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Daily News

December 10, 2019

The Senate passed over-the-counter (OTC) drug monograph reform legislation by a vote of 91-2 on Tuesday (Dec. 10), coming after the lower chamber’s counterpart bill, reintroduced over the summer, was added to the House GOP’s drug pricing legislation.

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The updated version of the Senate health committee’s drug pricing bill includes myriad new tobacco-related proposals that, among other things, aim to improve age verification, place labeling and advertising restrictions on electronic nicotine delivery system (ENDS) products, prevent online sales of e-cigarettes to children and require FDA to submit user fee financial reports for fiscal 2020 to Congress.

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The U.S. District Court of the District of Columbia ruled on Friday (Dec. 6) that FDA cannot regulate Genus Medical Technologies’ barium sulfate contrast agent as a drug because it qualifies as a medical device under the statute.

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A top HHS official plugged the parallel review program between FDA and CMS as a key step to close what is sometimes a years-long gap between approval of new therapies and Medicare coverage decisions, and a CMS official said the agency hopes to better promote and support the program.

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House Democrats on Tuesday unveiled new tweaks to the U.S.-Mexico-Canada Agreement, which include the removal of biologics exclusivity protections, and said a vote on an implementing bill could come as soon as next week.

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Senate Finance Committee Chair Chuck Grassley (R-IA) is expected to unveil legislation to improve nursing home oversight, possibly before the end of the year, according to a source working on the legislation.

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December 09, 2019

Sen. Maggie Hassan (D-NH), who advocated for arbitration along with Sen. Bill Cassidy (R-LA), expressed frustration that hospitals and providers are unhappy with the House and Senate surprise billing compromise, noting that most of the policies providers were pushing for made it into the final bill.

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Sen. Maggie Hassan (D-NH), who advocated for arbitration along with Sen. Bill Cassidy (R-LA), expressed frustration that hospitals and providers are unhappy with the House and Senate surprise billing compromise, noting that most of the policies providers were pushing for made it into the final bill.

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A second federal appeals court ruled Monday (Dec. 9) that the Trump administration should be allowed to enforce its so-called public charge rule while litigation over the rule proceeds, but a nationwide injunction blocking implementation of the rule remains in effect for now.

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The House GOP-led drug pricing package of bipartisan proposals introduced Monday also includes a measure being pushed by seniors’ advocates that would permanently reverse an Affordable Care Act provision that increased the percent of income above which taxpayers can claim a medical expense deduction.

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The latest version of the Senate health committee’s drug pricing legislation no longer contains three key provisions: one that would give FDA new authority to address outdated drug labeling, another that would exempt biologic products from having to follow U.S. Pharmacopeial standards and a third that would stop brand drug makers from inappropriately using FDA citizen petitions to delay generic competition, based on a section-by-section of the bill released Monday (Dec. 9).

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The Senate health committee’s updated cost-cutting package unveiled Monday (Dec. 9) includes various privacy and security provisions to strengthen protections for health data, after several members of the committee introduced their own bills to tighten privacy standards, but it strips language from the original bill unveiled in May on CMS’ Blue Button initiative.

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The Senate health committee’s updated cost-cutting package includes provisions from both Senate and House bills to improve maternal health, including calls for various HHS grant programs to reduce maternal mortality and morbidity rates.

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House Republicans on Monday (Dec. 9) introduced a bill (H.R. 19) that combines many bipartisan measures to control drug prices, including several from the Senate Finance bill, but it excludes a key measure from the upper chamber’s bill that would make drug companies pay back the government when they raise prices faster than inflation.

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The House and Senate surprise billing compromise sets a benchmark payment rate for out-of-network bills at the median in-network rate for a geographic area, and the insurer or provider can move to an independent dispute resolution process if the median in-network payment is above $750.

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The president’s June 24 executive order directed Treasury to issue a regulation by Dec. 21 that would let payments to the controversial health care sharing ministries and other health care arrangements count as qualifying medical expenses that could be reimbursed by a tax-free account, but it is unclear whether the department will be able to do so under existing statute.

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The House Energy & Commerce Committee is now set to examine nine health care bills at a Tuesday hearing, having added a bill that would incentivize Medicaid expansion and another that would create a federal public option to the list of seven bills that aim to expand health coverage to more Americans.

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One day before lawmakers revealed they had come to an agreement to add arbitration to compromise surprise billing legislation, North Dakota insurance commissioner Jon Godfread told the insurance industry to keep working to keep the policy out of the bill.

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December 08, 2019

The Senate health and House Energy & Commerce committees have reached an agreement on surprise billing legislation that includes arbitration, and they hope to attach the deal to a year-end spending bill, lawmakers announced Sunday (Dec. 8).

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December 06, 2019

The Medicare Payment Advisory Commission discussed possible 2021 pay recommendations on Thursday and Friday (Dec. 5 and 6) for a number of industries, including reducing the hospice pay cap and tying some hospital pay to the Hospital Value Incentive Program, though the commissioners plan to have a further discussion in January on what to pay hospitals.

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