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Daily News

May 31, 2019

Avalere says about half of providers in the voluntary Oncology Care Model could end up owing CMS money if they join a two-sided risk model with less downside than CMS’ initial offering -- the initial two-sided risk option included in the OCM could lead more than 70% of participants to owe money, according to Avalere’s analysis.

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May 30, 2019

A new proposal to curb surprise billing by implementing “network-matching,” floated by Senate health committee Chair Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA), could save the federal government $7 billion over 10 years, according to a new analysis by the Council for Affordable Health Coverage.

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The Health Innovation Alliance (HIA) is calling on the Office of the National Coordinator for Health IT (ONC) to “go back to the drawing board” and rework its proposed interoperability rule, saying that proposed exceptions to information blocking prohibitions are too broad and the definitions of electronic health information (EHI) and health information networks (HINs) go beyond the intent of Congress and the agency’s regulatory authority.

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The Mississippi hospital industry is leading an aggressive public push for a version of Medicaid expansion after behind-the-scenes negotiations with the state’s Republican governor failed to garner political support for expansion.

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Medicaid beneficiaries who are potentially subject to work requirements are far more likely than privately insured individuals to face obstacles to steady employment, such as a lack of a high school degree, limited English proficiency, limited home internet access, physical or mental health issues and residence in high-unemployment areas, according to a study from the Urban Institute released Thursday (May 30).

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As FDA weighs how to regulate cannabidiol (CBD) from hemp in food and dietary supplements, the budding industry will hold up a court case from the 1990s to argue that hemp extract with CBD should be allowed in dietary supplements as long as it is not highly concentrated, an industry lawyer said.

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FDA is considering how it could go about requiring certain opioids to be dispensed in unit-of-dose, or blister, packaging and is seeking input from stakeholders, the agency announced in the Federal Register Friday (May 30).

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A medical device regulatory expert raised concerns that companies may see no benefit from participating in FDA’s newly announced plan to test its software precertification program, and, given the added burdens of doing so, there might not be enough volunteers to properly test the program.

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May 29, 2019

The Department of Justice and the White House have yet to respond to a May 13 letter from five House committee chairs who are seeking background material and other information on the administration’s decision to stop defending any part of the Affordable Care Act in the high-profile Texas v. Azar case, congressional aides confirm.

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CMS says the systems issue that caused Medicare Advantage and Part D premiums not to be automatically deducted from beneficiaries’ Social Security payments has been fixed and beneficiaries should be provided a grace period to repay those missed premiums, but one beneficiary advocate has been told that some individuals have already lost coverage because of missing payments and the agency needs to make sure beneficiaries are held harmless.

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Stakeholders are urging FDA to quickly write regulations to strictly monitor the burgeoning cannabis industry, with one marijuana legalization advocacy group warning the lack of guidance and regulation on manufacturing, marketing, testing and selling products infused with cannabidiol (CBD) is creating an opportunity for “predatory companies” to market potentially unsafe products and is leading to confusion about the legal status and safety of CBD-containing products.

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FDA’s approval Friday (May 24) of a new drug to treat breast cancer marks the first novel drug that has moved through the agency’s Real-Time Oncology Review (RTOR) Pilot program.

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Senate Democratic Whip Dick Durbin (IL) again took FDA Acting Commissioner Ned Sharpless to task in a letter on Wednesday (May 29), saying their May 14 meeting in which they discussed youth e-cigarette use was “one of the most disappointing and alarming meetings” in his time in public service.

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If HHS waits until November to ban Medicare drug rebates, consistent with the department’s regulatory agenda, it would be too late to implement the new policy in 2020, sources say.

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A new CMS bulletin on spread pricing could pave the way for getting Medicaid managed care plans and pharmacy benefit managers to disclose spread-pricing amounts, according to Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors.

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May 28, 2019

CMS on Tuesday (May 28) finalized long-awaited updates to the Programs of All-Inclusive Care for the Elderly, including a reduction in PACE organization audits, a tweaked compliance oversight program and a decision to let some non-physician primary care providers be part of interdisciplinary teams.

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The Trump administration’s decision to stop defending any parts of the Affordable Care Act in Texas v. Azar may bolster a separate lawsuit filed by several cities that point to a wide range of regulatory and other actions to argue the president is failing to abide by his constitutional duty to take care that the country’s laws are faithfully executed.

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Texas state lawmakers approved legislation to ban surprise medical bills that looks very similar to bipartisan Senate bills that would create an arbitration process for insurers and providers to settle disputes.

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The HHS Office for Civil Rights (OCR) says it can’t limit the fees that business associates charge patients to obtain their health records, unlike its ability to restrict the fees charged by “covered entities,” in a new fact sheet outlining when business associates can be held liable under the Health Insurance Portability and Accountability Act (HIPAA).

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Colorado Democratic Gov. Jared Polis has signed legislation that clears the way for a new county-based health insurance cooperative to leverage the purchasing power of residents enrolled in the large group, small group and individual markets to directly negotiate payment rates with providers.

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