CMS Issues Stark, Anti-Kickback Reform Final Rule

The Centers for Medicare and Medicaid Services (CMS) released its Stark and anti-kickback final rule, which has been under review since July. The Physician Self-Referral Law, also known as the “Stark Law,” generally prohibits providers from making referrals to an entity for certain health care services if the provider has a financial relationship with the entity. The new regulation finalizes new, permanent exceptions for value-based arrangements that will permit health care providers to design and enter into value-based arrangements, add additional guidance on key requirements of the exceptions to the physician self-referral law, and finalize protection for non-abusive, beneficial arrangements.

White House Finalizes OPO Rule

The White House has finalized a rule aimed at increasing the number of organs available for transplant and shortening transplant wait times. The regulation from the Centers for Medicare and Medicaid Services (CMS) would require organ procurement organizations (OPOs) to be more transparent about their performance and establish more stringent quality measurements. The rule is a part of President Trump’s July 2019 Executive Order on Advancing American Kidney Health. It would require each OPO to track the number of usable organs procured, the number that are actually transplanted, and the number donated for research.

House Dems Continue Push to Begin Presidential Transfer of Power

Agroup of top House Democrats have sent a letter to the General Services Administration (GSA) demanding a briefing on the status of the decision to allow President-elect Joe Biden and his transition team to access government services and facilities. GSA Administrator Emily Murphy has yet to ascertain that Joe Biden was the winner of the November 3 presidential election. Oversight and Reform Committee Chair Carolyn Maloney (D-N.Y.), Appropriations Chair Nita Lowey (D-N.Y.), Financial Services Subcommittee Chair Mike Quigley (D-Ill.), and Government Operations Subcommittee Chair Gerald Connolly (D-Va.) argue that the blocking of transition activities are “impairing the incoming administration’s ability to respond to the coronavirus pandemic, hampering its ability to address our nation’s dire economic crisis, and endangering our national security.” House Energy and Commerce Chair Frank Pallone (D-N.J.) had also sent a letter to the President earlier in the week urging him to begin the transition process for the sake of the government’s COVID-19 response. While the transition team cannot contact federal agencies to discuss their policies and operations, Biden’s team has begun to contact congressional lawmakers and staff in order to prepare for the incoming administration.

House Passes 10 Health Care Related Measures

Last week, the House of Representatives passed the following health care related bills by voice vote under suspension of the rules:

  • H.R. 4499 – NIMHD Research Endowment Revitalization Act of 2020
  • H.R. 5668 – Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act of 2020
  • H.R. 4712 – Fairness in Orphan Drug Exclusivity Act
  • H.R. 2466 – State Opioid Response Grant Authorization Act of 2020
  • H.R. 2281 – Easy MAT for Opioid Addiction Act
  • H.R. 2117 – Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2020
  • H.R. 5855 – Bipartisan Solution to Cyclical Violence Act of 2020
  • H.R. 3878 – Block, Report, And Suspend Shipments Act of 2020
  • H.R. 4806 – Debarment Enforcement of Bad Actor Registrants (DEBAR) Act of 2020
  • H.R. 4812 – Ensuring Compliance Against Drug Diversion Act of 2019

Grassley, Warren Request Release of Hearing Aid Regulations

Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass.) sent a letter to the Food and Drug Administration (FDA) urging the agency to issue an overdue rule to overhaul over-the-counter (OTC) hearing aid regulations. The update, which would change how certain hearing aids are categorized and institute new patient safety protections, was required by August 18, 2020 as a part of the FDA Reauthorization Act of 2017. The lawmakers write that the FDA should “make issuing the OTC hearing aid regulations a priority, consistent with the law.”

E&C Republicans Ask for Info on Lab Capacity

House Energy and Commerce Committee Ranking Member Greg Walden (R-Ore.), along with Rep. Michael Burgess (R-Texas) and Brett Guthrie (R-Ky.), sent a letter to the Centers for Disease Control and Prevention (CDC) requesting full, updated data on domestic lab capacity with BioSafety Level 3 (BSL-3) status. “The lack of information on BSL-3 laboratory capacity is of concern because it may be contributing to delays and bottlenecks in preclinical COVID-19 research. Although the BSL-3 laboratory capacity is not fully known, the extraordinary demand for COVID-19 preclinical research may have overwhelmed the known, available capacity,” the lawmakers state. “It is critical for the nation’s response to the pandemic to have the best understanding of the totality of such research assets in the U.S. in order to improve access for researchers, maximize research opportunities for identifying medical advances for COVID-19, bring in any underutilized laboratories to help relieve burdens on overworked research entities, and understand through traditional gap analysis whether there is appropriate high-containment laboratory capacity for biodefense strategic planning.”

Hoyer Urges Strengthening of Whistleblower Protections

House Majority Leader Steny Hoyer (D-Md.) has sent a letter to House Rules Committee Chair Jim McGovern (D-Mass.) urging the panel to adopt a new prohibition on lawmakers revealing the identities of whistleblowers under the protection of federal law, making the disclosure of a whistleblower’s identity a violation of the House Code of Official Conduct. “While its application would only extend to the House,” Hoyer writes, “it is my hope that the Senate would follow the House’s example and adopt a similar provision in its own rules.” The Majority Leader states that he will work with the Rules Committee to ensure that his proposed rule is written precisely enough to hold violators accountable without impinging on lawmakers’ ability to work with whistleblowers and conduct oversight.

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