It has been a tumultuous year for the renal community, and 2015 will keep everyone with their ear to the ground. Here are select important events in the 12 months of 2014 that shaped renal policy.
• Washington politics: Like “a box of chocolates…”
Helping to understand what Congress wants to do, plans on doing, and actually does is in fact like the second part of that well-known phrase from Forrest Gump: “You never know what you are gonna get.”
Nonetheless, we always ask Rob Blaser, the Director of Public Policy at the Renal Physician Association (www.renalmd.org) to give it his best shot. How did he do in 2014? Well …
• On the Sustainable Growth Rate: “ So, will SGR repeal actually happen in 2014? The prediction here is a cautious and optimistic yes, as there is an alignment of the stars in place that just hasn’t happened previously.” And, Blaser noted,“…there are the somewhat paradoxical coexisting facts that Congress is very tired of this issue hanging over their heads every year and wants it off their plate, and that legislators recognize that instability and unpredictability in physician payment is fundamentally unfair and thus a fix is the right thing to do.”
Result: They sure came close. But no dice when it came time to figure out how to pay for it, as well as agreement on how to build a pay-for-performance program. Congress bailed out the stubborn SGR in March and gave physicians a small raise in House bill HR 4372, the "Protecting Access to Medicare Act.” The 13-month patch on the SGR—the 17th such reprieve since the policy was enacted in 1995—prevented a 24% Medicare payment cut and replace it with a 0.5% update for the rest of 2014 and 0.0% update from January 1, 2015 until April 1, 2015. Who was against the bill? The American Medical Association. They don’t want a raise—they want reform!
• The Prospective Payment System (the ESRD bundle)
“Unlike the SGR, we know with greater certainty that the End-Stage Renal Disease Program’s Prospective Payment System will undergo some degree of refinement in the next year, by virtue of the mandated rulemaking cycle (so I guess it wasn’t going out on much of a limb in predicting change here). And while there is no guarantee that whatever refinement occurs will be positive in a fiscal sense and thus begin to offset the 12% cut from the 2014 ESRD PPS final rule, we do know that there are some valid arguments indicating that CMS was methodologically inconsistent in developing the final rule.
…The forecast here is that CMS will begin to address some of the issues as part of the 2015 ESRD PPS rulemaking cycle and that by 2016 there will have been some revisions that will in part mitigate the 12% cut.”
Result: On target. Congress softened the blow from the 12% cut, plus gave physicians practices more time to prepare for ICD-10, and decided it would be cheaper for the Medicare program to keep payment for oral drugs outside the bundle for another eight years.
• Lifetime immunosuppressive drug coverage for kidney transplant patients
“All of the right steps toward passage of this legislation to end the three-year limit on coverage for these expensive drugs are being taken. The underlying legislation, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 (S. 323, H.R.1428) continues to gain co-sponsors, with the House bill in December passing the symbolic 100 co-sponsor mark. Additionally, there are indications that the legislation will be re-scored at a lesser cost, thus lowering the bar for this measure to be added to a broader Medicare bill. House leadership has also given its blessing for the immunosuppressive drug bill to proceed. RPA’s advocacy agenda for the past seven years has included extension of immunosuppressive drug coverage as a top priority.”
Result: Maybe in 2015. This bill needs to become law.
• Business is good.
Warren Buffet thought so at Davita Healthcare Partners, so his company, Berkshire Hathaway Inc., purchased 1.13 million more shares in February. Berkshire's total stake in the company climbed to 37.62 million shares, or 17.7%.
He paid between $66.12-$68.00 a share. At this writing, DaVita shares are up 20% for the year, despite legal settlements (including one announced in February for $389 million) and concerns about performance of the Healthcare Partners business.
• Changing of the guard
After 14 years of producing the unique, annual compendium of data on the U.S. dialysis and transplant population known as the U.S. Renal Data System, the Chronic Kidney Research Group based at the Minneapolis Medical Research Foundation handed over the assignment to the University of Michigan Kidney Epidemiology and Cost Center. UM-KECC was awarded a five-year, $8.5 million federal contract to serve as the coordinating center for the USRDS.
Speaking about changes to the guard, Satellite Healthcare CEO Mark Burke announced he was retiring in May. In 23 years at the helm, Burke led the company growth to more than 60 dialysis centers serving more than 6,000 patients in six states
• Building a new set of guidelines
A new blueprint developed by Kidney Care Partners calls for renewed focus on improving outcomes in the kidney disease population, based on goals that include cutting down on hospitalizations, improving health-related quality of life and patient experience with care, and increasing patient survival.
The blueprint proposes to direct change through nine “domains” for kidney care quality: care coordination, disease management, infrastructure, palliative and end-of-life care, patient engagement and education, patient satisfaction and experience with care, pediatric-specific issues, quality of life, and safety. It also identifies 32 “strategic opportunities” to improve quality. Building a quality measure on fluid management with by the group’s first project.
• Good job
The percentage of dialysis clinics that took a penalty based on lower performance scores for quality measures in 2012 is similar to the 2010 results, according to data released by the Centers for Medicare & Medicaid Services. About 9.5% of U.S. dialysis clinics will see a reduction. That is close to the 10% seen in 2013, and considerably lower than the 30% of clinics that got penalized in 2012.
• What did your kids eat today?
Researchers reported in May that the prevalence of both type 1 and type 2 diabetes increased significantly among children and adolescents between 2001 and 2009, according to a study in the May 7 issue of JAMA. The study included data from more than three million children and adolescents from diverse geographic regions of the United States.
• NaturaLyte in trouble
Louisiana filed a lawsuit against Fresenius Medical Care North America and its nearly 100 clinics in the state, saying the company used deceptive trade practices and fraudulent marketing to sell substandard dialysate made by the company. The litigation joins other class action suits filed by patients claiming injury and death over use of GranuFlo and NaturaLyte, but this appears to be the first state to join the litigation.
The suit is asking for recovery of payments made through Louisiana’s Medicaid program to Fresenius for the liquid bicarbonate dialysate, saying the company has known since 2004 that if not used properly, GranuFlo and NaturaLyte could elevate dialysis patients’ bicarbonate levels and increase the risk of a heart attack. And the company failed to notify its customers of the concerns until well after making changes at it own clinics.
Fresenius issue a voluntary recall of certain lots of NaturaLyte after discovering high bacteria levels. The FDA said it received one report of death and two reports of injury that may be related to use of the recalled lots. The recall included 49 lots, announced April 4, but was expanded to include nine additional lots on May 1.
• Ebola hits dialysis care
The Centers for Disease Control released recommendations at the end of the month for hospital-based dialysis providers to help them safely perform hemodialysis in patients confirmed to have the Ebola virus. The CDC collaborated with the American Society of Nephrology to develop the recommendations.
"Inpatient care of patients with Ebola should be provided in a hospital with capacity to perform continuous renal replacement therapy (CRRT)," according to the CDC. "Efforts to minimize direct blood exposure to health care personnel and blood contamination of the environment are of principal importance due to the high concentration of Ebola virus that can be present in an infected patient’s blood and the large volumes of blood involved in hemodialysis."
(Look for NN&I coverage on the Ebola virus at NephrologyNews.com/ebola)
• Be prepared…
The end of the year for the ESRD Program always means the beginning of a new year with regulatory updates. The much-criticized five-star rating system goes into effect Jan. 15 (go to nephrologycom.wpengine.com/5star for NN&I’s coverage) despite protest from the renal community (see National News, pg. 12). And, providers can expect a flat rate for treatments in 2015. Finally, while the changes in the Quality Incentive Program are minimal for performance year 2015, look out for 2016 and beyond. Providers will need to monitor patient care beyond just what takes place in the dialysis setting. CMS and Medicare are heading into a new direction that leaves fee-for-service behind and promotes more holistic care for beneficiaries. The forthcoming renal ACO demonstration project is a good example.
• Health care’s future
In what RPA Public Policy Director Rob Blaser gave us as a “bonus prediction,” he felt the Nov. 4 elections would leave the House and Senate in status quo mode: the House Republicans and Senate Democrats would continue to hold their respective chambers. “The Senate is a dicier call but it still seems like it would require a lot for the Republicans to take over.”
Well, enter crises in the Ukraine, a late response to ISIS, Ebola, the Veterans Administration scandal, and the Obama Administration did some damage this fall.
As the renal care community prepares this month for next year, we can look at the potential impact changes in the Senate that may influence health care, and ultimately the renal care program. If Republicans push for the dismantling of ObamaCare, could CMS’ Innovative Center be another target? The center has been key in looking at new ways for health care delivery through demonstrations and quality measure review and development. What impact the conservative agenda may have on health care programs and research centers, like the National Institutes of Health, remains to be seen.