On Nov. 7, the U.S. Supreme Court decided it would hear a case concerning the health insurance subsidies provided to millions of Americans under the Patient Protection and Affordable Care Act. A June 2015 decision is expected in the case of King v. Burwell, which challenges the Internal Revenue Service’s authority to regulate tax-credit subsidies for coverage purchased through health insurance marketplaces established by the federal government (such as the Michigan health insurance marketplace). Nationwide, more than four out of five people who have received coverage through a federal marketplace are getting a tax credit. Read More ›
On Friday, October 17, Governor Rick Snyder signed the Right to Try Act, which allows patients to try experimental drugs and other treatments before they have been approved by the Food and Drug Administration (FDA). The law gives patients with advanced illnesses access to drugs that successfully cleared Phase 1 of an FDA approval. Phase 1 testing seeks to establish a drug's safety and profile and evaluates possible side effects. It involves 20-80 volunteers and lasts approximately one year. Read More ›
As is well known by now, transitional relief from the Patient Protection and Affordable Care Act's Employer Mandate in 2015 is available for certain applicable large employers that sponsor non-calendar year health plans. This transitional relief allows the employer to avoid penalties for those months of 2015 that predate the first day of the non-calendar plan year. What is not so well-known, however, are the requirements that must be met in order for the employer to be entitled to receive the transitional relief. Read More ›
Last month, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) issued guidance addressing the treatment of same-sex spouses under the HIPAA Privacy Rule in light of the Supreme Court’s decision in United States v. Windsor.
In Windsor, the Supreme Court held Section 3 of the Defense of Marriage Act (“DOMA”) to be unconstitutional. Section 3 of DOMA had excluded same-sex marriages from recognition under federal law.
As a result of the Windsor ruling, legally married same-sex spouses are entitled to additional rights under several federal regulations, one of which is the HIPAA Privacy Rule ("Rule"). The Rule provides certain protections to family members of patients. In its guidance, OCR clarifies that legally married same-sex spouses are family members for the purposes of the Rule, regardless of where they live. Read More ›
Accountable Care Organizations (ACO) are still a relatively new concept in the healthcare world. ACOs emerged in 2011 as a result of an initiative by the Centers for Medicare & Medicaid Services (CMS), as we documented in our blog articles ACO Regulations Finally Released, Braving the New Frontier of Accountable Care Organizations, and Final ACO Regulations are Released - Is this the Beginning of a New Era for Health Care?
While what exactly is an ACO is still kind of nebulous, ACOs generally are groups of doctors, hospitals, and other health care providers, who voluntarily join forces for the purpose of providing coordinated care to Medicare patients. The goal of ACO’s coordinated care is to ensure that patients, especially the chronically ill, receive the correct care at the right time, while avoiding unnecessary duplication of services and preventing medical errors. ACOs that achieve cost saving from providing timely and accurate care that meet quality benchmarks share in Medicare savings. Lofty and worthy goals, no doubt. Read More ›
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.
Julie C. LaVille authored this article as a Law Clerk.
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 ›