Efforts to bolster ACA might sink drug pricing bills | FDA issues 34 new or updated guidance docs on generics | CMS releases guidance on medical loss ratio calculation
May 16, 2019
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Efforts to bolster ACA might sink drug pricing bills
House Democrats included language shoring up the Affordable Care Act in bills meant to manage drug prices, which might doom the bills in the Republican-controlled Senate.
Politico (5/16) 
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Legislative & Regulatory News
FDA issues 34 new or updated guidance docs on generics
The FDA issued 25 new and nine updated draft guidance documents intended to support development of generic medications including HIV antiretrovirals, antibiotics, ophthalmic drugs, cancer drugs, azelaic acid and ivermectin. The documents offer product-specific recommendations on the design of bioequivalence studies.
Regulatory Focus (5/15) 
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CMS releases guidance on medical loss ratio calculation
The CMS issued new guidance calling on the Children's Health Insurance Program and Medicaid managed care plans to include spread pricing in calculation of medical loss ratios. According to the CMS, any price concessions or discounts obtained by a managed care plan or its pharmacy benefit manager must be included in the calculation of medical loss ratios.
Modern Healthcare (tiered subscription model) (5/15),  Healthcare Finance (5/15) 
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Coalition pushes for changes in US health care financials
A coalition that includes labor, advocacy and health groups has launched the Consumers First campaign to change financial incentives in health care and increase funding of primary care. The group's action areas include health care prices, provider payment system distortions, industry consolidation, tax policy for nonprofits, workforce policy, and access to data and transparency.
Medscape (free registration) (5/15) 
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Drug Industry Spotlight
Pharma, biotech play catch-up in digital health
Pharmaceutical and biotech companies are lagging in digital health care, and only seven out of almost 30 valued at more than $10 billion have a chief digital or information officer on their executive committees, six of them appointed in the past two years. "The pharma industry is behind compared to other industries in terms of digital disruption," said Novartis CDO Bertrand Bodson. "But, gosh, the impact could be bigger than in most industries."
BioPharma Dive (5/13) 
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J&J building pipeline
Johnson & Johnson plans to file marketing applications for at least 10 new drugs by 2023, including gene therapies and RNA therapeutics.
Reuters (5/15) 
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Other News
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PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 266 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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