{"id":6942,"date":"2021-02-26T08:24:24","date_gmt":"2021-02-26T14:24:24","guid":{"rendered":"https:\/\/ibio.org\/?p=6942"},"modified":"2021-02-26T08:24:24","modified_gmt":"2021-02-26T14:24:24","slug":"ibio-joins-sister-state-organizations-in-letter-to-cms-on-protected-classes","status":"publish","type":"post","link":"https:\/\/ibio.org\/ibio-joins-sister-state-organizations-in-letter-to-cms-on-protected-classes\/","title":{"rendered":"iBIO Joins Sister State Organizations in Letter to CMS on Protected Classes"},"content":{"rendered":"

iBIO joined 17 other State Biosciences Associations in a letter to Liz Richter, Acting Administrator of the Centers for Medicare & Medicaid Services. A copy of the letter can be found here.<\/a><\/p>\n

The\u00a0<\/span>Council of State Bioscience Associations<\/span>, represents 46 state bioscience\u00a0 associations across the United States, appreciate the opportunity to provide comment on\u00a0 the CY 2022 Part D Payment Modernization Model RFA, issued on 19 January 2021.\u00a0\u00a0<\/span><\/p>\n

CSBA is a confederation of state-based, non-profit trade associations and advocates for\u00a0 public policies that support responsible development of the bioscience industry. iBIO President & CEO John Conrad serves as a board member of CSBA. \u00a0<\/span><\/p>\n

We are committed to ensuring that Patients have access to the treatments they need, when\u00a0 they need them, and we support policies aimed at improving access to groundbreaking\u00a0 therapies and treatments. We also firmly believe that lowering the costs patients pay at the\u00a0 pharmacy counter should be a central tenet of any measure aimed at addressing the cost of\u00a0 prescription treatments.\u00a0\u00a0<\/span><\/p>\n

The Center for Medicare and Medicaid Innovation (CMMI) started the Part D Payment\u00a0 Modernization Model in 2020 to test methods for improving cost managing plan incentives in\u00a0 Part D. The calendar year 2022 Part D Payment Modernization Model RFA substantially\u00a0 narrows beneficiary protections by allowing plan sponsors to treat five of the six \u201cprotected\u00a0 classes\u201d (anticonvulsants, immunosuppressants, antidepressants, antipsychotics, and\u00a0 antineoplastics) as plans would treat other classes of treatments starting in 2022. The\u00a0 remaining protected class \u2013 antiretrovirals \u2013 would have its protection removed beginning in\u00a0 2023. In addition, CMS would allow participating plan sponsors to cover only one drug per\u00a0 class, instead of the statutorily required two drugs per class. These changes mean that Part\u00a0 D plans participating in the program could offer as few as a single drug per protected class\u00a0 beginning in 2022.\u00a0\u00a0<\/span><\/p>\n

We are gravely concerned that these policies can and will have significant impacts on\u00a0 patient access to new and novel treatments. Further, allowing plans not to cover all drugs\u00a0 in Part D protected classes while applying more aggressive utilization management to these\u00a0 classes will disrupt treatment for many life-threatening diseases, resulting in worse health\u00a0 outcomes and increasing medical costs for the Medicare program. For example, members of\u00a0 the epilepsy community have for years reported experiencing seizures and other harmful\u00a0 effects after switching from one version of an anticonvulsant to another, and a switch from\u00a0 an antiretroviral with a high barrier to resistance to a drug with a lower barrier to resistance\u00a0<\/span>can be problematic, especially if the patient does not have access to continued use of one of\u00a0 the approved dual nucleoside\/nucleotide reverse transcriptase inhibitors (NRTIs)<\/span>1<\/span>.\u00a0\u00a0<\/span><\/p>\n

Medicare\u2019s six protected classes policy is critical to reducing health disparities by ensuring\u00a0 that vulnerable and largely low-income patients have access to critical therapies that treat\u00a0 HIV, cancer, epilepsy, mental health conditions, and other serious illnesses. Congress has\u00a0<\/span>periodically reviewed the protected classes and repeatedly reaffirmed the six categories\u00a0 identified by CMS, and CMS has twice in response to significant stakeholder concerns\u00a0 declined to finalize proposed changes that would undermine the protected classes.\u00a0\u00a0<\/span><\/p>\n

Part D plan sponsors already have wide discretion to utilize multiple tools, such as cost sharing and tiered formularies, to encourage beneficiaries to utilize lower-cost alternatives.\u00a0 In fact, Part D generic utilization is high among drug classes within the six protected\u00a0 classes, and generic utilization for drugs within the six protected classes is higher than for\u00a0 other drug classes (92 percent versus 84 percent).<\/span>2 <\/span>In addition, by allowing plans to cover\u00a0 as little as one drug per class, the RFA will enable plans to take away treatment choice for\u00a0 many patients with dangerous diseases outside the protected classes. The changes in the\u00a0 RFA unnecessarily and inexplicably propose to erect yet another barrier to necessary and\u00a0 lifesaving treatments for patients at the time they need them the most.\u00a0\u00a0<\/span><\/p>\n

Acting Administrator Richter, our members work tirelessly every day to research and\u00a0 develop treatments and cures \u2013 for COVID-19, cancer, hepatitis, diabetes, and hundreds of\u00a0 rare diseases. The patients we serve should be afforded access the treatments prescribed\u00a0 to them. Unfortunately, we believe the CY22 Part D Payment Modernization Model RFA will\u00a0 disrupt the patient-physician relationship and delay needed treatments. We oppose placing\u00a0 plan sponsors above Medicare beneficiaries, and we urge CMS to instead focus efforts on\u00a0 solutions that reduce patient out-of-pocket costs while ensuring access to the most\u00a0 appropriate treatment. We strongly urge the Administration to reverse the new formulary\u00a0 flexibilities and rescind the RFA.\u00a0<\/span><\/p>\n

 <\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

iBIO joined 17 other State Biosciences Associations in a letter to Liz Richter, Acting Administrator of the Centers for Medicare & Medicaid Services. A copy of the letter can be found here. The\u00a0Council of State Bioscience Associations, represents 46 state bioscience\u00a0 associations across the United States, appreciate the opportunity to provide comment on\u00a0 the CY […]<\/p>\n","protected":false},"author":12,"featured_media":4300,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[143,146],"tags":[],"class_list":["post-6942","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ibio-news","category-policy-news"],"_links":{"self":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts\/6942","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/comments?post=6942"}],"version-history":[{"count":0,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts\/6942\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/media\/4300"}],"wp:attachment":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/media?parent=6942"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/categories?post=6942"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/tags?post=6942"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}