ࡱ> Ԑ( G*/ 0DTimes New Romanbb b0DbDb~0DArial Blackmanbb b0DbDb~0" DMonotype Sortsbb b0DbDb~0  @n?" dd@  @@`` ,$dZA     !$"% '),.2536(49:-(3;<#&(=&?/+*Ac $@8 g42d2dPb~0Hbf ppppp@ <4KdKd$bf2 K? ,O =HAPPY BIRTHDAY, MRS. JONESyA HIPAA Marketing Guide for Health Care Providers Barbara L. Crawford, Esq. Stromberg Cleveland Crawford & Schmidt, P.C. z2HAm I Marketing?If you are communicating with your patients outside the exam room or hospital bed in an effort to create good will or to encourage them to return for future services or to purchase your products, you are marketing. Am I Marketing?hBirthday cards Appointment reminders Newsletters Discount coupons Refrigerator logo magnets Free samplesii XWebsite Announcements about new facilities Wellness programs Health education brochures YWAm I Marketing?If you give the names of all patients with cardiac problems to the drug rep so that the drug company can send a special mailing about a new cardiac drug to those patients, you are marketing.HIPAA Definition of MarketingA communication made by a health care provider about a service or product that encourages the purchase or use of the product or service. An arrangement between a health care provider and any other entity whereby the health care provider, in exchange for direct or indirect remuneration, discloses PHI to the other entity for that entity s marketing communication. 45 C.F.R. 164.501(ll The RuleIf an activity is marketing, a health care provider is required to obtain advance written authorization from the patient for the use of PHI in connection with the activity. 45 C.F.R. 164.508(a)(3)(i) UNLESS...B   NExceptions to the Rule: Not  Marketing A communication to describe the health care provider s own health-related products and services A communication related to the treatment of the patient A communication for care management or to recommend alternative treatments, providers or settings 45 C.F.R. 164.501( +Exceptions to the Authorization Requirement6In addition, a health care provider may, without authorization, conduct the following marketing: communicate face-to-face (i.e., in office) about any type of service or product, even a non-health related service or product give or send promotional gifts of nominal value. 45 C.F.R. 164.508(a)(3)(i)(A) and (B)(bb<6*Can I Hire a Third Party to Market For Me?OK to use telemarketers, business associates or other third parties IF the third party has agreed in writing to only use the PHI for communications on your behalf in the permitted fashion.  HIPAA Does not Apply to . . .Marketing conducted without the use of PHI, i.e., without the use of your patient database Coupons included in the local  Valu-Pak Mailings sent to  current resident or even mailings sent to a targeted population, e.g., the elderly, when the mailing list is not derived from your patient database Newspaper or magazine ads 8[Z  OCR GuidanceThe Office of Civil Rights (the Privacy Rule enforcement agency) issued guidance re Privacy Rule on December 2, 2002 summary of major aspects of the Privacy Rule Q & As best source for interpretation of Privacy Rule marketing addressed in pages 65-76(uu )Appointment Reminders Rx Refill RemindersOCR Guidance states:  Appointment reminders are considered part of treatment of an individual and, therefore, can be made without an authorization. Guidance p. 74  It is not marketing for a doctor to make a prescription refill reminder even if a third party pays for the communication. The prescription refill reminder is considered treatment. . . Similarly, it is not marketing when a doctor or pharmacy is paid by a pharmaceutical company to recommend an alternative medication to patients. Guidance p. 73-746@2@2)Appointment Reminders Rx Refill RemindersTAppointment reminder OK Rx refill reminder OK even if a drug company pays a doctor or pharmacist to send a prescription reminder even if goes beyond reminder to recommend an alternative medication to a patient (at request of a drug company) Not OK if a drug company pays for a patient list and it sends out a recommendation to your patientsh.d.2,61)Appointment Reminders Rx Refill Reminders Letter or Postcard? Not addressed in OCR Guidance If minimal PHI included, minimal risk to use of postcard But what amount of information must be included to be useful as a reminder to patient? Rx reminder requires more information than should be placed on postcard PHH Direct Mail Marketing  The HIPAA Privacy Rule excludes from the definition of  marketing communications made to describe a covered entity s health-related product or service (or payment for such product or service) that is provided by . . . the covered entity making the communication. Thus, it would not be marketing for a physician who has developed a new anti-snore device to send a flyer describing it to all of her patients (whether or not each patient has actually sought treatment for snoring). Nor would it be marketing for an ophthalmologist . . . to send existing patients discounts for eye exams or eye glasses available only to patients. Guidance p. 72Direct Mail MarketingOCR Guidance, in summarizing the Rule re marketing, states that a health care provider can communicate about its own services and products and gives the following example:  A hospital uses its patient list to announce the arrival of a new specialty group or the arrival of new equipment through a general mailing or publication. Guidance p. 67<Direct Mail MarketingA health care provider can also communicate about treatment options or recommendations. The OCR Guidance states:  For example, it would be an alternative treatment communication if a doctor, in response to an inquiry from a patient with skin rash about a range of treatment options, mails the patient a letter recommending that the patient purchase various ointments and medications described in brochures enclosed with the letter. Guidance p. 74(rOrO=7Direct Mail MarketingTreatment alternatives can also mean alternative medicine. The OCR Guidance states:  Thus, alternative treatments would include communications by a midwife who recommends or sells vitamins and herbal preparations, dietary and exercise programs, massage services, music or other alternative types of therapy to her pregnant patients. Guidance p. 74(U U Direct Mail MarketingMailing an unsolicited discount service coupon for your services OK Mailing an unsolicited discount product coupon OK, if it is a product that you typically furnish through your office Mailing a product recommendation OK, if the product is among the treatment options for the patient@2Direct Mail MarketingrMailing product brochures in response to an inquiry from a patient OK regarding treatment for a condition for which the product may be used Mailing an announcement about your new services or your new facilities OK NOT OK to announce opening of an unrelated facility Recommending that patient obtain test at nearby facility OK, if the test is needed for current treatmentn@24@2i@24i Newsletters OCR Guidance states:  [A] communication that merely promotes health in a general manner and does not promote a specific product or service from a particular provider does not meet the definition of  marketing . Guidance p. 71 A newsletter, without more, OK - not marketing at all A newsletter, with promotions, falls into the exception from marketing if it promotes your services or products and OKbHealth BrochuresSame Guidance as newsletters. Same section provides:  Examples of general health promotional material include mailings reminding women to get an annual mammogram; mailings providing information about how to lower cholesterol, new developments in health care (e.g., new diagnostic tools), support groups, organ donation, cancer prevention and health fairs. Guidance p. 71(6?6?72Health BrochuresMailing of health education brochures, without more, OK - not marketing Mailing of health education brochures listing office locations and hours falls into the exception from marketing if you are marketing your services.,@2 Wellness ProgramsxOCR Guidance states:  To the extent that the . . . wellness program is operated by the covered entity directly or by a business associate, communications about such programs are not marketing because they are about the covered entity s own health-related services. So, for example, a hospital s Wellness Department could start a weight-loss program and send a flyer to all patients seen in the hospital over the past year who meet the definition of  obese , even if those individuals were not specifically seen for obesity when they were in the hospital. Guidance p. 712((83Wellness ProgramsEMailings re your wellness program to all patients, OK Mailings re your cardiac rehab or wellness program to all patients seen for cardiac problems, OK Mailings re your weight loss program to all patients who were overweight per your records, OK Not OK to send info re the Jenny Craig franchise in your medical office buildingFFIn-House Marketing&OCR Guidance states:  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 prior authorization. Physicians may give out free pharmaceutical samples, regardless of their value. Similarly, hospitals may give infant supplies to new mothers. Moreover, the face-to-face exception would allow providers to leave general circulation materials in their offices for patients to pick up during office visits. Guidance p. 750In-House MarketingGiving free samples, OK even if not health related, e.g. formula, diapers even if more than nominal value Product sales in office, OK But adding buyers or browsers to patient database for future marketing not OK if no patient-provider relationship.PRsRs In-House MarketingExceptions to the Privacy Rule are for  patients - aimed at not interfering with the provider-patient relationship and patient treatment.  Patient relationship requires actual exam and treatment.Magnets, Pens, Note Pads, MugsXOCR Guidance states re promotional gifts of nominal value:  [T]he HIPAA Privacy Rule allows covered entities to distribute items commonly known as promotional gifts of nominal value . . . even if such items are distributed with the intent of encouraging the receiver to buy the products or services. . . A covered doctor, for instance, may send patients items such as pens, note-pads and cups embossed with a health plan s logo without prior authorization. Similarly, dentists may give patients free toothbrushes, floss and toothpaste. Guidance p. 74-752;;!Magnets, Pens, Note Pads and MugsAs long as cost is nominal: Giving or sending promotional items with your logo OK Giving or sending promotional items with a third party s logo OK Giving or sending health-related items OK Giving or sending non-health-related items OK(Birthday CardsNo OCR Guidance Is birthday card in same category as mug or pen? Probably Birthday card, without more, OK Birthday card, with discount offer, is more like direct mail marketing - must be discount on your services or product*Web SiteNo OCR Guidance Informational web site that does not collect the PHI of a browser does not trigger the Privacy Rule - more like a newspaper ad. Web site offering discounts or information only after browser provides personal information triggers Privacy Rule because PHI potentially being gathered fulfilling order or request OK adding browser to  patient database not OK because not patient.()`)`94 Give NoticeIf you are going to conduct any of the marketing discussed, add disclosure to your Notice of Privacy Practices Be specific regarding the types of activities you might conduct Complaints more likely if patient is surprised to receive a mailing@2!Caution!Regardless of whether you CAN communicate with a patient in the ways discussed, you must delete a patient from your mailing list if the patient requests that you do so. @2;5Caution!Nothing in the marketing provisions of the Privacy Rule is to be construed as amending, modifying or changing any rule or requirement related to any other federal laws, including anti-kickback, Stark, etc.@2"Caution!The OCR Guidance states on this subject:  In particular, although the Privacy Rule defines  marketing to exclude communications to an individual to recommend, purchase or use a product or service as part of the treatment of the individual . . ., such communication by a health care professional may violate the anti-kickback statute. Guidance p. 75<)7(6E>Caution!PAugust 2002 Special Fraud Alert re offering gifts and inducements to Medicare/Medicaid beneficiary Cannot offer valuable gifts to beneficiaries to influence choice of a provider, practitioner or supplier. BUT some of the exceptions dovetail with permitted HIPAA marketing, e.g.: inexpensive gifts (<$10) promotion of preventive services<c:c:D=Caution!8Physicians must also consider the Colorado BME Policy re sale of products in the office - BME Policy No. 40-11 BME criteria: sale, at reasonable price, of products with reasonable potential for therapeutic gain, with disclosure of financial arrangement with supplier BME frowns on exclusive sales arrangements.,o@2@2oH?#MRS. JONES, WE D LIKE TO THANK YOU FOR YOUR CONTINUED SUPPORT... $B@Using and Disclosing Protected Health Information for Fundraising Taylor T. Pollock Stromberg Cleveland Crawford & Schmidt, P.C. B@/*&Fundraising and Health Care Operations'&"Fundraising is considered part of a covered entity s health care operations (i.e., uses and disclosures that may be made without patient authorization) However, fundraising activities must be conducted in accordance with specific HIPAA Privacy Rule requirements.$ General Rule on FundraisingA health care provider may itself use certain protected health information for fundraising purposes and may also disclose the PHI to (i) a business associate, or (ii) to an institutionally-related foundation for purposes of raising funds for the provider.A;DKey Terms:  Fundraising Purposes 2# Not defined in the Privacy Rule, but the the Preamble to the Privacy Rule states that  permissible fundraising activities include appeals for money, sponsorship of events, etc. Does not include sale of products of third parties(330+@Key Terms:  Business Associate <! PA  business associate is a person or entity that performs certain functions or activities on behalf of the health care provider involving the use or disclosure of PHI.+&`Key Terms:  Institutionally-Related Foundation :1   $An  institutionally-related foundation is a nonprofit 501(c)(3) entity that has an explicit linkage to the health care provider in the foundation s organizational documents. Does not include a charitable organization that raises funds for general charitable purposes.(^^%!=What type of PHI may be disclosed for fundraising activities?>=  Demographic information relating to a patient. Dates of treatment provided to a patient. \@2\1,JKey Terms:  Demographic Information 4&     Demographic Information is not defined in the Privacy Rule, but the Preamble to the Privacy Rule clarifies that it includes: name and address age gender insurance status  Demographic information does not include detail of the patient s illness or treatment!l-Y~,6,'BWho can benefit from the use or disclosure of PHI for fundraising?CB JThe health care provider s PHI may only be used to raise funds for the provider. The PHI may not be used to raise funds for related entities that may be served by the same foundation. Example: a university system cannot use its hospital s PHI to raise funds for academic department research.N@2l@2[Xe&"2Notice of Privacy Practices: Special Requirements&3 4The health care provider s Notice of Privacy Practices must inform the patient of the potential for the use or disclosure of PHI for fundraising purposes.'%:Notice of Privacy Practices: Special Requirements (cont.); The Notice of Privacy Practices must also contain a statement that the health care provider may contact the individual to raise funds for the provider.(#/Opting Out of Future Fundraising Communications4The health care provider must include in all fundraising materials a description of how the individual may  opt-out of future fundraising communications.)$7Opting Out of Future Fundraising Communications (cont.)08/ The health care provider must make reasonable efforts to ensure that individuals who opt-out of receiving future fundraising communications are not sent future solicitations.-(^Targeted Mailings /  Mining Patient DatabasesZHealth care providers cannot search patient databases to create lists of targeted patients (e.g., patients with a specific health status, patients who received a specific treatment, etc.) Targeted mailings to wealthy donors permissible? (i.e., comparing list of patients with a publicly-available database or listing of wealthy potential donors) 0[@2l.)#Continued Use of Existing DatabasesAll databases maintained or held by a health care provider after April 14, 2003 are governed by the Privacy Rule. Databases created before April 14, 2003 by a separate legal fundraising entity that is not itself a covered entity are not covered by the Privacy Rule. Note: all updates and future disclosures from the health care provider to the fundraising entity will be subject to the Privacy Rule and must be limited to demographic information and dates of treatment.8 @2@2 3.Applying the Fundraising RulesIn connection with raising funds for a new orthopedic wing, a hospital hires an outside marketing firm to plan and conduct the fundraising program. ?8HH4/&Applying the Fundraising Rules (cont.)jThe marketing firm asks the hospital for a list of all orthopedic surgery patients in the last 5 years. ? JhhHH>8&Applying the Fundraising Rules (cont.)vThe hospital sends the marketing firm names and addresses of all patients seen at the hospital in the last 5 years. ? RtsHH?9&Applying the Fundraising Rules (cont.)The hospital revises its Notice of Privacy Practices to inform patients that they can opt out of future fundraising communications. ? RHH@:&Applying the Fundraising Rules (cont.)"A year after the new orthopedic facility is completed, the hospital gives the list to a local physician who has developed a medical device designed to speed recovery from knee surgery. The physician would like to use the list to raise money to further develop and market his new device. ? N  HH50)Summary of HIPAA Fundraising Requirements*)xAlways OK with patient authorization. Absent authorization, may only use demographic information and dates of treatment. Use and disclosure OK to business associate or related foundation to raise funds for the health care provider. Must include possible fundraising use in Notice of Privacy Practices. Must give the patient the opportunity to opt-out of future communications.yyC<,Stromberg Cleveland Crawford & Schmidt, P.C.;4600 South Ulster Street, Suite 300 Denver, Colorado 80237   ` MMM` 3fff3` 3f333` 3` ŀQ̙` ff3f` 3ff33` !f` !f>?" dd@$?lFd@ " d 8 @8`  n?" dd@   @@``@n?" dd@  @@``PR    @ ` ` p>> y(  X  0`^  6 ^  6 L sC # `  0s`  0[`   0[`   0C   s *$ 0  T Click to edit Master title style! !    c $T% @`  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     S   s *% `  E* 2  s *&    G*(2  s *t&   G*(2Z  B޽h))? ? !f  Zestyh  0 (   F    Z   s * `   0 `   0 T sC  # `   0s`   0[`   0[`   0C  s * 7  T Click to edit Master title style! !  c $ԅ  `   W#Click to edit Master subtitle style$ $  s *4 `  E* 2  s *    G*(2  s * `  G*(2Z  B޽h))? ? !f 0 P\.(  \ \ 0 P    Y*  \ 0     [* d \ c $ ?   \ 0T  @  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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H  0޽h ? !f  @(  @l @ C T 7  l @ C     H @ 0޽h ? !fr$ܐ}'G- `߽A' i]# M%i3 %  ӫwA [3p9 O}Cm;p3ſyYC0" G <#H Oh+'08 px  < H T `ltHAPPY BIRTHDAY, MRS. JONESSCCS BIKC:\Program Files\Microsoft Office\Templates\Presentation Designs\ZESTY.POTSCCSogr76SMicrosoft PowerPointoso@`QX@IZF@`Z@y(ZFd G oM  U I& &&#TNPP0D # & TNPP &&TNPP    & "--- !- "----- !---&&--- !0------ ! ------ !P---&P|--- ! P---!--- ! [------ ! f---f--- ! q---&&&Gy& - && "Arial Black0- . 2 1 .--XP-- "Arial Black0- .2 HAPPY BIRTHDAY,(%##%%%#(%&%. .2 C MRS. JONES-&" ((##.--8-- "Arial Black0- .02 A HIPAA Marketing Guide for!$"!($. .'2 Health Care Providers$"."Arial Black0- .-2 ABarbara L. Crawford, Esq.     . .I2 oJ,Stromberg Cleveland Crawford & Schmidt, P.C.            .--"System-&TNPP & ՜.+,D՜.+,     r On-screen ShowYSCO%=1 ATimes New Roman Arial BlackMonotype SortsZestyHAPPY BIRTHDAY, MRS. JONESAm I Marketing?Am I Marketing?Am I Marketing?HIPAA Definition of Marketing The Rule(Exceptions to the Rule: Not Marketing,Exceptions to the Authorization Requirement+Can I Hire a Third Party to Market For Me?HIPAA Does not Apply to . . . OCR Guidance*Appointment Reminders Rx Refill Reminders*Appointment Reminders Rx Refill Reminders*Appointment Reminders Rx Refill RemindersDirect Mail MarketingDirect Mail MarketingDirect Mail MarketingDirect Mail MarketingDirect Mail MarketingDirect Mail Marketing NewslettersHealth BrochuresHealth BrochuresWellness ProgramsWellness ProgramsIn-House MarketingIn-House MarketingIn-House MarketingMagnets, Pens, Note Pads, Mugs"Magnets, Pens, Note Pads and MugsBirthday Cards Web Site Give Notice Caution! Caution! Caution! Caution! Caution!No Slide TitleBMRS. JONES, WED LIKE TO THANK YOU FOR YOUR CONTINUED SUPPORT... 'Fundraising and Health Care OperationsGeneral Rule on Fundraising#Key Terms: Fundraising Purposes!Key Terms: Business Associate1Key Terms: Institutionally-Related Foundation>What type of PHI may be disclosed for fundraising activities?&Key Terms: Demographic InformationCWho can benefit from the use or disclosure of PHI for fundraising?3Notice of Privacy Practices: Special Requirements;Notice of Privacy Practices: Special Requirements (cont.)0Opting Out of Future Fundraising Communications8Opting Out of Future Fundraising Communications (cont.)0Targeted Mailings / Mining Patient Databases$Continued Use of Existing DatabasesApplying the Fundraising Rules'Applying the Fundraising Rules (cont.)'Applying the Fundraising Rules (cont.)'Applying the Fundraising Rules (cont.)'Applying the Fundraising Rules (cont.)*Summary of HIPAA Fundraising Requirements-Stromberg Cleveland Crawford & Schmidt, P.C.  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