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Daily News

August 23, 2019

HHS’s long-awaited proposal to relax a strict privacy scheme protecting substance use records has renewed calls from both Senate and House lawmakers, including Energy & Commerce Republicans, to pass a bill going further than the proposed rule to fully align the scheme with the less-stringent Health Insurance Portability and Accountability Act (HIPAA).

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Air ambulance providers are taking issue with Wyoming’s proposal to eliminate air ambulance surprise medical bills, which would make all citizens Medicaid-eligible for ambulance services.

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CMS plans to vigorously defend in court its cuts to hospital pay for 340B drugs, but the agency is also weighing fallback options in case the D.C. Circuit Court of Appeals sides with 340B hospitals.

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Hospitals have asked a federal court to update them on their lawsuit over deep reimbursement cuts for clinic visits at off-campus facilities after CMS last month proposed a 2020 hospital outpatient pay rule that doubled down on those cuts.

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House Ways & Means Democrats are scheduled to meet Sept. 10 and 11 to talk about drug pricing and surprise billing legislation, and the committee might even mark up a bill mid-month, but it’s unclear which measures might be marked up or what they might entail.

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A new group led by the Biotechnology Innovation Organization (BIO) is urging Congress to create additional incentives for drug and biologic makers to develop innovative antibiotics, starting with passage of the Medicare add-on payments included in the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019.

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A vaping product manufacturer and a newly formed trade association representing the vaping industry are asking a federal court in Mississippi to overturn FDA’s deeming rule so that the agency no longer has authority to regulate electronic nicotine delivery system (ENDS) products, including e-cigarettes.

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Three former FDA commissioners are calling for CMS to test using data from multiple sources to gauge outcomes of value-based pay models for high-cost drugs and biologics.

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Senate Homeland Security & Government Affairs Committee ranking Democrat Gary Peters (MI) is concerned FDA doesn’t have the data it needs to mitigate drug shortages, which he says can drive up prices and hurt patients and hospitals.

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The Congressional Budget Office estimates that providing $10 billion a year in federal funding to either create a reinsurance program or set up additional subsides starting in 2020 would cost about $34.4 billion over 10 years, and would increase the number of insured Americans by about 100,000 to 200,00 each year, mostly for those earning above 400% of the federal poverty level.

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Colorado Sen. Michael Bennett (D-CO) Thursday took a jab at rival presidential candidate Bernie Sanders for what he called a “retreat” on his Medicare for All stance after the Vermont senator released a labor platform clarifying that unions can still negotiate wrap-around coverage and maintain their clinics, and also ensuring that any employer savings go back to the workers.

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Colorado Sen. Michael Bennet (D-CO) Thursday took a jab at rival presidential candidate Bernie Sanders for what he called a “retreat” on his Medicare for All stance after the Vermont senator released a labor platform clarifying that unions can still negotiate wrap-around coverage and maintain their clinics, and also ensuring that any employer savings go back to the workers.

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August 22, 2019

Substance use record privacy restrictions would be loosened under a rule proposed Thursday (Aug. 22) by the Substance Abuse and Mental Health Services Administration (SAMHSA), but HHS Secretary Alex Azar said the administration is limited in fully aligning the scheme with the less-stringent Health Insurance Portability and Accountability Act (HIPAA) and would support congressional action to do so.

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New Mexico’s insurance chief announced this week that Christus Health Plan will not be allowed to offer products on the state’s exchange for 2020 due to compliance issues including a failure to provide transgender services and discrepancies on policies related to prior authorization and evidence of coverage, among other problems.

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The number of Medicaid-covered prescriptions for buprenorphine, a key drug used to treat opioid addiction, increased dramatically in states that expanded Medicaid under the Affordable Care Act while remaining relatively static in non-expansion states, according to a new study from researchers at the Urban Institute.

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Democratic staff of the House Energy & Commerce Committee are not negotiating on drug pricing with staff of the Senate Finance Committee, sources say, even though Finance Chair Chuck Grassley (R-IA) said bicameral drug-pricing talks would occur in August.

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E-cigarette maker JUUL Labs has dropped its membership with the Vapor Technology Association, saying Tuesday (Aug. 20) there are “too many critical policy issues” on which JUUL and the association disagree.

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Three former FDA commissioners are calling on FDA, CMS and Congress to work with stakeholders to increase the use of real-world evidence (RWE) and real-world data (RWD) in order to improve the evidence base for new drugs and biologics; refine regulatory decisions by FDA; and promote value-based payment models to make health care more affordable.

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House Energy & Commerce Committee Chair Frank Pallone (D-NJ) on Wednesday (Aug. 21) wrote to four leading e-cigarette makers, including JUUL and Reynolds American, seeking information about the public health effects of their products, their e-cigarette research efforts and their marketing practices, as well as timelines for when their products were introduced to the market and whether they plan to submit any premarket applications to FDA before May 2020.

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August 21, 2019

Overall enrollment in the individual market declined by 5% during the first quarter of 2019, the first quarter that the individual mandate penalty repeal was in effect, according to a new analysis from the Kaiser Family Foundation.

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