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Pediatric Coding Alert

Practice Management:

Answer These FAQs to Stay On the Right Side of the Rulebook

Published on Wed Feb 07, 2024

Find insight into free samples.

Sometimes, HIPAA and code of conduct (COC) rules and regulations can have you second-guessing yourself. Some rules seem so straightforward, but then there are situations that leave you asking around, “Are we allowed to do this?”

To help clear up confusion among you and your comrades, we’ve answered a handful of these frequently asked questions (FAQs).

Question: Are there healthcare regulations on gift giving?

Answer: In healthcare, there are rules and regulations to follow for both giving and receiving gifts.

A gift policy often lives within the company ethics or COC. Most COC guidance explains a gifting policy as a clear, carefully thought-out document that addresses gift-giving and receipt, in which it is made clear that gifts intended to encourage preferential treatment are unacceptable and must be rejected. Doctor’s offices work with a lot of different entities, and even “well-intentioned gifts between referral sources may have unintended consequences,” warns attorney Kim Stanger with Holland & Hart in Boise, Idaho. “Healthcare professionals should ensure that they and their staff comply with the rules,” Stanger urges in online analysis.

Besides the potential ethical dilemmas gifts pose, you do not want to unintentionally violate any current laws and regulations. Relevant laws can have possible collateral consequences including violation of the False Claims Act (FCA), the Civil Monetary Penalties Law (CMPL), and the federal healthcare program exclusion provisions.

Laws that directly impact gifting include:

  • Physician Self-Referral Law (Stark Law). This law prohibits the referring of patients for “designated health services” such as home health, therapy, and other ancillary services that are payable by Medicare or Medicaid from entities with which the provider or an immediate family member has a financial relationship, unless the arrangement fits within a regulatory exception or safe harbor.
  • The Stark Law also stipulates that providers may furnish some non-monetary (i.e., non-cash or cash equivalent) remuneration to physicians. Check that you have not already exceeded current limits by going to www.cms. gov/medicare/regulations-guidance/physician-self-referral/ cpi-u-updates.
  • Medicare’s Anti-Kickback Statute (AKS). This criminal law prohibits the knowing and willful payment of remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by the federal healthcare programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients).

Remuneration includes anything of value and can take many forms besides cash. This statute covers those who offer or pay remuneration, and the recipients who solicit or receive remuneration. A key consideration is the intent of the parties.

  • The Prescription Drug Marketing Act (PDMA). The PDMA addresses certain prescription drug marketing practices (e.g., the distribution of free samples, the use of coupons redeemable for drugs at no or low cost, and the sale of deeply discounted drugs to hospitals and healthcare entities.) For more details go to www.ecfr.gov/current/ title-21/chapter-I/subchapter- C/part-203#subpart-G.

Note: There may be relevant and even more restrictive state laws to consider.

Learn more: The HHS Office of Inspector General’s Toolkit for Measuring Compliance Programs identifies one element it uses to measure a compliance program’s effectiveness as verification of the maintenance of a gifts and gratuities policy. Go to oig.hhs. gov/compliance/compliance-toolkits for more details.

Question: In the past, the pediatricians in our practice have frequently supplied free samples to patients. An outside billing firm told us that this is a noncompliant practice, and it could get us in trouble. Are our pediatricians allowed to give out free samples to patients?

Answer: Under normal circumstances, free samples do not count as unethical gifts. For the most part, the physicians in your practice can give out free samples to their patients. According to the Department of Health and Human Services (HHS) Office for Civil Rights (OCR), “In face-to-face encounters, the HIPAA Privacy Rule allows covered entities to give or discuss products or services, even when not health-related, to patients without a prior authorization. This exception prevents unnecessary intrusion into the doctor-patient relationship.”

This allows providers to supply patients with free pharmaceutical samples, “regardless of value” Additionally, the face-to-face exception lets providers leave general circulation materials in the office, so patients can pick them up during visits.

Therefore, if you have no conflicting state laws in your area, your practice should be able to hand out medications or other items at no charge to your patients during face-to-face encounters.

Question: I’m not sure what the rules are on Transgender patients and pronouns. Can I get in trouble for misgendering them?

Answer: Whether you can get in trouble depends on the circumstance. Purposefully misgendering someone and providing less-than adequate care on the basis of someone’s gender identity is a violation of the Affordable Care Act, which includes antidiscrimination provisions for U.S. healthcare. Section 1557, for example, prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in a wide variety of healthcare programs and activities, which typically include hospitals, health clinics, community centers, rehab centers, and for doctors and other providers who receive federal funding.

On the other hand, honest mistakes aren’t likely to get you in trouble. Using the preferred pronouns is one way that healthcare professionals can show they respect trans patients. For many trans people, misgendering can fall on a spectrum somewhere between aggravating and traumatizing. Showing interest in getting it right is a good way to “demonstrate that you and your department value care for all,” said Trent Stechschulte, vice president and general counsel for I Am Boundless in Columbus, Ohio, in an AAPC Collaborative Compliance Conference presentation. “If you’re unsure what pronouns a person uses, ask them. If you, like all of us, make mistakes, don’t sweat it. Quickly acknowledge the mistake, correct yourself, and move on. Don’t dwell and don’t try to explain why you misgendered them,” he continued.

Also: Gender mismatches on claims can create a lot of issues at both the provider and reimbursement levels, Stechschulte said. Knowing how to document and report care for transgender patients is crucial for patient care as well as for fair reimbursement for your practice.

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