Health Care

As we've previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s Executive Order 562. Senior DPH staff presented these proposed regulations at a Public Health Council Meeting on September 14 (the “PHC Meeting”). 

Join us this Friday at 1:30 pm EDT for a webinar with two of our Antitrust colleagues, Robert Kidwell and Bruce Sokler. They will discuss recent events in the Hershey Hospital merger and their impact on FTC's hospital merger enforcement program. Learn more about these recent updates from the comfort of your computer in our one-hour webinar.

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for diagnostic tests that were never conducted.

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland.

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global centers of life sciences regulations, including the United States, the European Union (both the unified government and the individual countries), Brazil, Mexico, China, Japan, and other regions.

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable the regulations to meet a number of goals, among them ensuring a high quality of care, industry standardization and strong consumer protection for hospital patients.

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). 

Last month the California legislature passed AB-72, which amends the Health & Safety Code to address reimbursement for out of network (OON) providers who provide services at in-network facilities, such as hospitals and laboratories.

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means' health subcommittee held a hearing on spurring innovation in the health care system. In the meeting, Rep. Peter Roskam (R-Ill.)  said that he will revive legislation that will replace traditional Medicare identification cards with electronically readable cards.

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15.

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board's (the “Board”) appeal was inappropriate and the Court does not have jurisdiction over the appeal.

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center regulations, and proposed amended regulations for medical marijuana.

As stakeholders and watchers of the expansive field of regenerative medicine likely are aware, earlier this year a study published in the peer-reviewed journal Cell Stem Cell reported on the growth of so-called stem cell clinics operating in the U.S.

Although National Cyber Security Month isn't until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for Civil Rights (OCR) on cyberattacks, describe new state breach notification laws, and highlight the upcoming NIST/OCR security conference.

In a blog post last week, CMS acting administrator Andy Slavitt said that physicians will have the ability to choose among several options to report data to Medicare under the new physician payment system ushered in by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

Our colleagues at ML Strategies, Eli Greenspan and Alexander Hecht, recently published an article in HFMA Advisor, the newsletter of the Massachusetts-Rhode Island chapter of the Healthcare Financial Management Association, on the impact of state Medicaid program transitions to managed care on brain injury waiver populations. 

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years.

Last month, the U.S. Government Accountability Office (GAO) released a report in which it found that manufacturer drug coupon programs for privately insured patients could potentially cause the Medicare Part B program to overspend on certain high-cost Part B drugs.

On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry.

Congress returns after Labor Day for a four-week sprint that will likely be centered on funding the government by way of a continuing resolution. Since Congress was last in session, the landscape on a number of health care issues remains unchanged.