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.
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:
- Raise awareness of cybersecurity;
- Provide vetted cybersecurity practices;
- Move organizations towards consistency in mitigating cybersecurity threats to the sector;
- Aid health care and public health organizations to develop meaningful cybersecurity objectives and outcomes.
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.
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.
The Centers for Medicare and Medicaid Services (CMS) issued a final rule (the Rule) on December 21, 2018, which reshapes the Medicare Shared Savings Program (MSSP). Termed “Pathways to Success,” the Rule, among other things,
- Redesigns the options for participation in the MSSP,
- Requires accelerated movement to downside risk,
- Is designed to increase savings for the Medicare program
The Rule also allows greater flexibility for accountable care organizations (ACOs) in the areas of new beneficiary incentives, telehealth services, and choice of beneficiary assignment methodology, all as established in the Bipartisan Budget Act of 2018.