We will continue to monitor the situation and follow the advice of public health agencies. >> Manufacturers rely on the policing of pricing to exist with the distributors. According to STAT News' "Pharmalot," an estimated 12,400 covered entities participate in the program, including about 2,500 hospitals. The PHSA of 1992 mandates pharmaceutical manufacturers that want to be included in the Medicare and Medicaid formularies to provide medications at substantially reduced pricing to entities that are considered eligible. At least five major drugmakers in the past several weeks have notified hospitals that they may no longer provide discounts to the providers under Medicare's 340B Drug Discount Program, sparking the latest in a series of clashes over the long-controversial program. ... Pharmaceutical Companies Push for Clarity and Accountability. �'�Q���Xv��a6���/�������k]��.�j�m��J��~�)���g=8�T�~�e_���/M����!s��!�dN�����rb�7�w��o�~��5Y,������!�/!�6 ��W ��!U��GE�[��^��+B��?o�1��T�%�1��jM*G3P6�f�����U��Lv���+��% �6lk���9�3����{�P��3C��+UӮ\��n��. %���� Explore this option. �r ��P�,؀E��>n_�_/����u��������v |4���~����w���e��[zy�-(W��b��\_����tr%`������1���o�Ͽ�Os}}���K��������'$�7Eg��x;��;pـ=�3�������-c?�E��}��>�������s��?o__/gS�Vm5 ۭ(��^��#�3�e���a�\ ��}�]���d�װ����`?ף/7������d�]��/�˄�t‘�������4n�Q��?o���������6^�/�̯�{��?/�ݫ��`� s�k�=6���& ��|�}�������b�O��h�bPʇ-�� v�L��/������^�@!g�� ;$�#Fp�(Zk��b��|2��A�p ��� 1e�A(2�ӱvk���l��\c�-2�ȰA�\ ؊ ؎1�!`T�ݚ������,0�X�C��3l+W���L�$� � �g�X�g����t�c�X�0&@0aJ��Q�vk�f��=+��-2�ȰA�\ ؊؎0�Aޘ0���vm���|� In a statement sent to STAT News, a Novartis spokesperson said, "[W]e believe, as many other manufacturers do, that the [340B] program has grown beyond its original intent" and, "[a]s a result, we are transitioning to a new system that will allow Novartis to identify and mitigate the issue of duplicate discounts and ineligible rebates from 340B contract pharmacies." He added, "These data requests have no clear link to program integrity. The program requires drug manufacturers to provide outpatient drugs to eligible health care providers at discounts ranging from 20% to 50%. 340B does need to be reformed so that all stakeholders have greater clarity on how the program should work. Now, at least five drugmakers in recent weeks have notified hospitals that they may stop providing discounts under the programs if hospitals do not meet certain requirements. Be confident…we can help. Contreras later blocked the final rule, but instead of granting hospitals a permanent injunction against the payment cuts, he ordered HHS to come up with a remedial measure to address the cuts. With CLARITY, you can generate a self-audit of randomly selected claims based on your own parameters that meet HRSA audit requirements. �� :4Ʉ#�����U/Ap.b���:k�&`l,�m��� yt�c�����_o�@�����woA������@C5C�R>l�������_Wt_W��τ٫�!䌧�Ċ�������R� d��r�.Ek��z[�6>��O&A6�.�� � �l1EFu:�nM�V��6�k,РE6��+[�1f^C d�j��[|}~���th�{� b�J�V��v�)��AB5!�������0ڸ�C��cl+Z��#L�b�0��nM��X�g������E6��+[���`1�Fu2֮M�W��Ya�1A�&�p��!V�Q��%�EL�b��aT�c���̀e� ]�Y�!�N8bl��������}�@��+�{�C4T1(�Ôb�����ľ�n��ͦ�!d���Ċ�������R� d��rDB�Gњ3��%�L8�l+�B�-A�5@L�b���t�ۚ�-`� �ʂ zf��a�X��A�c�5B6��P�5�7��q݂re�=;`ϰA�\ YES. Many of these populations may reside in geographically isolated areas and rely on contract pharmacies as a critical point of access for obtaining their prescriptions. 161 0 obj <> endobj But as of Jan. 1, 2018, hospitals were reimbursed at average sales price minus 22.5%, a change CMS estimated would cut payments by $1.6 billion. It’s no April Fools’ joke. 2 0 obj hޜ�O��ߊ����l'�iB*�z( �Ʀ M�uiҤO�2�W��9iiKl�\������oD�0�D�Ya%|S$��(�:`��!� �b"ԃ�qL>�� �����GH�L�d�>A�4e#���p^V�C����..[��e� H;�U3i���ZX��O-=���ga`��rڌ��3����ɱ�^l�X�t���f�cǴ�;6Uj���f`a�lU�W�¨�U0(�@�zp While our team continues to analyze the 2000+ pages of both rules, there are several key items that health system and hospital leaders should know. 4 0 obj /Filter/FlateDecode © Copyright 2020 PharmalytIQ, LLC. And despite HRSA suggested self-audit and vendor audit documents, covered entities can abuse and create vulnerabilities in their organization, for their c-suite and ultimately for the patients which they serve. Fundamental reform of the 340B program requires a clear linkage between the patients who establish 340B eligibility and those who benefit from receipt of 340B-discounted drugs. The ability to save audit results provides documentation of program integrity. << endstream endobj startxref Eli Lilly will no longer offer discounted products to 340B contract pharmacies, with the exception of insulin. @vH(G�����!�C���K �L8�l+\��-A�5@L�b���t�����0i��( r�G� b�J�V�v���� �`��(�(�롤���t�Y�6��+[���\� Մ��p�����t�Z�16�-c��d1��j�F9l ����)׋�e��a�X��?�a %PDF-1.4 New York, NY 10001. %PDF-1.6 %���� Its critics say it "hurts patients" and is being "abused" by hospitals, and a report issued earlier this year by the Government Accountability Office found that HHS was not adequately monitoring the 340B and Medicaid Drug Rebate Programs, which could increase the risk of pharmaceutical companies paying duplicate discounts for eligible drugs. 340B CLARITY™ A 100% transparent view into your 340B program, providing an opportunity to maximize claim capture, optimize your 340B program, and monitor overall program compliance. The American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), America's Essential Hospitals (AEH), and three health systems sued CMS over the cuts in September 2018, arguing the agency lacked the authority to lower the payments. Fundamental reform of the 340B program requires a clear linkage between the patients who establish 340B eligibility and those who benefit from receipt of 340B-discounted drugs. The Health Resources Services Administration defines its 340B program thusly: The 340B Drug Pricing Program is a federal program that requires drug manufacturers participating in the Medicaid drug rebate program to provide outpatient drugs to enrolled “covered … "Without comprehensive regulatory authority, HRSA has only limited ability to issue enforceable regulations to ensure clarity in program requirements … is 23% higher than corresponding 2018 volume, is over 330% higher than corresponding 2014 volume, rivals the total volume of outpatient drugs paid for under the Medicaid program, accounts for 8.3% of total US net prescription drug sales, implies total 340B discounts on the order of $28 billion off of list price for branded drugs, or 16% of all gross-to-net price discounts provided on branded drugs. The spokesperson added that, although the drugmaker is seeking data on claims for drugs provided to patients enrolled in Medicare and private health plans in addition to Medicaid plans, that would not conflict with federal privacy laws because "no protected health information is collected and the data cannot be combined with other data sets to reveal the identity of a patient.". 0 The company's filing status is listed as Active and its File Number is 23003296. The 340B Drug Discount Program is one of the most contentious issues in health care. Here's what you need to know. ", Last month, HHS' Human Resources and Services Administration (HRSA) which oversees 340B, in a statement said it has only limited authority to enforce certain policies under the program unless there is a clear violation of law, in accordance with guidance the federal government issued in 2010, "Pharmalot" reports. Learn more about 340B CLARITY. 340B: Nearly 30 Years of Controversy. 1 0 obj "If this continues to expand, with the ramifications of the [federal] payment reductions it calls into question viability of some covered entities long term at worst, and their participation in 340B program in the first place.

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