Immune Globulin Intravenous (Human) (Octapharma)

CMS released an unpublished rule Wednesday that includes increasing CY 2024 home health payments by 0.8%. Centers for Medicare & Medicaid Services (CMS) released a rule Wednesday that increases the 2024 home health payments by 0.8%, or $140 million. “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said. CMS expects increasing the rate will bring home health payments in line with statutory payment authority. In July, the Biden administration proposed cutting reimbursements to home health providers by 2.2% next year, or an estimated $375 million less than 2023 payment levels. It also proposed cutting home health rates by 5.1% or $460 million. Instead, CMS is finalizing a -2.89% adjustment, just half of the proposed home health cut earlier in the year, acknowledging that 5.1% could’ve been “too burdensome” a cut for many providers. The proposed rule will be published in the Federal Register Nov. 13, effective Jan. 1, 2024. Several home health advocacy groups criticized the final rule's implications on systems around the country. "The Partnership for Quality Home Healthcare is extremely disappointed that the Centers for Medicare & Medicaid Services (CMS) finalized a -2.89% cut to home health in its CY2024 Home Health Prospective Payment System (HH PPS) Final Rule," said the Partnership in a statement to Fierce Healthcare. "On top of last year’s nearly -4% cut, CMS’s decision to only partially mitigate their proposed cut to home health will cause further harm to patient access and create financial instability that will make it harder to provide care in the home." "Both patients and providers have described how difficult it already is to access and deliver home health services because of years of continuous Medicare cuts, a significant staffing shortage, and rising inflation," said CEO Joanne Cunningham. "I do not understand what the disconnect is. With labor and inflation costs continuing to rise dramatically and home health providers dealing with a national healthcare workforce crisis, any cut to home health will cause further harm. To put these numbers into context, the rule finalizes a base rate year-over-year increase of less than $1 per day to care for Medicare’s sickest patients. And while CMS is slightly delaying implementation of the permanent cut for next year, those dollars will be cut from home health in future years.” The Partnership stated that it shared both quantitative and anecdotal data with CMS showing that patients are struggling with access, and that these changes would result in more access problems. Cunningham called on lawmakers to block cuts to home health. “We continue to strenuously disagree with CMS’ rate setting actions, including the budget neutrality methodology that CMS employed to arrive at the rate adjustments,” NAHC President William A. Dombi told Home Health Care News. “We recognize that CMS has reduced the proposed 2024 rate cut. However, overall spending on Medicare home health is down, 500,000 fewer patients are receiving care annually since 2018, patient referrals are being rejected more than 50% of the time because providers cannot afford to provide the care needed within the payment rates, and providers have closed their doors or restricted service territory to reduce care costs.” Shortly after CMS released its 5.1% proposal in July, the NAHC petitioned the U.S. District Court for the District of Columbia to strike down and vacate the home health prospective payment system final rule, and to withhold apply the 2024 proposal, saying Congress would prohibit the pay cuts for causing "substantial financial harm" to home health agencies under the Bipartisan Budget Act of 2018. Other changes include increasing the CY 2024 home health market basket percentage by 3.3% before adjusting the rate by 0.3% to 3.0%, a finalized labor related share of 74.9% and non-labor-related share of 25.1% and codify a $270.09 payment toward home health purchases for disposable negative pressure wound therapy (dNPWT) devices. “The actions CMS is taking in this final rule will help improve patient care and also protect the Medicare program’s sustainability for future generations,” CMS said in a release. Wednesday’s rule drop included modifications to the Home Health (HH) Quality Reporting Program (QRP) as well, removing the Application of Percent of Long-Term Care Hospital (LTCH) Patients with an Admission and Discharge Functional Assessment beginning in CY 2025. It also removed two Outcome and Assessment Information Set (OASIS) items no longer necessary for collection. Additionally, home health agencies must meet a 90% threshold of all required OASIS items. Changes under the HH QRP is estimated to reduce cost by more than $5M by reducing unnecessary data collection. The Home Healthy Value-Based Purchasing (HHVBP) Model will codify the measure removal factors finalized in the CY 2022 final rule, replace the claims-based Acute Care Hospitalization During the First 60 Days of Home Health Use measures with the Potentially Preventable Hospitalization measure, effective Jan. 1, 2025, according to the release. “The overall economic impact of the expanded HHVBP Model for CYs 2024 through 2027 is an estimated $3.376 billion in total savings to FFS Medicare from a reduction in unnecessary hospitalizations and SNF usage as a result of greater quality improvements in the HH industry,” the rule said. Permanent coverage and payment of items related to IVIG (Medicare Intravenous Immune Globulin) for patients at home with a primary immune deficiency disease was finalized, now that the Medicare Demonstration program will cease payment using the average sales price (ASP) methodology at the end of the year. This should account for an increase in $8.7 million in total costs to traditional Medicare plans. Under the new rules, Medicare Part B will have an expanded definition for identifying lymphedema treatment that is covered. CMS also finalized plans that codify documentation requirements for Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) refills. “For the conforming change to sections in CAA of 2023 provision, the overall economic impact for CY 2023 and CY 2024 is an estimated $100 million in total cost to FFS Medicare,” the rule said. “For the lymphedema provision, the overall economic impact for CYs 2023 to 2028 is an estimated $150 million in total cost to FFS Medicare.”

The Myositis Association, Octapharma Celebrating Milestone AnniversariesGrammy Winner Peter Frampton To Receive Patient Ambassador Award PARAMUS, N.J., Sept. 6, 2023 /PRNewswire/ -- Octapharma USA will be presented with the Research & Development Award for Outstanding Innovation in Myositis Research during the Heroes in the Fight Awards Celebration at The Myositis Association's 2023 International Annual Patient Conference to be held September 7 - 10 in San Diego. Continue Reading Octapharma has been committed to developing life-saving therapies for patients with rare diseases for the last 40 years. Tweet this Octapharma USA will be presented with the R&D Award for Outstanding Innovation in Myositis Research during the Heroes in the Fight Awards Celebration at The Myositis Association’s 2023 International Annual Patient Conference to be held September 7 - 10 in San Diego. Until Octagam 10% received FDA approval for the treatment of adult dermatomyositis, those who live with myositis had to rely on off-label medications to treat their debilitating symptoms. "Until Octagam® 10% [Immune Globulin Intravenous (Human)], received U.S. Food and Drug Administration (FDA) approval for the treatment of adult dermatomyositis (DM), those who live with myositis had to rely on off-label medications to treat their debilitating symptoms," said Rhonda Buckley-Bishop, Interim Executive Director, The Myositis Association (TMA). "TMA is grateful to Octapharma for being the first pharmaceutical company to take the chance on a treatment for this rare autoimmune disease of the muscles. As we celebrate our 30th anniversary, we are pleased to also celebrate Octapharma's 40 years of developing therapies that improve the lives of those who live with rare diseases." During the awards ceremony on September 9th, The Heroes in Research Award will be presented to Rohit Aggarwal, MD, MS, who led Octapharma's pivotal Progress in DERMatomyositis (ProDERM) study, which demonstrated that Octagam® 10% is an efficacious and well-tolerated treatment for adults with dermatomyositis. The ProDERM study was featured in the New England Journal of Medicine. "We are honored to be recognized by TMA for Octapharma's groundbreaking research on dermatomyositis," said Octapharma USA President Flemming Nielsen. "TMA and Octapharma are celebrating special anniversaries this year, and we congratulate TMA on 30 great years serving the myositis community. Octapharma has been committed to developing life-saving therapies for patients with rare diseases for the last 40 years and we value the opportunity to partner with organizations like TMA who are dedicated to improving patients' lives." Kellie Jo Bell, 61, a patient living with dermatomyositis and now an Octapharma consultant, will participate in a keynote address at the conference. "I tell everyone I meet that Octapharma gave me back my life," said Bell of Lexington, Kentucky. "I have suffered with DM symptoms for about 16 years and was officially diagnosed six years ago when I was really knocking at death's door. My weight had fallen from about 130 pounds to about 90 pounds and my hair was falling out at that time, but Octagam® 10% has enabled me to return almost completely to the person I was before my life started falling apart." Peter Frampton, the Grammy award-winning guitarist who is diagnosed with Inclusion-Body Myositis (IBM), will receive the Patient Ambassador Award and the ALS and Neuromuscular Center at the University of California, Irvine will receive the Heroes in Healthcare Award. Myositis is a general inflammation or swelling of the muscle. The disease is highly variable and includes dermatomyositis, polymyositis (PM), necrotizing myopathy (NM), sporadic inclusion body myositis (sIBM), and juvenile forms of myositis (JM). Dermatomyositis is a rare systemic autoimmune disorder of unknown cause affecting approximately 10 out of every million U.S. residents. Patients commonly suffer from severe rashes, chronic muscle inflammation and progressive muscle weakness, usually affecting adults in their late 40s to early 60s and children between the ages of 5 and 15. Complications include difficulty swallowing, breathing problems from lung scarring, joint pains, and calcium deposits on muscles, skin and connective tissues. Octapharma is the Premier Sponsor for the conference, which features myositis specialists and expert presenters on everything related to these debilitating diseases. The program includes educational workshops, research-based presentations, breakout sessions for all stages of the myositis journey, a focus on care partners, networking opportunities, and social activities. For more information, please visit myositis.org. About Octagam ® 10% Octagam® 10% [Immune Globulin Intravenous (Human)] is an immune globulin intravenous (human) liquid preparation indicated for chronic idiopathic thrombocytopenic purpura in the U.S., European Union and Canada. Octagam® 10% also is indicated for primary immunodeficiency, secondary immunodeficiencies and Guillain Barré syndrome in the EU and Canada, and adult dermatomyositis in the EU and U.S., and for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal motor neuropathy (MMN), and Kawasaki disease in the EU. WARNING THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of immune globulin intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. For full prescribing information, including complete boxed warning, please visit octagamusa.com/gam10pi. To learn more about Octagam® 10%, please visit octagamusa.com. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. GAM10-0404-PPR SOURCE Octapharma