Last week, Mintz Levin released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA). The Advisory summarizes the notification requirements as well as the risks associated with failing to provide the required information, including removal of a manufacturer’s drug products from the active section of FDA’s Orange Book. The data submission requirements are part of the FDA Reauthorization Act (FDARA), which aims to improve FDA’s ability to track drug products in the commercial marketplace and represents one of Congress’ attempts to control drug pricing and address patient access issues for prescription drugs.
Carrie Roll is an Associate in the firm’s Washington, DC office. Carrie's practice involves a variety of transactional, regulatory, and fraud and abuse matters. Her transactional experience focuses on advising health care clients on joint ventures, mergers and acquisitions, service agreements, and corporate stock and asset acquisitions. She has served as corporate and regulatory counsel to pharmacy benefit managers, retail pharmacies, and health care providers in acquisitions, and also advises health care clients on a variety of regulatory issues.
Last week, ML Strategies released an Advisory providing a comprehensive review of the sweeping health care legislation recently released by the Massachusetts Senate. The Advisory summarizes the notable provisions contained in the bill, including, among other things, how to handle the rising cost of prescription drugs, hospital reimbursement rates, changes to MassHealth (the Massachusetts Medicaid agency), and commercial insurance market tiering. The bill represents the latest in a series of proposals lawmakers and the Baker administration have made this year aimed at lowering health care costs and improving quality of care. Given the uncertain future of health care at the national level, all eyes will be on Massachusetts as it grapples with these important issues.
Earlier this month, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 23 health care-related qui tam cases unsealed in June 2017. The Update provides an in-depth analysis of six cases in which the government intervened, and discusses why these cases are notable in the health care industry.
The Update also provides a summary of the trends revealed in these recently unsealed cases:
- The cases identified were filed in federal district courts in 18 states, including four filed in the active Middle District of Florida.
- Of the cases identified, the federal government intervened, in whole or in part, in eight cases and declined to intervene in 13. There were two cases in which the intervention status could not be determined from the case docket.
- The entities named in the qui tam actions included outpatient medical providers, laboratory testing companies, inpatient hospitals, and medical supply companies.
- In all but three cases, the relators were current or former employees of the defendants.
- Once again, there were long delays in unsealing these cases, with an average time under seal of just over two years and four months. And one case had been under seal for almost nine years.
Click HERE for the full Update and to find our key takeaways from the cases discussed.
A few months ago, two states that previously imposed onerous telemedicine requirements – Texas and Oklahoma – enacted laws that loosen restrictions on telemedicine providers and generally fall into line with what a vast majority of states already permit. However, these laws continue a pattern in which each state’s telemedicine laws use different definitions for what constitutes telemedicine and imposes disparate restrictions on telemedicine providers. This lack of uniformity imposes an ongoing challenge for telemedicine providers.
The Texas law, passed by the state legislature on May 12, 2017, permits telemedicine providers to establish a valid patient-provider relationship via telemedicine and without the need a prior in-person visit. This law follows a long and arduous court battle between the Texas Medical Board and Teladoc Inc. A summary of the case can be found here. At the crux of the controversy were Board regulations that prohibited physicians from establishing a valid physician-patient relationship in the absence of an in-person visit. Continue Reading Holdout States Loosen Restrictions on Telemedicine but Obstacles Remain
Earlier this month, two states – Maryland and Nevada – passed legislation aimed at controlling drug prices. The two laws are being touted by proponents as decisive action against pharmaceutical manufacturers. Opponents note that the laws have limitations and are really more of an annoyance for drug makers and will not do anything to help patients access or afford their medicines. Notably, both measures were enacted without the governors’ signatures (who are both Republican) but neither governor vetoed the legislation.
Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate. Continue Reading CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act
Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.
The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption
In 2016 and now in early 2017, state legislatures and regulatory boards continue to enact laws and rules setting telemedicine practice standards. Such standards generally include clarifying the definition of telemedicine as well as providing standards related to prescribing in an online setting, patient informed consent, treatment of medical records generated during a telemedicine encounter, and confidentiality. A recent survey conducted by the Federation of State Medical Boards (FSMB) found that telemedicine standards are the number one priority for state medical boards going into 2017. Continue Reading States Continue Trend to Reduce Telemedicine Barriers
Last week, the Medicare Payment Advisory Commission (the “Commission”) debated a package of policy reforms that would change the way Medicare reimburses physicians for Medicare Part B drugs. In the midst of calls to lower drug prices, the Commission has been developing its Part B reform package over the last two years and now, finally, appears poised to move forward with a vote at next month’s meeting.
Medicare Part B drugs are a multi-billion dollar benefit and typically include higher cost specialty drugs that are administered in a physician’s office on an outpatient basis. Drugs covered under Medicare Part B are reimbursed through a so-called “buy and bill” approach. That is, the physician buys the drugs and bills Medicare for their use. Medicare pays the provider the average sales price (“ASP”) of the drug plus a markup of 6% of the ASP. The 6% markup is generally considered compensation to physicians for the storage, handling, and other administrative costs associated with these specialty drugs. Continue Reading Medicare Advisors Debate Part B Drug Payment Reforms
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP). These amendments and updates to the AKS and CMP regulations attempt to clarify the OIG’s enforcement position in light of changes due to health reforms, to streamline the OIG’s advisory opinion workload, and to implement long-existing mandates enacted in statutes. This post discusses the amendments to the beneficiary inducement provisions of the CMP codified in 42 C.F.R. Part 1003 (CMP Regulations). Continue Reading At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors