Four Key Strategies For Navigating Regulatory Issues at the Letter of Intent Stage When Selling a Healthcare Company

It is a rare healthcare company that has no regulatory risk exposure in at least a few material areas.  As sellers of healthcare companies prepare them for sale, they will need to navigate first the letter of intent (LOI) stage with potential buyers and ultimately the more detailed definitive agreements.

The key differences between negotiating deal points at the LOI stage versus the same negotiation at the definitive agreement stage are leverage and information.   At the LOI stage, the buyer is often still trying to get the deal (especially in an auction environment) and is operating with limited visibility into the potential magnitude of issues.  The seller often knows more about potential issues but believes the realistic exposure (vs. worst-case scenario exposure) is relatively small.  Once the LOI is signed, the leverage in the hands of the buyer often increases as the closing of the transaction becomes more certain  usually a key desire of the seller  and arguments that the buyer should absorb more risk usually devolve into re-pricing negotiations which the seller wants to avoid.

What should a seller do or not do at the LOI stage?

1.   Do not try to minimize sell-side due diligence.  While commissioning some level of sell-side legal due diligence will increase the initial expense of a transaction, it can avoid costlier pitfalls later in terms of late pricing renegotiations, risk to ultimate closing and delay.  It is difficult for the seller’s legal team to shield or shade these issues in the dark.  David Stienes, a Principal at LLR Partners, noted that “Dealing with prospective sellers who have performed preliminary work around the key regulatory issues and are willing to have open discussions in advance of an LOI is very comforting to us as buyers and allows greater certainty around our offers.   From the sellers’ perspective, it can also be a valuable tool in assessing the knowledge and ultimate viability of us as prospective buyers.   If interested parties are unwilling and/or unable to discuss these issues upfront, it could be a sign that they do not have a full grasp of the matters and will be educating themselves throughout the process.   This will greatly impact both certainty and speed to close.”

2.  Do not hide the ball.  While slowly parsing information at the early stage is the best pathway to getting an LOI signed, it is the worst way to limit the cost of such issues in terms of pricing, escrows and indemnity exposure.  

3.  Negotiate indemnity cap/survival terms for known issues.  This is often difficult prior to substantial due diligence; however, sellers can often pressure buyers to accept narrower limits at the LOI stage than later in the transaction process.

4.  Force heavier pre-LOI diligence on known issues.  It is unlikely that a buyer will do full legal diligence on issues at the LOI stage, but a request that buyers more fully review known issues can lead to more advantageous LOI treatment or at least swing some of the post-LOI leverage to the seller.

None of these strategies can fully insulate a seller from the impact of known regulatory issues on the sale process; but they can minimize the pain, expense and delay that these issues often cause.

 

McGuireWoods to Co-Host Current Trends in Healthcare M&A Breakfast Seminar in St. Louis

Current Trends in Healthcare M&A

Tuesday, September 20, 2011

7:30 – 10 a.m.
The Ritz-Carlton
100 Carondelet Plaza
St. Louis, Missouri

McGuireWoods LLP, Clayton Capital Partners, KPMG, Lockton and the St. Louis RCGA invite you to join us for an interactive conference with representatives from regional healthcare companies and private equity funds. Following a networking breakfast, Dr. John Short, former CEO of RehabCare Group and director of Kindred Healthcare, will address current merger and acquisition trends in the healthcare sector. Dr. Short and other healthcare CEOs and private equity investors will then participate in a panel discussion examining best practices in both buying and selling healthcare and healthcare related businesses.

Who Should Attend

CEOs, CFOs and VPs of Business Development at middle market healthcare and life sciences companies, as well as private equity funds that invest in these sectors.

A full agenda will follow in the coming weeks.  Online registration is available here

Conducting Due Diligence on Medical Device Manufacturers: Changes in the 510(k) Process

FDA is clearing up confusion about what types of changes to existing medical devices require new 510(k) submissions by updating its 1997 guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device." The 2011 Version has been published with the intent of clarifying the requirements in an effort to improve predictability, consistency, and transparency of the premarket review program. When conducting diligence on medical device manufacturers, investors should be aware of historical and planned changes to existing devices.  These changes may need to follow the new requirements.  Click here to read more.  Contact Melissa Gilmore, McGuireWoods' FDA counsel at mgilmore@mcguirewoods.com.

Investment Opportunities in ACOs

Accountable Care Organizations (ACOs) have become a catchphrase within today’s healthcare industry. As we have discussed in prior posts, ACOs are intended to be a vehicle for providing physicians and medical centers financial incentives to continue offering high-quality medical services to their Medicare patients while keeping costs at an acceptable level. Currently, Medicare habitually reimburses physicians and hospitals more when patients are on the receiving end of more tests and additional procedures, increasing costs. By emphasizing preventative care and monitoring patients with chronic illnesses, the ACO approach is designed such that doctors and their institutions would receive higher reimbursements for keeping their patient population healthy.


Under the new law, which goes into effect January 2012, an individual ACO would manage the health care needs of at least 5,000 Medicare beneficiaries for a minimum of three years. ACOs will, ideally, systematize such components of patient care as hospitals, primary care and specialty physicians, as well as both in-home and institutional long-term health care, ensuring optimal patient care and physician financial benefits. Medical centers, health care practices and insurers across the country are looking to form ACOs that will include privately-insured patients as well as Medicare recipients.


Multispecialty groups have begun establishing ACOs throughout the country, with several initial efforts appearing in California. Large medical centers are buying up practice groups for a variety of reasons, a consolidation trend that now also has the additional benefit to some systems of formation of ACOs that would employ a majority of their providers. With more access to the necessary start-up capital, these institutions will, conceivably, have at least a monetary advantage over many smaller private practice groups. Some of the largest health care insurance providers in the country, such as Cigna, Humana and United Health Care, have also announced plans to form ACOs; these companies already collect a plethora of information on patients, vital for coordinating and reporting healthcare.


Start-up and first year cash costs will typically come from an ACO’s providers, with a CMS estimate of $1.76 million. As with any venture, particularly innovative ones, careful contractual delineation of the parties’ relative rights and responsibilities is paramount for success. For example, if funding obtained via financing, loan documents should be clear as to the extent to which ACO participants are obligated to guarantee such debt (e.g. dollar and time limits on the guarantees relative to the entire ACO investment, etc.). At the conclusion of each year, an ACO will either receive payment from CMS or, conversely, remit funds to the agency. These profits/losses will then be allocated to the participants.   Investors may opt to place finances in escrow or offer bank letters of credit to ensure the availability of funds potentially owing back to CMS should the ACO fail to hit performance targets. Normally, an ACO would issue profits and losses based on a formula that incentivizes providers to meet the organization’s objectives, details of which would be included in negotiations, another aspect of ACO contracts critical in determining investors’ rights as well as risks.
 

McGuireWoods Announces 3rd Annual Medical Device, DME and Diagnostics Conference

Join us on November 2 in Deerfield, Illinois for an interactive conference designed for all stakeholders from medical device, durable medical equipment and diagnostic manufacturers and distributors.  Speakers will be joining us from Baxter, Sg2, Medtronic, Stryker and more. 

Topics Covered Will Include:

  • Structuring successful MedTech partnerships
  • Physician payment sunshine laws
  • Underlying changes in healthcare reimbursement and their effects on medical device companies
  • Preparing for venture funding and use of incubators to fuel start-up growth
  • New developments in regulation of mobile health devices
  • Many more topics for growth stage and established device, DME and diagnostics companies!

Please watch the blog for more agenda information and registration details.  Please contact lsams@mcguirewoods.com with any questions. 

Where to invest (and where not to invest) in healthcare now

Some healthcare sub-sectors are hot and some are not - read more here at Becker's Hospital Review about "Private Equity Investing in Healthcare: 13 Hot and 4 Cold Areas".  Hot areas for potential investments include:

  1. Hospitals and Health Systems
  2. Hospital-Based Specialty Groups
  3. Ambulatory Surgery Center Chains
  4. Health Care IT and mHealth
  5. Chronic Disease Management
  6. Cancer and Oncology Services and Products
  7. Hospice
  8. Dental Practice Management
  9. Wound Care
  10. Rehab and Addictive Treatment Centers
  11. Physical Therapy
  12. Revenue Cycle Management
  13. Certain Overseas Investments

Areas that are not as hot for potential investment right now:

  1. Home Healthcare
  2. Nursing Homes
  3. Imaging
  4. Some Life Sciences Areas

Read more here about each of these "hot" and "cold" sub-sectors. 

Hospital CEOs Focus on Communicating Healthcare Reform, Leadership and Managing Change

We recently had the opportunity in Chicago to participate in a roundtable discussion with four prominent hospital CEOs as well as the CEO of Medline and SCA. The hospital CEOs highlighted the following key issues for the acute care hospital industry:

  • Each of the CEOs expressed that they spend significant amounts of their time communicating with patients, physicians and other stakeholders about the realities of healthcare reform and the changes that it will bring to the healthcare system. The hospital CEOs are planning ways to communicate to uninsured and underinsured patients the need to access new insurance options through health insurance exchanges and other avenues.
  • Executive leadership is clearly a high priority and key concern for all hospital CEOs. Many are planning internal leadership transitions as well as seeking to bring in new leaders from other industries.
  • In the coming years, hospitals’ primary mission will change from their traditional role of providers of acute care to a new role of ensuring community health. This change will be forced by bundling of hospital payments with pre- and post-discharge care, private and Medicare “accountable care organizations” and new models for care of patients with chronic disease. 

Investors in the healthcare industry are examining ways to fund companies that will partner with hospitals in tackling the challenges associate with healthcare reform. A key investment focus spurred by health reform is health care IT – here deal volume has been increasing as hospitals continue to invest heavily in HCIT solutions in order to position their business to survive in the post-health reform world.   Earlier this year, for example, Doximity secured a $10.8 million Series A investment from Emergence Capital Partners and InterWest Partners - Doximity is a provider of a free communication platform that links medical professionals to other professionals via mobile devices or computers, JMI Equity acquired a minority interest in PointClickCare, a long-term care EMR company, and Riverside Partners completed a majority investment in Eliassen Group, an IT staffing and clinical data management consulting firm.

Preparing Healthcare Companies for Sale

Buyers of healthcare companies are heavily scrutinizing potential healthcare and life science investments for compliance with increasingly onerous regulatory requirements, reimbursement risk and contractual risk.  The Deal recently published our article on how private equity funds and healthcare business owners can prepare healthcare companies in advance for this scrutiny.  Check out the article "Prepping Healthcare Portfolio Companies for Market".

United States Chief Technical Officer Aneesh Chopra Holds Roundtable Discussion with Venture Capitalists on Health IT

McGuireWoods was pleased to recently sponsor a "DC to VC" roundtable during Chicago's TechWeek featuring Aneesh Chopra, the United States Chief Technical Officer and 35 venture capital investors and early-stage health IT companies. Mr. Chopra and the venture capitalists exchanged thoughts on the following key issues facing Health IT investment opportunities:

  • Opportunities for Data Analysis. Hospital electronic medical records systems, the Medicare, Medicaid and health insurers are compiling an enormous amount of health data. This data is not currently being used effectively to achieve physician decision support, cost savings and better patient outcomes. Investors are looking to for opportunities to capitalize in this space. 
  • Investors in Health IT Need Certainty. To invest in healthcare, investors need certainty in the regulatory process. Venture funds are deterred from investing in companies with products that require FDA approval due to uncertainty in treatment and time to get approval. FDA’s new draft mobile application guidance provides some assistance in this regard but the results of the IOM report on the 510(k) clearance process will likely hurt investment. 
  • Large Health Systems Are Not the Only Customers in the Market. Although many health IT systems are intended for use by large health systems, there exists opportunity to sell products to smaller groups of physicians and providers as they grapple with new challenges and opportunities. Mr. Chopra gave the example of smaller groups of 15-25 primary care physicians who seek to qualify as an ACO. 

If you are interested in more information or contact with Mr. Chopra, please contact me at kwerling@mcguirewoods.com or Jake Plummer at Hyde Park Angels at plummer05@gmail.com

Blog Authors

Amber McGraw Walsh

Amber McGraw Walsh Amber Walsh is a partner with McGuireWoods LLP focusing on healthcare transactional work and regulatory matters. Her experience includes representationMore...

Geoff Cockrell

Geoff Cockrell As a partner with the firm, Geoff has a wide scope of expertise spanning mergers and acquisitions, senior andMore...

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