Privacy Policy: The Midterm Effect

By Robert E. Slavkin on Posted in Electronic Health Records & Medical Records, Healthcare Law, Technology

Congress has long attempted to grapple with issues of cyber-security, both within the healthcare field, and generally in the United States.  The Health Insurance Portability and Accountability Act (HIPAA), as well as the Health Information Technology for Economic and Clinical Health Act (HITECH) have provided significant compliance requirements for healthcare entities in the area of data security. For the last eight years, though, a united Congress has not addressed whether or not there should be a federal standard for how companies as a whole manage electronic data. Additionally, there is yet to be a federal law that addresses curtailing attempted foreign disruption of both government and private industry.

Ironically, it is possible that a divided Congress may do more to move the needle on cybersecurity than the current one? On most controversial issues, tax cuts, healthcare, there will likely be little to no movement due to partisan gridlock. However, issues like privacy tend to have bipartisan support, so there may be movement forward on the issue.

The issue of an overarching federal privacy regulation has been spurred on by the European Union’s General Data Privacy Regulation (GDPR) enacted earlier this year. It has caused all companies that do business in Europe to take a deep, hard look at their data infrastructure, and, in some cases, make significant investments in order to come into compliance. Additionally, states such as California enacted what is considered our country’s first laws to provide consumers with greater control of what companies may do with their data. In some ways, the California law contains similar aspects to the EU’s GDPR regulations.

Up until now, certain congressional committees have held hearings with tech industry representatives to discuss what a privacy framework might come to look like. Of course, as of yet, no proposed legislation has resulted from those conversations. With calls for action in the last several months from some industry giants such as Google and Microsoft, bipartisan action may not be far behind.

On-Line Resources Help Nonprofit Organizations Prepare for Cybersecurity Threats

By Elizabeth F. Hodge and Paul L. Kobak on Posted in Tax Exempt

The effects of a data breach can be disastrous for any company, but especially for a nonprofit organization, not only because of the harm to the affected individuals, including those served by the organization, but also the crippling effect it could have on day-to-day operations of an organization with limited resources. A security incident can also damage the organization’s reputation and ability to raise funds. Mitigating a data breach – which could include hiring network forensics investigators, retaining legal counsel, and sending breach notification letters to every person whose data may have been compromised – can get expensive quickly. Moreover, an organization’s own unintentional release of sensitive information could have consequences as serious as a security breach caused by a scammer.

Nonprofit organizations often collect personal information from a variety of sources such as donors, employees, volunteers, and the people who benefit from their services. This information is diverse and might include credit card and personal contact information of donors, financial and health information about the people served by the organization, and payroll and other employment information of its employees. The information collected and retained by nonprofit organizations is exactly the type of data cyber criminals pursue. Yet, often due to the nonprofit model, limited resources that could be used to proactively address cybersecurity threats may be allocated elsewhere. Even if resources are dedicated to cybersecurity, cyber criminals may perceive nonprofits as “soft targets.” Continue Reading

TV Drug Commercials Must Disclose the Drug’s List Price if HHS Adopts Proposed Rule

By Martin R. Dix and Thomas A. Range on Posted in Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them. The U.S. Department of Health and Human Services (HHS) announced a proposed rule that would require pharmaceutical companies that advertise their prescription drug products on television to also disclose the “list price” (also known as the Wholesale Acquisition Cost) of certain drugs. The list price is the price that a drug manufacturer charges a drug wholesaler and does not include the wholesaler’s charges for delivering the drugs to the pharmacy or the pharmacy’s charges for dispensing the medication to the patient. Thus, list price is somewhat lower than an uninsured patient paying cash would normally pay and would be more useful to patients if it reflected what they could expect to pay for the drug.

Under the proposed rule, if a drug manufacturer advertises a prescription drug on television (including broadcast, cable, streaming, and satellite), the advertisement must disclose the list price of a 30-day supply for the drug if it can be reimbursed through Medicare or Medicaid. Drugs whose list prices do not exceed $35 per month for a 30-day supply or typical course of treatment will not be subject to the price-disclosure requirement.

The proposed rule is designed to encourage consumers to become more price sensitive, which in turn could minimize their out-of-pocket costs as well as the costs to prescription drug programs. Patients with high-deductible health plans often pay for their drugs until their insurance coverage is triggered. Additionally, seniors covered under Medicare Part D have coinsurance and out-of-pocket expenses. If consumers have access to better pricing information, HHS believes consumers may select lesser cost alternatives if all else is equal relative to the patient’s care. HHS also cites economic data indicating that a price-disclosure requirement would be likely to motivate drug manufacturers to be less willing to raise prices. Continue Reading

DOJ Approves CVS/Aetna Merger, Contingent on the Sale of Aetna’s Medicare Part D Business

By James M. Burns on Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

The United States Department of Justice Antitrust Division announced on October 10, 2018, that it was conditionally approving the CVS/Aetna merger, a $69 billion transaction that combines the nation’s largest retail pharmacy chain and the nation’s third largest health insurer. The deal, which was announced late last year, has been under review by the Antitrust Division (and state regulators) since that time. The approval is contingent upon the sale of Aetna’s Medicare Part D Individual Prescription Drug business to WellCare, which Aetna recently announced it was prepared to do to gain regulatory approval. Accordingly, while some additional state approvals are still required, the deal now appears poised to close before the end of the year.

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Drug Pricing Legislation Sent to the President for Enactment into Law

By James M. Burns on Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House. The legislation prohibits any restrictions on the ability of pharmacists to alert consumers to situations where it may be less expensive for them to pay for prescription drugs out-of-pocket, rather than through their insurance benefits. The legislation received bipartisan support in both the Senate and the House, and is expected to be signed into law by the President (in September, President Trump tweeted his support for the legislation).

While the two bills apply to different insurance products, the provisions of both bills are largely the same. S. 2553, the “Know the Lowest Price Act of 2018,” prohibits contractual provisions that forbid a pharmacist from disclosing pricing information to enrollees with respect to Medicare Advantage and Medicare Part D drug plans, while S. 2554, the “Patient Right to Know Drug Prices Act,” eliminates such provisions in employee-sponsored and individual health insurance plans. By eliminating these restrictions, the legislation is designed to permit pharmacists to alert consumers that, on occasion, it may be less expensive for them to purchase drugs out-of-pocket, rather than through their insurance benefits. Notably, S. 2554 also amends the Medicare Prescription Drug, Improvement and Modernization Act of 2003 to require the reporting to the Federal Trade Commission of patent settlements between the manufacturers of biologics and biosimilar drugs (currently such reporting only applies to settlements between generic and branded pharmaceutical companies). Continue Reading

CMS Announces Loosening of Rules Regarding Part D Formularies

By Robert E. Slavkin on Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

In a memorandum issued by the Centers for Medicare and Medicaid Management (“CMS”) on August 29, 2018, the federal government outlined new ‘flexibility’ and tools for Part D plans to “expand choices and lower drug prices for patients.” Beginning in 2020, Part D plans will be able to utilize what is called ‘indication-based formulary design’ to change their drug formularies to allow different drugs to be included for different indications. The theory behind this shift in policy is that it will allow Part D plans to negotiate more freely for lower drug prices. The theory also posits that such actions will provide Part D beneficiaries with more drug choices in a formulary.

At the present time, if a Part D plan includes a drug in a formulary, the Part D plan must provide coverage for all FDA-approved indications for the drug, even if another medication may be more appropriate for a certain diagnosis. The end result, according to the federal government, is that the present policy disincentivizes Part D plans from including more medications on a formulary, and thus, limits the Part D plans’ negotiating power. Continue Reading

DOJ Antitrust Division Grants Approval to Proposed Cigna/Express Scripts Merger

By James M. Burns on Posted in Antitrust, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

On September 17, the United States Department of Justice (DOJ) Antitrust Division issued a “closing statement” in which it announced that it was closing its investigation into Cigna’s proposed acquisition of Express Scripts, a transaction valued at $67 billion. The announcement states that “After a thorough review of the proposed transaction, the Antitrust Division has determined that the combination of Cigna, a health insurance company, and ESI, a pharmacy benefits management (“PBM”) company, is unlikely to result in harm to competition or consumers.” Notably, the announcement brings to an end a six-month investigation by the Antitrust Division, during which it reportedly reviewed over two million documents received from the merging parties and interviewed over one hundred industry participants. Continue Reading

FTC Announces Settlement of Antitrust Action Against Therapist Staffing Company Accused of Fixing Therapist Wages

By James M. Burns on Posted in Antitrust, Government Affairs, Licensure & Regulatory

In the Matter of Your Therapy Source, LLC – is the most recent example of federal antitrust enforcers’ increasing interest in curtailing anticompetitive conduct in employee markets, which was first announced when the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued guidance on the subject in late 2016. See Antitrust Guidance For Human Resource Professionals (available here). On July 31, the FTC announced that it had reached a settlement with a Texas therapist staffing company that the FTC alleged had agreed with a rival staffing company to reduce the compensation paid to their therapist employees.

In the Therapy Source matter, the FTC accused Sheri Yabray, the owner and CEO of Therapy Source, a Dallas therapist staffing company, of conspiring with Neeraj Jindal, the owner of a rival company, to reduce the rates paid to their physical therapists and physical therapist assistants.  Specifically, the FTC Complaint alleges that, in response to a reduction in the fees that the staffing companies were receiving from insurers, Mr. Jindal and Ms. Yabray sought to reduce the rates paid to their therapist employees. After Mr. Jindal shared his proposed new rate schedule with Ms. Yabray in a text message, she allegedly responded by texting “Ok, we are going to lower [physical therapist rates] to your numbers.” The Complaint further alleges that Ms. Yabray subsequently sent text messages to other therapist staffing companies in the Dallas/Fort Worth area encouraging them to join in the agreement as well. Continue Reading

How the Trump Tariffs Affect Healthcare

By Sheryl D. Rosen on Posted in Government Affairs, Licensure & Regulatory

It’s not just pile drivers, combines, and frozen fish. Much of the news coverage has discussed how industrial and agricultural products are subject to new Trump administration tariffs on goods imported from China.  However, the list of Chinese products subject to the new tariffs also includes goods more familiar to healthcare providers: items like pacemakers, rubber medical gloves, MRI and CT machines, and sterilizers.

Since April 2018, the United States Trade Representative (USTR) has announced three lists of Chinese products that will be subject to 25% tariffs.  Together, the lists cover $250 billion of imports from China.  Tariffs on the first list of goods are already in effect, and imposition of tariffs on the second and third lists is in progress.

Under the direction of President Trump, USTR has the power to impose trade sanctions on foreign countries under section 301 of the Trade Act of 1974, codified at U.S. Code title 19, section 2411. The tariffs are based on what the USTR has determined are discriminatory trade practices by China, including forced transfer of American intellectual property to Chinese firms and stealing of American trade secrets through attacks on companies’ computer networks. Continue Reading

House Commerce Committee Urges the FTC to Investigate Past PBM Mergers

By James M. Burns on Posted in Antitrust, Government Affairs, Licensure & Regulatory, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

The leadership of the House Energy & Commerce Committee has called upon the Federal Trade Commission to undertake a retrospective review of past mergers involving pharmacy benefit managers (PBMs). Specifically, in a July 27 letter to FTC Chairman Joseph Simons, House Commerce Committee Chairman Greg Walden (R-OR) requested that the FTC examine “(1) how these mergers have affected downstream prices for consumers and (2) whether these mergers have helped PBMs save plan sponsors money.”

The Commerce Committee’s request follows a February 14 hearing on the effects of consolidation in the healthcare industry generally, in which several witnesses testified that the competitive impact of several large mergers in the PBM industry over the last decade (which ultimately created what are today Caremark, Express Scripts and Optum Rx) were somewhat unclear. The letter cites a 2016 report that concluded that PBMs help plan sponsors generate savings by, among other things, reducing waste, negotiating discounts and encouraging the use of generic drugs. However, the letter also notes that other reports suggest that, in some circumstances, consolidation among PBMs may have led to an increase in drug costs and increased co-pays for insureds. Given these opposing views, several witnesses, including Professor Leemore Dafny, who previously served as the Deputy Director for Healthcare and Antitrust in the FTC’s Bureau of Economics, expressly suggested that a retrospective review of these mergers by the FTC would likely be beneficial. Continue Reading

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