CMS Issues: Stark Voluntary Self-Referral Disclosure Protocol

Section 6409 of the Patient Protection and Affordable Care Act (PPACA) required CMS to develop a Medicare Self-Referral Disclosure Protocol (SRDP) to facilitate the resolution of potential Stark violations. The SRDP was published on September 23, 2010 with two caveats:

1.         Despite the fact that potential violations or situations might violate more than just the Stark Act, such as the Anti-Kickback Statute or the False Claims Act, SRDP applies only to Stark Violations. 

2.         The Self-Referral Disclosure Protocol is not a replacement or substitute for the advisory opinion process, which remains available and is described by 42 CFR §§ 411.37 through 411.389.

The required elements in the process for participating in SRDP are described in the proposed protocol. You should be aware that electing to participate in SRDP waives all other appeal rights, unless a mutually satisfactory settlement cannot be arrived at or you withdraw from participation in SRDP.  

 

Legal and Practical Issues of Billing and Collection Practices

Contributed by Michael Cassidy & Donna Kell

mcassidy@tuckerlaw.com, djk@kellgroup.com

An overlooked byproduct of health care reform and the general economic recession is the “multiplier” effect of larger deductibles and co-pays and the reduced ability of patients to make those payments, resulting in more collection problems and the perhaps unintended creation of consumer financing issues. This article is intended to address both the legal and practical issues of your billing and collection practices. 

I.          Legal Issues

Two legal issues that are often overlooked are the federal Truth in Lending Act (TLA) and the federal Fair Debt Collection Practice Act (Fair Debt Act).

Most physicians jump to the conclusion that the TLA does not apply to them because they are not engaged in consumer financing. However, TLA applies to any person who regularly extends consumer credit and the definition of consumer credit characterizes the transaction as one in which the party to whom the credit is extended is an actual person and the services which are the subject of the transaction are primarily for personal, family or household purposes -- this definition applies directly to the extension of credit for medical services and the TLA will apply if your practice meets either of these thresholds:

1.  You regularly extend credit, which is defined as extending credit more than 25 times per year; and

2.  The credit is either subject to a finance charge, or payable and subject to a written agreement in more than four installments.

Interest, or “the finance charge,” does not include charges for actual, but unanticipated late payment, for exceeding a credit limit, or for events of default or delinquency such as checks returned for insufficient funds.

If you are extending credit and subject to TLA, then you should consult with your lawyer to prepare the necessary disclosure documents necessary for the Truth in Lending Disclosures, which are basically the same documents you receive in any of the lending transactions in which you may have been involved.

The Fair Debt Act makes it unlawful for anyone to give a consumer, in this case the patient, the false belief that the person other than the creditor is participating in the collection process. For example, if you threaten to turn patients over to a collection agency, but actually have no arrangements to do so, you are violating the Act. Therefore, you should follow the following guidelines with regard to compliance with the Fair Debt Collection Practice Act:

1.  Do not threaten to refer a bill to a collection agency or take any other action unless you plan to do so or regularly do so with others;

2.  Do not disclose to any third party, over the phone or otherwise, that you are attempting to collect a debt from a patient;

3.  Do not send correspondence which reveals collection activities, such as post cards, envelopes with “past due” stamped on the outside;

4.  Do not call patients before 8:00 a.m. or after 9:00 p.m. or at work if you know they are not permitted to take personal calls; and

5.  You may not call a patient directly if the patient has advised you they are represented by counsel.

II.  Practical Issues

In order to ensure that your medical practice is compliant, it is prudent to create a self-pay financial policy. A written financial policy not only helps your office support staff to be consistent in how self-pay collections are implemented, but also allows your patients who have self-pay balances to know what to expect from your practice. 

Consider including the following elements into your policy:

1.  How and when your practice verifies patient insurance coverage. The person who verifies insurance should be instructed to document co-payment amounts by specialty and/or type of service into the patient chart so that office staff knows exactly what to collect from the patient on the date of service.

2.  Specifics about what the patient can expect for collection of other patient-responsible balances such as deductibles and co-insurance amounts. Explain the billing cycle to every patient. Inform them about your patient invoicing procedures; such as, the frequency of invoicing and the types of collection activities your practice employs.

3.  Patient Due Statements. Design a statement that is readable, that clearly identifies the balance due, specifies the due date, and clearly states how patients can contact your office.

4.  Bad Addresses. Create a procedure to quickly investigate patient statements that are returned to you due to a bad address. If you are unable to correct it, the patient chart should be flagged so that any future contact with the patient, including subsequent appointments and invoices, are halted until the address is updated.

5.  Reporting Bad Debt. If you determine that you want to affect a patient’s credit score, you may chose to sign-up with a credit bureau. Patients’ concerns about bad debt reporting may prompt them to pay you promptly.

6.  Financial hardship. What criteria does your practice utilize to reduce a patient-due balance? If your practice participates with Medicare, you need to be certain that you are charging all payers equally. This means that co-payments, deductibles and coinsurance amounts are not be written off subjectively.  Developing standard discounts that are based upon income guarantees that self-pay reductions are handled equitably and objectively.

7.  Payment methods that are accepted by the practice. For example: cash, checks, payment plans, debit cards, and credit cards. 

     i.      Cash – Collect co-payments on the date of service, preferably at patient check-out. Practices that collect at check-in may miss co-payments that are assessed by type of service. If you accept cash, be sure to have procedures in place for daily reconciliation.

     ii.      Payment Plans – Your policy should specify acceptable payment thresholds, with the goal being to collect all balances in three months or less. Determine if your practice management system has functions that can easily create payment coupons. This can help your patients to keep their payment commitment. If your financial policy allows for assessing interest, make sure that the system is set-up to follow TLA guidelines.

     iii.      Debit and Credit Cards - Think about ways to make it easy for your patients to pay their balances; including giving patients an online payment option.

After you’ve established your policy, take the time to train your front desk and billing staff. Practices can be exposed to legal liability simply due to an employee who is not appropriately trained or who is uncomfortable or incapable of accurately communicating with patients who are delinquent. 

Complete understanding of a well-designed financial policy, combined with frequent staff training and refresher seminars - especially with regard to the Fair Debt Act guidelines, patient communications, and conflict resolution techniques – can assure legal compliance, patient satisfaction and a steady cash flow regardless of the many economic changes that you face.

CMS Announces New Stark Self-Referral Disclosure Protocol

 

New - Medicare Self-Referral Disclosure Protocol

CMS has published the self referral disclosre protocol required by ACA. Link and announcement below. Analysis will be posted next week.

Section 6409(a) of the Affordable Care Act (ACA) ACA requires the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol (“SRDP”) that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of Section 1877 of the Social Security Act (the Act).

The SRDP requires health care providers of services or suppliers to submit all information necessary for CMS, on behalf of the Secretary, to analyze the actual or potential violation of Section 1877 of the Act.  Section 6409(b) of the ACA, gives the Secretary of HHS the authority to reduce the amount due and owing for violations of Section 1877.  The SRDP is located on the CMS website at http://www.cms.gov/PhysicianSelfReferral/.

New Claims and Appeals Rules for Non-Grandfathered Plans

Contributed by Jo-Anne Mineweaser

jmineweaser@tuckerlaw.com, 412.594.3920

The Patient Protection and Affordable Care Act and subsequent regulations set forth new rules for group health plans regarding the processing of claims and appeals. These rules are effective for plan years beginning on or after September 23, 2010 (January 1, 2011 for calendar year plans) and apply only to plans that are not grandfathered under the Act.

Under the new rules, both insured and self-funded plans will be required to comply with the internal claims and appeals procedures currently set out in Department of Labor regulations. In addition, the plans must meet the following new requirements for internal claims and appeals:
 

  • Rescissions of coverage will now be considered “adverse benefit determinations” subject to the claims and appeals procedures, whether or not there is an adverse effect on any particular benefit at the time;
  • Benefit determinations on “urgent care” must be given within 24 hours (as opposed to 72 hours under prior regulations);
  • The plan must provide the claimant with any new or additional evidence or rationale that is considered, relied upon, or generated by the plan in connection with the claim; 
  • The plan must avoid conflicts of interest in adjudicating the claim; 
  • Claims notices must contain additional information (model notices have been issued); and 
  • Failure to strictly follow the claims rules will allow the claimant to seek external or judicial review of the claim. 


New External Review Requirements

The biggest change for plans under these new rules is the requirement to have an external review process available. For fully-insured plans, the insurance company is on the hook. However, for self-insured plans (including Health Reimbursement Arrangements), the plan will need to be amended to comply with the new provisions.

Recently, the Department of Labor issued Technical Release 2010-01 which provides an interim safe harbor for non-grandfathered self-insured plans. The safe harbor applies for plan years beginning on or after September 23, 2010 and continues until future guidance is issued on the new Federal external review process. The safe harbor allows a plan to meet the external review requirements either by complying with the procedures outlined in the Technical Release (see below) or by voluntarily complying with the State external review process, if available.

In the Technical Release, there are procedures for standard external review and expedited external review. In both cases, the plan must assign an accredited independent review organization (IRO) to conduct the review. To ensure independence and eliminate bias, the plan is required to contract with at least three IROs for assignments under the plan and rotate claims assignments among them.

A standard external review is an external review that is not considered “expedited” (as described below). With this type of review, the claimant has up to four months after receipt of an adverse benefit determination to request an external review. Within five days of receipt of that request, the plan must complete a preliminary review to confirm that the claimant was covered by the plan, the claim does not relate to eligibility, the internal appeal process was exhausted, and all relevant information was provided. The plan must notify the claimant in writing within one business day after completing the preliminary review of the results of the review. The claimant will have 48 hours (or the remainder of the four-month filing period, if longer) to submit any missing information. If the claim is complete and meets the requirements, the plan must submit the claim to the IRO, and the IRO must provide written notice of the final external review decision within 45 days after the IRO receives the request for the external review. If the IRO reverses the denial of the claim, the plan must immediately provide coverage or payment for the claim.

An expedited external review is available to the claimant when an adverse benefit determination involves a medical condition for which the standard external review timeframe would seriously jeopardize the life or health of the claimant, or would jeopardize the claimant’s ability to regain maximum function. The plan must immediately do its preliminary review of the request and notify the claimant of its eligibility determination. If the request meets the requirements, the plan must submit the claim to the IRO, and the IRO must provide notice of the final review decision within 72 hours of receiving the request.

If you have any questions regarding this information, need plan amendments or IRO contracts to be drafted, or would like a copy of the model notices, please contact Jon Grossman at 412.594.5574 or Jo-Anne Mineweaser at 412.594.3920, or jgrossman@tuckerlaw.com or jmineweaser@tuckerlaw.com.
 


 

OIG Approves "Per Click" Sleep Venture

 In OIG Advisory Opinion No. 10-14, the OIG concluded that it would not seek enforcement of the Anti-Kickback Statutes under an arrangement in which an independent sleep testing provider entered into an arrangement to provide a hospital-owned sleep testing facility with equipment and staff on a per test basis.

CMS EHR Incentive Programs

CMS has created a web page on EHR Incentive Programs.  Click on this link or the button below to go to the CMS web page.

 

New Guidance Released Under the Affordable Care Act Regarding Reimbursement of Over-The-Counter Drugs

Contibuted by Jo-Anne Mineweaser

412.594.3920, jmineweaser@tuckerlaw.com

On September 3, 2010, the Internal Revenue Service issued Notice 2010-59 to provide guidance on the revised definition of “medical expenses” under the Patient Protection and Affordable Care Act.   Beginning on January 1, 2011, expenses incurred for medicines or drugs may be paid or reimbursed by an employer-provided plan, including a health Flexible Spending Arrangement (FSA) or Health Reimbursement Arrangement (HRA), only if:

·         The medicine or drug requires a prescription;

·         The medicine or drug is available without a prescription, but the individual gets a prescription for it; or

·         The medicine or drug is insulin.

Expenses for over-the-counter medicines or drugs incurred on or after January 1, 2011 will no longer be eligible for reimbursement without a prescription.  Expenses incurred for over-the-counter medicines or drugs purchased without a prescription before January 1, 2011 may be reimbursed tax-free at any time (even after January 1, 2011) in accordance with the terms of the plan.  For example, if an FSA allows individuals to submit claims for 2010 until March 31, 2011, an expense for over-the-counter medicine purchased on December 14, 2010 would be reimbursable, even if the reimbursement is made on February 20, 2011.   Similar rules apply for reimbursement under a Health Savings Account (HSA) or Archer Medical Savings Account (MSA).  As long as the medicine or drug meets one of the points listed above, it will be considered a qualified medical expense. 

These rules apply only to medicines and drugs; they do not apply to other medical care items such as equipment, supplies or diagnostic devices.  So, FSAs, HRAs, HSAs, and Archer MSAs may still reimburse individuals for things like crutches, bandages, and blood sugar test kits without the individual obtaining a prescription.

For FSAs or HRAs that use debit cards, the current systems are not capable of substantiating compliance with the new rules because they cannot recognize whether the medicine or drug was prescribed.  Therefore, the Notice provides that health FSA and HRA debit cards may not be used to purchase over-the-counter medicines or drugs on or after January 1, 2011.  The IRS is allowing a limited transition period for using a debit card for expenses incurred through January 15, 2011 provided that the existing rules for debit card usage and substantiation are met.  Debit cards may continue to be used for medical expenses other than over-the-counter medicines or drugs.

Plan documents may need to be amended to conform to these new rules.  Generally, amendments to cafeteria plans must be prospective only.  However, the IRS will allow a retroactive amendment to a cafeteria plan to comply with these rules provided the amendment is adopted no later than June 30, 2011. 

If you have any questions regarding this information or need an amendment to your current plan, please contact Jon Grossman at 412.594.5574 or Jo-Anne Mineweaser at 412.594.3920, or jgrossman@tuckerlaw.com or jmineweaser@tuckerlaw.com.

Exhaustion of Administrative Remedies Requirement Reaffirmed

In Vranos v. Skinner, the Massachusetts Appeals Court reaffirmed the doctrine of exhaustion of administrative remedies. The Court affirmed the dismissal of the lawsuit arising out of a summary suspension of a physician’s staff privileges. The bylaws of Franklin Medical Center contained the typical internal grievance procedures. Dr. Vranos alleged that the hospital had not complied with his procedures, but the Court held that the fair hearing process was the proper venue for contesting the hospital’s actions, including an allegation of violation of the bylaws procedures. The Court stated that the hospital’s “failure to follow the provisions of the bylaws was a basis for evoking the bylaws’ appellate review procedures, nor grounds for ignoring them.”