CMS approved work rules without considering costs, GAO report says | FDA guidance would let drugmakers avoid rebate payments | HHS moves to create National Volunteer Care Corps
October 11, 2019
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CMS approved work rules without considering costs, GAO report says
A Government Accountability Office report said the CMS approved state plans to implement Medicaid work rules without requiring states to submit estimates of the measures' administrative costs, which could reach hundreds of millions of dollars and put the agency's transparency and budget neutrality goals at risk. GAO said the approach "is inconsistent with federal internal control standards that call for agencies to identify, analyze, and respond to risks related to achieving program objectives."
The Wall Street Journal (tiered subscription model) (10/10),  The Fiscal Times (10/10) 
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Legislative & Regulatory News
FDA guidance would let drugmakers avoid rebate payments
Draft FDA guidance being reviewed by the Office of Management and Budget would provide pharmaceutical firms a legal loophole to avoid paying rebates to health insurers and pharmacy benefit managers. The agency would also allow manufacturers to obtain national drug codes for imported medications, though they would have to ensure that the imported products are identical to those manufactured for the US market.
BioCentury (10/8) 
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HHS moves to create National Volunteer Care Corps
The HHS' Administration for Community Living is working to create a National Volunteer Care Corps that would help the elderly with household chores and medical appointments and provide companionship to reduce isolation and give family caregivers a break. The Care Corps project is expected to have $19 million in funding over five years and this fall will seek proposals for providing nonmedical care for older adults and people with disabilities, with the goal of awarding grants to up to 30 organizations next year.
Kaiser Health News (10/10) 
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HHS guideline aims to prevent abrupt opioid withdrawal
A new HHS guideline recommends that clinicians wean patients off opioid medication slowly and involve patients in shared decision-making unless a life-threatening crisis may occur if opioids are continued. The guideline aims to discourage clinicians from abruptly stopping opioid prescriptions, which may result in acute withdrawal symptoms, and encourage consideration of behavioral and non-opioid pain treatments during a taper.
MedPage Today (free registration) (10/10) 
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Sensor-embedded drugs track adherence better than clinician supervision
Drugs embedded with ingestible sensors that transmit data to monitoring tools have a 93% accuracy rate in determining tuberculosis medication adherence, compared with a 63% accuracy rate for clinician-supervised adherence programs, researchers reported in PLOS Medicine.
mHealth Intelligence (10/10) 
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Drug Industry Spotlight
Landmark opioids trial to proceed
A landmark trial against opioid makers and distributors will proceed after the 6th US Circuit Court of Appeals said US District Judge Dan Polster has not appeared to be biased against the industry in his rulings or public statements.
Reuters (10/10) 
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Gene testing firm fined $41.6M, banned from federal health programs
Gene testing firm UTC Laboratories was fined $41.6 million and banned from participating in federal health care programs for 25 years, and three executives were fined $1 million, to resolve six whistleblower lawsuits alleging the company paid kickbacks and billed Medicare for unneeded testing.
Reuters (10/9) 
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Don't plan it all. Let life surprise you a little.
Julia Alvarez,
Dominican American poet, writer
National Hispanic Heritage Month is Sept. 15 to Oct. 15
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PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 270 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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