HHS Proposes New Rules To Eliminate Drug Rebates and Encourage Direct Discounts for Federal Beneficiaries

pharmacy

On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for federal beneficiaries.  Specifically, the rule would:

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American Telemedicine Association Letter Offers Recommendations on DEA Special Registration for Telemedicine Prescribing of Controlled Substances

pharmacy

On January 9, 2019, the American Telemedicine Association (ATA) issued a policy comment letter to the U.S. Drug Enforcement Administration (DEA), advocating for provider-friendly changes to federal controlled substance prescribing rules. Note: the firm’s Telemedicine & Digital Health Industry Team participated in the ATA’s special workgroup to develop the recommendations.

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DHHS Releases Guidance on Managing Cybersecurity Threats in the Health Care Sector

data mining

The U.S. Department of Health and Human Services (DHHS) recently released Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP). DHHS states that the purpose of the HICP is to:

  1. Raise awareness of cybersecurity;
  2. Provide vetted cybersecurity practices;
  3. Move organizations towards consistency in mitigating cybersecurity threats to the sector;
  4. Aid health care and public health organizations to develop meaningful cybersecurity objectives and outcomes.

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Medication or Hazardous Waste? EPA Creates Significant New Requirements for Managing Unused Pharmaceuticals

drug testing

On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent from health care facilities to reverse distributors first be considered “disposed of,” regulated as solid waste and evaluated for hazardous classification at the health care facility. This rule will impose significant new obligations on health care providers, including pharmacies and long-term care providers, as well as forward and reverse distributors of pharmaceuticals.

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DC District Court Holds that Medicare Payment Cuts for 340B Drugs Exceeded Agency’s Authority

telemedicine rules in D.C.

Last week, a federal district court held that the Secretary of the Department of Health and Human Services (HHS) exceeded his authority when he reduced Medicare outpatient prospective payment system (OPPS) reimbursement to hospitals for most separately payable drugs purchased under the 340B program by almost 30%. The court—hearing the case for the second time after the first lawsuit was dismissed for being premature—decided that it now had subject matter jurisdiction because a claim for payment had been presented. On the merits, the court sided with the plaintiffs, holding that the Secretary of HHS’ authority to “adjust” reimbursement rates does not justify “basic and fundamental changes” to the OPPS reimbursement methodology for separately payable drugs.

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