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.  This webpage provides further information for potential attendees.  The upcoming event will be the first public meeting convened by FDA to address DSCSA-related issues.  The DSCSA requires the Agency to conduct at least 5 such meetings during the lengthy implementation period in order to keep it engaged and communicating with relevant stakeholders.

As we have described previously (see here and here), the goal of the DSCSA is to implement enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.  It created phased-in obligations for various “trading partners,” such as manufacturers, distributors, and dispensers, over a 10-year period, beginning with the law’s passage at the end of 2013.

Among many others, one of the impending obligations facing industry is the requirement that manufacturers and repackagers affix or imprint a product identifier, at the package level, to prescription drug products that they introduce into commerce.  This product identification step is also referred to as “serialization,” and eventually trading partners will only be allowed to sell and buy serialized drug products.  Manufacturers and repackagers must comply with their initial product serialization mandates by November 2017 and November 2018, respectively. Continue Reading FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

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. These amendments are part of DPH’s overall regulatory review process needed to comply with Governor Baker’s Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve regulations.

The presentation to the Public Health Council (PHC) by attorneys Sherman Lohnes, Director of the Division of Health Care Facility Licensure and Certification, Bureau of Health Care Safety and Quality and Lauren Nelson, the Bureau’s Director of Policy and Quality Improvement, offers a good summary of many of the proposed changes.  This post features several items that are particularly noteworthy. Continue Reading Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

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. Conference topics centered predominantly on international themes, such as the European Union Medical Device Regulation, China’s drug and medical device regulations, international implementation of the Medical Device Single Audit Program, and international implementation of social media promotion regulations.

Continue Reading Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

money_388130419The 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”).  Through an interim final rule, the Department of Justice nearly doubled the per-claim FCA penalty. The minimum per-claim FCA penalty increased from $5,500 to $10,781 and the maximum per-claim FCA penalty increased from $11,000 to $21,563. The FCA penalties nearly doubled because the Federal Civil Penalties Inflation Adjustment Act of 2015 (the “2015 Adjustment Act”) required federal agencies to update civil monetary penalties (“CMPs”) within their jurisdiction by August 1, 2016 to catch-up with inflation.

Because of the 2015 Adjustment Act, numerous other CMPs—in addition to the FCA—recently have increased or likely will increase. Continue Reading Penalties For Health Care Law Violations Surge

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.  In so doing, California joins several other states, including New York, Connecticut and Florida, which offer consumers protections against surprise OON bills, as well as a process for providers and insurers to resolve payment disputes for OON care.  If signed into law as expected, the legislation will apply to plans issued, amended or renewed on or after July 1, 2017.

Out of Network Coverage

The legislation provides that if an insured receives services covered by his/her health plan by an OON provider at an in-network facility, the insured is only obligated to pay the OON provider the cost sharing amount that he/she would otherwise be obligated to pay had the same covered service been provided by an in-network provider.

The OON provider is prohibited from billing or collecting any amount beyond the insured’s cost sharing obligation, unless the insured has a plan that includes an OON benefit and the insured consents in writing to receive services from the OON provider at least 24 hours in advance of the episode of care.  At the time consent is provided, the OON provider must give the insured a written estimate of his/her total out-of-pocket cost of care.  Continue Reading California Joins New York and Florida, Passes Out-Of-Network Legislation

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.

As we discussed last year, the move is caused by two provisions in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The first provision requires Social Security Numbers to be removed from Medicare identification cards within four years after MACRA’s enactment. The second provision requires the Secretary of the Department of Health and Human Services to consider using electronic Medicare beneficiary and provider cards if the Secretary determines that it is cost effective and technologically viable. A report by the Government Accountability Office (GAO) entitled “Medicare — Potential Uses of Electronically Readable Cards for Beneficiaries and Providers“ casts some doubt on whether a robust implementation of electronically readable cards is either cost effective or technologically viable. However, electronically readable Medicare cards could receive a more limited introduction as means of more efficiently conveying beneficiary identity and insurance information. In addition to reducing errors, this could serve to combat fraud that is made possible by the personal information currently found on each beneficiary’s identification card.

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. More than 150 people attended in-person, including our own Joanne Hawana, with another 500 webinar attendees. Continue Reading FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm

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. But the government did not stop there. The brief goes on to argue that if the Court does in fact find that it has jurisdiction, it should affirm the district court’s order denying the Board’s motion to dismiss and allow the case to proceed. Continue Reading Teladoc Receives Support from the Feds

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. At a very busy September 14, 2016 Public Health Council Meeting, senior DPH staff presented the proposed regulations, highlighting key objectives and fielding questions and comments from Council members.  Commissioner Monica Bharel, MD, MPH, commended DPH staff for their hard work on the amendments.

In the proposed facility licensing regulations, key themes across all facility types included:

  • Removing outdated regulations;
  • Updating standards to give additional flexibility while protecting patient safety and tying regulatory standards to nationally recognized, evidence-based guidelines;
  • Aligning state and federal requirements; and
  • Providing clearer timelines and guidance for initial license applications, change of ownership or location, and facility closure.

The proposed regulations and the presentations are available below, along with public hearing dates and comment deadlines.  As discussed in a recent post regarding proposed amendments to the Determination of Need Regulations, consistent with Governor Baker’s Executive Order 562, DPH is reviewing and, where possible, streamlining, simplifying and improving its regulations. These proposals are sure to generate much discussion and comment.  In the meanwhile, please stay tuned for more detailed posts on these amendments.

Topic Citation Proposed Amended Regulations DPH Presentation Public Hearing Date Comment Deadline
Hospitals 105 CMR 130.00 Link Link October 24, 9:30AM October 28
Clinics 105 CMR 140.000 Link Link October 25, 9:30AM October 28
Dialysis Units 105 CMR 145.000 Link Link October 25, 9:30AM October 28
Birth Centers 105 CMR 142.000 Link Link October 24, 9:30AM October 28
Medical Marijuana 105 CMR 725.000 Link Link

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. Continue Reading September Privacy and Security Updates