Compounded drug use and related government spending, particularly on topical creams and ointments, has skyrocketed. Many argue that drug compounding regulation remains murky, making it too easy to prosecute traditional compounders. Compounding advocates suggest regulation of compounders has been heavy-handed and ignores the multiple benefits associated with compounding. Continue reading “Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed”
Category: Merle M. DeLancey Jr.
Targeting Generic Drug Prices
Merle M. DeLancey Jr., James R. Staiger, and Jennifer J. Daniels
DOJ’s New Healthcare Fraud Target—Medicare Advantage Insurers
Critical GAO Bid Protest Deadlines and Timeline
GSA’s Transactional Data Reporting Rule Ushers in a New Era
Merle M. DeLancey Jr. , Justin Chiarodo, and Philip Beshara
Last month, the General Services Administration (“GSA”) finalized a rule marking what the agency describes as the most significant development to its Schedules program in over two decades. The rule completely changes how GSA will analyze vendor pricing for products and services.
Under the rule, vendors will eventually be required to submit monthly transactional data reports with information related to orders and prices under certain GSA Schedule contracts and other vehicles. Along with the implementation of the new Transactional Data Reporting (“TDR”) requirement, GSA will relieve vendors from two preexisting compliance burdens—eliminating the Commercial Sales Practices (“CSP”) and Price Reductions Clause (“PRC”) reporting requirements when vendors begin submitting transactional data.
While vendors should welcome the relief provided from the elimination of two burdensome regulations, the shift to TDR will not be without cost and risk; and, the eventual efficiencies promised by GSA remain to be seen. Indeed, the impact of the change will likely extend beyond compliance burdens, with potential effects varying from the nature of False Claims Act suits to the potential publication of competitive information.
We summarize these and other key takeaways from the new rule below, and answer questions important to vendors as GSA rolls out this significant development. Continue reading “GSA’s Transactional Data Reporting Rule Ushers in a New Era”
Department of Labor Issues Final Rule Updating Sex Discrimination Guidelines
Merle M. DeLancey Jr. and Lyndsay A. Gorton
Supreme Court Affirms Small Business Preference Requirement in Veterans Affairs Contracts in Kingdomware Technologies, Inc. v. United States
Merle M. DeLancey Jr. and Lyndsay A. Gorton
Kingdomware Technologies, Inc. is a veteran-owned small business (“VOSB”) that filed suit after unsuccessfully bidding for a VA emergency-notification services contract that was eventually awarded to a non-VOSB via the Federal Supply Schedule (“FSS”). In its protest to the Government Accountability Office, and subsequent suits in the Federal Circuit, Kingdomware argued that the VA violated the Veterans Act of 2006 by failing to award the contract to a VOSB because it did not award the contract based on the mandatory Rule of Two provision. The Rule of Two states that the VA “shall award” contracts to VOSBs when there is a “reasonable expectation” that two VOSBs will submit bids “at a fair and reasonable price that offers the best value to the United States.” Continue reading “Supreme Court Affirms Small Business Preference Requirement in Veterans Affairs Contracts in Kingdomware Technologies, Inc. v. United States“
We Just Received a Government Subpoena. Now What?
Merle M. DeLancey Jr., Steven J. Roman, James R. Murray, and Christian N. Curran
If you are a multi-million dollar company and receive a subpoena for your documents and records, you simply send it to the legal department. But what if you are a smaller healthcare provider? Responding to a government subpoena can be daunting, especially if it is your first one, and you may not have the personnel or resources to respond without a significant disruption to your business. Does the subpoena mean you or your company is about to be charged with a crime? Do you have to submit original records? Will the government insist on the production of all documents within the often broadly worded scope of a subpoena? How do you deal with electronic information on your computer system? How do you protect patient confidentiality? Will your insurance help with the costs of complying with the subpoena? What can you do to ensure the company is prepared ahead of time?
Step One: Issue a Document Hold Notice and Consult Counsel
The first thing you should do when you receive a government subpoena is issue a written notice to your employees to protect and maintain any documents and records that may be encompassed by the subpoena. As part of that process, you will also need to suspend any records destruction practices that you currently have in place. The failure to produce or preserve potentially relevant documents and information can result in significant exposure. Courts have regularly penalized companies and individuals who fail to produce or preserve potentially relevant materials. It is important to send the notice out as soon as possible and to thoroughly document its distribution. You should also simultaneously consult with counsel to review the subpoena and ensure that you are taking all necessary steps to preserve information. Continue reading “We Just Received a Government Subpoena. Now What?”
Medicare Advantage Program Enforcement: Increased Publicity May Lead to Increased Scrutiny
Merle M. DeLancey Jr. and Lyndsay A. Gorton
- What steps has the Department of Justice (DOJ) taken, and is currently taking, to ensure that insurance companies are not fraudulently altering risk scores?
- Is DOJ working in conjunction with CMS to investigate risk score fraud? If not, why not?
- In the past five years, how many Medicare Advantage risk score fraud investigations has DOJ conducted? Of the investigations, how many have resulted in criminal and/or civil sanction?
Senator Grassley’s letters were sent only weeks after CMS issued its 2016 Rate Announcement and Call Letter on April 6, 2015. After accepting and reviewing comments on its Advance Notice and Draft Call Letter, which estimated a 0.95 percent decrease in revenue for plan providers, the April 6 announcement estimated a 3.25 percent increase in revenue based on finalized 2016 rates. Neither the Attorney General nor CMS has responded to Senator Grassley’s requests. Continue reading “Medicare Advantage Program Enforcement: Increased Publicity May Lead to Increased Scrutiny”
Responding to a Warrant—What to Do if Your Company Is Subject to a Fraud Investigation
Merle M. DeLancey Jr., Steven J. Roman, and Philip E. Beshara
This may sound like an unlikely scenario, but such government investigations happen all of the time around the country and are rarely expected. In recent years, prosecutors and agents from the Department of Justice (DOJ) and Inspector General Offices have brought charges of procurement fraud and corruption against over 100 defendants, including officers and employees of companies of all sizes. In September 2014, DOJ’s Criminal Division announced that it would be “stepping up” its investigation and prosecution of criminal violations of the False Claims Act, using a team of senior federal prosecutors dedicated exclusively to procurement fraud. DOJ’s announcement cited the use of search warrants as one of the significant investigative tools at prosecutors’ disposal. In addition to their increased exposure to law enforcement authorities, small businesses should expect greater scrutiny of their contracting dollars, an initiative that has received bipartisan support in Congress. In March, the House Small Business Committee approved a measure calling for a sweeping examination into abuses in small business contracting, and the Small Business Administration recently proposed a rule for harsher penalties relating to small business subcontracting limitations. Continue reading “Responding to a Warrant—What to Do if Your Company Is Subject to a Fraud Investigation”