For Performance programs in hospitals[xxxi] In the hospital, if you are randomly selected for the CAHPS survey, that could result in the hospital getting a reduction in Medicare payment or a bonus.[xxxii]

8. The Result: once these surveys began to count for money, the hospitals were more diligent and gave better service.[xxxiii]

This is the rationale for applying this to dialysis clinics, to raise the standard and quality of care for Medicare dialysis patients. The idea is that if clinic patient satisfaction counts towards payment, the quality of service will improve. It is a way to make the patients voice heard in a more direct and tangible manner.[xxxiv] This is one I agree with.

9. Proposal #2 deals with Anemia Management. Anemia occurs when your body does not have enough iron.[xxxv] This is a particular issue for ESRD patients on dialysis, because your kidneys make iron cells, but when your kidneys fail, they no longer make enough iron to sustain you without medication.[xxxvi] In my experience, I am administered Epogen for this purpose at the dialysis lab.[xxxvii]

10. A little history is necessary to explain this proposal. The initial QIP programs included measures on how well dialysis facilities kept the hemoglobin[xxxviii] reading of patients in a certain range. The lower limit was eliminated years ago. Observers felt that the clinic should not be graded on a lower limit but rather whether the patient needed a blood transfusion.[xxxix] The new rule proposes to monitor the transfusion rate for each facility and to penalize the group that has a disproportionate level of transfusions.[xl] The Solution is to measure the transfusion rate of a facilities’ patients. If a particular clinic had a disproportionately high rate of transfusions, this would result in a penalty.[xli] This gives facilities the incentive to make sure they give everybody the adequate dosage.[xlii] This is another proposal I agree with.

11. Proposal #3 deals with Hospital Readmissions. Of the three proposals, this one may be the most controversial. This proposal refers to hospital readmission rates.[xliii] In a hospital setting, if a Medicare patient is discharged, and within 30 days readmitted for the same ailment, the hospital is penalized by Medicare in terms of its payment.[xliv] The CMS want to bring this same procedure to dialysis centers and Medicare patients. [xlv]

The rule proposes that dialysis centers would be penalized based on readmissions.[xlvi] Dialysis centers are already screaming foul as it is their position that this is not their responsibility.[xlvii] Hospitals have hired a case manager to prevent readmissions and subsequent cuts to Medicare payments. Clinics have no such person and no money to do that.[xlviii] Hospitals check with the patient at home, and if necessary make appointments with the doctor or pharmacist to make sure medications prescribed are compatible. [xlix] This part if the proposal is considered to be controversial because the dialysis centers may not have the responsibility or control over the patient’s health in the same way as one’s doctors or hospitals might. The hospital knows when they discharge you and dialysis clinic may not. They usually find out a few days later when the patient comes to the clinic.[l] For this reason, the National Quality Forum[li], a group that evaluates and debates quality measures, failed to approve proposal number three, as they could not come to a consensus.[lii]

There is a second line of controversy that goes with this proposal. Currently, the readjustment basis for hospitals does not take into account the socioeconomic status of the patient[liii]. The hospitals getting hit the hardest by penalties are poorer or in poorer areas, health and life expectancy of their patients is lower and morbidity is higher.[liv] The NQF held that Medicare Hospital penalties need to be adjusted for socioeconomic status for hospitals, however; this is still an open question for dialysis clinics.[lv]

IV. DESCRIBE THE PROPOSAL/CHANGE

The basic proposal contains 3 parts[lvi]:

a. Patient experience

b. Anemia Management

c. Hospital Readmissions Rate

The rules and objections have been discussed in detail in the above section. The rationale for the changes are:

“Last week, the Centers for Medicare and Medicaid Services (CMS) released its Proposed Rule specifying how dialysis facilities will be paid in 2015 and beyond. Most of the proposed changes relate to the Quality Improvement Program for dialysis. The Quality Improvement Program (QIP) sets performance standards for each clinic and penalizes clinics that do not meet or make progress toward the standards by cutting their payments by up to two percent. The purpose is to incentivize providers to do a better job by tying their pay to performance.[lvii]”

V. PROVIDE THE "DEADLINE" BY WHICH THE PUBLIC COMMENT MUST BE MADE. (IF THE DATE HAS ALREADY PASSED, PLEASE PROVIDE WHEN THE DEADLINE WAS).

According to the NKF, there are 60 days from July 1, 2014 to comment on the rule.[lviii]

VI. WRITE THE PUBLIC COMMENT THAT YOU WOULD SUBMIT TO THIS PROPOSAL. IF THE PROPOSED REGULATION DEADLINE HAS ALREADY PASSED, WRITE THE COMMENT YOU WOULD HAVE SUBMITTED. EXPLAIN BRIEFLY WHAT YOU WISH TO ACCOMPLISH WITH YOUR COMMENT.

In my comment, I am assuming the letter is send by regular mail.

Marilyn Tavenner,

Administrator,

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-1614-P,

P.O. Box 8010,

Baltimore, MD 21244-8010.

Madame Administrator:

I am writing to you today to comment on Proposed Regulation, CMS-1614-P. My name is James Myers. I am from Crown Point, Indiana. I am a patient at a small town clinic, Fresenius Medical Center, Crown Point. I am a dialysis patient and a kidney advocate.

I have several objections to the proposed new rules for Medicare payments to dialysis centers. First, the proposal envisions a 0.5% cut to rural centers like mine. This would mean a cut back in services like social workers, dieticians, nurses and dialysis technicians to a point where the patient ratio to techs/nurses is a much more reduced level.

Secondly, as, the cost of care continues to increase, even though payment remains the same, providers will be asked to do more with the same level of funding. At the same time, there are some adjustments to payment formula, increasing the weight accorded to labor costs (which vary geographically) and decreasing the weight accorded to drug costs (which are the same everywhere). This means that more of the overall dialysis budget will be directed to facilities in regions with a high cost of living, and less to areas with a low cost of living. This is expected to reduce payments to rural facilities by a little over one percent. The effect that this could have on patient access in areas with low population density, could be closings, which in turn require patients to travel great distances at additional costs, an unintended consequence.

Thirdly, concerning the proposal on hospital readmissions, I have two objections. I believe it is unfair to hold a dialysis center to the same standards as a hospital. I do not believe it is fair to penalize dialysis clinics for readmissions within 30 days times as they have neither, the personnel or the cash to constantly monitor their patients. All too frequently, the clinic is the last to know when an individual has been discharged. They just do not have the control or ability to follow up with a patient in this manner. The National Quality forum was unable to acquire a consensus on this item in the proposal for that reason.

Fourth, the proposal does not take into account the socioeconomic status of either the patient or the clinic. This experiment with hospitals have shown that care providers in poorer areas are the ones who more frequently suffer the penalties.

Fifth, for these reasons, the issues raised with the Medicare reimbursement not only affect the clinics, but also Medicare patients. As you know, most dialysis patients are Medicare patients. The costs of additional travel and loss of services that keep dialysis patients healthy are being put in jeopardy. Having ESRD is challenging enough; making dialysis and preventive patient services more difficult to obtain leads to poorer health for dialysis patients and in some cases, even death. 400,000 of us depend on CMS to protect us while we are on dialysis. This is the greatest failure of these proposed rules.

Very truly yours,

James W. Myers, III

Advocate for the National Kidney Foundation for the State of Indiana

Ambassador for the Dialysis Patient Citizens

Ambassador for the PKD Foundation

VII. ONCE YOU HAVE SUBMITTED YOUR COMMENT, WHAT WILL YOU BE LEGALLY ENTITLED TO DO LATER IN THE PROMULGATION PROCESS (IF YOU SHOULD CHOOSE TO DO SO)?

Once you have written a comment for the agency, you then have the right to intervene in a formal adjudication.[lix]

“Pursuant to 5 USCS § 702, a person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof. The Administrative Procedure Act confers a general cause of action upon persons adversely affected or aggrieved by an agency action within the meaning of a relevant statute, but restricts that cause of action if the relevant statute precludes judicial review. While the standing requirements imposed by U.S. Const. art. III require a plaintiff to suffer a sufficient injury in fact, § 10 of the Administrative Procedure Act, requires that the plaintiff also demonstrate that s/he has prudential standing. For a plaintiff to have prudential standing under the APA, the interest sought to be protected by the complainant must be arguably within the zone of interests to be protected or regulated by the statute in question.[lx]”

In other words, by sending a complaint, you have put the agency on notice, and in my opinion, like filing a notice of tort claim in a state court, you now have the right to be a part of the future adjudication should one ever take place.[lxi]

VIII. IF THE PROPOSAL PASSES, IDENTIFY AND EXPLAIN THE FIVE LEGAL THEORIES YOU COULD USE IN AN ATTEMPT TO HAVE (ANY) ADMINISTRATIVE REGULATION DECLARED INVALID AND OVERTURNED IN COURT.

There are five legal theories that can be used to attempt to declare an administrative regulation invalid. They are:

“The reviewing court shall ... hold unlawful and set aside agency action, findings, and conclusions found to be -

(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;

(B) contrary to constitutional right, power, privilege, or immunity;

(D) without observance of procedure required by law;

(E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or

(F) Unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court.

In making the foregoing determinations, the court shall review the whole record or those parts of it cited by a party, and due account shall be taken of the rule of prejudicial error.[lxii]”

IX. WHICH OF THESE CHALLENGES WOULD BE THE BEST WAY TO CHALLENGE THE REGULATION YOU SELECTED FOR THIS ASSIGNMENT IF YOU WANTED TO HAVE THE REGULATION OVERTURNED, AND WHY?

The methods of challenge need to be discussed and compared to find the correct one to choose. There are three standards of review:

(1) Substantial evidence; (2) arbitrary and capricious; and (3) statutory interpretation[lxiii].

The substantial evidence theory of review is used when there is a formal rulemaking and formal adjudication.[lxiv] Recent evidence suggests that it can be used in adjudicating the more informal rule coming from the informal rule making process.[lxv] Under this standard, courts are required to uphold this rule if it is found that the agency’s decision is “reasonable, or the record contains such evidence as a reasonable mind might accept as adequate to support a conclusion.[lxvi]" Agency actions that are invalidated by substantial evidence review are typically abandoned[lxvii].

The "arbitrary and capricious" standard is mainly applied to informal rulemakings like the one in this instance.[lxviii] Under this standard, the agency must provide a satisfactory explanation for its actions, there must be a “rational connection between facts and judgment . . . to pass muster under the 'arbitrary and capricious' standard.[lxix]"

It would be my position that portions of the proposed new rule are arbitrary and capricious because there is not a rational basis between the facts and the judgment.

Those portions of the rule are:

1. The portion of the proposed rule that leaves payments flat has a tremendous effect on rural dialysis clinics and their Medicare patients. First there is a 0.5% deduction to what is being paid to rural clinics. When you add this to the deductions required by the Fiscal Cliff and Medicare Bundling, this is particularly devastating[lxx]. At this point, many rural clinics are already paid a fee by Medicare that does not meet their actual costs.[lxxi] This in turn leads to clinics cutting hours and services and in the severest of circumstances closing clinics.[lxxii] The costs to disenfranchised dialysis patients is immeasurable. Lengthening travel distances could cause people to skip dialysis due to costs. This in turn leads to increased illness or even death. In the words of the National Kidney Foundation:

In previous years, CMS used 2008 cost information, but facility costs have changed in recent years. In 2011, Medicare payment for dialysis services, staff wages, and drugs were bundled together into one payment. According to CMS, dialysis facilities are now spending less on drugs, but more on staff wages than in 2008. Therefore, CMS is proposing to weigh payment more heavily on staff wages and reduce the weight on drugs.

Impact on Rural Dialysis Facilities

2. Proposal 3, concerning Hospital Readmissions Rates has major issues:

(1) There was significant division over whether dialysis facilities are in a good position to prevent readmission of their patients, because often they are not notified that a patient was in the hospital, nor given access to hospital medical records. By contrast, hospitals often have a staff member dedicated to discharge follow-up and can arrange appointments with the nephrologist when the patient is discharged[lxxiv].

(2) The proposed rules do not take into account the socioeconomic status of the dialysis clinic or the patient[lxxv]. The hospital version of the rule has shown that poorer clinic with poorer locations are penalized the most frequently. The rule is not rationally related to its purpose and violates Due Process and Equal Protection.[lxxvi]

X. CONCLUSION

When the CMS makes rules that apply to dialysis clinics, the inevitable justification that you hear is that dialysis chains like Fresenius or DaVita are making such incredible profits, that they can handle a reduction in payment. What the CMS forgets is that we as dialysis patients cannot handle such a reduction where services are lost, clinics closed or are consolidated, travel to dialysis becomes increasing difficult or under predictable circumstances, impossible. We did not ask for kidney failure; 26 million Americans suffer from chronic kidney disease[lxxvii] and 400,000 of us rely on dialysis to sustain life.[lxxviii] 86% of all dialysis patients are Medicare[lxxix]. Kidney failure is thrust upon us and dialysis keeps us alive. Experts have told me that as little as 4 days without dialysis could cause death for some patients.[lxxx] There are over 100,000 of us now waiting for a kidney transplant and last year they transplanted only 14,000[lxxxi]. Every day 18 of on the waiting list die.[lxxxii] I have spoken to a representative from the CMS who accused me of frightening people. I don’t frighten anyone; I advocate on behalf of the people who are not as fortunate as me, who live in a nursing home, come to dialysis every other day in an ambulance, walk with a cane or a walker, have the mental acuity of a 10 year old, have the added complication of diabetes, congestive heart failure, amputations. I am not exaggerating when I tell you that every time I take dialysis this is what I witness. One thing I am very sure of. I am right; I am on the right side of history.

You want to know what frightens me? Check out these articles about the CMS’s recent proposal to force dialysis patients to choose between staying at the dialysis center and receiving life-saving dialysis or going to hospice where Medicare will no longer pay for dialysis:

CMS New Proposal Makes Chronic Kidney Disease Patients Choose Between Dialysis And Hospice Care, http://www.kidneybuzz.com/cms-new-proposal-makes-chronic-kidney-disease-patients-choose-between-dialysis-and-hospice-care/ (July14, 2014). See also: End of Life Decisions for Dialysis Patients: Update on Proposed Medicare Rule, http://nkfadvocacy.wordpress.com/2014/07/08/end-of-life-decisions-for-dialysis-patients-update-on-proposed-medicare-rule/ (July 8, 2014).

“Currently dialysis patients who have a terminal illness that is unrelated to their kidney failure can choose to enter hospice care and still receive dialysis paid for by Medicare. However, under a proposal by the Centers for Medicare & Medicaid Services (CMS), this policy could change. That’s because CMS is proposing to expand the definitions for terminal illness and related care, which could effectively require hospice providers to pay for dialysis under their current payment even when the patient may be dying of another condition or disease unrelated to their kidney failure. However, the Medicare payment for Hospice is not enough to cover dialysis treatments in addition to other treatments terminally ill patients need. Therefore, it is unlikely that most hospice providers will cover dialysis care, leaving patients and their families to choose between giving up dialysis and entering hospice or continuing to dialyze, but give up the supportive care and psychological benefits that hospice providers deliver.

A recent study published in the American Journal of Kidney Disease highlights the difficulty patients and families experience when faced with the decision to withdraw from dialysis. The article also suggests that differences in decision making for withdrawing from dialysis may also be attributed to cultural beliefs and customs. This study is an example of how dialysis patients could benefit from the psychological support that hospice care can provide to patients and their families.

In comments to CMS on this proposal, NKF stated that dialysis patients should receive an exception from the CMS proposal and be allowed to have Medicare pay separately for dialysis treatment and hospice care. Doing so would provide the patient with a terminal illness with access to hospice benefits while also continuing to receive dialysis. End of life decisions are not easy for anyone involved, and CMS should not be implementing payment policies that force a patient to suffer unnecessarily.” (Emphasis added).

Now, I’m scared. Do you understand now why many kidney advocates dread the 4^th of July?

ENDNOTES

[i] http://cms.hhs.gov/ (Accessed 2014); https://www.cms.gov/Medicare/Medicare.html (Accessed 2014); https://www.cms.gov/Medicare/End-Stage-Renal-Disease/ESRDGeneralInformation/index.html (Accessed 2014)(CMS is the administrative body that controls the ESRD program for Medicare including payments to dialysis centers for Medicare patients).

[ii] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014). See also: Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014).

See Generally: ESRD Quality Incentive Program, What is the ESRD QIP? http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/ (Accessed 2014)(An explanation of how the QIP program works)(“ The Centers for Medicare & Medicaid Services (CMS) administers the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) to promote high-quality services in outpatient dialysis facilities treating patients with ESRD. The first of its kind in Medicare, this program changes the way CMS pays for the treatment of patients with ESRD by linking a portion of payment directly to facilities’ performance on quality of care measures. These types of programs are known as “pay-for-performance” or “value-based purchasing” (VBP) programs.”).

[iii] http://www.dialysisreports.org/ (Accessed 2014)

[iv] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014)(“ While basing payment on more recent costs may be a fairer way to control federal health care spending, it will result in lower payments to facilities in areas where wages are typically lower and a small increase to dialysis facilities in areas where wages are higher. Wages are typically lower in rural areas because the cost of living is also less. Unfortunately, on average, rural facilities are already losing money on treatments for patients who have only Medicare and/or Medicaid as their insurance. Some dialysis providers have indicated that in the face of flat and declining payments by Medicare, Medicaid and even by some private insurance companies, they may decide to close some of their clinics that are losing money.”); Small pay increase for dialysis clinics in proposed rule for 2015, http://www.nephrologynews.com/articles/110311-small-pay-increase-for-dialysis-clinics-in-proposed-rule-for-2015 (July 3, 2014)(“ rural facilities will receive a decrease of 0.5%”); Kidney Care Community Plans Careful Review of CMS' Proposed Rule with Goal of Ensuring Continued Quality Improvement and Economic Stability, http://www.wfmj.com/story/25938114/kidney-care-community-plans-careful-review-of-cms-proposed-rule-with-goal-of-ensuring-continued-quality-improvement-and-economic-stability (Accessed 2014)(“ Medicare reimbursement for dialysis care is not keeping pace with the rising costs of delivering quality health care to individuals with kidney disease," said Dr. Edward R. Jones, Chair of KCP. "While the proposed rule implemented Congressional intent by modifying deep cuts planned for 2015, many dialysis facilities continue to face economic hardship."); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula, (Accessed 2014)(“ That said the cost of care continues to increase, so even though payment remains the same, providers will be asked to do more with the same level of funding. At the same time, there are some adjustments to payment formula, increasing the weight accorded to labor costs (which vary geographically) and decreasing the weight accorded to drug costs (which are the same everywhere). This means that more of the overall dialysis budget will be directed to facilities in regions with a high cost of living, and less to areas with a low cost of living. This is expected to reduce payments to rural facilities by a little over one percent.”).

[v] Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 14, 2014)(“ CMS is proposing to hold dialysis facilities accountable for the percentage of their patients that are readmitted to the hospital, for nearly any reason, within 30 days of being discharged. The intent of this measure is to encourage facilities with higher than average readmissions, to go beyond their facility walls and work to improve communication with the hospital and the patients’ other health care providers.”); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014)(“ The new rule proposes that dialysis facilities will also be penalized for hospital readmissions of their patients”); CMS releases proposed ESRD QIP measures, http://www.nephrologynews.com/articles/110310-cms-releases-proposed-esrd-qip-measures (July 3, 2014); CMS Proposes Slight Increase in ESRD Payments for CY 2015, https://www.aamc.org/advocacy/washhigh/highlights2014/385172/071114cmsproposesslightincreaseinesrdpaymentsforcy2015.html (July 14, 2014).

[vi] Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); Video, Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014)(11:43); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014)(“… the new rule proposes to monitor the transfusion ratio for each facility and penalize those facilities whose patients are disproportionately requiring transfusions.”)

[vii] Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014)(“ CMS proposes to review responses from the In-centered Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey and score facilities based on patients’ responses to questions related to their nephrologists’ communication and caring, the quality of their dialysis centers care and operations, and how well the facility provides information to patients. It would also include a score related to patients’ overall feeling about the nephrologist, dialysis facility staff and dialysis facility. The idea is to ensure that facilities are motivated to address issues of concern to patients in order to improve patients’ satisfaction and experience.”); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014)(“ For several years now, dialysis facilities have administered the “CAHPS” survey to patients. However, under current regulations, dialysis facilities are only required to give the survey; poor results are not held against the facility in determining the payment. If the proposed rule is finalized, survey results would be tabulated and used to set payment.

In Medicare’s pay-for-performance system for hospitals, CAHPS survey results count toward bonuses and penalties. On the hospital side, observers have taken notice that hospitals are behaving much differently now that patient surveys affect their payment.

Counting the survey results could help to amplify the patients’ voice when giving feedback in their clinics.”); 2014 ESRD final rule: key components, www.asn-online.org/.../tab_04b_esrd_o, (Accessed 2014); Medicare ESRD Payments To Be Flat in 2015, http://www.medpagetoday.com/Nephrology/ESRD/46656?xid=nl_mpt_DHE_2014-07-08&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ST&eun=g532215d0r&userid=532215&email=ealmond%40schmidtpa.com&mu_id=5655223&utm_term=Daily%20Headlines%20IP%20Warming (July 10, 2014).

[viii] http://cms.hhs.gov/ (Accessed 2014); https://www.cms.gov/Medicare/Medicare.html (Accessed 2014); http://www.cms.gov/Research-Statistics-Data-and-Systems/Research-Statistics-Data-and-Systems.html (Accessed 2014).

[ix] 42 CFR 413.210 - Conditions for payment under the end-stage renal disease (ESRD) prospective payment system, http://www.law.cornell.edu/cfr/text/42/413.210 (Accessed 2014); 42 CFR 417.423 - Special rules: ESRD and hospice patients, http://www.law.cornell.edu/cfr/text/42/417.423 (Accessed 2014); http://www.cms.gov/Center/Special-Topic/End-Stage-Renal-Disease-ESRD-Center.html, (Accessed 2014). See Generally: http://innovation.cms.gov/initiatives/comprehensive-esrd-care/ (Accessed 2014) (“The Comprehensive ESRD Care initiative was designed to identify, test, and evaluate new ways to improve care for Medicare beneficiaries with End-Stage Renal Disease (ESRD). Through the Comprehensive ESRD Care initiative, CMS will partner with health care providers and suppliers to test the effectiveness of a new payment and service delivery model in providing beneficiaries with patient-centered, high-quality care.”); http://www.medicare.gov/people-like-me/esrd/esrd.html (Accessed 2014); http://www.medicare.gov/people-like-me/esrd/getting-medicare-with-esrd.html (Accessed 2014); https://www.cms.gov/Medicare/End-Stage-Renal-Disease/ESRDGeneralInformation/index.html (Accessed 2014).

[x] http://kidney.niddk.nih.gov/KUDiseases/pubs/choosingtreatment/index.aspx#fail (Accessed 2014); http://www.choosingwisely.org/doctor-patient-lists/chronic-kidney-disease/ (Accessed 2014); http://dpcedcenter.org/what-are-my-options-if-i-have-kidney-failure (Accessed 2014).

[xi] http://iuhealth.org/transplant/ (Accessed 2014); http://www.rush.edu/rumc/page-1230579852739.html (Accessed 2014).

[xii] Davich, Dialysis patients drained by proposed budget cut, http://posttrib.suntimes.com/news/davich/21770756-452/jerry-davich-dialysis-patients-drained-by-proposed-budget-cut.html#.U8k0Yukg9jo (July 13, 2013); http://www.nwitimes.com/news/opinion/columnists/guest-commentary/jim-myers/image_36907def-92ad-5412-95c0-aed42c3a3bc3.html (December 31, 2013); Myers, GUEST COMMENTARY: Early detection is important for chronic kidney disease, http://www.nwitimes.com/news/opinion/columnists/guest-commentary/guest-commentary-early-detection-is-important-for-chronic-kidney-disease/article_dc5e4853-7f39-5c98-82b0-3bbafc4bbd35.html (December 31, 2013); Myers, Maureen O’Brien — Kidney Pioneer & Hero, http://www.dialysispatients.org/blog/maureen-o%E2%80%99brien-%E2%80%94-kidney-pioneer-hero (June 24, 2013).

[xiii] http://kidneystoriesblog.wordpress.com/2013/02/24/kidney-stories-james-myers/ (Accessed 2014)

[xiv] https://www.change.org/petitions/withdraw-the-proposed-cuts-to-dialysis-centers-and-esrd-patients (Accessed 2014); https://www.change.org/petitions/congressional-kidney-caucus-pass-h-r-4814-the-chronic-kidney-disease-improvement-in-research-and-treatment-act (Accessed 2014).

[xv] http://www.therenalnetwork.org/index.php (Accessed 2014).

[xvi] http://www.ultracare-dialysis.com/dialysis-centers/indiana/crown-point/851-w-burrell-dr-46307/8732.aspx (Accessed 2014).

[xvii] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, https://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014); Small pay increase for dialysis clinics in proposed rule for 2015, http://www.nephrologynews.com/articles/110311-small-pay-increase-for-dialysis-clinics-in-proposed-rule-for-2015 (July 3, 2014); ESRD Quality Incentive Program (QIP), http://www.nephrologynews.com/topics/6024-esrd-quality-incentive-program-qip (July 3, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014).

[xviii] Chronic dialysis nurse/patient ratio, http://allnurses.com/dialysis-renal-urology/chronic-dialysis-nurse-536985.html (Accessed 2014)(“ the general norm is 4 pts to each tech & 25 patients for 1 nurse”); 6 to 1 ratio patient to tech in PORTLAND OREGON DSI!!!!, http://forums.homedialysis.org/threads/1928-6-to-1-ratio-patient-to-tech-in-PORTLAND-OREGON-DSI!!!! (October 13, 2008); Staff Ratio in dialysis units, http://allnurses.com/dialysis-renal-urology/staff-ratio-dialysis-491173.html (Accessed 2014)(“ The usual ratios:

Techs - 4-5 pts/tech, RNs - 10-15 pts/RN”).

[xix] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014).

[xx] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, https://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014);

[xxi] Id.

[xxii] MapQuest, http://www.mapquest.com/#bee923e39c6e3c518e835281 (Accessed 2014).

[xxiii] MapQuest, http://www.mapquest.com/#c689dc65cf258a3bb9d74fac (Accessed 2014)

[xxiv] Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, https://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014).

[xxv] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014).

[xxvi] Id.

[xxvii] Id.

[xxviii] https://cahps.ahrq.gov/ (Accessed 2014); About CAHPS, https://cahps.ahrq.gov/about-cahps/index.html (Accessed 2014)(“ Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys ask consumers and patients to report on and evaluate their experiences with health care. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services. CAHPS originally stood for the Consumer Assessment of Health Plans Study, but as the products have evolved beyond health plans, the name has evolved as well to capture the full range of surveys. The acronym "CAHPS" is a registered trademark of the Agency for Healthcare Research and Quality (AHRQ)”).

[xxix] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014).

[xxx] Id.

[xxxi] http://www.medicare.gov/hospitalcompare/linking-quality-to-payment.html?AspxAutoDetectCookieSupport=1 (Accessed 2014); http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Quality_Measures_Standards.html; http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=78. (Accessed 2014).

[xxxii] Id.

[xxxiii] Id.

[xxxiv] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, https://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014)(“ CMS proposes to review responses from the In-centered Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey and score facilities based on patients’ responses to questions related to their nephrologists’ communication and caring, the quality of their dialysis centers care and operations, and how well the facility provides information to patients. It would also include a score related to patients’ overall feeling about the nephrologist, dialysis facility staff and dialysis facility. The idea is to ensure that facilities are motivated to address issues of concern to patients in order to improve patients’ satisfaction and experience.”).

[xxxv] Iron Deficiency Anemia, http://www.webmd.com/a-to-z-guides/iron-deficiency-anemia-topic-overview (Accessed 2014).

[xxxvi] Anemia Management and Chronic Kidney Disease, http://www.davita.com/kidney-disease/overview/treatment-overview/anemia-management-and-chronic-kidney-disease/e/4840 (Accessed 2014).

[xxxvii] Id. http://www.epogen.com/ (Accessed 2014).

[xxxviii] Definition of hemoglobin: a red protein responsible for transporting oxygen in the blood of vertebrates. http://www.nlm.nih.gov/medlineplus/ency/article/003645.htm, (Accessed 2014); Normal hemoglobin range for dialysis patients: http://www.uptodate.com/contents/anemia-of-chronic-kidney-disease-target-hemoglobin-hematocrit-for-patients-treated-with-erythropoietic-agents (Accessed 2014)(a mean Hgb level among dialysis patients of 12.0 g/dL [4,5]; two-thirds of all patients had Hgb levels between 11 and 13 g/dL).

[xxxix] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, https://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014). In my experience, I have had blood transfusions when I have dropped below the level of 7.0 g/dL. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2572297/ (Accessed 2014).

See Generally: ii. https://www.kidney.org/professionals/kdoqi/guidelines_updates/doqiupan_ii.html (Accessed 2014); http://kidney.niddk.nih.gov/kudiseases/pubs/anemia/ (Accessed 2014).

[xl] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, https://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014)(“ Currently, dialysis facilities are penalized for patients who are prescribed an Erythropoietin Stimulating Agent (ESA) and have a hemoglobin <12g/dl. CMS proposes to remove this as a measure in the QIP. In the past, this measure was included to ensure that facilities were not prescribing too much of an ESA. However, very few facilities have patients who are taking an ESA and have a hemoglobin greater than 12g/d so CMS believes the measure is no longer necessary. However, to ensure that facilities are still properly treating anemia with ESAs, when appropriate, CMS is proposing to penalize facilities that have a high number of patients who receive a blood transfusion. This measure is intended to ensure that facilities provide proper anemia management and do not subject patients to unnecessary blood transfusions which pose risks that can make it harder for patients to find a kidney donor.”).

[xli] Id.

[xlii] : http://www.rockwellmed.com/therapeutic-anemia-kidney-disease-treating-dialysis-patients.htm (Accessed 2014)( i. Hemodialysis patients lose up to 5-7 mg of iron during each dialysis treatment, which is a primary contributor to their anemia. There is also an increased need for their iron level to be maintained within the hemoglobin range to maximize the response to erythropoiesis-stimulating agent (ESA). Because oral iron supplementation generally is ineffective due to patient noncompliance and gastrointestinal adverse effects, most dialysis patients receive intravenous (IV) iron to help maintain sufficient iron stores. However, IV iron is stored in the liver which is toxic, causing inflammation or infection, and is also dosed infrequently, which can impede the ESA’s ability to be fully utilized.).

[xliii] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

[xliv] Id. Readmissions Reduction Program, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html (Accessed 2014); Hospital readmissions reduction program, http://www.medicare.gov/hospitalcompare/readmission-reduction-program.html (Accessed 2014); Rau, Armed With Bigger Fines, Medicare To Punish 2,225 Hospitals For Excess Readmissions, http://www.kaiserhealthnews.org/stories/2013/august/02/readmission-penalties-medicare-hospitals-year-two.aspx (August 2, 2013).

[xlv] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

[xlvi] Id.

[xlvii] Id.

[xlviii] Id.

[xlix] Video: Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014).

[l] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

[li] http://www.qualityforum.org/Home.aspx (Accessed 2014).

[lii] http://www.qualityforum.org/News_And_Resources/Endorsement_Summaries/Endorsement_Summaries.aspx (Accessed 2014).

[liii] Hu, Socioeconomic Status And Readmissions: Evidence From An Urban Teaching Hospital, http://content.healthaffairs.org/content/33/5/778.abstract (Accessed 2014)( Patients living in high-poverty neighborhoods were 24 percent more likely than others to be readmitted, after demographic characteristics and clinical conditions were adjusted for.)

[liv]New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

[lv] Id.

[lvi] Id.

[lvii] New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014).

[lviii]New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (July 1, 2014); Dialysis Patient Citizens, July Policy Update, https://www.youtube.com/watch?v=0AfeGFk7rek&feature=youtu.be (July 8, 2014). See also:

[lix] The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lx] Dismas Charities, Inc. v. United States DOJ, 401 F.3d 666 (6th Cir. Ky 2005) http://administrativelaw.uslegal.com/judicial-review-of-administrative-decisions/standing-under-federal-administrative-procedure-act/#sthash.xu5jVVZV.dpuf (Accessed 2014).

[lxi] Id.

[lxii] 5 U.S.C. § 706(2), Burrows, A Brief Overview of Rulemaking and Judicial Review, www.wise-intern.org/orientation/documents/CRSrulemakingCB.pdf (January 4, 2011); The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014); Kubasek, N.K., Brennan, B.A., & Browne, M.N. (2010). The Legal Environment of Business, 6th ed. Upper Saddle River, NJ: Pearson Education, Inc., pg. 484-85. (“the congressional delegation of legislative authority in the enabling act was unconstitutional because it was too vague and not limited;

an agency action violated a constitutional standard, such as the right to be free from unreasonable searches and seizures under the Fourth Amendment (for example, if an agency such as OSHA promulgated a rule that allowed its inspectors to search a business property at any time without its owners’ permission and without an administrative search warrant, that rule would be in violation of the Fourth Amendment); and

the act of an agency was beyond the scope of power granted to it by Congress in its enabling legislation.”).

[lxiii] 5 U.S.C. § 706(2), Burrows, A Brief Overview of Rulemaking and Judicial Review, www.wise-intern.org/orientation/documents/CRSrulemakingCB.pdf (January 4, 2011); The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014); Kubasek, N.K., Brennan, B.A., & Browne, M.N. (2010). The Legal Environment of Business, 6th ed. Upper Saddle River, NJ: Pearson Education, Inc., pg. 484-85.

[lxiv] The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lxv] Kubasek, N.K., Brennan, B.A., & Browne, M.N. (2010). The Legal Environment of Business, 6th ed. Upper Saddle River, NJ: Pearson Education, Inc., pg. 484-85; Matthew J. McGrath, Note, Convergence of the Substantial Evidence and Arbitrary and Capricious Standards of Review During Informal Rulemaking, 54 GEO. WASH. L. REV. 541 (1986) and Antonin Scalia & Frank Goodman, Procedural Aspects of the Consumer Product Safety Act, 20 UCLA L. REV.

, 935 n.138 (1973). See Generally: Lubbers, A Guide to Federal Agency Rulemaking, 4^th Edition, ABA Press, (June 25, 2006); Koch and Murphy, Administrative Law and Practice, 3^rd Edition, Thompson West, (2014 with pocket parts).

[lxvi] Citizens to Preserve Overton Park v. Volpe 401 U.S. 402 (1971); The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lxvii] Burrows, A Brief Overview of Rulemaking and Judicial Review, www.wise-intern.org/orientation/documents/CRSrulemakingCB.pdf (January 4, 2011); The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lxviii] The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lxix] Motor Vehicle Manufacturers Association of the United States, Inc. v. State Farm Mutual Automobile Insurance, 463 U.S. 29 (1983);cited in The Administrative Procedure Act (APA), http://epic.org/open_gov/Administrative-Procedure-Act.html (Accessed 2014).

[lxx] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014). See also: Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014).

See Generally: National Kidney Foundation Flyer, “Protect Dialysis Patient Access and Quality of Care” (March 2013) “Goal:

Preserve dialysis payments to ensure patients have appropriate access to quality care

Who:

Over 415,000 people with end-stage renal disease receive dialysis treatments 3 or more times per week to replace kidney function and 82% are Medicare beneficiaries

Background:

• In 2011, the Centers for Medicare & Medicaid Services (CMS) implemented a bundled payment system for dialysis services and built in a 2% reduction in payment.

• The American Taxpayer Relief Act of 2012 called on CMS to “rebase” (reduce) the bundled payment rate based on changes in the utilization of certain end stage renal disease (ESRD) medications.

• Sequestration will further reduce Medicare payments for dialysis by 2% on April 1, 2013.

What:

• Continued cuts may deter providers from opening additional facilities at a time when the number of ESRD patients continues to rapidly grow.

• The bundled payment system currently does not provide a separate payment for innovation and further cuts will leave little room for new advancements in patient care.

• Cuts may result in reduced staffing hours at facilities and a greater burden on staff, which detracts from providing direct patient care.

• In January 2013, the Medicare Payment Advisory Committee (MedPAC) finalized a recommendation to maintain the current level of funding for dialysis in 2014. The Chairman noted that the recommendation did not take into account sequestration or recent changes in law, which would reduce payment below MedPAC’s recommendation.

• Given that the dialysis bundled payment system is still new, the MedPAC Chairman stated that payment rates should be held constant in order to fully assess the implications of the new payment system on patient care.

NKF requests Congress protect patient access to quality dialysis care, by ensuring no further cuts to payment are made.” (Emphasis added).

[lxxi] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014). See also: Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014).

[lxxii] Id.

[lxxiii] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014).

[lxxiv] Proposed Dialysis Payment Changes Could Hurt Rural Facilities, http://nkfadvocacy.wordpress.com/2014/07/10/proposed-dialysis-payment-changes-could-hurt-rural-facilities/ (July 10, 2014). See also: Changes Proposed to the Way Quality of Care is Measured in Dialysis Facilities, http://nkfadvocacy.wordpress.com/2014/07/17/changes-proposed-to-the-way-quality-of-care-is-measured-in-dialysis-facilities/ (July 17, 2014); New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula, http://www.dialysispatients.org/articles/new-medicare-rule-dialysis-facilities-brings-changes-%E2%80%9Cpay-performance%E2%80%9D-formula (Accessed 2014).

[lxxv] Id.

[lxxvi] Id. Substantive Due Process, http://legal-dictionary.thefreedictionary.com/Substantive+Due+Process (Accessed 2014)

(“The substantive limitations placed on the content or subject matter of state and federal laws by the Due Process Clauses of the Fifth and Fourteenth Amendments to the U.S. Constitution.
In general, substantive due process prohibits the government from infringing on fundamental constitutional liberties. By contrast, procedural due process refers to the procedural limitations placed on the manner in which a law is administered, applied, or enforced. Thus, procedural due process prohibits the government from arbitrarily depriving individuals of legally protected interests without first giving them notice and the opportunity to be heard.
The Due Process Clause provides that no person shall be "deprived of life, liberty, or property without due process of law." When courts face questions concerning procedural due process, the controlling word in this clause is process. Courts must determine how much process is due in a particular hearing to satisfy the fairness requirements of the Constitution. When courts face questions concerning substantive due process, the controlling issue is liberty. Courts must determine the nature and the scope of the liberty protected by the Constitution before affording litigants a particular freedom.”);

Equal Protection, http://legal-dictionary.thefreedictionary.com/Equal+Protection+Clause (Accessed 2014)

“The constitutional guarantee that no person or class of persons shall be denied the same protection of the laws that is enjoyed by other persons or other classes in like circumstances in their lives, liberty, property, and pursuit of happiness… The Supreme Court has developed a three-tiered approach to examine all such legislative classifications. Under the first tier of scrutiny, known as Strict Scrutiny, the Court will strike down any legislative classification that is not necessary to fulfill a compelling or overriding government objective. Strict scrutiny is applied to legislation involving suspect classifications and fundamental rights. A Suspect Classification is directed at the type of "discrete and insular minorities" referred to in the Carolene Products footnote. A fundamental right is a right that is expressly or implicitly enumerated in the U.S. Constitution, such as Freedom of Speech or assembly. Most legislation reviewed by the Supreme Court under the strict scrutiny standard has been invalidated, because very few classifications are necessary to support a compelling government objective.

The second tier of scrutiny used by the Court to review legislative classifications is known as heightened, or intermediate, scrutiny. Legislation will not survive heightened scrutiny unless the government can demonstrate that the classification is substantially related to an important societal interest. Gender classifications are examined under this middle level of review, as are classifications that burden extramarital children.

The third tier of scrutiny involves the least amount of judicial scrutiny and is known as the rational relationship test. The Supreme Court will approve legislation under this standard so long as the classification is reasonably related to a legitimate government interest. The rational relationship test permits the legislature to employ any classification that is conceivably or arguably related to a government interest that does not infringe upon a specific constitutional right. An overwhelming majority of social and economic laws are reviewed and upheld by courts using this minimal level of scrutiny.”

[lxxvii] Kidney Disease by the Numbers, https://www.kidney.org/.../KIDNEY_DISEASE_BY_THE_NUMBERS.pdf, (Accessed 2014); Kidney Disease Statistics, https://www.asn-online.org/khi/stats.aspx (Accessed 2014); Organ Donation and Transplantation Statistics, http://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats.cfm (Accessed 2014)(Stats are the most recent from the National Kidney Foundation).

[lxxviii] Id.

[lxxix] LaVarne Burton, Hrant Jamgochian, Bruce Skyer and Lori Hartwell, CMS’ proposed rule to cut Medicare payment for dialysis care bad for patients, http://thehill.com/blogs/congress-blog/healthcare/321129-cms-proposed-rule-to-cut-medicare-payment-for-dialysis-care-bad-for-patients#ixzz37xFsyxPt (September 13, 2013)( 85 percent depend on Medicare’s dialysis benefit to pay for their treatments.) Kidney Disease by the Numbers, https://www.kidney.org/.../KIDNEY_DISEASE_BY_THE_NUMBERS.pdf, (Accessed 2014); Kidney Disease Statistics, https://www.asn-online.org/khi/stats.aspx (Accessed 2014); Organ Donation and Transplantation Statistics, http://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats.cfm (Accessed 2014)(Stats are the most recent from the National Kidney Foundation).

[lxxx] Dialysis: Deciding to Stop, http://www.kidney.org/atoz/content/dialysisstop.cfm (Accessed 2014)(From the NKF)( People who stop dialysis may live anywhere from one week to several weeks, depending on the amount of kidney function they have left and their overall medical condition.); What happens if someone stops dialysis? http://www.davita.com/kidney-disease/dialysis/treatment/what-happens-if-someone-stops-dialysis?/e/1521 (Accessed 2014)(From DaVita)( death usually comes within a few weeks); L U Mailloux, A G Bellucci, B Napolitano, R T Mossey, B M Wilkes and P A Bluestone, Death by withdrawal from dialysis: a 20-year clinical experience, http://jasn.asnjournals.org/content/3/9/1631.abstract (JASN March 1, 1993 vol. 3 no. 9 1631-1637).

[lxxxi] Kidney Disease by the Numbers, https://www.kidney.org/.../KIDNEY_DISEASE_BY_THE_NUMBERS.pdf, (Accessed 2014); Kidney Disease Statistics, https://www.asn-online.org/khi/stats.aspx (Accessed 2014); Organ Donation and Transplantation Statistics, http://www.kidney.org/news/newsroom/factsheets/Organ-Donation-and-Transplantation-Stats.cfm (Accessed 2014)(Stats are the most recent from the National Kidney Foundation).

[lxxxii] Id. The Need Is Real: Data, U.S. Department of Health and Human Services, U.S. Government Information on Organ and Tissue Donation and Transplantation, http://www.organdonor.gov/about/data.html (Accessed 2014)(Each day, an average of 79 people receive organ transplants. However, an average of 18 people die each day waiting for transplants that can't take place because of the shortage of donated organs.)

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Tuesday, July 29, 2014

New Medicare Rule for Dialysis Facilities Brings Changes to “Pay for Performance” Formula

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