North America

Change Is Here – President Trump’s First Day Includes Addressing the Affordable Care Act and Freezing Regulations

On his first day in office, President Trump issued an Executive Order entitled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal.” The Executive Order is, in effect, a policy statement by the new administration that it intends to repeal the Patient Protection and Affordable Care Act (the “ACA” or the “Act”) as promptly as possible. The Executive Order also directs the Secretary of Health and Human Services and the heads of all other executive departments and agencies that, pending repeal of the ACA, they are to exercise the full extent of their authority and discretion to “take all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the Act, and prepare to afford the States more flexibility and control to create a more free and open healthcare market.”

Read full article

Robert J. Munnelly, Jr. and Patrick T. Clendenen to Present Data Security Program for MCLE

On April 5, Robert J. Munnelly, Jr. and Patrick T. Clendenen, shareholders at Davis Malm, will present the program, “Protecting Data & Dealing with Breaches Globally in 2017,” as a seminar for Massachusetts Continuing Legal Education (MCLE).

The program will provide a comprehensive overview of data security developments affecting Massachusetts businesses and institutions in 2017, including global issues, recent litigation precedents affecting exposure to class action lawsuits for significant breaches, and emerging insurance coverage issues. The panel will also provide a timely update on recent enforcement trends and the evolving roles of the Consumer Protection Division of the Massachusetts Attorney General’s Office as reviewers of business practices and protectors of consumer rights relative to sensitive data.

Read full article

FDA Says Yes to Pre-Approval Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

Early January has seen the release by FDA of a flurry of information on drug and device manufacturer communications, largely reaffirming FDA’s long-held approach to restricting manufacturer communications regarding off-label uses of approved drugs and medical devices. The most significant positive development arising from these documents is the Agency’s concession on proactive pre-approval communications with payors about investigational drugs and devices, allowing certain information to be provided to payors prior to a product’s approval. FDA’s guidance documents issued this week also clarify some grey areas surrounding the circumstances under which manufacturers may communicate about information that is consistent with or related to an approved indication, but is not included in approved product labeling.

Read full article

(Français) Témoignage d’un étudiant – Une diversité salutaire

Il est monnaie courante de voir, au cours de la course aux stages ou dans les facultés de droit, des étudiants évoqués leurs intérêts de « spécialisation juridique »*. Fiscalité, famille, affaires, assurances, travail, pénal : en cette ère de la spécialisation, tout un chacun tente de trouver une branche qui cadre avec ses intérêts et dans laquelle il souhaiterait développer une expertise particulière.

Read full article

Connecticut Public Utilities Regulatory Authority Implements New Connecticut Bar Requirements; Davis Malm in Full Compliance

The Connecticut Public Utilities Regulatory Authority (“CT PURA”) issued notices in its pending dockets confirming that, as required by new state ethics rules effective January 1, 2017, out of state attorneys can no longer practice before CT PURA without meeting Connecticut Bar requirements – either membership or securing pro hac vice status from a Connecticut Superior Court. Going forward, attorneys must file proof of state bar compliance in each PURA docket. Pro hac vice status is potentially difficult to obtain and is supposed to be granted to out of state attorneys only “upon special and infrequent occasion and for good cause shown…” See Connecticut Practice Book, Section 2-15, which can be found here. Section 2-15 also requires that a Connecticut licensed attorney participate in CT PURA hearings along with the attorney granted pro hac vice status.

Read full article

Supreme Court Set To Resolve Class Action Waiver Dispute

Supreme Court Set To Resolve Class Action Waiver DisputeOn January 13, 2017, the United States Supreme Court granted certiorari to hear three cases involving the enforceability of arbitration agreements that contain class action waivers.

Whether such agreements are enforceable has been a hotly contested issue for several years now, particularly in cases involving wage-hour disputes.

Read full article

Sudanese sanctions sailing into the sunset

Effective today, January 17, 2017, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) has announced the conditional lifting of 20 years of U.S. sanctions against Sudan.1 This action is occurring in connection with an Executive Order issued by President Barack Obama on January 13, 2017, “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions,” as a result of what the administration has deemed “sustained progress” by the Government of Sudan on a variety of fronts, including: a marked reduction in offensive military activity; a pledge to maintain a cessation of hostilities in conflict areas in Sudan; steps toward improving humanitarian access throughout Sudan; and cooperation with the United States on counterterrorism and addressing regional conflicts.2

Read More

Read full article

Final rule allows more sharing of substance abuse treatment information

The Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services recently issued a final rule that will allow more flexibility for sharing patient records relating to substance use disorders.

The final rule amends Title 42 of the Code of Federal Regulations Part 2 (Part 2 Regulations), which governs the confidentiality of substance use disorder records and sets forth more stringent privacy protections than the HIPAA Privacy Rule. The Part 2 Regulations had not been substantively amended since 1987 and therefore did not reflect changes in health care such as the use of electronic health records and integrated care models involving the sharing of information to coordinate care. SAMHSA stated its goal with this final rule is to ensure patients with substance use disorders can benefit from new integrated health care models without fear of putting themselves at risk.

Read More

Read full article

Stakeholder Agendas in the Washington Transition: 5 Takeaways for Converting Ideas into Technically Effective Proposals

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

Read full article

A Student’s Perspective – Eight Tips for Surviving Your First Summer As A Student at RSS

(1)   Always smile and be kind with each person you cross at RSS. You will be surprised how much every single person in the office plays an integral part in the firm’s extended ecosystem. Whether it is a late-night security guard or a bike messenger in the elevator, every individual you see come in and out of the office merits your respect and energy. This applies especially to the office’s amazing team of secretaries and receptionists!

Read full article