New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.
The first rule exempts “autosomal recessive carrier screening gene mutation detection systems” that are offered DTC from FDA premarket review. FDA first proposed this exemption in
After July 1, 2017, optometrists and ophthalmologists (“Ophthalmic Providers”) in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship “by an examination through face-to-face interactive, two-way, real-time communication” or through “store-and-forward technologies.” Licensed Ophthalmic Providers may establish a provider-patient relationship so long
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Most reasonably-well-informed citizens, and certainly everyone concerned with health care, is well aware that the Supreme Court concluded its most-recent term with the Chief Justice joining the Court’s so called “liberal” wing in National Federation of Independent Business v. Sibelius, in upholding essentially all of the Obama Administration’s Affordable Care Act (“ACA”), including its most
Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their
by René Y. Quashie and Lynn Shapiro Snyder
As the health care industry analyzes the recently released final rule and related guidance regarding the Medicare Shared Savings Program (“MSSP”) for accountable care organizations (“ACOs”), it is important for the industry to also pay attention to key deadlines related to initiatives being implemented by the Center
by Patricia M. Wagner and Ross K. Friedberg
Among the criteria that the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) uses to evaluate an accountable care organization’s (“ACO’s”) risk of an antitrust challenge is the ACO applicant’s “market share” within each of its
by Patricia M. Wagner and Ross K. Friedberg
On April 19, 2011, the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) was published in the Federal Register. As noted in the Proposed Statement, the antitrust enforcement agencies (the Department of Justice Antitrust Division and
by Shawn M. Gilman, Douglas A. Hastings, Mark E. Lutes, David E. Matyas, Lynn Shapiro Snyder, Carrie Valiant, Dale C. Van Demark, Patricia M. Wagner, and Lesley R. Yeung
On March 31, 2011, the Centers for Medicare & Medicaid Services ("CMS") released for public comment a much-anticipated
According to the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), Dr. Donald M. Berwick, the long-awaited proposed regulations implementing the Medicare Shared Savings Program should be out soon. Given the incredible proliferation of policy, business, and legal thinking about accountable care organizations (“ACOs”) that has taken place
As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:
1. Flexibility.
"Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande’s advice and