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Third-Party Health Apps Not Subject To HIPAA Rules, OCR Says

According to new information by the HHS Office of Civil Rights (OCR) released Friday (April 19), smartphone apps created by third-party developers and not by providers or business associates covered under the Health Insurance Portability and Accountability Act (HIPAA) are not subject to HIPAA rules, even if a breach occurs.

CMS, ONC Gives Stakeholders More Time To Comment On Health IT Rules

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Proposed Nursing Home Pay Rule Has No Major Changes To New Model

CMS is moving forward with its plan to launch a new Medicare pay model for nursing homes beginning in fiscal 2020, and the agency is proposing a 2.5% pay bump for nursing homes in a proposed rule released Friday (April 19).

CMS Proposes 2.7% Pay Increase For Hospices In Fiscal 2020

CMS on Friday (April 19) proposed to increase Medicare payments to hospices by 2.7% in fiscal 2020 as well as to modify the content of hospice election statements to better inform beneficiaries of exactly what services are provided, and which ones aren’t tied to their terminal illnesses.

FDA Okays First Generic Naloxone Spray, Will Prioritize Naloxone ANDAs

FDA on Friday (April 19) approved the first generic naloxone nasal spray, commonly known as Narcan, for use in a community setting by people who do not have medical training.

McConnell Will Introduce Bill To Raise Tobacco Purchase Age To 21

Senate Majority Leader Mitch McConnell (R-KY) plans to introduce legislation in May that would raise the national minimum age to purchase tobacco products, including vaping devices, from 18 to 21, the senator announced Thursday (April 18).

FDA Issues Draft Guidance On Nitinol In Devices

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.

CMS Proposes 1.7% Pay Increase For Inpatient Psychiatric Facilities

CMS on Thursday (April 18) proposed to increase Medicare payments to inpatient psychiatric facilities by 1.7% in fiscal 2020 while adding a new quality measure intended to assess whether patients with certain diagnoses are filling their prescriptions after being discharged from such facilities.

Pallone Bill Would Ban Online E-Cig Sales, Raise Minimum Purchase Age

House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and Florida Rep. Donna Shalala (D) on Tuesday (April 16) introduced a bill that would allow FDA to collect user fees for e-cigarettes, raise the minimum age to purchase tobacco to 21, prohibit online sales of tobacco products, ban all characterizing tobacco product flavors, require FDA to finalize rulemaking to implement graphic health warnings for cigarette packages, and hold all deemed tobacco products to the same advertising and sales requirements applied to combustible cigarettes.

Supplement Lobbies Support Incentives But First Want More Enforcement

The heads of two major dietary supplement lobbies support establishing incentives for the dietary supplement industry, including the possibility of exclusivity, but they are adamant such incentives should not mirror exclusivity as it exists in the prescription drug space.

CMS Adds 12 DME Items To Required Prior Authorization List

CMS on Thursday (April 18) added more power wheelchairs and pressure reducing support surfaces to the list of durable medical equipment that must undergo prior authorization.