The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened investigations for HIPAA breaches affecting more than 500 individuals.
The use of telemedicine has expanded access to care to patients in rural areas and provided a convenient alternative to battling congested physician offices and emergency department waiting rooms. In repeated studies the delivery of medicine through electronic means has reduced the cost of care, improved efficiencies, and provided a realistic solution to increasing shortages of physicians. Despite promising studies, however, multiple barriers continue to present obstacles to widespread adoption and implementation of telemedicine. One of the greatest barriers to adoption continues to be variances and inconsistencies in state laws governing the practice of medicine.
A new study by Stanford University researchers finds that Medicare Advantage plans pay lower prices than traditional fee-for-service (FFS) Medicare for most types of hospital admissions. According to the study—published earlier this month in Health Affairs—Medicare Advantage plans pay hospitals about 8% less than FFS Medicare for the same services. These findings may come as a surprise to policy experts, as commercial insurers for the non-elderly generally pay far higher prices than FFS Medicare.
This past May, the Department of Health and Human Services (HHS) issued a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in the healthcare system. While Section 1557 has been in effect since 2010, the final rule extends additional protections to transgender individuals seeking transition-related health services, which can include gender reassignment surgery. The rule went into effect July 18th, although provisions affecting health insurance plan benefit design will become effective January 2017.
Childbirth is the leading indication for hospital admission in California, with roughly 500,000 deliveries in the state each year. This is particularly challenging for health plans serving Northern California, the most expensive region in the country to give birth. New research suggests that increased health system consolidation may be a factor contributing to high prices, and sheds light on considerable regional differences in costs of delivery across the US. Furthermore, rising rates of Caesarian Section (C-section) deliveries statewide may be driving costs despite evidence of increased risks to mother and baby.
The Center for Medicare & Medicaid Innovation first introduced its Oncology Care Model (OCM) last year. OCM went into effect July 1, 2016, and will run through June 30, 2021. The new multi-payer model is the first CMS physician-led care model aimed at improving cancer treatment for Medicare beneficiaries. CMS hopes to see improvements in care coordination and access, as well as a decrease in unnecessary services and Medicare expenditures. OCM may be an important experiment for Medicare’s initiatives to implement alternative payment models for specialists, but will the rewards be enough to move the dial away from entrenched payment arrangements that reward volume?
There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf. Individuals who are blind or have low vision may require assistive devices and specialized software to access the Internet. These devices often include software that enables them to magnify the content of a web page, reads the content to them, or enables them to use a braille reader to read a website. Some individuals with disabilities cannot use a mouse and can only navigate with a keyboard, touchscreen, or voice recognition software. For persons with hearing impairments, the visual aspects of a website are accessible, but audio on a website may not be.
In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to return the overpayment or face penalties and treble damages under the False Claims Act (“FCA”). As described below, recent regulations have clarified some of the issues surrounding the ACA obligation to refund overpayments, at least for overpayments under Medicare Parts A and B. But, determining whether a provider has “identified” an overpayment – and thus started the 60 day countdown – can still be nuanced and complex. Diligent providers that have proactive and robust compliance and audit functions in place may find some comfort, since such providers are presumably able to respond quickly to credible information that there has been a potential overpayment, as required by the new regulations, and thereby have a reasonable period of time to conduct an investigation and quantify the amount of any overpayment before the 60 day clock begins to run.
After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR).
The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for example, to product classification; quality system standards; pre-market authorization; and reporting of adverse events.
The final version of the MDR – a hefty 352 pages – was published on June 27 and is now reviewed by the EU’s legal editor for drafting or law-technical errors. It then needs to be translated into all EU member languages, followed by formal publication. After publication, expected in late 2016 or early 2017, there will be a three-year transition period as the medical device industry will need time to comply with the new requirements.
On July 6, 2016, CMS released the 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule which, among other things, implements Section 603 of the Bipartisan Budget Act of 2015. Despite extensive lobbying efforts by the hospital industry, CMS’ proposed rule would effectively preclude the relocation or the expansion of service lines of existing off-campus provider-based departments. In reaching this position, CMS noted its belief that Section 603 was intended to “curb the practice of hospital acquisition of physician practices that then result in receiving additional Medicare payment for similar services.”