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Daily News

January 24, 2019

Brand-drug lobbyists are warning new House lawmakers to steer clear of Rep. Lloyd Doggett (D-TX) and not sign on to his drug-pricing bills, a staff member for the House Ways & Means health subcommittee chair said Thursday (Jan. 24) at the Families USA Health Action Conference.

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FDA issued two draft guidances on Thursday (Jan. 24) that lay out a framework for drug and biologic companies to evaluate their risk management programs, one describing how to develop an assessment plan and the second proposing ways to gauge patient or health care provider knowledge.

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As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.

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January 23, 2019

Medicare for All is picking up support among the American public and federal lawmakers are beginning to consider the idea more seriously.

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The president, HHS secretary and other administration officials touted the administration’s efforts to lower drug prices at a White House meeting Wednesday (Jan. 23) where the president talked of his amazement upon recently learning that generics work as well as the brands they copy.

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CMS’ annual letter describing key policy changes for health and dental plan issuers seeking to participate in the federally facilitated marketplaces in the 2020 plan year largely relies on processes spelled out in previous letters, but it does warn the agency may audit issuers to ensure they’re following rules on cost-sharing for out-of-network services provided in an in-network setting.

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Despite opposition from industry, FDA is not budging from its plan to require that drug and biologics makers with a product approved through the accelerated approval pathway disclose that information on the product’s Indications and Usage section and include a statement explaining that continued approval may be subject to additional trials to confirm the drug’s clinical benefit.

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FDA just took two steps toward realizing a controversial plan that would change parts of the 510(k) process: introducing objective performance criteria and encouraging medical device makers to use younger predicates in their applications.

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Maine’s new Democratic governor, Janet Mills, has rejected a plan to add work requirements to the state’s Medicaid program just one month after CMS approved the plan in the waning days of the administration of controversial former Republican governor Paul LePage.

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Senate Finance Committee Chair Chuck Grassley (R-IA) will hold a drug-pricing hearing Tuesday (Jan. 29), the same day the House oversight committee will hold its own hearing on drug prices and a day before HHS Deputy Secretary Eric Hargan will speak at the Brookings Institution about the anti-kickback law’s treatment of drug value-based pay arrangements.

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Health IT Now said at a briefing on Tuesday (Jan. 22) that it will focus on modernizing the Health Insurance Portability and Accountability Act (HIPAA) in 2019 -- though the group will not say what that entails -- and aligning the stricter 42 CFR Part 2 privacy with a revamped version of HIPAA.

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America’s Health Insurance Plans (AHIP) is calling on CMS to withdraw changes to the Medicare Advantage Risk Adjustment Validation (RADV) program included in a proposed MA and Part D rule, even though other groups have backed the agency’s proposals.

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January 22, 2019

Accountable care organizations, hospitals, doctors and others are asking CMS to push back the Feb. 19 deadline for applications to participate in the revamped Medicare Shared Savings program, with 12 stakeholder groups asking CMS to move the deadline to March 29 and AMGA urging CMS to push it back further to April 19.

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An analysis from the National Association of Accountable Care Organizations says CMS’ changes to the threshold for differentiating high-revenue and low-revenue ACOs is estimated to keep more physician-affiliated ACOs and those affiliated with Federally Qualified Health Centers from having to take on risk at a faster rate under the new Medicare Shared Savings program rules, but NAACOS says concerns remain that the system could keep ACOs from integrating specialty care.

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The proposed 2020 Notice of Benefit and Payment Parameters includes a proposal requiring insurers that offer Affordable Care Act plans covering abortion also to offer at least one other identical plan that does not cover abortion.

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The judge overseeing the federal lawsuit challenging Kentucky’s plan to implement Medicaid work requirements denied a request from the Department of Justice to put the case indefinitely on hold during the partial government shutdown.

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In a win for the generic drug industry, the Supreme Court unanimously ruled Tuesday (Jan. 22) that secret sales of inventions start the one-year clock to file patents.

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Federal DC District Judge John Bates is slated to hear oral arguments Thursday (Jan. 24) on the Department of Justice’s motion to dismiss or move to judgment the lawsuit brought by 12 Democratic attorneys general over the Trump administration’s final association health plan (AHP) rule.

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FDA Commissioner Scott Gottlieb said the month-old partial government shutdown “represents one of the most significant operational challenges in FDA’s recent history,” and he warned that more staff will be furloughed as the agency’s drug center runs out of Prescription Drug User Fee Amendment (PDUFA) funding.

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Multiple organizations applauded CMS’ regulatory proposal to provide additional telehealth benefits to Medicare Advantage enrollees in 2020, while some also called for CMS to take more aggressive steps and others urged caution.

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