The State of Health Insurance After President Obama

In President Obama’s weekly address on December 10, 2016, the President encouraged Americans who do not currently have healthcare, to enroll in a health insurance plan under the Affordable Care Act (ACA). In the address, the President likely also wanted to remind everyone listening that the threat of Republicans in Congress repealing this law was now a real possibility. President Obama stated “that if Congress repeals Obamacare as they’ve proposed, nearly 30 million Americans would lose their coverage. Four in five of them would come from working families. More than nine million Americans who would receive tax credits to keep insurance affordable would no longer receive that help.” Now that President-elect Trump will take office in a matter of days, what is the fate of healthcare in America?

“The first order of business is to keep our promise to repeal Obamacare and replace it with the kind of healthcare reform that will lower the cost of health insurance without growing the size of government,” Vice President Elect Pence told a news conference recently. Pence also said that Trump would work with congressional leaders for a “smooth transition to a market-based healthcare reform system” through legislative and executive action. House Speaker Paul Ryan said that lawmakers would take action that did not “pull the rug out from anybody” and that the party had “plenty of ideas.” Democrats and many health-care experts are warning that a swift repeal could lead insurers to stop selling policies to individuals on federally mandated exchanges. More than 12 million Americans are covered under those policies.

The current Health and Human Services Secretary, Sylvia Mathews Burwell, briefed Senate Democrats on December 8, 2016, on the expected unraveling of Obamacare’s insurance exchanges. As previously discussed on the MDM&C blog, Trump’s selection of Representative Tom Price to the position of Secretary of Health and Human Services seems to be Trump’s first step towards repealing the ACA. Price has been a regular voice in opposition to the ACA. Price’s philosophy on fixing Obamacare is rooted in “clear[ing] out the bureaucratic impediments” to health-care providers so that the marketplace can figure out the best way to get people health insurance.

Some commentators have stated that a possible less drastic route Congress may go is to replace the ACA rather than an all-out repeal. Congress could pass a plan that doesn’t call for repeal for several years. Between now and then, there would need to be some kind of transition to whatever replaces Obamacare that did not just dump people off coverage with no alternative. However, others still believe that the Republican Congress will swiftly replace ACA’s ban on health status underwriting and pre-existing condition exclusions, as well as its individual mandate, with a continuous coverage guarantee and high-risk pools. This could mean that if individuals were initially uninsured or if they had to drop coverage because of financial hardship, they may face a penalty when they seek coverage significantly greater than the repealed individual mandate penalty. Many argue that these Republican plans would fall far short of the assistance lower-income Americans need, who are currently being helped by ACA.

However, in his recent 60 Minutes interview, President-Elect Trump assured the public that he agrees with certain parts of ACA. Trump plans to keep the ACA policy that allows young adults to stay on their parents’ insurance plans until age 26, as well as the provision that insurers must cover people with pre-existing conditions.

We are likely to know more in the coming months as Congress and the President-Elect begin to take action.

CMS Brings Clarity to ACA’s 60-Day Overpayment Rule

Part of the antifraud provisions of the Affordable Care Act (ACA) requires any person who receives an “overpayment” of Medicare or Medicaid funds to “report and return” said overpayment to HHS, the State, or another party if appropriate within sixty (60) days of the “date on which the overpayment was identified.” See, 42 U.S.C. § 1320a-7k(d)(1).  A violation of this so-called “Sixty-Day Rule” is a per se violation of the False Claims Act (FCA) which may lead to treble damages, fines of between $5,500 – $11,000 per claim, and possible imprisonment. Id. § 1320a-7k(d).   See, 31 U.S.C. § 3729(a).

Since the ACA’s enactment there have been serious questions raised by providers regarding when an “overpayment” is “identified” for purposes of starting the clock under the Sixty-Day Rule. Finally, on February 11, 2016, CMS released a final rule, effective March 14, 2016, (the “Final Rule”) which clarifies that : (1) the 60 day window for refunding overpayments is not triggered until both the fact and amount of an overpayment are known; (2) the standard for knowledge is not “actual knowledge,” but when the provider would have identified the overpayment had it exercised reasonable diligence; and (3) the manner in which the refund must be made.

Prior to this Final Rule, it was unclear when the 60-day period began to run, leaving courts to interpose their own interpretation of the ACA in this regard. As we have previously discussed on this blog, U.S. ex rel. Kane v. Continuum Health Partners, No. 11 Civ. 2325, 2015 WL 4619686 (S.D.N.Y. Aug. 3, 2015), addressed that very issue.  In Kane, three hospitals received payment for Medicaid claims that should never have been submitted.  In September 2010, auditors from the New York State Comptroller’s office raised the potential overpayments and determined that these claims were caused by a third-party’s software glitch. The glitch was fixed in December 2010.  The hospitals’ management asked relator Robert Kane to identify claims potentially implicated by the glitch. On February 4, 2011, Kane wrote an email to management attaching a spreadsheet of approximately 900 claims totaling over $1 million that had potentially been affected by the glitch.  Four days later, Kane was terminated, allegedly in retaliation.

Kane filed an FCA and wrongful termination suit on April 5, 2011, which is exactly 60 days after he provided his spreadsheet. In June 2014, the United States government and New York Attorney General intervened on Kane’s behalf, alleging that by failing to further investigate the potential overpayments identified by Kane and delaying repayment for over two years, the hospitals improperly withheld “overpayments” in violation of the Sixty-Day Rule.

The hospitals moved to dismiss, stating that Kane’s spreadsheet had not identified any overpayment for purposes of the ACA, but was merely preliminary. Further, they claimed that because the overpayments had not been definitively ascertained, the sixty-day clock did not start and that they had no obligation to begin repayment for claims until they determined with certainty that those claims had, in fact, been overpaid, and to what extent.

The District Court rejected this argument, and held that the 60-day period begins to run when a provider is put “on notice of a potential overpayment, rather than the moment when an overpayment is conclusively ascertained.” If left as precedent, this would have dramatically lowered the knowledge requirement to sustain a violation of the Sixty-Day Rule, potentially exposing Medicaid providers and suppliers to a myriad of liability under the FCA for “overpayments” not repaid within sixty days.  CMS’s Final Rule changes this, clarifying that the 60-day period for refunding overpayments is not triggered until both the fact and amount of an overpayment are known. The CMS final rule also stated that the standard for knowledge is not “actual knowledge,” but when the provider would have identified the overpayment had it exercised reasonable diligence.  While providers must act with due alacrity to investigate possible overpayments, they need not fear that mere possibility of an overpayment will lead to liability under the FCA unless it is repaid within sixty days.

Although it remains to be seen how the court will apply the Final Rule under the facts and circumstances of Kane, it seems likely that the defendants will renew their motion to dismiss armed with CMS’s new interpretation set forth in the Final Rule.

Stark Undergoes Another Change

The Stark Act, 42 U.S.C. § 1395nn, prohibits physicians from engaging in a “self-referral” when referring patients elsewhere for certain services. Generally, if a physician (or an immediate family member of such physician) has a financial relationship with an entity, then the physician may not make a referral to the entity for the furnishing of designated health services for which payment otherwise may be made under Medicare. For example, an orthopedist may not refer a patient for imaging to a facility in which the physician or a member of her immediate family has an interest. The entity accepting the prohibited referral may not present or cause to be presented a claim to Medicare or bill to any individual, third party payor, or other entity. If the referral entity collects payments billed in violation of this prohibition, it must refund those amounts on a timely basis, typically within 60 days of identification.

Exceptions to Stark do exist, and on November 16, 2015, the Department of Health and Human Services, Centers for Medicare and Medicaid Services, (CMS) issued a final rule revising and adding further exceptions to offer providers additional flexibility in their efforts to comply with Stark. Some of the major changes include:

1.) CMS created a new exception for assistance to compensate a non-physician practitioner. The exception permits remuneration from a hospital, federally qualified health center, or rural health clinic to a physician to recruit a non-physician practitioner (physician assistants; nurse practitioners; clinical nurse specialists; certified nurse midwives, clinical social workers and clinical psychologists) where substantially all of the services furnished by the non-physician practitioner to the patients of the physician’s patients are for primary care services or mental health care services;

2.) CMS created a new timeshare arrangement exception to cover the use of some premises, equipment, personnel, items, supplies, or services. Compensation for such arrangements must be carefully structured. Percentage compensation and per-unit services fees are prohibited; hourly or half day rates are acceptable. The arrangement cannot be conditioned upon referrals and cannot convey a possessory interest in the office space;

3.) CMS revised the temporary noncompliance with signature requirement. Previously, parties who inadvertently failed to comply with the signature requirement had 90 days to comply with others having 30 days. The revision provides a flat 90 day period to comply with this requirement, regardless of whether the failure to obtain a signature was inadvertent or not;

4.) CMS created a new, indefinite holdover provision. An expired arrangement under the office space and equipment rental exceptions and the personal service arrangements exception can now be “held over” indefinitely rather than for only six months, provided the arrangement: (a) satisfies all of the requirements [list] at the time of expiration; (b) continues on the same terms and conditions; and (c) continues to satisfy all of the enumerated requirements during the holdover;

5.) CMS clarified the writing requirement, requiring only an arrangement need be set out in writing. Although CMS recommends having one signed written contract that satisfies every requirement of the exception, this requirement may also be satisfied through a collection of documents that relate to one another and to the exact arrangement.

These are only some of the revisions and only the highlights of a very technical set of regulations. It is critical that physicians, hospitals, health care facilities and business associates ensure that they are aware and up-to-date with all of the major changes to Stark. Complying with Stark in practice can be particularly complex and thus must be closely monitored.