After High Stakes Feb. Meeting, MACs Will Not Make Local Coverage Determination For RPM, RTM Coverage

Novitas Solutions and First Coast Service Operations (FCSO) sent an email Friday afternoon (May 19) telling select remote physiologic monitoring and remote therapeutic monitoring advocates that the Medicare Administrative Contractors will not be releasing a local coverage determination at this time after reviewing the extensive list of studies sent by advocates and hearing testimony at the Feb. 28 Contractor Advisory Committee meeting that sought to tease out the value of the services. Most importantly, the MACs’ hesitation will give the...
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Oncologists Weigh Options As CMS Reiterates No Drug Delivery Post-PHE

The Community Oncology Alliance (COA) is weighing its legal and legislative options after being informed by CMS hours before the COVID-19 public health emergency ended midnight last Thursday that the agency was sticking by its plan to prohibit physicians from delivering outpatient prescription drugs to patients’ homes via the mail or similar delivery options post PHE, COA Executive Director Ted Okon told Inside Drug Pricing . A lawsuit would be the most expedient form of action, as legislation to address...
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IDP Issue: 
Inside Drug Pricing - 05/22/2023
IDP Volume: 
Vol. 6, No. 21
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Oncologists Weigh Options As CMS Reiterates No Drug Delivery Post-PHE

The Community Oncology Alliance (COA) is weighing its legal and legislative options after being informed by CMS hours before the COVID-19 public health emergency ended midnight last Thursday that the agency was sticking by its plan to prohibit physicians from delivering outpatient prescription drugs to patients’ homes via the mail or similar delivery options post PHE, COA Executive Director Ted Okon told Inside Drug Pricing . A lawsuit would be the most expedient form of action, as legislation to address...
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CMS Issue: 
Inside CMS - 05/25/2023
CMS Volume: 
Vol. 26, No. 21
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FTC Seeks To Make Health App, Tracker, Connected Device Vendors Report Privacy Breaches

The Federal Trade Commission on Thursday (May 18) proposed changes to its Health Breach Notification Rule that would require vendors of health apps and direct-to-consumer digital health technologies that are not covered by HIPAA to start notifying the agency when there are breaches of consumer health information. The proposed updates come one day after FTC charged ovulation and fertility app Premom with breaking the breach rule in part by exposing users’ social media accounts, device information and geolocation. FTC says...
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FDA Issue: 
FDA Week - 05/26/2023
FDA Volume: 
Vol. 29, No. 21
HEA Issue: 
Health Exchange Alert Weekly Report - 05/24/2023
HEA Volume: 
Vol. 11, No. 21
Author: 


Advocates, Providers Rallying In Support Of MN Public Option

Health care advocates and providers in Minnesota are rallying in support of legislation that would create a new public option by allowing residents to buy into the state’s Basic Health Program that currently covers people earning up to 200% of poverty. Minnesota’s house and senate have passed bills that support the option but differ on whether undocumented residents can access the program, with the house version opening the plan to all individuals while the senate bill would bar undocumented residents...
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HEA Issue: 
Health Exchange Alert Weekly Report - 05/24/2023
HEA Volume: 
Vol. 11, No. 21
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KFF: Likely $1.1B In 2023 MLR Rebates May Foretell 2024 Premium Hikes

Insurers are expecting to issue about $1.1 billion in rebates to consumers in 2023 under the Affordable Care Act’s medical loss ratio policy that limits the amount of premium revenue plans can spend on plan administration, marketing and profit, according to a Kaiser Family Foundation analysis of data insurers sent to states . The estimate is far lower than the record-high rebates issued during the peak of the pandemic, but $1.1 billion is still higher than in most previous years...
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CMS Issue: 
Inside CMS - 05/25/2023
CMS Volume: 
Vol. 26, No. 21
HEA Issue: 
Health Exchange Alert Weekly Report - 05/24/2023
HEA Volume: 
Vol. 11, No. 21
Author: 


Expert: FDA’s MAUDE Database Can’t Track Bias In AI/ML Health Tech

FDA’s Manufacturer and User Facility Device Experience database is insufficient in monitoring bias in artificial intelligence and machine learning health technologies, according to experts, as federal agencies and lawmakers scramble to monitor the rapid expansion of AI/ML systems in the health care sector . FDA and the Federal Trade Commission are in the process of drafting new regulatory requirements to eliminate bias in AI/ML technologies bias before and after devices and software are on market as the technologies’ use in...
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