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Cathy Kelly

Senior Writer

Washington, DC
Cathy Kelly has been covering reimbursement and market access news for more than a decade for "The Pink Sheet" and other publications that are now part of Informa's pharmaceutical intelligence resources. Her expertise spans legislative, regulatory and public policy topics as well as coverage trends in public and private insurance markets. Cathy is especially interested in following the ongoing transformation of the US health care system and its effect upon major stakeholders in the biopharma industry. She is based in Washington D.C.

Latest From Cathy Kelly

340B Dispute Resolution Process On Ice As Feuds Between Pharma, Providers, HHS Heat Up

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

Reimbursement Pricing Debate

Medicare Part D Protected Classes Targeted in Last-Minute Payment Demo Update

If not reversed by the Biden Administration, demo program that puts plans at increased risk in catastrophic phase would also enhance negotiating leverage for drugs in the protected classes.

Medicare Pharmacy Benefit Management

Biden Regulatory Freeze May Pause SUNSET Rule

Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

FDA Regulation

Biden Regulatory Freeze Could Slam Brakes On SUNSET Reg Review Rule From HHS

The tactic aims to allow the new Biden administration to scrutinize so-called “midnight rules” issued in the final days of the Trump administration before they take effect. One reg targeted by the freeze is the recent SUNSET rule from the US HHS, which would require the department and its agencies – including the FDA – to review all regulations every 10 years to determine whether they’re still necessary.

Regulation Policy

Two-Tier Specialty Drug Policy: Part D Plans Gain Formulary Flexibility But Impact May Be Limited

Use of preferred and non-preferred specialty formulary tiers will be allowed but preferred tiers are not necessarily limited to generics and biosimilars and coinsurance for non-preferred specialty drugs cannot exceed 33%.

Pricing Strategies Medicare

Biden Regulatory Freeze May Pause Sunset Rule, Medicare Rebate, Medicaid Line Extension Regs

Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.

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