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December 22, 2020 | Daily News

Drug makers are largely unscathed by the year-end government spending bill because Congress instead used hospital surprise billing legislation to pay for coronavirus relief, but the legislative package does include proposals that were part of drug price transparency bills, including one to give congressional Medicare and Medicaid advisers data on closely guarded rebates.

December 22, 2020 | Daily News

Congress on Monday evening (Dec. 21) passed a combined year-end spending and coronavirus relief package that gives FDA a total of $3.2 billion in discretionary funding in fiscal 2021, a $43 million dollar increase over fiscal 2020 levels, and $55 million for the agency’s COVID-19 response efforts.

December 21, 2020 | Daily News

As part of the year-end package, lawmakers plan to mitigate effects of changes to the 2021 physician fee schedule that would raise pay for some while drastically cutting pay for others, according to a House Ways & Means Republican summary, and the bill also is expected to extend the Medicare sequester moratorium for three months -- a shorter extension than sought by providers.

December 21, 2020 | Daily News

House and Senate leadership agreed to include surprise billing legislation in the year-end spending deal that both chambers plan to take up Monday (Dec. 21), but the legislation now bans the arbiter from considering Medicare and Medicaid rates.

December 21, 2020 | Daily News

Congress’ year-end coronavirus relief and spending deal appears to include FDA-related provisions that would extend the agency’s rare disease priority review voucher program until 2024, allow biosimilars applicants to reference previously approved indications in their applications, give FDA authority to require that generic drug labels be updated, and clarify that orphan drugs and biologics must prove clinical superiority.

December 20, 2020 | Daily News

A ban on so-called “gag clauses” between insurers and providers, a push to ensure compliance with mental health parity rules and new disclosures on drug spending’s effect on insurance premiums are in the final COVID-19 relief package, according to an unconfirmed text of the bill floating late Sunday (Dec. 20).

December 18, 2020 | Daily News

The House on Friday evening (Dec. 18) passed a two-day stopgap continuing resolution that gives lawmakers the weekend to hammer out the details of a year-end package that wraps together spending and pandemic relief measures, and possibly also surprise billing legislation, health extenders and other key health policies.

December 17, 2020 | Daily News

As lawmakers continue to negotiate a year-end package, hospitals, doctors, nursing homes and home health providers are urging them to extend the moratorium on the 2% Medicare sequester cuts through the end of the COVID-19 public health emergency -- but some lobbyists say getting such an extension could be an uphill battle.

December 17, 2020 | Daily News

Generic drug lobbyists are scrambling after learning that health extenders might be paid for with legislation that would stop generic drug makers from blocking competitors by parking 180-day exclusivity periods.

December 16, 2020 | Daily News

Senate Finance ranking Democrat Ron Wyden (OR) and committee member Tom Carper (D-DE) are pressing Finance Chair Charles Grassley (R-IA) to begin the confirmation process for President-elect Joe Biden’s HHS and Treasury nominees so they’ll be ready to tackle the pandemic and the economy on day one of the new administration.

December 15, 2020 | Daily News

A bipartisan group of 27 senators, led by Sens. Bill Cassidy (R-LA) and Maggie Hassan (D-NH), sent a letter to Senate leaders Monday (Dec. 14) urging them to include the compromise surprise billing legislation in the year-end spending bill.

December 15, 2020 | Daily News

Compromise surprise billing legislation, the No Surprises Act, relies heavily on providers’ preferred surprise billing solution, arbitration, but national hospital groups want Congress to change the bill’s arbitration process more in hospitals’ favor and route savings to providers.

December 14, 2020 | Daily News

Liability protections have become enough of a sticking point for the bipartisan coalition of senators who proposed a $908 billion COVID-19 relief package that they’ve broken it into two bills -- tying in a separate, narrow bill the $160 billion for state, local and tribal governments to whether lawmakers can agree on liability protections.

December 11, 2020 | Daily News

House Ways & Means Committee Chair Richard Neal (D-MA) on Friday (Dec. 11) convinced his colleagues to back a provider-friendly fix to ending surprise medical billing.

December 10, 2020 | Daily News

Incoming House Appropriations Committee Chair Rosa DeLauro (D-CT) could play a key role in FDA-related spending decisions due to her close dealings with Rep. Sanford Bishop (D-GA), who heads the FDA appropriations subcommittee that DeLauro has previously chaired, the Alliance for a Stronger FDA suggests.

December 10, 2020 | Daily News

House lawmakers on Wednesday (Dec. 9) introduced a bipartisan bill that would establish a subscription-style reimbursement model for antimicrobial drugs to incentivize drug makers to create new, innovative antibiotics by removing volume sales as the payment driver.

December 09, 2020 | Daily News

The House on Wednesday (Dec. 9) passed a one-week government funding extension as lawmakers continue to negotiate a potential COVID-19 relief package and stakeholders push to get their priorities, like a fix for pay cuts to certain physicians and a continued moratorium on the Medicare sequester, into an end-of-the-year bill.

December 09, 2020 | Daily News

The House on Wednesday (Dec. 9) passed by voice vote a bipartisan bill that would require FDA and the National Institute on Drug Abuse to issue guidelines on the production of marijuana, as part of the legislation’s larger goal to make marijuana accessible to be studied for medical purposes.

December 07, 2020 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) on Monday (Dec. 7) said the Senate will likely pass a bill to push back the expiration of government funding through next week and urged Democrats to support his COVID-19 relief legislation -- but his speech on the floor did not mention the $908 billion bipartisan COVID-19 relief package that House Speaker Nancy Pelosi (D-CA) and Senate Minority Leader Chuck Schumer (D-NY) previously said should serve as a starting point for negotiations.

December 04, 2020 | Daily News

The health insurance industry says that with COVID-19 surging and unemployment still twice as high as before the pandemic, the 116th Congress must act quickly with timely, targeted and temporary relief solutions, which include strengthening Medicaid and helping people to keep and afford their private coverage in addition to providing more funding for testing and vaccine distribution.