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Federal agencies and leaders are taking a multipronged approach to the opioid crisis.
Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.
The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.
The agency is taking the further step of limiting special enrollment periods for dual eligibles – those beneficiaries eligible for both Medicare and Medicaid – if they are identified as at-risk or potentially at-risk for prescription drug abuse under the programs. Beneficiaries maintain the right to challenge the determination.
Patients who are being treated for cancer-related pain and those receiving hospice/palliative/end-of-life care are exempted from the drug management programs.
The policies also update opioid prescription limits. CMS is calling on “all Part D sponsors to implement a hard safety edit to limit initial opioid prescription fills for the treatment of acute pain to no more than a 7-day supply,” according to the fact sheet.
For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”
There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.
Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.
The executive and legislative branches also are taking action.
President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.
For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.
When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.
The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.
The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.
On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.
In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.
The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.
Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.
Federal agencies and leaders are taking a multipronged approach to the opioid crisis.
Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.
The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.
The agency is taking the further step of limiting special enrollment periods for dual eligibles – those beneficiaries eligible for both Medicare and Medicaid – if they are identified as at-risk or potentially at-risk for prescription drug abuse under the programs. Beneficiaries maintain the right to challenge the determination.
Patients who are being treated for cancer-related pain and those receiving hospice/palliative/end-of-life care are exempted from the drug management programs.
The policies also update opioid prescription limits. CMS is calling on “all Part D sponsors to implement a hard safety edit to limit initial opioid prescription fills for the treatment of acute pain to no more than a 7-day supply,” according to the fact sheet.
For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”
There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.
Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.
The executive and legislative branches also are taking action.
President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.
For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.
When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.
The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.
The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.
On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.
In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.
The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.
Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.
Federal agencies and leaders are taking a multipronged approach to the opioid crisis.
Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.
The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.
The agency is taking the further step of limiting special enrollment periods for dual eligibles – those beneficiaries eligible for both Medicare and Medicaid – if they are identified as at-risk or potentially at-risk for prescription drug abuse under the programs. Beneficiaries maintain the right to challenge the determination.
Patients who are being treated for cancer-related pain and those receiving hospice/palliative/end-of-life care are exempted from the drug management programs.
The policies also update opioid prescription limits. CMS is calling on “all Part D sponsors to implement a hard safety edit to limit initial opioid prescription fills for the treatment of acute pain to no more than a 7-day supply,” according to the fact sheet.
For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”
There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.
Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.
The executive and legislative branches also are taking action.
President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.
For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.
When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.
The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.
The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.
On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.
In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.
The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.
Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.