Life Science Compliance Update

March 01, 2018

Ontario Open Payments: Proposed Rule for the Health Sector Payment Transparency Act

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Pharmaceutical and Device Payment Transparency is making its way to our Northern neighbor, Canada. On December 12, 2017, the Health Sector Payment Transparency Act, 2017 (HSPTA) received Royal Assent and became part of the Strengthening Quality and Accountability for Patients Act, 2017. The passage and enactment of the HSPTA allows Ontario to claim the title of the first Canadian province or territory to require the reporting of transfers of value between the pharmaceutical and medical device industry to health professionals and hospitals. The information must be reported to the Minister of Health and Long-Term Care for publication in an online database.

Recently, the Ontario government issued draft regulations that lay out how the transparency law is expected to work, including the way anyone will be able to search the name of a health charity or non-profit in the online database to access funding information.

HSPTA was enacted in an attempt to strengthen the transparency and increase patient trust in the health care system. Under the Act, payors (those that provide a transfer of value to a recipient in relation to “medical products”) will be required to report information about both direct and indirect transfers of value over a prescribed threshold. Transfers of value, as defined in the legislation, is overly broad and includes items such as meals and hospitality, travel expenses, financial grants, referral fees, items provided on a value-added basis in connection with a procurement, renovations or leasehold improvements, and fees paid for consulting on speaking events. Medical products is also broadly defined and includes drugs, medical devices, or other prescribed products used in the healthcare system.

Different from the Open Payments system we are used to in the United States, the definition of a payor includes:

  • a manufacturer that sells a medical product under its own name or trademark, or a name or mark that is owned or controlled by the manufacturer;
  • a person who fabricates, produces, processes, packages or labels a medical product on behalf of a manufacturer;
  • wholesalers, distributors, importers or brokers facilitating the sale of medical products;
  • pharmacies;
  • laboratories or specimen collection centers;
  • marketing firms and individuals performing activities to market or promote a medical product;
  • persons who organize continuing education events for members of a health profession on behalf of a manufacturer; and
  • any prescribed person or entity.

The proposal excludes the following transactions from the reporting requirements:

  • Those with a dollar value of less than $10;
  • Salaries and benefits provided as part of employment;
  • Medical products intended to be provided to patients free of charge;
  • Educational materials and items intended for use within a clinical setting;
  • Compensation for expert testimony or other services with respect to a legal proceeding; and
  • Benefits that are provided by a drug manufacturer in accordance with ordinary commercial terms as set out in the regulations under the Ontario Drug Benefit Act.

Also included in the proposed regulation is a correction process, which includes the following:

  • A payor is required to notify recipients in writing of the information it intends to report to the Minister about each transfer of value it provided to the recipient in the previous calendar year.
  • The payor must provide the information to the recipients no later than March 31st and provide a minimum of 45 days for the recipient to review the information before it is submitted to the ministry.
  • If the recipient wishes to have the information corrected, the recipient must ask the payor to correct the information and provide substantiating materials to support the request.
  • Once the payor receives a request to correct information, the payor must respond to the recipient with its decision within 30 days.
  • If the payor agrees with the recipient’s request to correct information, the payor must provide the corrected information to the ministry within 15 days.
  • If the payor denies the recipient’s request to correct information the payor must, within 15 days, submit to the Minister a request to mark the information as “disputed”.
  • The recipient or the payor can submit a request to the Minister to correct information up to 12 months after the information has been published.

Both payors and recipients are required to retain all records of any qualifying transactions. Payors would then have to report transfers of value to the Minister of Health and Long-Term Care no later than June 30th of the following calendar year via an electronic data collection platform created and maintained by the Minister. The ministry is proposing that the Act and regulation would come into force on January 1, 2019, with the first annual reporting to the ministry from payors required by June 30, 2020.

However, while both parties to any transfer of value are required to retain records, the law places the burden for reporting the payments on the medical-device makers, not the recipients. Durhane Wong-Rieger, the president of the Canadian Organization for Rare Disorders (CORD,) a national network of patient-advocacy groups, said she has "no problem" with revealing the specifics of CORD's funding, as long as the administrative burden of reporting the information is not placed on small non-profits such as those she represents.  The inclusion of continuing medical events is unique to Canada as there is still no viable rigorous self-regulation for CME in Canada as there is in the United States.

The regulations are open for public comment until April 5, 2018. You can submit comments here.

February 28, 2018

Checking In: Are Your State Legislators Concentrating on Drug-Price Transparency?

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Price transparency is such a hot topic today that it is oftentimes hard to keep up with the different state legislatures that are reviewing different ideas on price transparency and price gouging when it comes to the pharmaceutical industry. Below are some of the states and the bills that are pending before the legislatures.

Colorado

The state of Colorado has two bills pending – one in the House and one in the Senate – that each focus on different aspects of pricing. HB18-1009, the Diabetes Drug Pricing Transparency Act of 2018, has been introduced in the House and assigned to the Health, Insurance, and Environment subcommittee. The bill would require drug manufacturers and pharmacy benefit managers to submit annual reports to the state board regarding drugs used to treat diabetes that are subject to price increases of certain percentages. The state board would have the ability to impose penalties on drug manufacturers or pharmacy benefit managers who do not comply with the reporting requirements. Nonprofit organizations that advocate on behalf of patients with diabetes or funding diabetes medical research that receive contributions from certain diabetes drug manufacturers must annually report those contributions. In the Senate, SB18-152, Prohibit Price Gouging on Prescription Drugs, has been indefinitely postponed by the Senate Committee on State, Veterans & Military Affairs. The bill would have: (1) prohibited a pharmaceutical manufacturer or wholesaler from price gouging on sales of essential off-patent or generic drugs; (2) made the practice of price gouging a deceptive trade practice under the “Colorado Consumer Protection Act;” and (3) required the state board of pharmacy and executive director of the department of health care policy and financing to report suspected price gouging to the attorney general, who is then authorized to seek subpoenas and file lawsuits with the appropriate district courts.

Hawaii

In Hawaii, there is one bill pending that focuses on price transparency, HB2668, “Relating to Prescription Drugs.” The bill would require the Department of Health to compile, analyze, and report certain information on essential prescription drugs marketed in Hawaii for the treatment of diabetes. It would also require certain entities to provide information that justifies the cost increases in drug products. The bill has been referred to HHS, CPC, and FIN for further deliberations.  

Illinois

In Illinois, HB4900, has been introduced and is currently in the Human Services Committee. The legislation creates the Illinois Generic Drug Pricing Fairness Act, which would provide in part that manufacturers and wholesale drug distributors shall not engage in price gouging in the sale of an essential off-patent or generic drug. It would also allow the Director of Healthcare and Family Services or Director of Central Management Services to notify the Attorney General of any increase in the price of any essential off-patent or generic drug under the Medical Assistance Program under the Illinois Public Aid Code or a State health plan that amounts to price gouging.

Maine

The Maine Legislature has introduced bills LD1406 and SP 484, An Act to Promote Prescription Drug Price Transparency, in each of its chambers. The bills are currently in committee.

Maryland

The state of Maryland has three separate bills in motion right now that all deal with price transparency. The first bill, HB1194, Health – Drug Cost Review Commission, would establish the Drug Cost Review Commission; provide for the purpose and the membership of the Commission; provide for the election of the chair of the Commission and requiring the chair to hire certain staff; and requiring that the staff of the Commission receive a certain salary. This bill is cross-filed with SB1023, a Senate bill with the same ideal outcome.

SB0201, Public Health – Prescription Drug Manufacturers – Sales to Wholesale Distributors, would require a prescription drug or device manufacturer to submit certain average sales prices to the Maryland Department of Health for each calendar quarter within 30 days after the end of the quarter and require the Department to make the average sales price submitted by a manufacturer available on the Department's website not later than 10 days after it receives the average sales prices.

Michigan

In Michigan, the Senate has introduced SB0825, Health; pharmaceuticals; annual report on the costs associated with prescription drugs; require manufacturers of prescription drugs to file in certain circumstances. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding secs. 17748e & 17748f. The bill would require an annual report on the costs associated with prescription drugs and would require manufacturers of prescription drugs to file in certain circumstances.

Mississippi

Mississippi legislators tried and failed to pass two bills relating to price transparency. HB 137, Prohibition on Price Gouging for Essential Drugs Act, would have created such an act and defined price gouging and then prohibited manufacturers and wholesale distributors from engaging in price gouging. HB 784, Prescription drugs; require Attorney General to compile certain lists of those essential for treating diabetes and costs of, would have required the Attorney General to compile certain lists of prescription drugs that are essential for treating diabetes and the wholesale acquisition cost of each such drug on the list and those drugs on the list that have been subject to an increase in WAC by a certain percentage during the preceding calendar year or years.

Nebraska

In Nebraska, legislators are currently considering LB862, Adopt the Prescription Drug Cost Transparency Act.  This bill would require notice and disclose of the information relating to the cost and pricing of prescription drugs in order to provide accountability to the state for prescription drug pricing; allow a manufacturer of a prescription drug to voluntarily make pricing decisions regarding the prescription drug, including any price increases; and permit both public and private purchasers of prescription drugs to negotiate discounts and rebates for prescription drugs consistent with state and federal law.

New Hampshire

In New Hampshire, legislators are currently looking at HB1418, Relative to Transparency and Cost Control of Pharmaceutical Drug Prices. This bill would require the commissioner of the department of health and human services, in consultation with the insurance commissioner, to develop a list of certain critical prescription drugs for purposes of cost control and transparency.  Under this bill, the commissioner shall make an annual report on prescription drugs and their role in overall health care spending in the New Hampshire.

New Jersey

In New Jersey, there are currently three bills pending before the legislature. A583, introduced in the Assembly, and S983, introduced in the Senate, would establish the Prescription Drug Review Commission and require that production costs be reported for certain prescription drugs. S1590, introduced in the Senate, would prohibit excessive increases in prices that are charged for essential off-patent and generic prescription drugs and biological products.

New York

In New York, there are three bills pending before the two houses of the legislature. S02544 (in the Senate) and A05733 (in the Assembly), are entitled, “Prohibits price gouging by manufacturers of prescription drugs.” These bills would amend the public health law and general business law, in relation to price gouging on prescription drugs. Also introduced in the Assembly is A02939, Relates to prescription drug cost transparency. This bill would make information available to the public about the cost and utilization of pharmaceutical drugs. To fulfill this goal, the legislature finds that there should be annual reporting of drug costs and use that would be of use by policymakers, government agencies and others to understand pharmacy cost trends.

Oregon

In Oregon, HB 4005 A, Relating to the price of prescription drugs, would require prescription drug manufacturers to report annually information to Department of Consumer and Business Services regarding prices of prescription drugs and costs associated with developing and marketing prescription drugs.

Rhode Island

In Rhode Island, there are two bills pending with the House. H7004, would direct the state board of pharmacy, in collaboration with the department of health, to annually identify up to fifteen (15) prescription drugs on which the state spends significant health care dollars due to increases in costs. This list would be provided to the attorney general's office, and the attorney general‘s office would require the drug's manufacturers to submit relevant information and documentation to justify these cost increases. The act would also direct the department of health to use the same dispensing fee in its reimbursement formula for 340B prescription drugs as it uses to pay for non-340B prescription drugs under the Medicaid, program, and to provide information to the general assembly and the governor about these programs. The act would also establish an advisory commission on out-of-pocket prescription drug costs who would study these costs and make reports and recommendations to the governor and the general assembly.

H7042, on the other hand, would direct the state board of pharmacy, in collaboration with the Rhode Island department of health, to annually develop a list of critical prescription drugs for which there is a substantial public interest in understanding the development of the drugs' price. The act would also authorize the board to obtain certain information from manufacturers of the critical prescription drugs. The act would also allow the commission to set the maximum allowable price that a manufacturer can charge for a prescription drug if the commission determines that the cost of a prescription drug is significantly high.

Both bills are currently in committee.

South Carolina

In South Carolina, H4490 has been introduced, which would require manufacturers of diabetes prescription drugs to provide certain cost information to the department of health and environmental control, and for the department of health and environmental control to post the reported information on its publicly accessible website.

Utah

In Utah, HB0163 has been introduced, which would create a program and reporting requirements relating to prescription drugs and the importation of prescription drugs, including specific instructions for the Department of Health and drug manufacturers.

Virginia

In Virginia, HB 1436, “Prescription drugs; price transparency,” has been introduced and is in Committee. The bill requires every manufacturer of a prescription drug that is made available in the Commonwealth and has a wholesale acquisition price of $10,000 or more for a single course of treatment to report to the State Health Commissioner no later than July 1 of each year information related to the cost of developing, manufacturing, and marketing the prescription drug; any changes in the average wholesale price and average wholesale acquisition cost of the prescription drug; the amount of profits derived from sale of the prescription drug; and the total amount of financial assistance provided to consumers of the prescription drug. The bill adds this reported data to the list of reports that the Commissioner causes to be published on a website maintained by a nonprofit entity with which the Commissioner has entered into a contract for such purpose and requires the Commissioner to annually report on such information, in aggregate form, to the Chairmen of the House Committees on Appropriations and on Health, Welfare and Institutions and the Senate Committees on Finance and on Education and Health.

Vermont

In Vermont, there are two bills relating to price transparency and gouging pending. H713, An act relating to prohibiting price gouging for essential off-patent or generic drugs, which proposes to prohibit prescription drug manufacturers and wholesale distributors from engaging in price gouging in the sale of essential off-patent or generic drugs. S175, An act relating to the wholesale importation of prescription drugs into Vermont, bulk purchasing, and the impact of prescription drug costs on health insurance premiums, proposes to establish a program to allow wholesale importation of prescription drugs from Canada into Vermont. It would create a bulk purchasing program for prescription drugs through the Department of Health and require prescription drug manufacturers to provide notice before introducing new, high-cost drugs to the market. The bill would also require health insurers to provide information about the impact of prescription drug spending on premium rates as part of the Green Mountain Care Board’s rate review process and direct the Board to publish an annual report demonstrating the overall impact of drug costs on health insurance premiums.

Washington

In Washington, there are seven bills pending (three bills with components in the House and Senate, with one extra bill in the Senate). SB5401 and HB1541 both entitled, “Addressing prescription drug cost transparency,” would: (1) require the office of financial management to use a competitive procurement process to select a data organization to collect, verify, and summarize the prescription drug pricing data provided by issuers and manufacturers; (2) require an issuer to submit certain prescription drug cost and utilization data to the data organization for the previous calendar year; (3) require a covered manufacturer to report certain data for each covered drug to the data organization; and (4) require the data organization to compile the data submitted by issuers and manufacturers, prepare an annual report for the public and the legislature summarizing the data, and provide the report to the office of financial management and the joint select committee on health care oversight.

HB 2299 and SB 6032, “Making supplemental operating appropriations,” both make 2018 supplemental operating appropriations.

HB2556 and SB5995, “Protecting consumers and purchasers from excessive increases in generic prescription drug prices,” would both require the state institute for public policy to: (1) Review and study policy recommendations for protecting consumers against excessive prescription drug price increases, including a two-year look back of increases where the wholesale acquisition cost increased by a percentage equal to or greater than one hundred percent at any one time or in the aggregate in any twelve-month period; and (2) Report the findings to the legislature.

SB 5586-S2 would provide notice and disclosure of information regarding the cost and pricing of prescription drugs to provide accountability to the state for prescription drug pricing.

February 20, 2018

12th International Pharmaceutical and Medical Device Compliance Congress

IPC-2018-Blast-Header

This May, the 12th International Pharmaceutical and Medical Device Compliance Congress will take place in Vienna, Austria, at the Hotel Savoyen, from the 14th through the 16th.

Keynote speakers for this conference include: Nicola Bedlington, Secretary General, European Patients Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium; Jan Oliver Huber, General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria; Camilla de Silva, Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK; and George “Ren” McEachern, CFE, CAMS, Managing Director, Exiger, Former Supervisory Special Agent, International Corruption Squad, US Federal Bureau of Investigation, Washington, D.C.

Co-Chairs of the event include: Dante Beccaria (Sanofi, Paris, France); Stephen Nguyn Duc (Rungis, France); Suzanne Durdevic, LLM (Boston Scientific International, Paris, France); Dominique Laymand, Esq. (Ipsen, Paris, France); and Roeland Van Aelst (Johnson & Johnson, Brussels, Belgium).

The event was just announced on February 8, 2018, and a call for proposals has been sent out. If you are interested in submitting a proposal, you may do so here.

To register for this conference, click here, or call (800) 503-8171. Standard conference registration is €1,795 (est. $2,198.05) through March 16, 2018; €1,995 (est. $2,442.96) through Friday, April 13, 2018; and €2,195 (est. $2,687.87) after Friday, April 13, 2018.

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