The Senate health committee’s top lawmakers Wednesday (April 25) vowed to include biosimilars in the scope of a generic drug provision, included in the committee-passed user fee bill, that would prevent companies from using Risk Evaluation and Mitigation Strategies to restrict access to drugs used in bioequivalence studies.

Hospital officials say government data showing that nearly half of all Medicare integrity program audits and claims denials are overturned on appeal by providers highlight major problems in the CMS audit process.

Senators said they will continue to work on the development of a drug tracking system, a measure limiting drug patent settlements, penalties related to drug shortages and due process concerns related new FDA authorities for destroying unsafe drugs before the health committee-passed user fee bill moves to the full Senate.

The House Energy and Commerce Committee’s budget reconciliation recommendations approved Wednesday (April 25) included an additional amendment from Rep. Joe Barton (R-TX) to repeal CHIP performance bonuses given to states for enrolling more children into Medicaid.

A cosmetics placeholder was dropped from the latest version of House Energy and Commerce Committee user fee legislation released late Tuesday (April 24), just prior to the panel's decision to delay a markup scheduled for Thursday, as lawmakers continued to disagree over proposals to beef up FDA's oversight.

The House Ways and Means oversight subcommittee is the latest congressional panel to launch an investigation into the success of CMS' myriad anti-fraud contractor programs, asking CMS on Wednesday (April 25) to provide details about its fraud-fighting efforts and how the agency gauges its contractors' success.

The government's health care fraud-fighting efforts are increasingly focusing on home health, according to federal officials who warned senators this week that health care fraud is undergoing an evolution as bad actors move away from the durable medical equipment schemes that integrated government teams had already learned to identify and often into more-difficult-to-catch home health fraud.

House Energy and Commerce Chairman Fred Upton's decision Wednesday to abruptly postpone markup of FDA user fee legislation came after the panel's top Democrats pushed for a delay to resolve outstanding policy issues, sources say.

In a pleasant surprise to long-term care hospitals, CMS indicates in a proposed hospital-pay regulation that it will not enforce the looming “25 percent” rule that LTCHs have been trying to avoid with a legislative proposal that sets criteria for admitting patients to LTCHs, but the proposed rule includes a separate pay cut, called the “budget neutrality adjustment,” that some had predicted CMS would postpone by another year.

Device safety advocates on Tuesday (April 24) voiced support for a proposed amendment to the Senate user fee bill that would limit the use of recalled devices as predicates, with the amendment tweaking a House Democrat's proposal by clarifying that the measure would only apply to predicates that have been recalled based on a design flaw.

The Senate Appropriations Committee will mark up the FDA funding bill Thursday (April 26), the committee announced Tuesday, with funding advocates also anticipating a markup of the House appropriations bill within the next few weeks.

Senators will seek to include a drug tracking system, civil monetary penalties for failing to notify FDA of drug shortages and limits on drug patent settlements, among other proposals included in 27 user fee amendments, obtained by Inside Health Policy, filed by lawmakers in preparation for Wednesday's health committee markup.

The lead sponsor of antibiotic incentive legislation Tuesday (April 24) is raising concerns to FDA about a separate proposal floating on Capitol Hill for a limited population antibiotic drug approval measure, saying the limited approval idea could damage the incentives in his broader bill and discourage antibiotic development, although committing to further vetting the idea, according to a letter obtained by FDA Week.

A legislative proposal to dismantle or reform the Medicaid Integrity Contractor program that was slammed again by the Office of the Inspector General on Monday (April 23) could be unveiled within the next few weeks, according to a congressional aide who has been closely following the issue.

The Medicare-Medicaid (Medi-Medi) data match initiative needs a complete overhaul before Congress decides whether it should remain a part of the agency's overall program integrity strategy, HHS' Office Of Inspector General said in a report unveiled prior to a Senate Finance Committee hearing Tuesday during which lawmakers also raised concerns about the program.

The Medicare Advantage demonstration that pays bonuses for average performance is a way to keep MA enrollment high because the bonuses are sufficient for plans to maintain some of the extra benefits that they provide, a government official said Monday (April 23).

CMS is rejecting an HHS Office of Inspector General call for the agency to create a national payment code that authorizes the off-label use of Avastin for treating a leading cause of blindness among the elderly -- a move that comes as HHS also faces pressure from Senate Aging Committee Chair Herb Kohl (D-WI) to establish such a payment code.

A manager's amendment to the Senate health committee user fee bill released Monday (April 23) includes provisions backed by a duo of Senate Republicans addressing customized devices, 510(k) modifications, the drug approval risk-benefit framework, global clinical trials, regulatory science, information technology, reporting requirements and FDA's integrated management plans.

HHS earlier this month informed consumer advocates that it will no longer allow individuals to only give a letter from a provider indicating the patient has a pre-existing condition to enroll in the health law's Pre-Existing Condition Insurance Plan (PCIP), Inside Health Policy has learned.

Medicare advantage payments are spotlighted in two government reports issued Monday morning: one that touts savings resulting from reductions to MA overpayments and another that says CMS is using a demonstration to pay those same private MA plans too generously.