The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).  DPH believes that believes the proposed amendments will streamline the Medical Use of Marijuana Program (the “Program”) by updating existing processes, providing additional clarity, and creating consistency with changes made to related laws, all with the goal of promoting patient access while assuring public safety is maintained.  At a meeting of the Public Health Council (PHC) held on September 14, 2016, DPH representatives, including Program Director Bryan Harter, MBA, LICSW, presented the proposed amendments.  DPH’s presentation to the PHC at the meeting includes a summary of the proposed amendments, as well as a brief history of the Program, including applications received, provisional Certificates of Registration to operate a Registered Marijuana Dispensary (RMD) (41), and number of RMDs currently open and dispensing marijuana for medical use (7).

Amendments are undoubtedly necessary. The current regulations, which became effective on May 24, 2013, were implemented in connection the creation of the Program, and DPH now has the benefit of experience with the RMD process to amend its regulations to reflect, in some cases, lessons learned.  As with proposed amendments to other regulations (see our prior posts here and here), these amendments are also necessary 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 their regulations.  Continue Reading Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

You can access the slides here and the recording here!

On Friday, Robert Kidwell and Bruce Sokler, members of the Firm’s Antitrust and Federal Regulatory practice group, presented a webinar on the Third Circuit’s hotly anticipated decision on the FTC’s appeal of the District Court’s denial of its request for a preliminary injunction on the merger of Penn State Hershey Medical Center and Pinnacle Health System.

This case became a topic of interest after the U.S. District Court for the Middle District of Pennsylvania denied the FTC’s request for a preliminary injunction in May 2016.  In reaching its decision, the District Court defined the “relevant geographic market” in a manner that, if upheld on appeal, would have essentially gutted the FTC’s approach to hospital merger enforcement.  Ultimately, the Third Circuit found that the District Court committed legal error in failing to properly formulate and apply the “hypothetical monopolist test” and issued an opinion that Rob and Bruce characterized as a “big win” for the FTC.

Rob and Bruce also expect this decision to be helpful to the FTC in its ongoing challenge to the Advocate/North Shore merger in Chicago (check out our previous blog post on this topic by clicking here).  Stay tuned for further updates!

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”).  Today we are looking at proposed regulations related to Dialysis Units.  For our prior analysis of the proposed regulations on hospital licensing, please see here. Continue Reading Massachusetts Dialysis Unit Licensing Proposed Regulations – Key Take-Aways

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.

Hershey Hospital Merger Blocked

Yesterday, the Third Circuit granted a preliminary injunction preventing the merger between Penn State Hershey Medical Center and Pinnacle Health System. Previously, the district court had denied the FTC’s and State of Pennsylvania’s motion challenging the merger. The district court found that the merger challenge was not meritorious, particularly in light of Affordable Care Act policies. But the FTC’s hospital merger enforcement program was revived with yesterday’s Third Circuit’s decision, which is significant to healthcare lawyers and providers.

During the webinar, Rob and Bruce will review this important decision and the court’s approach to:

  1. Geographic markets in hospital merger cases
  2. The central role of the FTC’s hypothetical monopolist test
  3. Renewed emphasis on the testimony and role of insurers
  4. Using the efficiency defense in merger litigation
  5. Relevance of merging parties’ forward-looking contracts with payers
  6. The capital-avoidance justification for mergers
  7. The place of the ACA in hospital merger analysis

Possible Impact on Advocate Merger

And because Pennsylvania can’t have all the fun, Rob and Bruce will also discuss how the Hershey decision might impact the FTC’s pending challenge to the Advocate merger in Chicago, which we have blogged about before.

Register today for this webinar on Friday, September 30, 2016; 1:30-2:30pm EDT.

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. On September 19, 2016, the owner and operator of a New Jersey billing company entered into a $100,000 settlement agreement with HHS-OIG and agreed to be excluded from participation in federal health care programs for a minimum of five years under the Civil Monetary Penalties Law.

The medical billing company was responsible for preparing and submitting claims to Medicare on behalf of an OB-GYN practice based, in part, on “superbills” identifying the services purportedly performed during a patient encounter. According to HHS-OIG, the billing company routinely added additional CPT codes to Medicare claims for unperformed services that the billing company knew were neither performed nor identified as performed on the superbill. Continue Reading Billing Companies Beware – OIG Signals a Crack Down on Fraud and Abuse at All Levels

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