RPA Public Policy in a Minute - January 2012

Kidney disease deaths move up a notch in CDC ranking

Based on state records, kidney disease was the eighth leading cause of death among Americans in 2010, moving up a notch from the year before, according to preliminary data released this week by the Centers for Disease Control and Prevention.  Diabetes remained as the seventh leading cause of death.

According to the CDC, kidney disease was the cause of death for 50,003 people in 2010, or 16.2 people per 100,000 population. That is a 1.3% increase over 2009, the CDC said, and one of five leading causes of death that the agency labeled as having a 'significant' increase in 2010. The other causes were Alzheimer's disease (3.3%), chronic liver disease and cirrhosis (3.3%), Parkinson's disease (4.6%), and pneumonitis due to solids and liquids (4.1%). The agency defines kidney disease as nephritis, nephrotic syndrome, and nephrosis.

There were 68,905 deaths associated with diabetes melitus in 2010, a 1% decrease from 2009.

The preliminary number of deaths in the United States for 2010 was 2,465,936. Non-Hispanic black males saw the largest year-to-year decrease in death rates (a 1.9% drop), followed by black males (1.8% decrease), and black females and non-Hispanic black females  (1.5% decrease). White males had the lowest year-to-year change (0.3% decrease) in death rates. Individuals  85 years and over experienced the only statistically significant increase in death rates (1.9% increase).

By state of residence, Hawaii had the lowest mortality in 2010 with an age-adjusted death rate of 589.6 deaths per 100,000 standard population. Mortality was highest in Mississippi, with an age-adjusted death rate of 961.9 per 100,000 standard population.

The 10 most common causes of death 
1 Diseases of heart 
2 Malignant neoplasms 
3 Chronic lower respiratory diseases 
4 Cerebrovascular diseases 
5 Accidents (unintentional injuries) 
6 Alzheimer’s disease 
7 Diabetes mellitus 
8 Nephritis, nephrotic syndrome and nephrosis 
9 Influenza and pneumonia 
10 Intentional self-harm (suicide)

Death rates for 2010 are based on population estimates consistent with the April 1, 2010 census. Preliminary data in the CDC report are based on records of deaths received from state vital statistics offices and processed by the CDC's  National Center for Health Statistics.

Novartis halts late-stage Aliskiren trial due to lack of benefit, adverse events

Novartis will terminate the late-stage ALTITUDE study investigating Rasilez (aliskiren) in patients with type 2 diabetes and renal impairment on the recommendation of an independent data monitoring committee. The company indicated that the committee concluded that "patients were unlikely to benefit" from the addition of Rasilez to standard anti-hypertensives and also identified higher adverse events in this group.

"The finding comes very unexpected," commented Vontobel analyst Andrew Weiss, who had forecast peak annual sales for Rasilez of as much as $2.9 billion, assuming that the drug would have additional benefits for key organs if taken over a long period of time. Weiss said he now plans to reduce his sales estimate for the product. Meanwhile, there were suggestions that Novartis could accelerate plans to reduce its US workforce, with Deutsche Bank predicting that the drugmaker may cut up to 1000 sales jobs as a direct result of the study failure.

The trial, which included 8,606 patients with type 2 diabetes and renal impairment, was designed to evaluate the potential benefits of Rasilez to reduce the risk of cardiovascular and renal events. In the study, Rasilez was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Novartis said the trial was the first to investigate Rasilez for more than one year in this specific patient group.

However, the drugmaker noted that in patients given Rasilez in combination with standard of care, "there was an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension." Novartis indicated that it is in talks with health authorities regarding the implications of the findings, and in the meantime will stop promotion of products containing Rasilez for use in combination with an ACE-inhibitor or ARB. Spokesman Eric Althoff said the company is also looking at the data of other similar trials, which are currently ongoing.

Novartis suggested that sales of Rasilez, which is marketed as Tekturna in the US, "are likely to be negatively impacted by the study results going forward." According to the company, revenue for Rasilez-based products for the first nine months of 2011 reached $449 million, although "product profitability" in the year was negative.

The product was approved in 2007 in the EU and US for the treatment of hypertension either as a monotherapy or in combination with other therapies. The drugmaker has been looking to expand use of the agent, and has launched several trials to examine if the compound could protect organs such as kidneys and the heart if taken over a longer period of time.

RPA's Public Policy in a Minute for Novemeber 2011

Life in the Spincycle

New AJKD Blog, Congrats and Best Wishes!

Id like to congratulate the team of the new AJKD blog. A group of my colleagues I know (most) and respect (all).

Best of luck and all my best guys:

Kenar D. Jhaveri, MD eAJKD Blog Editor
Matthew A. Sparks, MD Blog Advisory Board Member
Sidharth Kumar Sethi, MD Blog Advisory Board Member
Tejas Desai, MD Blog Advisory Board Member
Jordan Weinstein, MD Blog Advisory Board Member
Kellie Calderon, MD Blog Advisory Board Member
Vinay Nair,  DO Blog Advisory Board Member
Joel Topf, MD Blog Advisory Board Member


Description from the blog:

The American Journal of Kidney Diseases (AJKD) is the official journal of the National Kidney Foundation and is recognized worldwide as a leading clinical kidney journal. Every month AJKD publishes clinically oriented original investigations, review articles, case reports, editorials, quizzes, and teaching cases and materials describing the latest findings in kidney diseases, hypertension, dialysis, and kidney transplantation.

AJKD is pleased to now offer eAJKD, the official blog of the journal. A central goal ofeAJKD is to highlight selected journal content in an engaging, timely format.  The blog will have interviews with authors, educational material, as well as podcasts and video. We are looking forward to bringing AJKD into the future and offering engaging new means for authors and readers alike to interact with the journal!

CMS ANNOUNCES STRONGER INCENTIVES TO IMPROVE ESRD TREATMENT OUTCOMES

CMS ANNOUNCES STRONGER INCENTIVES TO IMPROVE ESRD TREATMENT OUTCOMES
FINAL RULE UPDATES POLICIES AND PAYMENT RATES FOR DIALYSIS FACILITIES IN 2012

The Centers for Medicare & Medicaid Services (CMS) today issued a final rule that updates Medicare policies and payment rates for 5,503 dialysis facilities paid under the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) that was first implemented in calendar year (CY) 2011. 

The final rule will also strengthen incentives for improved quality of care and better outcomes for beneficiaries diagnosed with ESRD through improvements to the ESRD Quality Incentive Program (QIP).  The provisions in the final rule will be effective for payments to dialysis facilities furnished on or after Jan. 1, 2012; and the new requirements for the ESRD QIP described in today’s final rule will affect the payment rates in payment years (PY) 2013 and 2014.

Payment rates for dialysis treatments will increase by 2.1 percent in CY 2012, representing the ESRD market basket increase of 3.0 percent less a productivity adjustment of 0.9 percent, as required by statute.  CMS estimates that Medicare payments to ESRD facilities in CY 2012 will total $8.3 billion.

“This is the second year of a four year transition to the new fully bundled payment system for certain dialysis facilities, although nearly 90 percent of facilities have chosen to forgo the transition and be paid entirely under the new system,” said Jonathan Blum, deputy administrator and director of the Center for Medicare.  “We believe that the policies and rate changes we are announcing today will ensure that beneficiaries diagnosed with ESRD will continue to have access to the care they need.”

The final rule also strengthens the QIP.  Under the QIP, payments to individual facilities are reduced if the facility does not achieve a certain total performance score based on their performance with respect to measures that assess the quality of dialysis care the facility provided. 

The initial ESRD QIP, finalized in a rule earlier this year, will affect payments to individual facilities in PY 2012 based on their performance on performance standards CMS established with respect to two anemia management measures and one measure of dialysis adequacy. 

The final rule changes the QIP performance measures for PY 2013 by retiring the anemia management measure of hemoglobin level less than 10 grams per deciliter measure from the initial measure set.

This decision is consistent with new medical evidence regarding the safety of a common treatment for anemia in dialysis patients – administration of erythropoiesis-stimulating agents (ESAs).  In addition, this change is consistent with the recent labeling for ESAs approved by the U.S Food and Drug Administration (FDA).   For PY 2013, CMS will give equal weight to the two finalized measures: (1) an anemia management measure of hemoglobin levels greater than 12 grams per deciliter and (2) a hemodialysis adequacy measure as measured by a Urea Reduction Ratio (URR) of at least 65 percent. 

“CMS believes that new concerns about the safety of ESAs for dialysis patients strongly argue for providers to work more closely with their patients to develop anemia management strategies that respond the patient’s unique medical issues, rather than adopting a one-size fits all approach to care,” said Patrick Conway, M.D., CMS chief medical officer and director of the Agency’s Office of Clinical Standards & Quality.  “This patient-centered approach should result in better treatment outcomes. We plan to monitor hemoglobin levels by facility and to transparently share this information with consumers.”

ESAs promote the production of red blood cells in patients with certain types of anemia, including anemia related to kidney disease.  New medical evidence about the risks and benefits of ESA use in patients with kidney disease or kidney failure led the FDA to approve a new label for these drugs to that offers guidance on how these drugs should be prescribed and used. 

CMS is continuing to work on ways to address the incentives for treating anemia in dialysis patients in various programs, including the ESRD QIP.  In the meantime, CMS also plans to actively monitor patients’ clinical outcomes to ensure that the retirement of this measure does not harm patients.

“CMS stresses that it continues to believe that anemia management is a critical part of treatment for patients on dialysis,” said Dr. Conway. “The anemia management and therapy should be determined by the patient’s physician in light of the patient’s individual needs and in consultation with the patient.”

For PY 2014, CMS is retaining one anemia management measure (hemoglobin level greater than 12 grams per deciliter) and the dialysis adequacy measure (URR of at least 65 percent). CMS is also adopting four new measures that expand the breadth of the program and will give greater insight into the quality of care Medicare patients with ESRD receive in dialysis facilities.  Specifically, CMS is adopting the following six measures for PY 2014:

• Dialysis adequacy, as measured through the URR, which assesses the percentage of patients with a URR of at least 65 percent;
• Anemia management, as measured by the rate of patients with a hemoglobin level greater than 12 grams per deciliter;
• Percent of patients receiving treatment through an arteriovenous fistula or catheter–  types of vascular access used to connect patients’ bloodstreams to dialysis equipment for cleansing;
• Whether the facility reports certain dialysis-related infections to the Centers for Disease Control & Prevention’s National Healthcare Safety Network;
• Whether the facility administers a patient experience of care survey; and
• Whether the facility monitors phosphorus and calcium levels on a monthly basis.

The final rule also adopts two changes to how CMS will score a facility’s performance under the QIP—one change relates to the two-measure framework for PY 2013, and the second change outlines how CMS would score facilities on the six measures adopted for PY 2014. The PY 2014 scoring methodology will more closely align the QIP with the scoring methodology adopted for the Medicare Hospital Inpatient Value-Based Purchasing Program.

Both the ESRD PPS and the QIP were mandated by the Medicare Improvements for Patients and Providers Act of 2008.  The previous ESRD payment system consisted of a composite rate payment for a defined set of services, including certain laboratory tests, drugs and other supplies, while separate payments were made for any items or services furnished as part of the dialysis treatment but for which no payment was made under the composite rate.  The composite rate payment was adjusted to reflect the facility’s case mix and a limited number of patient’s characteristics. The ESRD PPS is intended to improve efficiency and reduce incentives to use more items and services than needed for appropriate care, while the QIP is intended to promote quality of care provided to Medicare beneficiaries with ESRD.

The final rule also includes several provisions that are not related to the ESRD PPS and QIP, including the extension (through CY 2011) of certain payment rate increases for ground ambulance services and certain rural area designations for purposes of air ambulance payment, and establishing a 3-year minimum lifetime requirement for equipment to be considered durable for purposes of coverage as durable medical equipment. 

For more information about the final rule, please see: http://www.ofr.gov/OFRUpload/OFRData/2011-28606_PI.pdf . or

http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1

The final rule will appear in the Nov. 10, 2011, Federal Register.

For more information about the ESRD PPS and QIP, please see:

http://www.cms.gov/center/esrd.asp

Is It Beneficial to Take BP Medications at Bedtime?

MONDAY, Oct. 24 (HealthDay News) -- For the millions of Americans on blood pressure-lowering drugs, a new study suggests that taking the pills at bedtime may be best.

It was known that taking blood pressure medications at different times of the day can affect patients' blood pressure patterns, but the impact on health wasn't known.

The new Spanish study included 661 patients with chronic kidney disease and hypertension. Half of them took their prescribed blood pressure-lowering drugs at bedtime and half took their medications first thing in the morning.

After an average follow-up of 5.4 years, the researchers found that patients who took at least one blood pressure-lowering drug at bedtime had better control of their blood pressure and were about one-third as likely to suffer a heart-related event such as heart attack, heart failure or stroke.

The team at the University of Vigo also found that sleep-time blood pressure provided a much more accurate measure of heart health than wake-time blood pressure.

The study was published online Oct. 24 in the Journal of the American Society of Nephrology.

"Our results indicate that cardiovascular event rates in patients with hypertension can be reduced by more than 50 percent with a zero-cost strategy of administering blood pressure-lowering medications at bedtime rather than in the morning," study author Ramon Hermida wrote in a journal news release.

One U.S. doctor said taking advantage of "chronotherapy" -- timing drug delivery to a patient's biorhythms -- might have real value.

"Physicians don't commonly specify which time of day patients should take their medications; however, most patients with hypertension take their antihypertensive drugs in the morning. Upon taking these medications, patients oftentimes complain of side effects, most commonly, fatigue and drowsiness," noted Dr. Robert Graham, an internist at Lenox Hill Hospital in New York City.

He believes the study reveals a "low-cost, win-win scenario" of better adherence to blood pressure medications and higher effectiveness when they're taken in the evening versus the morning. "As a result, chronotherapy may help minimize the side effects, and maximize the beneficial effects of antihypertensive medications," Graham said.

RPA's Public Policy in a Minute for Oct 2011

NEJM: Long Interdialytic Interval and Mortality among Patients Receiving Hemodialysis

This will come as absolutely NO SURPRISE to the healthcare professionals who care for dialysis patients. The prestigious New England Journal of Medicine has just published a study basically saying hemodialysis patients who dialyze thrice weekly have higher mortality, morbidity, hospitalizations and other assorted problems associated with the 'extra day off' surrounding a weekend.


NEJM DISCUSSION: In this study of a relatively contemporary, representative population of U.S. adults receiving hemodialysis, we found that most events studied occurred more frequently on the day after the long interdialytic interval than on other days, including all-cause mortality, mortality from cardiac causes, infection-related mortality, mortality from cardiac arrest, and mortality from myocardial infarction. Similar patterns were observed for hospital admissions with myocardial infarction, congestive heart failure, stroke, dysrhythmia, and any of these cardiovascular events. Subgroup analyses suggested that this excess of adverse events on the day after the long interdialytic interval was close to being a generalized phenomenon.


More dialysis is better. This is simple, true and a fact that is hard to get around as data continues to mount. The economics are one of the factors that will make this difficult to change. Another is patient preferences. In my experience, the majority of dialysis patients want less and less dialysis and that is an unfortunate reality. Nevertheless, it is our job to educate the dialysis patients that all things being equal, more dialysis is better and less dialysis can be hazardous to your health.