Medicare Prescription Drug Abuse Prevention Act of 2016

“(5) Drug management program for at-risk beneficiaries

“(A) Authority to establish—A PDP sponsor may establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B), the PDP sponsor may, in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary’s access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by a prescriber (or prescribers) selected under subparagraph (D), and dispensed for such beneficiary by a pharmacy (or pharmacies) selected under such subparagraph.

“(B) Requirement for notices

“(i) In general—A PDP sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor—

“(I) provides to the beneficiary an initial notice described in clause (ii) and a second notice described in clause (iii); and

“(II) verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse, as described in subparagraph (C)(iv).

“(ii) Initial notice—An initial written notice described in this clause is a notice that provides to the beneficiary—

“(I) notice that the PDP sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse;

“(II) information, when possible, describing State and Federal public health resources that are designed to address prescription drug abuse to which the beneficiary may have access, including substance use disorder treatment services, addiction treatment services, mental health services, and other counseling services;

“(III) a request for the beneficiary to submit to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause (iii)(I);

“(IV) an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse, including an explanation of the drug management program established by the PDP sponsor pursuant to subparagraph (A);

“(V) clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the PDP sponsor;

“(VI) contact information for other organizations that can provide the beneficiary with information regarding drug management program for at-risk beneficiaries (similar to the information provided by the Secretary in other standardized notices to part D eligible individuals enrolled in prescription drug plans under this part); and

“(VII) notice that the beneficiary has a right to an appeal pursuant to subparagraph (E).

“(iii) Second notice—A second written notice described in this clause is a notice that provides to the beneficiary notice—

“(I) that the PDP sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse;

“(II) that such beneficiary has been sent, or informed of, such identification in the initial notice and is now subject to the requirements of the drug management program for at- risk beneficiaries established by such PDP sponsor for such plan;

“(III) of the prescriber and pharmacy selected for such individual under subparagraph (D);

“(IV) of, and information about, the right of the beneficiary to a reconsideration and an appeal under subsection (h) of such identification and the prescribers and pharmacies selected;

“(V) that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and

“(VI) that includes clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (V).

“(iv) Timing of notices

“(I) In general—Subject to subclause (II), a second written notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 30 days after an initial notice described in clause (ii) is provided to the beneficiary.

“(II) Exception—In the case that the PDP sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking by the Secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the PDP sponsor to provide a second notice described in clause (iii) to the beneficiary on a date that is earlier than the date described in subclause (II), the PDP sponsor may provide such second notice on such earlier date.

“(III) Form of notice—The written notices under clauses (ii) and (iii) shall be in a format determined appropriate by the Secretary, taking into account beneficiary preferences.

“(C) At-risk beneficiary for prescription drug abuse

“(i) In general—For purposes of this paragraph, the term “at-risk beneficiary for prescription drug abuse” means a part D eligible individual who is not an exempted individual described in clause (ii) and—

“(I) who is identified through criteria developed by the Secretary in consultation with PDP sponsors and other stakeholders described in section 2(g)(2)(A) of the Medicare Prescription Drug Abuse Prevention Act of 2016 based on clinical factors indicating misuse or abuse of prescription drugs described in subparagraph (G), including dosage, quantity, duration of use, number of and reasonable access to prescribers, and number of and reasonable access to pharmacies used to obtain such drug; or

“(II) with respect to whom the PDP sponsor of a prescription drug plan, upon enrolling such individual in such plan, received notice from the Secretary that such individual was identified under this paragraph to be an at- risk beneficiary for prescription drug abuse under a prescription drug plan in which such individual was previously enrolled and such identification has not been terminated under subparagraph (F).

“(ii) Exempted individual described—An exempted individual described in this clause is an individual who—

“(I) receives hospice care under this title;

“(II) resides in a long-term care facility, a facility described in section 1905(d), or other facility under contract with a single pharmacy; or

“(III) the Secretary elects to treat as an exempted individual for purposes of clause (i).

“(iii) Program size—The Secretary shall establish policies, including the criteria developed under clause (i)(I) and the exemptions under clause (ii)(III), to ensure that the population of enrollees in a drug management program for at-risk beneficiaries operated by a prescription drug plan can be effectively managed by such plans.

“(iv) Clinical contact—With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by a PDP sponsor, the PDP sponsor shall contact the beneficiary’s providers who have prescribed frequently abused drugs regarding whether prescribed medications are appropriate for such beneficiary’s medical conditions.

“(D) Selection of prescribers

“(i) In general—With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor, a PDP sponsor shall, based on the preferences submitted to the PDP sponsor by the beneficiary pursuant to clauses (ii)(III) and (iii)(V) of subparagraph (B) if applicable, select—

“(I) one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, individual who is authorized to prescribe frequently abused drugs (referred to in this paragraph as a “prescriber”) who may write prescriptions for such drugs for such beneficiary; and

“(II) one, or, if the PDP sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause (ii), more than one, pharmacy that may dispense such drugs to such beneficiary.

“(ii) Reasonable access—In making the selection under this subparagraph, a PDP sponsor shall ensure, taking into account geographic location, beneficiary preference, impact on cost-sharing, and reasonable travel time, that the beneficiary continues to have reasonable access to drugs described in subparagraph (G), including—

“(I) for individuals with multiple residences; and

“(II) in the case of natural disasters and similar emergency situations.

“(iii) Beneficiary preferences

“(I) In general—If an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor select in response to a notice under subparagraph (B), the PDP sponsor shall—

“(aa) review such preferences;

“(bb) select or change the selection of a prescriber or pharmacy for the beneficiary based on such preferences; and

“(cc) inform the beneficiary of such selection or change of selection.

“(II) Exception—In the case that the PDP sponsor determines that a change to the selection of a prescriber or pharmacy under item (bb) by the PDP sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary, the PDP sponsor may change the selection of a prescriber or pharmacy for the beneficiary. If the PDP sponsor changes the selection pursuant to the preceding sentence, the PDP sponsor shall provide the beneficiary with—

“(aa) at least 30 days written notice of the change of selection; and

“(bb) a rationale for the change.

“(III) Timing—An at-risk beneficiary for prescription drug abuse may choose to express their prescriber and pharmacy preference and communicate such preference to their PDP sponsor at any date while enrolled in the program, including after a second notice under subparagraph (B)(iii) has been provided.

“(iv) Confirmation—Before selecting a prescriber or pharmacy under this subparagraph, a PDP sponsor must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in the drug management program for at-risk beneficiaries and that the prescriber and pharmacy has been selected as the beneficiary’s designated prescriber and pharmacy.

“(E) Appeals—The identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph, a coverage determination made under a drug management program for at-risk beneficiaries, and the selection of a prescriber or pharmacy under subparagraph (D) with respect to such individual shall be subject to an expedited reconsideration and appeal pursuant to subsection (h).

“(F) Termination of identification

“(i) In general—The Secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier of—

“(I) the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription drug abuse described in subparagraph (C)(i); or

“(II) the end of such maximum period of identification as the Secretary may specify.

“(ii) Rule of construction—Nothing in clause (i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph (C)(i) after such termination on the basis of additional information on drug use occurring after the date of notice of such termination.

“(G) Frequently abused drug—For purposes of this subsection, the term “frequently abused drug” means a drug that is determined by the Secretary to be frequently abused or diverted and that is—

“(i) a Controlled Drug Substance in Schedule CII; or

“(ii) within the same class or category of drugs as a Controlled Drug Substance in Schedule CII, as determined through notice and comment rulemaking.

“(H) Data disclosure

“(i) Data on decision to impose limitation—In the case of an at-risk beneficiary for prescription drug abuse (or an individual who is a potentially at-risk beneficiary for prescription drug abuse) whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, the Secretary shall establish rules and procedures to require such PDP sponsor to disclose data, including necessary individually identifiable health information, about the decision to impose such limitations and the limitations imposed by the PDP sponsor under this part.

“(ii) Data to reduce fraud, abuse, and waste—The Secretary shall establish rules and procedures to require PDP sponsors operating a drug management program for at-risk beneficiaries under this paragraph to provide the Secretary with such data as the Secretary determines appropriate for purposes of identifying patterns of prescription drug utilization for plan enrollees that are outside normal patterns and that may indicate fraudulent, medically unnecessary, or unsafe use.

“(I) Sharing of information for subsequent plan enrollments—The Secretary shall establish procedures under which PDP sponsors who offer prescription drug plans shall share information with respect to individuals who are at-risk beneficiaries for prescription drug abuse (or individuals who are potentially at-risk beneficiaries for prescription drug abuse) and enrolled in a prescription drug plan and who subsequently disenroll from such plan and enroll in another prescription drug plan offered by another PDP sponsor.

“(J) Privacy issues—Prior to the implementation of the rules and procedures under this paragraph, the Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of (42 U.S.C. 1320d–2 note), related to the sharing of data under subparagraphs (H) and (I) by PDP sponsors. Such clarification shall provide that the sharing of such data shall be considered to be protected health information in accordance with the requirements of the regulations promulgated pursuant to such section 264(c).

“(K) Education—The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, including education—

“(i) provided through the improper payment outreach and education program described in section 1874A(h); and

“(ii) through current education efforts (such as State health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b–3 note)) and materials directed toward such enrollees.

“(L) CMS compliance review—The Secretary shall ensure that existing plan sponsor compliance reviews and audit processes include the drug management programs for at-risk beneficiaries under this paragraph, including appeals processes under such programs.”

“(v) The drug management program for at-risk beneficiaries under subsection (c)(5).”