On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a proposed rule to amend the safe harbors to the anti-kickback statute as well as the civil monetary penalty (CMP) rules. While much of the proposed rule codifies changes to the anti-kickback statute safe harbors already established by the Affordable Care Act (ACA) and Medicare Modernization Act of 2003 (MMA), it also proposes two new safe harbors and makes technical corrections to an existing safe harbor. The OIG also proposes to narrow the definition of "remuneration" in the Beneficiary Inducement CMP laws as well as codify and interpret the gainsharing CMP rules set forth in section 1128A(b) of the Social Security Act.
The proposed changes to the safe harbors and CMP laws would give providers greater flexibility to enter into beneficial arrangements with the assurance that they will not be subject to penalties under these laws. The proposed rule reflects the OIG's continued effort to adapt its regulations to the changing health care landscape.
For more details on these proposed changes, please visit our newsletter article, which provides an in-depth analysis of the proposed rule. If you have any questions on the proposed rule and how you are affected, please contact an attorney in our Health Care Practice Group.
While the healthcare industry has historically been knocked as slow to adapt to emerging technologies, the technological modernization of the industry is now occurring at a furious pace. From the digitization of health care records, to improved means of communications between doctors and patients, technology is transforming healthcare.
Tech behemoths like IBM, as well as scrappy Silicon Valley startups, have recognized the potential and are pouring resources into healthcare IT. According to data from investment company Rock Health, venture capital funding to healthcare information technology companies for 2014 reached $2.3 billion as of mid-year 2014. That's more than 10 times the nearly $200 million that was invested in healthcare IT in 2007.
One of the healthcare industry's newest tech innovations, called Figure 1, is the brainchild of a doctor named Josh Landy. Figure 1 is an Instagram-style app that allows doctors to share photos of patient conditions with other medical professionals in order to get their opinions regarding diagnosis and treatment. Read More ›
"It's a war we're in." That's how John Halamka, the chief information officer of Boston-based Beth Israel Deaconess Medical Center, described the current state of affairs between the health care industry and the hackers and identity thieves who are trying to steal patient records.
A recent Boston Globe article detailed the threat and provided some interesting - and sobering - statistics and information:
Hackers are motivated to target health records in order to facilitate identity theft, financial fraud and illegal drug use. The Boston Globe article, in particular, highlighted two recent incidents involving cyber-security breaches: (1) Chinese hackers seized the personal information of 4.5 million patients at a Tennessee-based hospital network, and (2) federal officials disclosed on September 4 that a hacker managed to install malicious software on HealthCare.gov. Read More ›
The Final HIPAA Omnibus Rule ("Final Rule"), published January 25, 2013, contains several new requirements for business associate ("BA") agreements. While the requirements went into effect on September 23, 2013, grandfathered BA agreements that were in place prior to January 25, 2013 were deemed to be in compliance for one year. Now that the one year expiration of the deemed compliance is quickly approaching, covered entities and business associates must ensure that their grandfathered BA agreements are updated to comply with the Final Rule before the September 22, 2014 deadline.
To meet the deadline, covered entities and business associates should review and update all existing BA agreements to determine whether they are HIPAA-compliant. The Final Rule also requires business associates to have written BA agreements with their subcontractors that comply with the new requirements. Read More ›
Michigan legislators Gretchen Whitmer (D- East Lansing) and Gretchen Driskell (D-Saline) plan to introduce a bill in the Senate and House this week entitled the "Reproductive Health Coverage Information Act," which would require employers to provide both prospective and current employees with information about health insurance coverage relating to reproductive health. Read More ›
On August 5, 2014, the Michigan Supreme Court (the "Court") declined to reconsider its decision to reject two class actions and a qui tam action against CVS Caremark Corporation, Rite Aid of Michigan, Inc., and several other pharmacies. The lawsuits were based on allegations that the companies had overcharged Medicaid for generic prescription drugs.
The underlying case was argued before the Court on January 16, 2014, and the Court ruled against the plaintiffs on June 11, 2014. The plaintiffs argued that the pharmacies violated Michigan Public Health Code, MCL 333.17755(2), which requires a pharmacist to “pass on the savings in cost” when dispensing a generic drug instead of a brand name drug. Read More ›
The Centers for Medicare & Medicaid Services ("CMS") recently announced proposed changes to the Medicare home health prospective payment system (“PPS”) for the 2015 calendar year. CMS is proposing to tighten eligibility requirements for home health services and set a minimum requirement on Home Health Agencies ("HHAs") to prove their effectiveness, as well as revise how much CMS will pay for certain services. These proposed changes are expected to reduce Medicare payments to HHAs by $58 million next year alone, a reduction of .30 percent.
To qualify for the Medicare home health benefit, a beneficiary must be under the care of a physician, have a need for skilled nursing care, physical therapy, speech-language pathology, or continued need for occupational therapy. Further, the beneficiary must be homebound and receive home health services from a Medicare approved agency.
The proposed changes include the following: Read More ›
The Office of the Inspector General for the United States Department of Health and Human Services (the “OIG”) recently issued a Special Fraud Alert regarding laboratory payments to referring physicians (the “Alert”). The Alert relates to two types of compensation arrangements - Specimen Processing Arrangements and Registry Arrangements - between clinical laboratories and physicians who order clinical laboratory tests that the OIG believes present a substantial risk of fraud and abuse under the federal anti-kickback statute. Read More ›
The United States Court of Appeals for the Sixth Circuit has upheld Michigan’s tax on paid health care claims in an opinion published on August 4. The decision has very significant implications for the State of Michigan, which uses the revenues to partially fund the Medicaid program, and for employers, group health plans, and third-party administrators, which are subject to the tax. Read More ›
The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced that it reached a resolution agreement with a health care system in connection with alleged violations of the Health Insurance Portability and Protection Act of 1996 (HIPAA). Pursuant to the settlement, Parkview Health System, Inc. (Parkview) agreed to adopt a corrective action plan (CAP) to address deficiencies in its compliance program and to pay $800,000.
As explained by OCR in a news release, Parkview, a covered entity under the HIPAA Privacy Rule, took custody of medical records of approximately 5,000 to 8,000 patients while assisting a retiring physician to transition patients to new providers, and while considering the purchase of some of the physician’s practice. Subsequently, Parkview employees, with notice that the physician was not at home, left 71 cardboard boxes full of medical records unattended and accessible to unauthorized persons on the driveway of the physician’s home. The physician complained, prompting the HHS investigation. Read More ›